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FDA grants emergency use authorization to Lilly’s antibody COVID-19 therapy
The monoclonal antibody therapy has emergency authorization for treating patients who have tested positive for SARS-CoV-2 infection and who are considered to be at high risk for progression to severe COVID-19 or hospitalization. To be eligible for treatment with bamlanivimab, patients must be at least 12 years of age and weigh at least 40 kg (approximately 88 lb). The agency notes that this includes patients aged 65 years and older or people with certain chronic conditions.
Bamlanivimab is not authorized for use in patients who are hospitalized or who require oxygen therapy because of COVID-19. The FDA’s action comes less than 2 weeks after Eli Lilly halted the ACTIV-3 study of the therapy for severe, hospitalized COVID-19 patients after evidence showed that adding the antibody therapy to standard care did not improve outcomes over standard care alone for patients with advanced COVID-19.
The government contract with Eli Lilly involves the purchase of 300,000 doses through December, with the option to procure another 650,000 doses through June 2021.
Because of Operation Warp Speed, “we have supplies to distribute now. Product distribution will begin this week,” US Health & Human Services (HHS) Secretary Alex Azar said at a news conference today.
“We talked about building the bridge to safe and effective vaccines” for COVID-19, Azar added. “With this therapeutic, the bridge is taking shape.”
Bamlanivimab 700 mg will be administered as a 1-hour infusion followed by a 1-hour observation period for detecting any infusion-related side effects. The authorized dose is 700 mg, which was on the lower end of the dose range evaluated in studies.
During the press conference, a reporter asked whether the lower dose was chosen in order that more doses of the antibody could be made available. “The lower dose is a rational choice in this situation because we don’t want to give more of a drug than you need,” said Janet Woodcock, MD, the therapeutics lead for Operation Warp Speed. “I think we could probably go lower.”
Bamlanivimab works by attaching to the virus and blocking its entry into the cells and possibly by helping the patients’ immune system clear the virus, said Woodcock, who is also director of the FDA’s Center for Drug Evaluation and Research.
“The goal is to treat high-risk people as soon as possible after they show symptoms and are diagnosed,” she added.
Infusions an initial challenge?
There could be some logistic challenges at first because the antibody is administered via infusion. “We expect there will initially be a challenge in administering ... these infusions and setting up infusion centers,” Woodcock said.
Outpatient intravenous infusions are normally performed at infusion centers for patients with cancer and immune disorders, she noted. “You really don’t want them mixing with people who have COVID-19 disease, so we will need to set up separate sites.”
Bamlanivimab will be provided free of cost to patients, Azar said. Patients should be aware that coinsurance may be required for the infusion.
“Fair and equitable” distribution planned
During phase 1 of distribution, the agent will first be allocated to hospitals and hospital-affiliated locations only, John Redd, MD, MPH, chief medical officer, Office of the Assistant Secretary for Preparedness and Response at HHS, said at the press conference.
During phase 2, “there will be expanded distribution to outpatient sites,” he said. In an effort to keep the process transparent, a new website features the latest updates on the distribution of bamlanivimab.
Allocation will be based on two factors: the number of new cases reported in a state or territory in the prior 7 days, and rates of COVID-19 hospitalization during the same period.
Asked why the government would determine distribution of the antibody on the basis of the number of hospitalized patients when the indication includes prevention of admission, Woodcock replied that hospitalization is a surrogate measure that can reflect risk factors in a particular state population, such as obesity, diabetes, or the proportion of older people.
Furthermore, the confirmed cases are a “leading indicator,” she said, that can help identify a steep rise in COVID-19 cases that could indicate more hospitalizations are likely soon. “We don’t want to miss that.”
Data underlying the EUA decision
A decrease in hospitalizations or emergency department visits within 28 days of treatment in preclinical studies was “the most important evidence that bamlanivimab may be effective,” the agency noted in the press release announcing the EUA. Among patients at high risk for progression, 3% required such interventions, compared with 10% of placebo-treated patients.
Potential side effects of bamlanivimab include anaphylaxis, infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.
“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate,” FDA Commissioner Stephen M. Hahn, MD, said in the news release.
Healthcare providers can download a detailed FDA fact sheet on the EUA for bamlanivimab, which includes dosing instructions.
This article first appeared on Medscape.com.
The monoclonal antibody therapy has emergency authorization for treating patients who have tested positive for SARS-CoV-2 infection and who are considered to be at high risk for progression to severe COVID-19 or hospitalization. To be eligible for treatment with bamlanivimab, patients must be at least 12 years of age and weigh at least 40 kg (approximately 88 lb). The agency notes that this includes patients aged 65 years and older or people with certain chronic conditions.
Bamlanivimab is not authorized for use in patients who are hospitalized or who require oxygen therapy because of COVID-19. The FDA’s action comes less than 2 weeks after Eli Lilly halted the ACTIV-3 study of the therapy for severe, hospitalized COVID-19 patients after evidence showed that adding the antibody therapy to standard care did not improve outcomes over standard care alone for patients with advanced COVID-19.
The government contract with Eli Lilly involves the purchase of 300,000 doses through December, with the option to procure another 650,000 doses through June 2021.
Because of Operation Warp Speed, “we have supplies to distribute now. Product distribution will begin this week,” US Health & Human Services (HHS) Secretary Alex Azar said at a news conference today.
“We talked about building the bridge to safe and effective vaccines” for COVID-19, Azar added. “With this therapeutic, the bridge is taking shape.”
Bamlanivimab 700 mg will be administered as a 1-hour infusion followed by a 1-hour observation period for detecting any infusion-related side effects. The authorized dose is 700 mg, which was on the lower end of the dose range evaluated in studies.
During the press conference, a reporter asked whether the lower dose was chosen in order that more doses of the antibody could be made available. “The lower dose is a rational choice in this situation because we don’t want to give more of a drug than you need,” said Janet Woodcock, MD, the therapeutics lead for Operation Warp Speed. “I think we could probably go lower.”
Bamlanivimab works by attaching to the virus and blocking its entry into the cells and possibly by helping the patients’ immune system clear the virus, said Woodcock, who is also director of the FDA’s Center for Drug Evaluation and Research.
“The goal is to treat high-risk people as soon as possible after they show symptoms and are diagnosed,” she added.
Infusions an initial challenge?
There could be some logistic challenges at first because the antibody is administered via infusion. “We expect there will initially be a challenge in administering ... these infusions and setting up infusion centers,” Woodcock said.
Outpatient intravenous infusions are normally performed at infusion centers for patients with cancer and immune disorders, she noted. “You really don’t want them mixing with people who have COVID-19 disease, so we will need to set up separate sites.”
Bamlanivimab will be provided free of cost to patients, Azar said. Patients should be aware that coinsurance may be required for the infusion.
“Fair and equitable” distribution planned
During phase 1 of distribution, the agent will first be allocated to hospitals and hospital-affiliated locations only, John Redd, MD, MPH, chief medical officer, Office of the Assistant Secretary for Preparedness and Response at HHS, said at the press conference.
During phase 2, “there will be expanded distribution to outpatient sites,” he said. In an effort to keep the process transparent, a new website features the latest updates on the distribution of bamlanivimab.
Allocation will be based on two factors: the number of new cases reported in a state or territory in the prior 7 days, and rates of COVID-19 hospitalization during the same period.
Asked why the government would determine distribution of the antibody on the basis of the number of hospitalized patients when the indication includes prevention of admission, Woodcock replied that hospitalization is a surrogate measure that can reflect risk factors in a particular state population, such as obesity, diabetes, or the proportion of older people.
Furthermore, the confirmed cases are a “leading indicator,” she said, that can help identify a steep rise in COVID-19 cases that could indicate more hospitalizations are likely soon. “We don’t want to miss that.”
Data underlying the EUA decision
A decrease in hospitalizations or emergency department visits within 28 days of treatment in preclinical studies was “the most important evidence that bamlanivimab may be effective,” the agency noted in the press release announcing the EUA. Among patients at high risk for progression, 3% required such interventions, compared with 10% of placebo-treated patients.
Potential side effects of bamlanivimab include anaphylaxis, infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.
“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate,” FDA Commissioner Stephen M. Hahn, MD, said in the news release.
Healthcare providers can download a detailed FDA fact sheet on the EUA for bamlanivimab, which includes dosing instructions.
This article first appeared on Medscape.com.
The monoclonal antibody therapy has emergency authorization for treating patients who have tested positive for SARS-CoV-2 infection and who are considered to be at high risk for progression to severe COVID-19 or hospitalization. To be eligible for treatment with bamlanivimab, patients must be at least 12 years of age and weigh at least 40 kg (approximately 88 lb). The agency notes that this includes patients aged 65 years and older or people with certain chronic conditions.
Bamlanivimab is not authorized for use in patients who are hospitalized or who require oxygen therapy because of COVID-19. The FDA’s action comes less than 2 weeks after Eli Lilly halted the ACTIV-3 study of the therapy for severe, hospitalized COVID-19 patients after evidence showed that adding the antibody therapy to standard care did not improve outcomes over standard care alone for patients with advanced COVID-19.
The government contract with Eli Lilly involves the purchase of 300,000 doses through December, with the option to procure another 650,000 doses through June 2021.
Because of Operation Warp Speed, “we have supplies to distribute now. Product distribution will begin this week,” US Health & Human Services (HHS) Secretary Alex Azar said at a news conference today.
“We talked about building the bridge to safe and effective vaccines” for COVID-19, Azar added. “With this therapeutic, the bridge is taking shape.”
Bamlanivimab 700 mg will be administered as a 1-hour infusion followed by a 1-hour observation period for detecting any infusion-related side effects. The authorized dose is 700 mg, which was on the lower end of the dose range evaluated in studies.
During the press conference, a reporter asked whether the lower dose was chosen in order that more doses of the antibody could be made available. “The lower dose is a rational choice in this situation because we don’t want to give more of a drug than you need,” said Janet Woodcock, MD, the therapeutics lead for Operation Warp Speed. “I think we could probably go lower.”
Bamlanivimab works by attaching to the virus and blocking its entry into the cells and possibly by helping the patients’ immune system clear the virus, said Woodcock, who is also director of the FDA’s Center for Drug Evaluation and Research.
“The goal is to treat high-risk people as soon as possible after they show symptoms and are diagnosed,” she added.
Infusions an initial challenge?
There could be some logistic challenges at first because the antibody is administered via infusion. “We expect there will initially be a challenge in administering ... these infusions and setting up infusion centers,” Woodcock said.
Outpatient intravenous infusions are normally performed at infusion centers for patients with cancer and immune disorders, she noted. “You really don’t want them mixing with people who have COVID-19 disease, so we will need to set up separate sites.”
Bamlanivimab will be provided free of cost to patients, Azar said. Patients should be aware that coinsurance may be required for the infusion.
“Fair and equitable” distribution planned
During phase 1 of distribution, the agent will first be allocated to hospitals and hospital-affiliated locations only, John Redd, MD, MPH, chief medical officer, Office of the Assistant Secretary for Preparedness and Response at HHS, said at the press conference.
During phase 2, “there will be expanded distribution to outpatient sites,” he said. In an effort to keep the process transparent, a new website features the latest updates on the distribution of bamlanivimab.
Allocation will be based on two factors: the number of new cases reported in a state or territory in the prior 7 days, and rates of COVID-19 hospitalization during the same period.
Asked why the government would determine distribution of the antibody on the basis of the number of hospitalized patients when the indication includes prevention of admission, Woodcock replied that hospitalization is a surrogate measure that can reflect risk factors in a particular state population, such as obesity, diabetes, or the proportion of older people.
Furthermore, the confirmed cases are a “leading indicator,” she said, that can help identify a steep rise in COVID-19 cases that could indicate more hospitalizations are likely soon. “We don’t want to miss that.”
Data underlying the EUA decision
A decrease in hospitalizations or emergency department visits within 28 days of treatment in preclinical studies was “the most important evidence that bamlanivimab may be effective,” the agency noted in the press release announcing the EUA. Among patients at high risk for progression, 3% required such interventions, compared with 10% of placebo-treated patients.
Potential side effects of bamlanivimab include anaphylaxis, infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting.
“As illustrated by today’s action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments and providing sick patients timely access to new therapies where appropriate,” FDA Commissioner Stephen M. Hahn, MD, said in the news release.
Healthcare providers can download a detailed FDA fact sheet on the EUA for bamlanivimab, which includes dosing instructions.
This article first appeared on Medscape.com.
Triple combination therapy for cystic fibrosis linked to plunging hospitalizations
.
The triple combination therapy elexacaftor/tezacaftor/ivacaftor was associated with a near elimination of hospital stays in one hospital in Oregon, according to a new report. The hospital savings still weren’t nearly enough to pay for the cost of therapy, but the study underscores what many institutions have observed and adds a new layer to the view of quality of life improvements that the new therapy brings.
“After we started prescribing it, we noticed pretty quickly that hospitalizations appeared to be declining after patients started triple combination therapy, and we were hearing [similar reports] from other centers as well. We wanted to quantify this,” Eric C. Walter, MD, a pulmonologist at the Kaiser Permanente Cystic Fibrosis Clinic in Portland, Ore., said during a presentation of the results at the virtual North American Cystic Fibrosis Conference.
“We’re seeing that across the board in real practice, the number of cystic fibrosis patients that have to be hospitalized since starting this triple combination has gone down,” Robert Giusti, MD, said in an interview. “When they’ve had pulmonary exacerbations in the past, it was frequently because they failed outpatient antibiotics, but I think with triple combination therapy, if they do get sick, the likelihood is they will respond to oral antibiotics, so they may not need that prolonged IV course in the hospital.” Dr. Giusti is clinical professor of pediatrics at New York University and director of the Pediatric Cystic Fibrosis Center. He was not involved in the study.
The therapy gained Food and Drug Administration approval in 2019 for the treatment of individuals with CF who are aged 12 years and older, and who have at least one copy of the F508del mutation. Its cost is about $317,000 per year within the Kaiser Permanente system, according to Dr. Walter. His group compared hospitalization days for CF-related diagnoses from Jan. 1 through Aug. 31, 2020, before and after initiation of triple combination therapy.
Of 47 eligible patients, 32 initiated therapy during the study period; 38% had severe lung disease, defined by forced expiratory volume in 1 second (FEV1) value less than 40%. In 2020, before initiation of therapy, there were an average of 27 hospital days per month, all among patients with severe lung disease.
Among the therapy group, there were no hospitalizations after initiation of therapy through Aug. 31. Dr. Walter noted that the first hospitalization of a patient on triple combination therapy didn’t occur until early October.
At an average daily cost of $6,700, the researchers calculated that triple combination therapy saved about $189,000 per month in this group of patients. Comparing numbers to previous years, in which some patients with FEV1 greater than 40% were hospitalized, the researchers calculated that the therapy saved about $151,000 per month among individuals with severe lung disease: Patients with severe lung disease contributed about 80% to total hospital costs.
The drug itself for the whole group cost $845,000, dwarfing the $189,000 savings overall. But among patients with severe disease, hospitalization savings were about $151,000 per month, while the drug cost in this group was $316,800 per month.
Cost savings are important, but the improvement in quality of life for a patient – avoiding hospitalization, fewer impacts on work and education – should not be overlooked, according to Ryan Perkins, MD, a pediatric and adult pulmonary fellow at Boston Children’s Hospital and Brigham and Women’s Hospital, who moderated the session. “Some of these aren’t things people typically quantify and assign a price tag to,” Dr. Perkins said in an interview.
A big limitation of the work is that it was conducted during the COVID-19 pandemic, which may have reduced hospitalizations. “We did have patients that called in, told us they were sick, that they needed to be treated for an exacerbation but didn’t want to go to the hospital,” said Dr. Walter. To help adjust for this, Dr. Walter’s team plans to compare intravenous antibiotic exposure before and after triple combination therapy, reasoning that it could help clarify the pandemic’s impact on hospitalizations.
Dr. Walter, Dr. Giusti, and Dr. Perkins have no relevant financial disclosures.
SOURCE: Walter E et al. NACFC 2020. Abstract 795.
.
The triple combination therapy elexacaftor/tezacaftor/ivacaftor was associated with a near elimination of hospital stays in one hospital in Oregon, according to a new report. The hospital savings still weren’t nearly enough to pay for the cost of therapy, but the study underscores what many institutions have observed and adds a new layer to the view of quality of life improvements that the new therapy brings.
“After we started prescribing it, we noticed pretty quickly that hospitalizations appeared to be declining after patients started triple combination therapy, and we were hearing [similar reports] from other centers as well. We wanted to quantify this,” Eric C. Walter, MD, a pulmonologist at the Kaiser Permanente Cystic Fibrosis Clinic in Portland, Ore., said during a presentation of the results at the virtual North American Cystic Fibrosis Conference.
“We’re seeing that across the board in real practice, the number of cystic fibrosis patients that have to be hospitalized since starting this triple combination has gone down,” Robert Giusti, MD, said in an interview. “When they’ve had pulmonary exacerbations in the past, it was frequently because they failed outpatient antibiotics, but I think with triple combination therapy, if they do get sick, the likelihood is they will respond to oral antibiotics, so they may not need that prolonged IV course in the hospital.” Dr. Giusti is clinical professor of pediatrics at New York University and director of the Pediatric Cystic Fibrosis Center. He was not involved in the study.
The therapy gained Food and Drug Administration approval in 2019 for the treatment of individuals with CF who are aged 12 years and older, and who have at least one copy of the F508del mutation. Its cost is about $317,000 per year within the Kaiser Permanente system, according to Dr. Walter. His group compared hospitalization days for CF-related diagnoses from Jan. 1 through Aug. 31, 2020, before and after initiation of triple combination therapy.
Of 47 eligible patients, 32 initiated therapy during the study period; 38% had severe lung disease, defined by forced expiratory volume in 1 second (FEV1) value less than 40%. In 2020, before initiation of therapy, there were an average of 27 hospital days per month, all among patients with severe lung disease.
Among the therapy group, there were no hospitalizations after initiation of therapy through Aug. 31. Dr. Walter noted that the first hospitalization of a patient on triple combination therapy didn’t occur until early October.
At an average daily cost of $6,700, the researchers calculated that triple combination therapy saved about $189,000 per month in this group of patients. Comparing numbers to previous years, in which some patients with FEV1 greater than 40% were hospitalized, the researchers calculated that the therapy saved about $151,000 per month among individuals with severe lung disease: Patients with severe lung disease contributed about 80% to total hospital costs.
The drug itself for the whole group cost $845,000, dwarfing the $189,000 savings overall. But among patients with severe disease, hospitalization savings were about $151,000 per month, while the drug cost in this group was $316,800 per month.
Cost savings are important, but the improvement in quality of life for a patient – avoiding hospitalization, fewer impacts on work and education – should not be overlooked, according to Ryan Perkins, MD, a pediatric and adult pulmonary fellow at Boston Children’s Hospital and Brigham and Women’s Hospital, who moderated the session. “Some of these aren’t things people typically quantify and assign a price tag to,” Dr. Perkins said in an interview.
A big limitation of the work is that it was conducted during the COVID-19 pandemic, which may have reduced hospitalizations. “We did have patients that called in, told us they were sick, that they needed to be treated for an exacerbation but didn’t want to go to the hospital,” said Dr. Walter. To help adjust for this, Dr. Walter’s team plans to compare intravenous antibiotic exposure before and after triple combination therapy, reasoning that it could help clarify the pandemic’s impact on hospitalizations.
Dr. Walter, Dr. Giusti, and Dr. Perkins have no relevant financial disclosures.
SOURCE: Walter E et al. NACFC 2020. Abstract 795.
.
The triple combination therapy elexacaftor/tezacaftor/ivacaftor was associated with a near elimination of hospital stays in one hospital in Oregon, according to a new report. The hospital savings still weren’t nearly enough to pay for the cost of therapy, but the study underscores what many institutions have observed and adds a new layer to the view of quality of life improvements that the new therapy brings.
“After we started prescribing it, we noticed pretty quickly that hospitalizations appeared to be declining after patients started triple combination therapy, and we were hearing [similar reports] from other centers as well. We wanted to quantify this,” Eric C. Walter, MD, a pulmonologist at the Kaiser Permanente Cystic Fibrosis Clinic in Portland, Ore., said during a presentation of the results at the virtual North American Cystic Fibrosis Conference.
“We’re seeing that across the board in real practice, the number of cystic fibrosis patients that have to be hospitalized since starting this triple combination has gone down,” Robert Giusti, MD, said in an interview. “When they’ve had pulmonary exacerbations in the past, it was frequently because they failed outpatient antibiotics, but I think with triple combination therapy, if they do get sick, the likelihood is they will respond to oral antibiotics, so they may not need that prolonged IV course in the hospital.” Dr. Giusti is clinical professor of pediatrics at New York University and director of the Pediatric Cystic Fibrosis Center. He was not involved in the study.
The therapy gained Food and Drug Administration approval in 2019 for the treatment of individuals with CF who are aged 12 years and older, and who have at least one copy of the F508del mutation. Its cost is about $317,000 per year within the Kaiser Permanente system, according to Dr. Walter. His group compared hospitalization days for CF-related diagnoses from Jan. 1 through Aug. 31, 2020, before and after initiation of triple combination therapy.
Of 47 eligible patients, 32 initiated therapy during the study period; 38% had severe lung disease, defined by forced expiratory volume in 1 second (FEV1) value less than 40%. In 2020, before initiation of therapy, there were an average of 27 hospital days per month, all among patients with severe lung disease.
Among the therapy group, there were no hospitalizations after initiation of therapy through Aug. 31. Dr. Walter noted that the first hospitalization of a patient on triple combination therapy didn’t occur until early October.
At an average daily cost of $6,700, the researchers calculated that triple combination therapy saved about $189,000 per month in this group of patients. Comparing numbers to previous years, in which some patients with FEV1 greater than 40% were hospitalized, the researchers calculated that the therapy saved about $151,000 per month among individuals with severe lung disease: Patients with severe lung disease contributed about 80% to total hospital costs.
The drug itself for the whole group cost $845,000, dwarfing the $189,000 savings overall. But among patients with severe disease, hospitalization savings were about $151,000 per month, while the drug cost in this group was $316,800 per month.
Cost savings are important, but the improvement in quality of life for a patient – avoiding hospitalization, fewer impacts on work and education – should not be overlooked, according to Ryan Perkins, MD, a pediatric and adult pulmonary fellow at Boston Children’s Hospital and Brigham and Women’s Hospital, who moderated the session. “Some of these aren’t things people typically quantify and assign a price tag to,” Dr. Perkins said in an interview.
A big limitation of the work is that it was conducted during the COVID-19 pandemic, which may have reduced hospitalizations. “We did have patients that called in, told us they were sick, that they needed to be treated for an exacerbation but didn’t want to go to the hospital,” said Dr. Walter. To help adjust for this, Dr. Walter’s team plans to compare intravenous antibiotic exposure before and after triple combination therapy, reasoning that it could help clarify the pandemic’s impact on hospitalizations.
Dr. Walter, Dr. Giusti, and Dr. Perkins have no relevant financial disclosures.
SOURCE: Walter E et al. NACFC 2020. Abstract 795.
FROM NACFC 2020
Great Barrington coauthor backs off strict reliance on herd immunity
A coauthor of the Great Barrington Declaration says that he and colleagues have never argued against using mitigation strategies to keep COVID-19 from spreading, and that critics have mischaracterized the document as a “let it rip” strategy.
Jay Bhattacharya, MD, PhD, a professor and public health policy expert in infectious diseases at Stanford University in California, spoke on a JAMA Livestream debate on November 6. Marc Lipsitch, MD, an epidemiology professor at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, represented the 6900 signatories of the John Snow Memorandum, a rebuttal to the Great Barrington document.
The Great Barrington approach of “Focused Protection” advocates isolation and protection of people who are most vulnerable to COVID-19 while avoiding what they characterize as lockdowns. “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk,” the document reads.
The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association denounced the declaration, as reported by Medscape Medical News, and the World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus called the proposal “unethical.” But the idea has gained some traction at the White House, where Coronavirus Task Force Member and Stanford professor Scott Atlas, MD, has been advising President Donald J. Trump.
On the JAMA debate, Bhattacharya said, “I think all of the mitigation measures are really important,” listing social distancing, hand washing, and masks when distancing is not possible as chief among those strategies for the less vulnerable. “I don’t want to create infections intentionally, but I want us to allow people to go back to their lives as best they can, understanding of the risks they are taking when they do it,” he said, claiming that 99.95% of the population will survive infection.
“The harmful lockdowns are worse for many, many people,” Bhattacharya said.
“I think Jay is moving towards a middle ground which is not really what the Great Barrington Declaration seems to promote,” countered Lipsitch. The declaration does not say use masks or social distance, he said. “It just says we need to go back to a normal life.”
Bhattacharya’s statements to JAMA mean that “maybe we are approaching some common ground,” Lipsitch said.
Definition of a lockdown
Both men were asked to give their definition of a “lockdown.” To Lipsitch, it means people are not allowed out except for essential services and that most businesses are closed, with exceptions for those deemed essential.
Bhattacharya, however, said he views that as a quarantine. Lockdowns “are what we’re currently doing,” he said. Schools, churches, businesses, and arts and culture organizations are shuttered, and “almost every aspect of society is restricted in some way,” Bhattacharya said.
He blamed these lockdowns for most of the excess deaths over and above the COVID-19 deaths and said they had failed to control the pandemic.
Lipsitch said that “it feels to me that Jay is describing as lockdown everything that causes harm, even when it’s not locked down.” He noted that the country was truly closed down for 2 months or so in the spring.
“All of these harms I agree are real,” said Lipsitch. “But they are because the normal life of our society is being interfered with by viral transmission and by people’s inability to live their normal lives.”
Closures and lockdowns are essential to delaying cases and deaths, said Lipsitch. “A case today is worse than a case tomorrow and a lot worse than a case 6 months from now,” he said, noting that a vaccine or improved therapeutics could evolve.
“Delay is not nothing,” Lipsitch added. “It’s actually the goal as I see it, and as the John Snow memo says, we want to keep the virus under control in such a way as that the vulnerable people are not at risk.”
He predicted that cases will continue to grow exponentially because the nation is “not even close to herd immunity.” And, if intensive care units fill up, “there will be a responsive lockdown,” he said, adding that he did not endorse that as a general matter or favor it as a default position.
Bhattacharya claimed that Sweden has tallied only 1800 excess deaths since the pandemic began. “That’s lockdown harm avoided,” he said, advocating a similar strategy for the United States. But, infections have been on the rise in Sweden, and the nation has a higher COVID-19 death rate — with 6000 deaths — than other Nordic countries.
“If we keep this policy of lockdown we will have the same kind of outcomes we’ve already had — high excess deaths and sort of indifferent control of COVID,” Bhattacharya said.
“We’re still going to have misery and death going forward until we reach a point where there’s sufficient immunity either though a vaccine or through natural infection,” he said.
This article first appeared on Medscape.com.
A coauthor of the Great Barrington Declaration says that he and colleagues have never argued against using mitigation strategies to keep COVID-19 from spreading, and that critics have mischaracterized the document as a “let it rip” strategy.
Jay Bhattacharya, MD, PhD, a professor and public health policy expert in infectious diseases at Stanford University in California, spoke on a JAMA Livestream debate on November 6. Marc Lipsitch, MD, an epidemiology professor at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, represented the 6900 signatories of the John Snow Memorandum, a rebuttal to the Great Barrington document.
The Great Barrington approach of “Focused Protection” advocates isolation and protection of people who are most vulnerable to COVID-19 while avoiding what they characterize as lockdowns. “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk,” the document reads.
The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association denounced the declaration, as reported by Medscape Medical News, and the World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus called the proposal “unethical.” But the idea has gained some traction at the White House, where Coronavirus Task Force Member and Stanford professor Scott Atlas, MD, has been advising President Donald J. Trump.
On the JAMA debate, Bhattacharya said, “I think all of the mitigation measures are really important,” listing social distancing, hand washing, and masks when distancing is not possible as chief among those strategies for the less vulnerable. “I don’t want to create infections intentionally, but I want us to allow people to go back to their lives as best they can, understanding of the risks they are taking when they do it,” he said, claiming that 99.95% of the population will survive infection.
“The harmful lockdowns are worse for many, many people,” Bhattacharya said.
“I think Jay is moving towards a middle ground which is not really what the Great Barrington Declaration seems to promote,” countered Lipsitch. The declaration does not say use masks or social distance, he said. “It just says we need to go back to a normal life.”
Bhattacharya’s statements to JAMA mean that “maybe we are approaching some common ground,” Lipsitch said.
Definition of a lockdown
Both men were asked to give their definition of a “lockdown.” To Lipsitch, it means people are not allowed out except for essential services and that most businesses are closed, with exceptions for those deemed essential.
Bhattacharya, however, said he views that as a quarantine. Lockdowns “are what we’re currently doing,” he said. Schools, churches, businesses, and arts and culture organizations are shuttered, and “almost every aspect of society is restricted in some way,” Bhattacharya said.
He blamed these lockdowns for most of the excess deaths over and above the COVID-19 deaths and said they had failed to control the pandemic.
Lipsitch said that “it feels to me that Jay is describing as lockdown everything that causes harm, even when it’s not locked down.” He noted that the country was truly closed down for 2 months or so in the spring.
“All of these harms I agree are real,” said Lipsitch. “But they are because the normal life of our society is being interfered with by viral transmission and by people’s inability to live their normal lives.”
Closures and lockdowns are essential to delaying cases and deaths, said Lipsitch. “A case today is worse than a case tomorrow and a lot worse than a case 6 months from now,” he said, noting that a vaccine or improved therapeutics could evolve.
“Delay is not nothing,” Lipsitch added. “It’s actually the goal as I see it, and as the John Snow memo says, we want to keep the virus under control in such a way as that the vulnerable people are not at risk.”
He predicted that cases will continue to grow exponentially because the nation is “not even close to herd immunity.” And, if intensive care units fill up, “there will be a responsive lockdown,” he said, adding that he did not endorse that as a general matter or favor it as a default position.
Bhattacharya claimed that Sweden has tallied only 1800 excess deaths since the pandemic began. “That’s lockdown harm avoided,” he said, advocating a similar strategy for the United States. But, infections have been on the rise in Sweden, and the nation has a higher COVID-19 death rate — with 6000 deaths — than other Nordic countries.
“If we keep this policy of lockdown we will have the same kind of outcomes we’ve already had — high excess deaths and sort of indifferent control of COVID,” Bhattacharya said.
“We’re still going to have misery and death going forward until we reach a point where there’s sufficient immunity either though a vaccine or through natural infection,” he said.
This article first appeared on Medscape.com.
A coauthor of the Great Barrington Declaration says that he and colleagues have never argued against using mitigation strategies to keep COVID-19 from spreading, and that critics have mischaracterized the document as a “let it rip” strategy.
Jay Bhattacharya, MD, PhD, a professor and public health policy expert in infectious diseases at Stanford University in California, spoke on a JAMA Livestream debate on November 6. Marc Lipsitch, MD, an epidemiology professor at the Harvard T.H. Chan School of Public Health in Boston, Massachusetts, represented the 6900 signatories of the John Snow Memorandum, a rebuttal to the Great Barrington document.
The Great Barrington approach of “Focused Protection” advocates isolation and protection of people who are most vulnerable to COVID-19 while avoiding what they characterize as lockdowns. “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk,” the document reads.
The Infectious Diseases Society of America (IDSA) and its HIV Medicine Association denounced the declaration, as reported by Medscape Medical News, and the World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus called the proposal “unethical.” But the idea has gained some traction at the White House, where Coronavirus Task Force Member and Stanford professor Scott Atlas, MD, has been advising President Donald J. Trump.
On the JAMA debate, Bhattacharya said, “I think all of the mitigation measures are really important,” listing social distancing, hand washing, and masks when distancing is not possible as chief among those strategies for the less vulnerable. “I don’t want to create infections intentionally, but I want us to allow people to go back to their lives as best they can, understanding of the risks they are taking when they do it,” he said, claiming that 99.95% of the population will survive infection.
“The harmful lockdowns are worse for many, many people,” Bhattacharya said.
“I think Jay is moving towards a middle ground which is not really what the Great Barrington Declaration seems to promote,” countered Lipsitch. The declaration does not say use masks or social distance, he said. “It just says we need to go back to a normal life.”
Bhattacharya’s statements to JAMA mean that “maybe we are approaching some common ground,” Lipsitch said.
Definition of a lockdown
Both men were asked to give their definition of a “lockdown.” To Lipsitch, it means people are not allowed out except for essential services and that most businesses are closed, with exceptions for those deemed essential.
Bhattacharya, however, said he views that as a quarantine. Lockdowns “are what we’re currently doing,” he said. Schools, churches, businesses, and arts and culture organizations are shuttered, and “almost every aspect of society is restricted in some way,” Bhattacharya said.
He blamed these lockdowns for most of the excess deaths over and above the COVID-19 deaths and said they had failed to control the pandemic.
Lipsitch said that “it feels to me that Jay is describing as lockdown everything that causes harm, even when it’s not locked down.” He noted that the country was truly closed down for 2 months or so in the spring.
“All of these harms I agree are real,” said Lipsitch. “But they are because the normal life of our society is being interfered with by viral transmission and by people’s inability to live their normal lives.”
Closures and lockdowns are essential to delaying cases and deaths, said Lipsitch. “A case today is worse than a case tomorrow and a lot worse than a case 6 months from now,” he said, noting that a vaccine or improved therapeutics could evolve.
“Delay is not nothing,” Lipsitch added. “It’s actually the goal as I see it, and as the John Snow memo says, we want to keep the virus under control in such a way as that the vulnerable people are not at risk.”
He predicted that cases will continue to grow exponentially because the nation is “not even close to herd immunity.” And, if intensive care units fill up, “there will be a responsive lockdown,” he said, adding that he did not endorse that as a general matter or favor it as a default position.
Bhattacharya claimed that Sweden has tallied only 1800 excess deaths since the pandemic began. “That’s lockdown harm avoided,” he said, advocating a similar strategy for the United States. But, infections have been on the rise in Sweden, and the nation has a higher COVID-19 death rate — with 6000 deaths — than other Nordic countries.
“If we keep this policy of lockdown we will have the same kind of outcomes we’ve already had — high excess deaths and sort of indifferent control of COVID,” Bhattacharya said.
“We’re still going to have misery and death going forward until we reach a point where there’s sufficient immunity either though a vaccine or through natural infection,” he said.
This article first appeared on Medscape.com.
Hospitals poised to launch first COVID-19 vaccines in clinicians
At first, when news spread of a 28-year-old doctor on the COVID-19 front lines in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story flipped. Although the vaccine maker wouldn’t confirm it, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.
That tragedy underscores the ongoing risk of COVID-19 to healthcare workers, who have been designated by US advisory panels as part of phase 1A – the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency set a November 15 vaccination “readiness date” for jurisdictions, such as state health departments, even though a vaccine isn’t likely to be authorized by then.
As hospitals scramble to prepare, their watchword is flexibility. They don’t yet know how many initial doses they will get, of which vaccine, or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines each fall, but that framework doesn’t align with the likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and differing storage needs.
“Healthcare organizations have consistently risen to the challenge. I wholeheartedly believe in their potential to do this,” Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists, told Medscape Medical News.
Healthcare workers won’t face a vaccine mandate
Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That was what occupational medicine physician Kevin Smith, MD, realized when his health system, Toledo, Ohio–based ProMedica, offered antibody testing to all its 50,000 employees. About 2% of the 6933 tests given came back positive, he says.
Yet many physicians, nurses, and other healthcare workers share the public’s skepticism about the safety and effectiveness of a vaccine that receives swift US Food and Drug Administration (FDA) approval for emergency use. About half of nurses (47%) and almost 1 in 3 physicians (30%) say that they don’t want to get the vaccine when it first becomes available or that they’re unsure about vaccination, according to a Medscape survey.
Because vaccination of healthcare workers will set the stage for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know that there will be some hesitancy in the healthcare workforce, just as there will be in the broader public,” said Marci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare in Newark, Delaware, and liaison from the Society for Healthcare Epidemiology of America to the CDC’s Advisory Committee on Immunization Practices.* “I do not think we can expect anyone to be vaccinated if we’re not willing to vaccinate ourselves.”
Healthcare workers are typically required to receive a range of vaccines, including measles, mumps, and rubella (MMR) and pertussis shots. Each year, close to half of US healthcare workers receive a flu vaccine under a workplace mandate. But COVID-19 will be different. The FDA requires anyone given products under an emergency use authorization (EUA) to receive information about risks and benefits and to have the option to decline. Hospitals instead will rely on education as they offer a novel vaccine (or more than one) that will have a minimum effectiveness of 50%.
ProMedica doesn’t require employees to be vaccinated against flu, but employees who decline must get a note from a doctor indicating that they have talked about the risks and benefits of the vaccine. A similar approach may be used with a COVID-19 vaccine, in which employees may be required to learn about the vaccine before they decline, Smith says. “I do believe some people will say they don’t want to get it,” he added.
Like colleagues across the country, Smith is identifying healthcare workers who are involved in direct care of COVID-19 patients and are at highest risk for exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide breathing treatments that spread aerosols and droplets, will be tagged as a priority group, he says. Healthcare workers who spend the most time in proximity to COVID patients, such as nurses in a COVID unit, also are likely to get the first doses, he says.
Swirl, don’t shake, the vaccine
Hospitals are adept at ramping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against influenza in their 1-day “Flulapalooza” event. The medical center even earned a Guinness world record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.
The 10th anniversary of the event was canceled this year because of COVID restrictions. Instead, nurses, pharmacists, and other clinicians pitched in to vaccinate their coworkers against influenza. Now, plans for COVID-19 vaccination move forward amid uncertainty.
Instead of holding a mass event, “the delivery mechanisms will need to be more targeted and focused,” said Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent version of its vaccination program “playbook,” the agency recommends giving the vaccines in an area that allows people to remain 6 feet apart and for them to wait for 15 minutes after receiving the shot to make sure they don’t faint, a potential risk common to almost all vaccines.
That’s the easy part. Planning becomes more complex, given the uncertainty as to which vaccines will receive approval and which one a hospital will receive.
If the Pfizer/BioNTech vaccine receives EUA in 2020, about 10 to 20 million doses could be available in November and 20 to 30 million doses in December. The ultracold containers used to ship the vaccines have to be replenished with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in the containers. The five-dose vials can be refrigerated before administering, but only for 5 days. The product must be diluted, and it then must be used within 6 hours.
The Moderna vaccine will be somewhat less plentiful at first. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once they are placed in a refrigerator to thaw, they have to be used within 7 days, and once they’re removed from the refrigerator, they have to be used within 12 hours. The pharmacist or other vaccinator must swirl – but not shake! – the vial before delivering a dose, according to the CDC playbook.
As more information emerges about the vaccines, instructions may change, and Smith is steeled for shifting scenarios. “These are all draft plans. We’re going to modify as we go along,” he says.
The Pfizer vaccine requires a second dose at 21 days, and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to track vaccinations and any adverse effects, hospitals will give employees a card indicating what vaccine they received, the date it was administered, and the date on which they need to return. (At this point, the time frame for the second dose doesn’t appear to be flexible.)
Regardless of the vaccine, one message stays the same: COVID precautions must continue. That means mask wearing, social distancing, and hand washing – practices that also must be followed by healthcare workers who test positive for naturally acquired antibodies.
“I don’t think anyone expects the COVID vaccine to be 100% effective at preventing COVID,” says Rolando. “So all of the other tools in our toolbox are going to need to be continued to be used as well.”
*Correction, 11/12/20: An earlier version of this article misstated the name of Dr. Drees' institution.
This article first appeared on Medscape.com.
At first, when news spread of a 28-year-old doctor on the COVID-19 front lines in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story flipped. Although the vaccine maker wouldn’t confirm it, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.
That tragedy underscores the ongoing risk of COVID-19 to healthcare workers, who have been designated by US advisory panels as part of phase 1A – the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency set a November 15 vaccination “readiness date” for jurisdictions, such as state health departments, even though a vaccine isn’t likely to be authorized by then.
As hospitals scramble to prepare, their watchword is flexibility. They don’t yet know how many initial doses they will get, of which vaccine, or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines each fall, but that framework doesn’t align with the likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and differing storage needs.
“Healthcare organizations have consistently risen to the challenge. I wholeheartedly believe in their potential to do this,” Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists, told Medscape Medical News.
Healthcare workers won’t face a vaccine mandate
Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That was what occupational medicine physician Kevin Smith, MD, realized when his health system, Toledo, Ohio–based ProMedica, offered antibody testing to all its 50,000 employees. About 2% of the 6933 tests given came back positive, he says.
Yet many physicians, nurses, and other healthcare workers share the public’s skepticism about the safety and effectiveness of a vaccine that receives swift US Food and Drug Administration (FDA) approval for emergency use. About half of nurses (47%) and almost 1 in 3 physicians (30%) say that they don’t want to get the vaccine when it first becomes available or that they’re unsure about vaccination, according to a Medscape survey.
Because vaccination of healthcare workers will set the stage for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know that there will be some hesitancy in the healthcare workforce, just as there will be in the broader public,” said Marci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare in Newark, Delaware, and liaison from the Society for Healthcare Epidemiology of America to the CDC’s Advisory Committee on Immunization Practices.* “I do not think we can expect anyone to be vaccinated if we’re not willing to vaccinate ourselves.”
Healthcare workers are typically required to receive a range of vaccines, including measles, mumps, and rubella (MMR) and pertussis shots. Each year, close to half of US healthcare workers receive a flu vaccine under a workplace mandate. But COVID-19 will be different. The FDA requires anyone given products under an emergency use authorization (EUA) to receive information about risks and benefits and to have the option to decline. Hospitals instead will rely on education as they offer a novel vaccine (or more than one) that will have a minimum effectiveness of 50%.
ProMedica doesn’t require employees to be vaccinated against flu, but employees who decline must get a note from a doctor indicating that they have talked about the risks and benefits of the vaccine. A similar approach may be used with a COVID-19 vaccine, in which employees may be required to learn about the vaccine before they decline, Smith says. “I do believe some people will say they don’t want to get it,” he added.
Like colleagues across the country, Smith is identifying healthcare workers who are involved in direct care of COVID-19 patients and are at highest risk for exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide breathing treatments that spread aerosols and droplets, will be tagged as a priority group, he says. Healthcare workers who spend the most time in proximity to COVID patients, such as nurses in a COVID unit, also are likely to get the first doses, he says.
Swirl, don’t shake, the vaccine
Hospitals are adept at ramping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against influenza in their 1-day “Flulapalooza” event. The medical center even earned a Guinness world record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.
The 10th anniversary of the event was canceled this year because of COVID restrictions. Instead, nurses, pharmacists, and other clinicians pitched in to vaccinate their coworkers against influenza. Now, plans for COVID-19 vaccination move forward amid uncertainty.
Instead of holding a mass event, “the delivery mechanisms will need to be more targeted and focused,” said Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent version of its vaccination program “playbook,” the agency recommends giving the vaccines in an area that allows people to remain 6 feet apart and for them to wait for 15 minutes after receiving the shot to make sure they don’t faint, a potential risk common to almost all vaccines.
That’s the easy part. Planning becomes more complex, given the uncertainty as to which vaccines will receive approval and which one a hospital will receive.
If the Pfizer/BioNTech vaccine receives EUA in 2020, about 10 to 20 million doses could be available in November and 20 to 30 million doses in December. The ultracold containers used to ship the vaccines have to be replenished with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in the containers. The five-dose vials can be refrigerated before administering, but only for 5 days. The product must be diluted, and it then must be used within 6 hours.
The Moderna vaccine will be somewhat less plentiful at first. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once they are placed in a refrigerator to thaw, they have to be used within 7 days, and once they’re removed from the refrigerator, they have to be used within 12 hours. The pharmacist or other vaccinator must swirl – but not shake! – the vial before delivering a dose, according to the CDC playbook.
As more information emerges about the vaccines, instructions may change, and Smith is steeled for shifting scenarios. “These are all draft plans. We’re going to modify as we go along,” he says.
The Pfizer vaccine requires a second dose at 21 days, and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to track vaccinations and any adverse effects, hospitals will give employees a card indicating what vaccine they received, the date it was administered, and the date on which they need to return. (At this point, the time frame for the second dose doesn’t appear to be flexible.)
Regardless of the vaccine, one message stays the same: COVID precautions must continue. That means mask wearing, social distancing, and hand washing – practices that also must be followed by healthcare workers who test positive for naturally acquired antibodies.
“I don’t think anyone expects the COVID vaccine to be 100% effective at preventing COVID,” says Rolando. “So all of the other tools in our toolbox are going to need to be continued to be used as well.”
*Correction, 11/12/20: An earlier version of this article misstated the name of Dr. Drees' institution.
This article first appeared on Medscape.com.
At first, when news spread of a 28-year-old doctor on the COVID-19 front lines in Brazil who died after receiving an experimental vaccine, doubts arose about the safety of one of the most promising coronavirus vaccine candidates. But then the story flipped. Although the vaccine maker wouldn’t confirm it, the doctor appeared to have been in the control group and had received a dose of an established meningitis vaccine. The danger came from exposure to the coronavirus itself.
That tragedy underscores the ongoing risk of COVID-19 to healthcare workers, who have been designated by US advisory panels as part of phase 1A – the first to receive doses of any approved vaccine. The Centers for Disease Control and Prevention (CDC) recently reported that 6% of adults hospitalized with COVID from March to May were healthcare workers. The report was based on surveillance data from 13 states. The average age of the patients was 49 years. The agency set a November 15 vaccination “readiness date” for jurisdictions, such as state health departments, even though a vaccine isn’t likely to be authorized by then.
As hospitals scramble to prepare, their watchword is flexibility. They don’t yet know how many initial doses they will get, of which vaccine, or in what time frame. They have a sophisticated infrastructure to deliver flu vaccines each fall, but that framework doesn’t align with the likely scenarios of limited supply, additional reporting requirements, two-dose regimens, and differing storage needs.
“Healthcare organizations have consistently risen to the challenge. I wholeheartedly believe in their potential to do this,” Anna Legreid Dopp, PharmD, senior director of quality improvement and guidelines for the American Society of Health-System Pharmacists, told Medscape Medical News.
Healthcare workers won’t face a vaccine mandate
Even after months of caring for COVID patients, most clinicians remain vulnerable to infection – at work and in their communities. That was what occupational medicine physician Kevin Smith, MD, realized when his health system, Toledo, Ohio–based ProMedica, offered antibody testing to all its 50,000 employees. About 2% of the 6933 tests given came back positive, he says.
Yet many physicians, nurses, and other healthcare workers share the public’s skepticism about the safety and effectiveness of a vaccine that receives swift US Food and Drug Administration (FDA) approval for emergency use. About half of nurses (47%) and almost 1 in 3 physicians (30%) say that they don’t want to get the vaccine when it first becomes available or that they’re unsure about vaccination, according to a Medscape survey.
Because vaccination of healthcare workers will set the stage for public acceptance of the vaccine, hospital epidemiologists are concerned. “We know that there will be some hesitancy in the healthcare workforce, just as there will be in the broader public,” said Marci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare in Newark, Delaware, and liaison from the Society for Healthcare Epidemiology of America to the CDC’s Advisory Committee on Immunization Practices.* “I do not think we can expect anyone to be vaccinated if we’re not willing to vaccinate ourselves.”
Healthcare workers are typically required to receive a range of vaccines, including measles, mumps, and rubella (MMR) and pertussis shots. Each year, close to half of US healthcare workers receive a flu vaccine under a workplace mandate. But COVID-19 will be different. The FDA requires anyone given products under an emergency use authorization (EUA) to receive information about risks and benefits and to have the option to decline. Hospitals instead will rely on education as they offer a novel vaccine (or more than one) that will have a minimum effectiveness of 50%.
ProMedica doesn’t require employees to be vaccinated against flu, but employees who decline must get a note from a doctor indicating that they have talked about the risks and benefits of the vaccine. A similar approach may be used with a COVID-19 vaccine, in which employees may be required to learn about the vaccine before they decline, Smith says. “I do believe some people will say they don’t want to get it,” he added.
Like colleagues across the country, Smith is identifying healthcare workers who are involved in direct care of COVID-19 patients and are at highest risk for exposure. Even within the top tier, those performing the riskiest tasks, such as respiratory therapists who provide breathing treatments that spread aerosols and droplets, will be tagged as a priority group, he says. Healthcare workers who spend the most time in proximity to COVID patients, such as nurses in a COVID unit, also are likely to get the first doses, he says.
Swirl, don’t shake, the vaccine
Hospitals are adept at ramping up vaccination campaigns. For example, last year, Vanderbilt University Medical Center, in Nashville, Tennessee, vaccinated nearly 16,000 employees against influenza in their 1-day “Flulapalooza” event. The medical center even earned a Guinness world record in 2011 at the first Flulapalooza for giving the most vaccinations ever within 8 hours.
The 10th anniversary of the event was canceled this year because of COVID restrictions. Instead, nurses, pharmacists, and other clinicians pitched in to vaccinate their coworkers against influenza. Now, plans for COVID-19 vaccination move forward amid uncertainty.
Instead of holding a mass event, “the delivery mechanisms will need to be more targeted and focused,” said Lori Rolando, MD, MPH, director of the Vanderbilt Occupational Health Clinic. In the CDC’s most recent version of its vaccination program “playbook,” the agency recommends giving the vaccines in an area that allows people to remain 6 feet apart and for them to wait for 15 minutes after receiving the shot to make sure they don’t faint, a potential risk common to almost all vaccines.
That’s the easy part. Planning becomes more complex, given the uncertainty as to which vaccines will receive approval and which one a hospital will receive.
If the Pfizer/BioNTech vaccine receives EUA in 2020, about 10 to 20 million doses could be available in November and 20 to 30 million doses in December. The ultracold containers used to ship the vaccines have to be replenished with dry ice within 24 hours of receipt and every 5 days thereafter. Hospitals will need temperature probes to monitor storage in the containers. The five-dose vials can be refrigerated before administering, but only for 5 days. The product must be diluted, and it then must be used within 6 hours.
The Moderna vaccine will be somewhat less plentiful at first. About 10 million doses are expected in November and 15 million doses by the end of December. The 10-dose vials are stored in a freezer. Once they are placed in a refrigerator to thaw, they have to be used within 7 days, and once they’re removed from the refrigerator, they have to be used within 12 hours. The pharmacist or other vaccinator must swirl – but not shake! – the vial before delivering a dose, according to the CDC playbook.
As more information emerges about the vaccines, instructions may change, and Smith is steeled for shifting scenarios. “These are all draft plans. We’re going to modify as we go along,” he says.
The Pfizer vaccine requires a second dose at 21 days, and the Moderna vaccine targets the second dose at 28 days. In addition to using information systems to track vaccinations and any adverse effects, hospitals will give employees a card indicating what vaccine they received, the date it was administered, and the date on which they need to return. (At this point, the time frame for the second dose doesn’t appear to be flexible.)
Regardless of the vaccine, one message stays the same: COVID precautions must continue. That means mask wearing, social distancing, and hand washing – practices that also must be followed by healthcare workers who test positive for naturally acquired antibodies.
“I don’t think anyone expects the COVID vaccine to be 100% effective at preventing COVID,” says Rolando. “So all of the other tools in our toolbox are going to need to be continued to be used as well.”
*Correction, 11/12/20: An earlier version of this article misstated the name of Dr. Drees' institution.
This article first appeared on Medscape.com.
United States adds nearly 74,000 more children with COVID-19
The new weekly high for COVID-19 cases in children announced last week has been surpassed already, as the United States experienced almost 74,000 new pediatric cases for the week ending Nov. 5, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of COVID-19 cases in children is now 927,518 in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly report.
Cumulatively, children represent 11.3% of all COVID-19 cases in those jurisdictions, up from 11.1% a week ago. For just the past week, those 73,883 children represent 13.0% of the 567,672 new cases reported among all ages. That proportion peaked at 16.9% in mid-September, the AAP/CHA data show.
Dropping down to the state level, cumulative proportions as of Nov. 5 range from 5.2% in New Jersey to 23.3% in Wyoming, with 11 other states over 15%. California has had more cases, 100,856, than any other state, and Vermont the fewest at 329, the AAP and CHA said.
The national rate per 100,000 children is now 1,232, up from 1,134 the previous week and more than doubled since mid-August (582.2 per 100,000 on Aug. 20). North Dakota’s rate of 3,990 per 100,000 children is the highest of any state (South Dakota is next at 2,779), while Vermont is again the lowest at 245 per 100,000, based on data collected from state health department websites.
Two COVID-19–related deaths in children were reported during the week ending Nov. 5, bringing the total to 123 but leaving the overall proportion of deaths in children unchanged at 0.06% of all deaths. Texas has reported the most COVID-19 deaths in children with 29, while 15 states have recorded no deaths so far (mortality data in children reported by 42 states and New York City), the AAP and CHA said.
The new weekly high for COVID-19 cases in children announced last week has been surpassed already, as the United States experienced almost 74,000 new pediatric cases for the week ending Nov. 5, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of COVID-19 cases in children is now 927,518 in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly report.
Cumulatively, children represent 11.3% of all COVID-19 cases in those jurisdictions, up from 11.1% a week ago. For just the past week, those 73,883 children represent 13.0% of the 567,672 new cases reported among all ages. That proportion peaked at 16.9% in mid-September, the AAP/CHA data show.
Dropping down to the state level, cumulative proportions as of Nov. 5 range from 5.2% in New Jersey to 23.3% in Wyoming, with 11 other states over 15%. California has had more cases, 100,856, than any other state, and Vermont the fewest at 329, the AAP and CHA said.
The national rate per 100,000 children is now 1,232, up from 1,134 the previous week and more than doubled since mid-August (582.2 per 100,000 on Aug. 20). North Dakota’s rate of 3,990 per 100,000 children is the highest of any state (South Dakota is next at 2,779), while Vermont is again the lowest at 245 per 100,000, based on data collected from state health department websites.
Two COVID-19–related deaths in children were reported during the week ending Nov. 5, bringing the total to 123 but leaving the overall proportion of deaths in children unchanged at 0.06% of all deaths. Texas has reported the most COVID-19 deaths in children with 29, while 15 states have recorded no deaths so far (mortality data in children reported by 42 states and New York City), the AAP and CHA said.
The new weekly high for COVID-19 cases in children announced last week has been surpassed already, as the United States experienced almost 74,000 new pediatric cases for the week ending Nov. 5, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of COVID-19 cases in children is now 927,518 in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA said in their weekly report.
Cumulatively, children represent 11.3% of all COVID-19 cases in those jurisdictions, up from 11.1% a week ago. For just the past week, those 73,883 children represent 13.0% of the 567,672 new cases reported among all ages. That proportion peaked at 16.9% in mid-September, the AAP/CHA data show.
Dropping down to the state level, cumulative proportions as of Nov. 5 range from 5.2% in New Jersey to 23.3% in Wyoming, with 11 other states over 15%. California has had more cases, 100,856, than any other state, and Vermont the fewest at 329, the AAP and CHA said.
The national rate per 100,000 children is now 1,232, up from 1,134 the previous week and more than doubled since mid-August (582.2 per 100,000 on Aug. 20). North Dakota’s rate of 3,990 per 100,000 children is the highest of any state (South Dakota is next at 2,779), while Vermont is again the lowest at 245 per 100,000, based on data collected from state health department websites.
Two COVID-19–related deaths in children were reported during the week ending Nov. 5, bringing the total to 123 but leaving the overall proportion of deaths in children unchanged at 0.06% of all deaths. Texas has reported the most COVID-19 deaths in children with 29, while 15 states have recorded no deaths so far (mortality data in children reported by 42 states and New York City), the AAP and CHA said.
Whales, seals, and dolphins: Will SARS-CoV-2–contaminated wastewater prove a killer?
Zoonoses are no respecter of biological boundaries and are notorious for crossing genus and even higher taxonomic boundaries. SARS-CoV-2 is no exception, the current outbreak most probably having originated in bats, a common source of human-affecting zoonoses throughout history. But it is not a one-way street, and the virus has been shown to spread from infected humans to a variety of other land mammals, including our domesticated animals and kept zoo species.
A recent troubling report, however, has indicated that sea mammals may be part of a next wave of likely candidates for infection, put at risk by the current human pandemic and environmental degradation on a global scale, according to a the results of a genomic analysis of four major groups of sea mammals.
Researchers Sabateeshan Mathavarajah and colleagues from Dalhousie University, Halifax, N.S., examined the sequences of the ACE2 receptors in the various marine mammal species. The ACE2 receptor has recently been identified as the SARS-CoV-2 receptor, which allows for infection.
The researchers examined genomic databases of the marine species to determine if their ACE2 receptor sequences indicated the potential for high, medium, or low susceptibility to infection, as reported in Science of the Total Environment. Database analysis was performed for four groups: Cetacea (whales and dolphins), Pinnepidia (seals), Sirenia (sea cows), and Fissipedia (sea otters and polar bears).
The researchers defined susceptibility values based on comparable binding with the receptor and came up with the following subgroups: higher than human, high (resembles human ACE2), medium (resembles cat ACE2), and low (resembles dog ACE2). It has yet to be established if these marine mammals actually are infected with SARS-CoV-2 and what the impact of such an infection might have on animal health or humans who come in contact with infected animals.
They also cross-referenced for the level of species endangerment and with maps of potential wastewater contamination for certain areas that species came in contact with, using Alaska as the model.
Populations in danger
The researchers found 15 species that are already at risk globally that fall under the categories of near threatened, vulnerable, endangered, and critically endangered that were predicted to be medium to higher susceptibility to the SARS-CoV-2 virus than humans. Cross infection is of particular concern because other coronaviruses have been shown to have severe and lethal effects among many of these species.
Among the potentially impacted species were the near threatened–status Antarctic Mink whale and the stellar sea lion; the vulnerable sperm whale, northern fur seal, and Atlantic walrus; the endangered northern and southern sea otters, the North Pacific right whale, and the Amazon River dolphin; and the critically threatened Baiji and Vaquita dolphin species.
Pollution risks
In Alaska, as of Aug. 7th, 2020, there were 4,221 confirmed cases of COVID-19 and this number continues to rise, according to the researchers. Since there is a diversity of marine mammals in Alaska and their populations are well documented, they compared this information with available data on the wastewater treatment plants in the state. They were thus able to determine the potential geographic locations and species at high risk for transmission of SARS-CoV-2 via wastewater effluent.
Among their findings, the city of Cold Bay discharges wastewater into Cold Bay, where there are Northern sea otter populations that are predicted to be highly susceptible to the virus. Beluga whales are also predicted to have high susceptibility and they can be found in Bristol Bay near Naknek, a city which relies only on lagoon treatment prior to the discharge of wastewater effluent; the city of Dillingham discharges wastewater into the Nushagak River where beluga whales are found. In Palmer, wastewater effluent flows into the Talkeetna River, which is a tributary to the Susitna River and home to two species predicted to have high susceptibility, beluga whales and harbor seals, the authors added.
Based on these results, the researchers predicted that there was likely a significant risk to sea mammals across the globe, especially where less-adequate treatment facilities and high population densities may lead to greater wastewater contamination.
“Given the proximity of marine animals to high-risk environments where viral spill over is likely, we must act with foresight to protect marine mammal species predicted to be at risk and mitigate the environmental impact of the COVID-19 pandemic,” the researchers concluded.
The authors reported that they had no disclosures.
SOURCE: Mathavarajah S et al. Sci Total Environ. 2020 Oct 29. doi: 10.1016/j.scitotenv.2020.143346.
Zoonoses are no respecter of biological boundaries and are notorious for crossing genus and even higher taxonomic boundaries. SARS-CoV-2 is no exception, the current outbreak most probably having originated in bats, a common source of human-affecting zoonoses throughout history. But it is not a one-way street, and the virus has been shown to spread from infected humans to a variety of other land mammals, including our domesticated animals and kept zoo species.
A recent troubling report, however, has indicated that sea mammals may be part of a next wave of likely candidates for infection, put at risk by the current human pandemic and environmental degradation on a global scale, according to a the results of a genomic analysis of four major groups of sea mammals.
Researchers Sabateeshan Mathavarajah and colleagues from Dalhousie University, Halifax, N.S., examined the sequences of the ACE2 receptors in the various marine mammal species. The ACE2 receptor has recently been identified as the SARS-CoV-2 receptor, which allows for infection.
The researchers examined genomic databases of the marine species to determine if their ACE2 receptor sequences indicated the potential for high, medium, or low susceptibility to infection, as reported in Science of the Total Environment. Database analysis was performed for four groups: Cetacea (whales and dolphins), Pinnepidia (seals), Sirenia (sea cows), and Fissipedia (sea otters and polar bears).
The researchers defined susceptibility values based on comparable binding with the receptor and came up with the following subgroups: higher than human, high (resembles human ACE2), medium (resembles cat ACE2), and low (resembles dog ACE2). It has yet to be established if these marine mammals actually are infected with SARS-CoV-2 and what the impact of such an infection might have on animal health or humans who come in contact with infected animals.
They also cross-referenced for the level of species endangerment and with maps of potential wastewater contamination for certain areas that species came in contact with, using Alaska as the model.
Populations in danger
The researchers found 15 species that are already at risk globally that fall under the categories of near threatened, vulnerable, endangered, and critically endangered that were predicted to be medium to higher susceptibility to the SARS-CoV-2 virus than humans. Cross infection is of particular concern because other coronaviruses have been shown to have severe and lethal effects among many of these species.
Among the potentially impacted species were the near threatened–status Antarctic Mink whale and the stellar sea lion; the vulnerable sperm whale, northern fur seal, and Atlantic walrus; the endangered northern and southern sea otters, the North Pacific right whale, and the Amazon River dolphin; and the critically threatened Baiji and Vaquita dolphin species.
Pollution risks
In Alaska, as of Aug. 7th, 2020, there were 4,221 confirmed cases of COVID-19 and this number continues to rise, according to the researchers. Since there is a diversity of marine mammals in Alaska and their populations are well documented, they compared this information with available data on the wastewater treatment plants in the state. They were thus able to determine the potential geographic locations and species at high risk for transmission of SARS-CoV-2 via wastewater effluent.
Among their findings, the city of Cold Bay discharges wastewater into Cold Bay, where there are Northern sea otter populations that are predicted to be highly susceptible to the virus. Beluga whales are also predicted to have high susceptibility and they can be found in Bristol Bay near Naknek, a city which relies only on lagoon treatment prior to the discharge of wastewater effluent; the city of Dillingham discharges wastewater into the Nushagak River where beluga whales are found. In Palmer, wastewater effluent flows into the Talkeetna River, which is a tributary to the Susitna River and home to two species predicted to have high susceptibility, beluga whales and harbor seals, the authors added.
Based on these results, the researchers predicted that there was likely a significant risk to sea mammals across the globe, especially where less-adequate treatment facilities and high population densities may lead to greater wastewater contamination.
“Given the proximity of marine animals to high-risk environments where viral spill over is likely, we must act with foresight to protect marine mammal species predicted to be at risk and mitigate the environmental impact of the COVID-19 pandemic,” the researchers concluded.
The authors reported that they had no disclosures.
SOURCE: Mathavarajah S et al. Sci Total Environ. 2020 Oct 29. doi: 10.1016/j.scitotenv.2020.143346.
Zoonoses are no respecter of biological boundaries and are notorious for crossing genus and even higher taxonomic boundaries. SARS-CoV-2 is no exception, the current outbreak most probably having originated in bats, a common source of human-affecting zoonoses throughout history. But it is not a one-way street, and the virus has been shown to spread from infected humans to a variety of other land mammals, including our domesticated animals and kept zoo species.
A recent troubling report, however, has indicated that sea mammals may be part of a next wave of likely candidates for infection, put at risk by the current human pandemic and environmental degradation on a global scale, according to a the results of a genomic analysis of four major groups of sea mammals.
Researchers Sabateeshan Mathavarajah and colleagues from Dalhousie University, Halifax, N.S., examined the sequences of the ACE2 receptors in the various marine mammal species. The ACE2 receptor has recently been identified as the SARS-CoV-2 receptor, which allows for infection.
The researchers examined genomic databases of the marine species to determine if their ACE2 receptor sequences indicated the potential for high, medium, or low susceptibility to infection, as reported in Science of the Total Environment. Database analysis was performed for four groups: Cetacea (whales and dolphins), Pinnepidia (seals), Sirenia (sea cows), and Fissipedia (sea otters and polar bears).
The researchers defined susceptibility values based on comparable binding with the receptor and came up with the following subgroups: higher than human, high (resembles human ACE2), medium (resembles cat ACE2), and low (resembles dog ACE2). It has yet to be established if these marine mammals actually are infected with SARS-CoV-2 and what the impact of such an infection might have on animal health or humans who come in contact with infected animals.
They also cross-referenced for the level of species endangerment and with maps of potential wastewater contamination for certain areas that species came in contact with, using Alaska as the model.
Populations in danger
The researchers found 15 species that are already at risk globally that fall under the categories of near threatened, vulnerable, endangered, and critically endangered that were predicted to be medium to higher susceptibility to the SARS-CoV-2 virus than humans. Cross infection is of particular concern because other coronaviruses have been shown to have severe and lethal effects among many of these species.
Among the potentially impacted species were the near threatened–status Antarctic Mink whale and the stellar sea lion; the vulnerable sperm whale, northern fur seal, and Atlantic walrus; the endangered northern and southern sea otters, the North Pacific right whale, and the Amazon River dolphin; and the critically threatened Baiji and Vaquita dolphin species.
Pollution risks
In Alaska, as of Aug. 7th, 2020, there were 4,221 confirmed cases of COVID-19 and this number continues to rise, according to the researchers. Since there is a diversity of marine mammals in Alaska and their populations are well documented, they compared this information with available data on the wastewater treatment plants in the state. They were thus able to determine the potential geographic locations and species at high risk for transmission of SARS-CoV-2 via wastewater effluent.
Among their findings, the city of Cold Bay discharges wastewater into Cold Bay, where there are Northern sea otter populations that are predicted to be highly susceptible to the virus. Beluga whales are also predicted to have high susceptibility and they can be found in Bristol Bay near Naknek, a city which relies only on lagoon treatment prior to the discharge of wastewater effluent; the city of Dillingham discharges wastewater into the Nushagak River where beluga whales are found. In Palmer, wastewater effluent flows into the Talkeetna River, which is a tributary to the Susitna River and home to two species predicted to have high susceptibility, beluga whales and harbor seals, the authors added.
Based on these results, the researchers predicted that there was likely a significant risk to sea mammals across the globe, especially where less-adequate treatment facilities and high population densities may lead to greater wastewater contamination.
“Given the proximity of marine animals to high-risk environments where viral spill over is likely, we must act with foresight to protect marine mammal species predicted to be at risk and mitigate the environmental impact of the COVID-19 pandemic,” the researchers concluded.
The authors reported that they had no disclosures.
SOURCE: Mathavarajah S et al. Sci Total Environ. 2020 Oct 29. doi: 10.1016/j.scitotenv.2020.143346.
FROM SCIENCE OF THE TOTAL ENVIRONMENT
Pfizer vaccine data show 90% efficacy in early results
A vaccine candidate against SARS-CoV-2 has been found to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus, results from an interim analysis of a phase 3 study demonstrated.
BTN162b2, a messenger RNA–based vaccine candidate that requires two doses, is being developed by Pfizer and BioNTech SE independently of the Trump administration’s Operation Warp Speed. A global phase 3 clinical trial of BTN162b2 began on July 27 and has enrolled 43,538 participants to date; 42% of enrollees have racially and ethnically diverse backgrounds.
According to a press release issued by the two companies, 38,955 trial volunteers had received a second dose of either vaccine or placebo as of Nov. 8. An interim analysis of 94 individuals conducted by an independent data monitoring committee (DMC) found that the vaccine efficacy rate was above 90% 7 days after the second dose. This means that protection was achieved 28 days after the first vaccine dose.
“It’s promising in that it validates the genetic strategy – whether it’s mRNA vaccines or DNA vaccines,” Paul A. Offit, MD, told Medscape Medical News. Offit is a member of the US Food and Drug Administraiton’s COVID-19 Vaccine Advisory Committee. “All of them have the same approach, which is that they introduce the gene that codes for the coronavirus spike protein into the cell. Your cell makes the spike protein, and your immune system makes antibodies to the spike protein. At least in these preliminary data, which involved 94 people getting sick, it looks like it’s effective. That’s good. We knew that it seemed to work in experimental animals, but you never know until you put it into people.”
According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed COVID-19 cases have accrued. So far, the DMC has not reported any serious safety concerns. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the FDA for emergency use authorization soon after the required safety milestone is achieved.
Pfizer CEO Albert Bourla, DVM, PhD, added in a separate press release, “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.
“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”
Offit, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, said that, if BTN162b2 is approved, administering it will be tricky. “This particular vaccine has to be shipped and stored at –70° C or –80° C, which we’ve never done before in this country,” he said. “That means maintaining the product on dry ice. That’s going to be a challenge for distribution, I think.”
Good news, but…
In the press release, BioNTech SE’s cofounder and CEO, Ugur Sahin, MD, characterized the findings as “a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
President-elect Joe Biden also weighed in, calling the results “excellent news” in a news release.
“At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away,” he said. “This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country.
“Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” Biden added.
This article first appeared on Medscape.com.
A vaccine candidate against SARS-CoV-2 has been found to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus, results from an interim analysis of a phase 3 study demonstrated.
BTN162b2, a messenger RNA–based vaccine candidate that requires two doses, is being developed by Pfizer and BioNTech SE independently of the Trump administration’s Operation Warp Speed. A global phase 3 clinical trial of BTN162b2 began on July 27 and has enrolled 43,538 participants to date; 42% of enrollees have racially and ethnically diverse backgrounds.
According to a press release issued by the two companies, 38,955 trial volunteers had received a second dose of either vaccine or placebo as of Nov. 8. An interim analysis of 94 individuals conducted by an independent data monitoring committee (DMC) found that the vaccine efficacy rate was above 90% 7 days after the second dose. This means that protection was achieved 28 days after the first vaccine dose.
“It’s promising in that it validates the genetic strategy – whether it’s mRNA vaccines or DNA vaccines,” Paul A. Offit, MD, told Medscape Medical News. Offit is a member of the US Food and Drug Administraiton’s COVID-19 Vaccine Advisory Committee. “All of them have the same approach, which is that they introduce the gene that codes for the coronavirus spike protein into the cell. Your cell makes the spike protein, and your immune system makes antibodies to the spike protein. At least in these preliminary data, which involved 94 people getting sick, it looks like it’s effective. That’s good. We knew that it seemed to work in experimental animals, but you never know until you put it into people.”
According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed COVID-19 cases have accrued. So far, the DMC has not reported any serious safety concerns. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the FDA for emergency use authorization soon after the required safety milestone is achieved.
Pfizer CEO Albert Bourla, DVM, PhD, added in a separate press release, “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.
“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”
Offit, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, said that, if BTN162b2 is approved, administering it will be tricky. “This particular vaccine has to be shipped and stored at –70° C or –80° C, which we’ve never done before in this country,” he said. “That means maintaining the product on dry ice. That’s going to be a challenge for distribution, I think.”
Good news, but…
In the press release, BioNTech SE’s cofounder and CEO, Ugur Sahin, MD, characterized the findings as “a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
President-elect Joe Biden also weighed in, calling the results “excellent news” in a news release.
“At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away,” he said. “This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country.
“Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” Biden added.
This article first appeared on Medscape.com.
A vaccine candidate against SARS-CoV-2 has been found to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus, results from an interim analysis of a phase 3 study demonstrated.
BTN162b2, a messenger RNA–based vaccine candidate that requires two doses, is being developed by Pfizer and BioNTech SE independently of the Trump administration’s Operation Warp Speed. A global phase 3 clinical trial of BTN162b2 began on July 27 and has enrolled 43,538 participants to date; 42% of enrollees have racially and ethnically diverse backgrounds.
According to a press release issued by the two companies, 38,955 trial volunteers had received a second dose of either vaccine or placebo as of Nov. 8. An interim analysis of 94 individuals conducted by an independent data monitoring committee (DMC) found that the vaccine efficacy rate was above 90% 7 days after the second dose. This means that protection was achieved 28 days after the first vaccine dose.
“It’s promising in that it validates the genetic strategy – whether it’s mRNA vaccines or DNA vaccines,” Paul A. Offit, MD, told Medscape Medical News. Offit is a member of the US Food and Drug Administraiton’s COVID-19 Vaccine Advisory Committee. “All of them have the same approach, which is that they introduce the gene that codes for the coronavirus spike protein into the cell. Your cell makes the spike protein, and your immune system makes antibodies to the spike protein. At least in these preliminary data, which involved 94 people getting sick, it looks like it’s effective. That’s good. We knew that it seemed to work in experimental animals, but you never know until you put it into people.”
According to Pfizer and BioNTech SE, a final data analysis is planned once 164 confirmed COVID-19 cases have accrued. So far, the DMC has not reported any serious safety concerns. It recommends that the study continue to collect safety and efficacy data as planned. The companies plan to apply to the FDA for emergency use authorization soon after the required safety milestone is achieved.
Pfizer CEO Albert Bourla, DVM, PhD, added in a separate press release, “It’s important to note that we cannot apply for FDA Emergency Use Authorization based on these efficacy results alone. More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study.
“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”
Offit, professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia, said that, if BTN162b2 is approved, administering it will be tricky. “This particular vaccine has to be shipped and stored at –70° C or –80° C, which we’ve never done before in this country,” he said. “That means maintaining the product on dry ice. That’s going to be a challenge for distribution, I think.”
Good news, but…
In the press release, BioNTech SE’s cofounder and CEO, Ugur Sahin, MD, characterized the findings as “a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
President-elect Joe Biden also weighed in, calling the results “excellent news” in a news release.
“At the same time, it is also important to understand that the end of the battle against COVID-19 is still months away,” he said. “This news follows a previously announced timeline by industry officials that forecast vaccine approval by late November. Even if that is achieved, and some Americans are vaccinated later this year, it will be many more months before there is widespread vaccination in this country.
“Today’s news does not change this urgent reality. Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year,” Biden added.
This article first appeared on Medscape.com.
Cystic fibrosis patients’ vulnerability to COVID-19 infection: Preliminary data ease fears
But early results suggest that social distance measures and perhaps the younger average age of individuals with CF have prevented a severe impact on this patient population.
Not all of the news is good. Some research suggests that posttransplant individuals may be at greater risk of severe outcomes. However, researchers warned that the data are too sparse to draw firm conclusions, and ongoing analyses of patient registries and other sources should lend greater insight into the burden of COVID-19 among individuals with CF. Those were some of the conclusions presented at a session of the virtual North American Cystic Fibrosis Conference.
D.B. Sanders, MD, who is a pediatric pulmonologist at Riley Hospital for Children and the Indiana University, both in Indianapolis, presented data from the Cystic Fibrosis Foundation’s Patient Registry, which includes patients in the United States. As in other populations, he showed that health care use has gone down among individuals with CF. From April to September 2019, 81% of clinical encounters were in the clinic and 12% in the hospital. Over the same period in 2020, those numbers dropped to 35% and 4%, respectively, with 30% by phone or computer. In-person health care use rebounded somewhat between July 1 and Sept. 16, with 53% of encounters at the clinic, 5% at the hospital, and 28% conducted virtually. There were also dips in forced expiratory volume in one second (FEV1) and microbiology testing, from about 90% occurring during health encounters at the end of 2019 to fewer than 10% of encounters by April.
As of Aug. 17, Dr. Sanders reported that 3,048 individuals with CF had been tested for COVID-19, with 174 positive results.
Racial and ethnic disparities in positive test results seen in other populations were also observable among individuals with CF. Several groups made up a higher proportion of COVID-19–positive CF patients than the general CF population, including Hispanics (18% vs. 9%), Blacks (7% vs. 5%), and individuals with FEV1 value less than 40% predicted (14% vs. 8%).
As of Sept. 17, there had been 51 hospitalizations and two deaths in the United States among 212 individuals with CF who tested positive for COVID-19, with increasing numbers that mirror trends in the U.S. population. One death occurred in a patient with advanced lung disease, the other in a post–lung transplant patient. “Thankfully [the numbers are] not higher, but this is being followed very closely,” said Dr. Sanders during his presentation.
One encouraging bit of news was that hospitalizations among individuals with CF have dropped since the start of the pandemic. “I think this shows how good our families are at socially distancing, wearing masks, and now that they not being exposed to viruses, I think we’re seeing the fruits of this with fewer hospitalizations,” said Dr. Sanders. He noted that it’s possible some of the decline could have been to reluctance to go to the hospital, and the introduction of triple combination cystic fibrosis transmembrane conductance regulator modulator therapy has also likely contributed. “We were already seeing fewer hospitalizations even before the pandemic hit,” he said.
At the session, Rebecca Cosgriff, director of data and quality improvement at the Cystic Fibrosis Trust in the United Kingdom, presented an international perspective on COVID-19 cases among individuals with CF. At the beginning of the pandemic, the Cystic Fibrosis Global Registry Harmonization Group recruited country coordinators to collect anonymized data on infections, hospitalizations, and other outcomes. In April, the group published its initial findings from 40 cases in eight countries, which concluded that these cases generally resembled the broader population in clinical course, which assuaged initial fears.
Ms. Cosgriff reported on results from a second round of data collection with a cutoff date of June 19, which expanded to 19 countries and included many from South America and more in Europe. The network encompassed about 85,000 individuals with CF, and tallied 181 cases of COVID-19. A total of 149 cases were nontransplant, and 32 were posttransplant (28 lung only). Fully 15% of the nontransplant group were over age 40 years, compared with 41% in the transplant group. Homozygous F508del mutations were more common in the posttransplant group (59% vs. 36%). However, lung function, as estimated by the best FEV1 measured in the previous year prior to infection, differed between the nontransplant (73%) and posttransplant (80%) COVID-19 patients.
Across all age groups, hospitalizations were more common in patients with best FEV1 percentage predicted values less than 70% (P = .001). Ms. Cosgriff also expressed concern about the posttransplant group. “Across all outcomes that might be indicative of infection severity – hospitalization, ICU admission, new supplementary oxygen, and non-invasive ventilation – the proportion of the posttransplant group was higher across the board,” she said during her presentation.
There were seven deaths. Ms. Cosgriff noted that there were too few deaths to analyze trends, but she presented a slide showing characteristics of deceased patients. “Factors like being post–lung transplant, being male, having less FEV1 than predicted, being over 40, or having CF-related diabetes, all appear pretty frequently amongst the cohort of people who died,” she said.
Overall, the results of these surveys are encouraging, suggesting that early fears that COVID-19 cases could be more severe among individuals with CF may not have been borne out so far. Dr. Sanders noted in his talk that there aren’t enough cases in the U.S. cohort to show links to risk factors with statistical significance. “But thankfully we’re not seeing a host of negative outcomes,” he said.
Dr. Sanders and Ms Cosgriff have no relevant financial disclosures.
But early results suggest that social distance measures and perhaps the younger average age of individuals with CF have prevented a severe impact on this patient population.
Not all of the news is good. Some research suggests that posttransplant individuals may be at greater risk of severe outcomes. However, researchers warned that the data are too sparse to draw firm conclusions, and ongoing analyses of patient registries and other sources should lend greater insight into the burden of COVID-19 among individuals with CF. Those were some of the conclusions presented at a session of the virtual North American Cystic Fibrosis Conference.
D.B. Sanders, MD, who is a pediatric pulmonologist at Riley Hospital for Children and the Indiana University, both in Indianapolis, presented data from the Cystic Fibrosis Foundation’s Patient Registry, which includes patients in the United States. As in other populations, he showed that health care use has gone down among individuals with CF. From April to September 2019, 81% of clinical encounters were in the clinic and 12% in the hospital. Over the same period in 2020, those numbers dropped to 35% and 4%, respectively, with 30% by phone or computer. In-person health care use rebounded somewhat between July 1 and Sept. 16, with 53% of encounters at the clinic, 5% at the hospital, and 28% conducted virtually. There were also dips in forced expiratory volume in one second (FEV1) and microbiology testing, from about 90% occurring during health encounters at the end of 2019 to fewer than 10% of encounters by April.
As of Aug. 17, Dr. Sanders reported that 3,048 individuals with CF had been tested for COVID-19, with 174 positive results.
Racial and ethnic disparities in positive test results seen in other populations were also observable among individuals with CF. Several groups made up a higher proportion of COVID-19–positive CF patients than the general CF population, including Hispanics (18% vs. 9%), Blacks (7% vs. 5%), and individuals with FEV1 value less than 40% predicted (14% vs. 8%).
As of Sept. 17, there had been 51 hospitalizations and two deaths in the United States among 212 individuals with CF who tested positive for COVID-19, with increasing numbers that mirror trends in the U.S. population. One death occurred in a patient with advanced lung disease, the other in a post–lung transplant patient. “Thankfully [the numbers are] not higher, but this is being followed very closely,” said Dr. Sanders during his presentation.
One encouraging bit of news was that hospitalizations among individuals with CF have dropped since the start of the pandemic. “I think this shows how good our families are at socially distancing, wearing masks, and now that they not being exposed to viruses, I think we’re seeing the fruits of this with fewer hospitalizations,” said Dr. Sanders. He noted that it’s possible some of the decline could have been to reluctance to go to the hospital, and the introduction of triple combination cystic fibrosis transmembrane conductance regulator modulator therapy has also likely contributed. “We were already seeing fewer hospitalizations even before the pandemic hit,” he said.
At the session, Rebecca Cosgriff, director of data and quality improvement at the Cystic Fibrosis Trust in the United Kingdom, presented an international perspective on COVID-19 cases among individuals with CF. At the beginning of the pandemic, the Cystic Fibrosis Global Registry Harmonization Group recruited country coordinators to collect anonymized data on infections, hospitalizations, and other outcomes. In April, the group published its initial findings from 40 cases in eight countries, which concluded that these cases generally resembled the broader population in clinical course, which assuaged initial fears.
Ms. Cosgriff reported on results from a second round of data collection with a cutoff date of June 19, which expanded to 19 countries and included many from South America and more in Europe. The network encompassed about 85,000 individuals with CF, and tallied 181 cases of COVID-19. A total of 149 cases were nontransplant, and 32 were posttransplant (28 lung only). Fully 15% of the nontransplant group were over age 40 years, compared with 41% in the transplant group. Homozygous F508del mutations were more common in the posttransplant group (59% vs. 36%). However, lung function, as estimated by the best FEV1 measured in the previous year prior to infection, differed between the nontransplant (73%) and posttransplant (80%) COVID-19 patients.
Across all age groups, hospitalizations were more common in patients with best FEV1 percentage predicted values less than 70% (P = .001). Ms. Cosgriff also expressed concern about the posttransplant group. “Across all outcomes that might be indicative of infection severity – hospitalization, ICU admission, new supplementary oxygen, and non-invasive ventilation – the proportion of the posttransplant group was higher across the board,” she said during her presentation.
There were seven deaths. Ms. Cosgriff noted that there were too few deaths to analyze trends, but she presented a slide showing characteristics of deceased patients. “Factors like being post–lung transplant, being male, having less FEV1 than predicted, being over 40, or having CF-related diabetes, all appear pretty frequently amongst the cohort of people who died,” she said.
Overall, the results of these surveys are encouraging, suggesting that early fears that COVID-19 cases could be more severe among individuals with CF may not have been borne out so far. Dr. Sanders noted in his talk that there aren’t enough cases in the U.S. cohort to show links to risk factors with statistical significance. “But thankfully we’re not seeing a host of negative outcomes,” he said.
Dr. Sanders and Ms Cosgriff have no relevant financial disclosures.
But early results suggest that social distance measures and perhaps the younger average age of individuals with CF have prevented a severe impact on this patient population.
Not all of the news is good. Some research suggests that posttransplant individuals may be at greater risk of severe outcomes. However, researchers warned that the data are too sparse to draw firm conclusions, and ongoing analyses of patient registries and other sources should lend greater insight into the burden of COVID-19 among individuals with CF. Those were some of the conclusions presented at a session of the virtual North American Cystic Fibrosis Conference.
D.B. Sanders, MD, who is a pediatric pulmonologist at Riley Hospital for Children and the Indiana University, both in Indianapolis, presented data from the Cystic Fibrosis Foundation’s Patient Registry, which includes patients in the United States. As in other populations, he showed that health care use has gone down among individuals with CF. From April to September 2019, 81% of clinical encounters were in the clinic and 12% in the hospital. Over the same period in 2020, those numbers dropped to 35% and 4%, respectively, with 30% by phone or computer. In-person health care use rebounded somewhat between July 1 and Sept. 16, with 53% of encounters at the clinic, 5% at the hospital, and 28% conducted virtually. There were also dips in forced expiratory volume in one second (FEV1) and microbiology testing, from about 90% occurring during health encounters at the end of 2019 to fewer than 10% of encounters by April.
As of Aug. 17, Dr. Sanders reported that 3,048 individuals with CF had been tested for COVID-19, with 174 positive results.
Racial and ethnic disparities in positive test results seen in other populations were also observable among individuals with CF. Several groups made up a higher proportion of COVID-19–positive CF patients than the general CF population, including Hispanics (18% vs. 9%), Blacks (7% vs. 5%), and individuals with FEV1 value less than 40% predicted (14% vs. 8%).
As of Sept. 17, there had been 51 hospitalizations and two deaths in the United States among 212 individuals with CF who tested positive for COVID-19, with increasing numbers that mirror trends in the U.S. population. One death occurred in a patient with advanced lung disease, the other in a post–lung transplant patient. “Thankfully [the numbers are] not higher, but this is being followed very closely,” said Dr. Sanders during his presentation.
One encouraging bit of news was that hospitalizations among individuals with CF have dropped since the start of the pandemic. “I think this shows how good our families are at socially distancing, wearing masks, and now that they not being exposed to viruses, I think we’re seeing the fruits of this with fewer hospitalizations,” said Dr. Sanders. He noted that it’s possible some of the decline could have been to reluctance to go to the hospital, and the introduction of triple combination cystic fibrosis transmembrane conductance regulator modulator therapy has also likely contributed. “We were already seeing fewer hospitalizations even before the pandemic hit,” he said.
At the session, Rebecca Cosgriff, director of data and quality improvement at the Cystic Fibrosis Trust in the United Kingdom, presented an international perspective on COVID-19 cases among individuals with CF. At the beginning of the pandemic, the Cystic Fibrosis Global Registry Harmonization Group recruited country coordinators to collect anonymized data on infections, hospitalizations, and other outcomes. In April, the group published its initial findings from 40 cases in eight countries, which concluded that these cases generally resembled the broader population in clinical course, which assuaged initial fears.
Ms. Cosgriff reported on results from a second round of data collection with a cutoff date of June 19, which expanded to 19 countries and included many from South America and more in Europe. The network encompassed about 85,000 individuals with CF, and tallied 181 cases of COVID-19. A total of 149 cases were nontransplant, and 32 were posttransplant (28 lung only). Fully 15% of the nontransplant group were over age 40 years, compared with 41% in the transplant group. Homozygous F508del mutations were more common in the posttransplant group (59% vs. 36%). However, lung function, as estimated by the best FEV1 measured in the previous year prior to infection, differed between the nontransplant (73%) and posttransplant (80%) COVID-19 patients.
Across all age groups, hospitalizations were more common in patients with best FEV1 percentage predicted values less than 70% (P = .001). Ms. Cosgriff also expressed concern about the posttransplant group. “Across all outcomes that might be indicative of infection severity – hospitalization, ICU admission, new supplementary oxygen, and non-invasive ventilation – the proportion of the posttransplant group was higher across the board,” she said during her presentation.
There were seven deaths. Ms. Cosgriff noted that there were too few deaths to analyze trends, but she presented a slide showing characteristics of deceased patients. “Factors like being post–lung transplant, being male, having less FEV1 than predicted, being over 40, or having CF-related diabetes, all appear pretty frequently amongst the cohort of people who died,” she said.
Overall, the results of these surveys are encouraging, suggesting that early fears that COVID-19 cases could be more severe among individuals with CF may not have been borne out so far. Dr. Sanders noted in his talk that there aren’t enough cases in the U.S. cohort to show links to risk factors with statistical significance. “But thankfully we’re not seeing a host of negative outcomes,” he said.
Dr. Sanders and Ms Cosgriff have no relevant financial disclosures.
FROM NACFC 2020
VA joins Pentagon in recruiting volunteers for COVID vaccine trials
according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.
The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system. DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.
Both federal departments have long experience in medical research and diverse populations – a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington.
Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Mr. Morrison said.
“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Mr. Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”
According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting – or have completed recruitment – for advanced-stage trials for Moderna, AstraZeneca, and Pfizer vaccines.
Matthew Hepburn, MD, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.
“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Dr. Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.
It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.
In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, MD, a doctor and former deputy surgeon general for the Navy.
Military health facilities are held to the same standards as private research facilities, he said.
No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.
Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.
That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program, and 6 in 10 said they were not satisfied with the information they were given on the vaccines.
To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least 2 years.
In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.
At the VA, officials are seeking to recruit healthy veterans aged 18-65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.
Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.
The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.
Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.
But Mr. Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.
“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Mr. Morrison said.
The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.
The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.
Senator Elizabeth Warren (D-Mass.) and Senator Mazie Hirono (D-Hawaii) have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution. The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.
“There may well be a valuable role for DoD officials in [Operation Warp Speed] – particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”
Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.
The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system. DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.
Both federal departments have long experience in medical research and diverse populations – a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington.
Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Mr. Morrison said.
“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Mr. Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”
According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting – or have completed recruitment – for advanced-stage trials for Moderna, AstraZeneca, and Pfizer vaccines.
Matthew Hepburn, MD, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.
“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Dr. Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.
It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.
In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, MD, a doctor and former deputy surgeon general for the Navy.
Military health facilities are held to the same standards as private research facilities, he said.
No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.
Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.
That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program, and 6 in 10 said they were not satisfied with the information they were given on the vaccines.
To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least 2 years.
In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.
At the VA, officials are seeking to recruit healthy veterans aged 18-65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.
Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.
The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.
Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.
But Mr. Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.
“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Mr. Morrison said.
The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.
The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.
Senator Elizabeth Warren (D-Mass.) and Senator Mazie Hirono (D-Hawaii) have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution. The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.
“There may well be a valuable role for DoD officials in [Operation Warp Speed] – particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”
Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
according to officials with the VA and Operation Warp Speed, the Trump administration’s initiative to fast-track a coronavirus vaccine.
The largely unpublicized effort follows a Department of Defense announcement in September that it has partnered with AstraZeneca to recruit volunteers at five of its medical facilities, which are separate from the VA system. DOD is also is in talks with developers of other vaccine candidates, although officials won’t say which ones.
Both federal departments have long experience in medical research and diverse populations – a crucial component of effective clinical trials, said J. Stephen Morrison, senior vice president and director of global health policy at the Center for Strategic and International Studies, a bipartisan think tank in Washington.
Since active troops are essential to national security, and veterans are extremely vulnerable to COVID-19, both departments have a vested interest in supporting the development of safe, effective vaccines, Mr. Morrison said.
“On the DOD active servicemen and -women side, it’s a question of making sure they’re ready, they are protected,” Mr. Morrison said. “With VA, their population, all elderly and infirm with underlying conditions, they could really be suffering if we don’t get a vaccine.”
According to a VA website, of its 20 medical centers involved, 17 would be part of the Johnson & Johnson vaccine trial, while the three others are recruiting – or have completed recruitment – for advanced-stage trials for Moderna, AstraZeneca, and Pfizer vaccines.
Matthew Hepburn, MD, head of vaccine development at Operation Warp Speed, said the VA effort lets veterans contribute to the overall well-being of the country.
“This is another way they can continue to serve in this way, fighting the pandemic as a volunteer,” Dr. Hepburn said during a discussion of vaccine and therapeutics development hosted by the Heritage Foundation on Oct. 27.
It’s not unusual for the military to participate in multicenter trials for treatments of ailments as diverse as cancer and trauma. Historically, many vaccines have been tested first by the military.
In the general population, clinicians often have difficulty recruiting African Americans and other minorities for medical research, and “the military provides a rich opportunity to find volunteers for those groups,” said retired Rear Adm. Thomas Cullison, MD, a doctor and former deputy surgeon general for the Navy.
Military health facilities are held to the same standards as private research facilities, he said.
No service members will be required to participate in the COVID vaccine trials. All volunteers will be paid by the developer.
Support for routine vaccinations runs high in the military, but some have expressed concerns about new vaccines and mandatory inoculations, especially for anthrax. In a 2002 federal study, 85% of those who received that vaccine reported an adverse reaction, with just under half noticing minor redness at the injection site. But nearly a quarter of the side effects reported were more systemic, including fevers, chills, fatigue and joint pain.
That survey of a small group of National Guard and Reserve members found that, while 73% said they believe immunizations are effective, two-thirds said they did not support the mandatory anthrax program, and 6 in 10 said they were not satisfied with the information they were given on the vaccines.
To quell concerns over the military’s role in supporting COVID vaccine development, the Pentagon has reiterated that troops or their dependents interested in participating in the research must provide voluntary written consent, and they will be allowed to take part only if they will be in the same location for the length of the research, expected to last at least 2 years.
In addition, active-duty members such as new recruits and boot camp participants will not be allowed to volunteer because they are “considered vulnerable from an ethical and regulatory standpoint,” an official said.
At the VA, officials are seeking to recruit healthy veterans aged 18-65 years old who are not pregnant and may be at risk for exposure. As with trials conducted in civilian facilities, participants will be paid by the developer, VA spokesperson Christina Noel said.
Also, VA nurses and caseworkers also are being asked to identify their sickest, highest-risk patients to determine who should be at the top of the list once a vaccine is approved, according to a VA nurse and other health officials who asked not to be identified because they were not authorized to speak with the press.
The U.S. military has a long history of contributing to research on vaccines, including a key role in developing inoculations against yellow fever and adenovirus, and the Walter Reed Army Institute of Research is developing its own vaccine against the coronavirus.
Some segments of the population remain skeptical of federal medical experiments. A survey by AP-NORC in May found that Black people are particularly reluctant to get the coronavirus vaccine. Many have concerns about federal research in part because of associations with the infamous Tuskegee Institute syphilis experiments, in which U.S. Public Health Service officials intentionally withheld a cure from Black men infected with the disease.
But Mr. Morrison, of the Center for Strategic and International Studies, said the Defense Department and VA are a “natural fit” for the COVID vaccine trials.
“DOD has lots of expertise. They know how to vaccinate; they know how to reach communities. They have a whole science infrastructure and research-and-development infrastructure. And when you are thinking what the mission of VA is, [VA] sees this is part of their mission,” Mr. Morrison said.
The Defense Department announced its agreement with AstraZeneca in September, shortly before the drugmaker’s vaccine trial was put on hold to study a serious medical condition that one participant reported. That research was approved by the Food and Drug Administration to begin again Oct. 23. The military plans to restart its efforts to recruit 3,000 volunteers.
The Pentagon has also signed an agreement with another vaccine developer, the head of the Defense Health Agency, Army Lt. Gen. Ronald Place, told reporters Oct. 8. He wouldn’t provide the company’s name.
Senator Elizabeth Warren (D-Mass.) and Senator Mazie Hirono (D-Hawaii) have called, unsuccessfully, for the Senate Armed Services Committee to investigate what they say is a lack of Pentagon transparency on its role in vaccine development and distribution. The Defense Department has awarded more than $6 billion in Operation Warp Speed contracts through an intermediary, Advanced Technology International, and the two senators want more information about those contracts.
“There may well be a valuable role for DoD officials in [Operation Warp Speed] – particularly given the department’s logistical capacity,” they wrote to the committee chair and ranking member. “But it is important that Congress conduct appropriate oversight of, and understand, DoD’s activities in this area.”
Neither department has disclosed the financial arrangements they have made with developers to support the vaccine research.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Pregnancy can be safe with interstitial lung disease
Pregnant women with interstitial lung disease (ILD) related to autoimmune disease may not need to terminate their pregnancies if they have close monitoring before, during, and after pregnancy with a multidisciplinary team of physicians, new research suggests.
Senior author Megan Clowse, MD, MPH, associate professor of medicine in the division of rheumatology at Duke University, Durham, N.C., explained during a press conference at the virtual annual meeting of the American College of Rheumatology that women with ILD are often advised by obstetricians or rheumatologists to avoid conception or terminate their pregnancies, though evidence for that has been based on small studies of 9-15 patients that have had mixed results.
“Many of these pregnancies were delivered 20-30 years ago, definitely with different rheumatic and obstetric care than we can provide now,” she said. “It’s really time to rethink our approach to interstitial lung disease and pregnancy.”
This study showed that while adverse pregnancy outcomes are common in these women, overall maternal morbidity and mortality are low.
ILD may be a secondary disease in people who have scleroderma, lupus, and sarcoidosis.
Largest study to date
This Pfizer-sponsored retrospective study of 67 pregnant women is the largest to date, and it analyzed 94 pregnancies (including five sets of twins).
Sarah Rae Easter, MD, maternal-fetal medicine doctor in the department of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, called the work “exciting” as the researchers were able to look back at a large number of cases for a rare condition for more than 20 years.
“Their data provides much-needed evidence to provide some reassurance for women affected by this type of pulmonary disease regarding the relative safety of pregnancy,” she said in an interview.
Study spanned 23 years
The researchers reviewed pregnancy records in patients diagnosed with ILD secondary to autoimmune disease at Duke University Health System from January 1996 to July 2019.
They classified the severity of ILD based on two standard breathing tests – forced vital capacity and diffusion capacity for carbon monoxide.
Overall, 69% of the women were diagnosed with sarcoidosis and the remaining 31% had a connective tissue disease associated with ILD (CTD-ILD). Of those measured for ILD severity, 11% were severe, 25% were moderate, 50% were mild, and 14% were normal. Their average maternal age was 32.1 and 83% were Black.
While 70% of the pregnancies resulted in live births, 9% were terminated. The remainder resulted in miscarriage or stillbirth.
Researchers reported a 15% rate of preeclampsia, a 34% rate of the composite measure PROMISSE-Adverse Pregnancy Outcome (APO), and a 15% rate of PROMISSE-APO SEVERE. Patients with severe disease had the highest rates of PROMISSE-APO (P = .03 across groups).
(PROMISSE stands for the Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus study.)
None of the women died
Dr. Clowse said it was a pleasant surprise to find that none of the women died, though patients with severe ILD had more adverse outcomes. Only 2.1% were treated in an intensive care unit during or soon after delivery. In 4.2%, ILD patients had significant shortness of breath due to fluid volume overload around the time of delivery.
For the women who had normal-to-moderate lung disease, Dr. Clowse said, “they really had remarkably good outcomes, really pretty comparable to the general population. About 15% delivered preterm and about 20% suffered a pregnancy loss.”
Dr. Easter, who was not involved with the study, noted the large number of Black women in the cohort.
“Focusing in on improving outcomes for Black and Brown women related to pregnancy in our country is a much-needed undertaking,” Dr. Easter said.
Being able to quote percentages from this research, based on a good-sized study “at least gives people a benchmark about what kind of risk they are willing to assume for themselves,” she said.
For providers, being able to place this rare disease within the spectrum of other diseases where there is more data is also very helpful, she said.
Dr. Clowse said in an interview that the preponderance of Black women in the study was a surprise but may be explained by two factors: Sarcoidosis is seen more frequently in Black women and in the study area in North Carolina there is a large population of Black women.
“Also, our patients with more severe lupus, the ones who are more likely to have interstitial lung disease, are often Black and that’s likely contributing as well,” she said.
Multidisciplinary teams advised
Dr. Clowse emphasized that women with ILD need multidisciplinary teams in pregnancy and should be managed at tertiary care centers where there is a full complement of obstetric and internal medicine experts.
“We do recommend evaluating the severity of their lungs and their heart disease around the time of pregnancy and during pregnancy if they have shortness of breath,” she said.
“We currently recommend that these patients with moderate or severe disease stay in the hospital for up to a week, just for monitoring,” she said.
Dr. Easter said having that kind of access to a large academic healthcare center should be an important part of the decision-making.
Patients need to think about whether they would have access to care similar to what the researchers are describing when they are making the decision to pursue or continue pregnancy, she said.
The study was sponsored by Pfizer Inc. Dr. Clowse reported relationships with UCB, GlaxoSmithKline, AstraZeneca, and Pfizer. Dr. Easter has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Pregnant women with interstitial lung disease (ILD) related to autoimmune disease may not need to terminate their pregnancies if they have close monitoring before, during, and after pregnancy with a multidisciplinary team of physicians, new research suggests.
Senior author Megan Clowse, MD, MPH, associate professor of medicine in the division of rheumatology at Duke University, Durham, N.C., explained during a press conference at the virtual annual meeting of the American College of Rheumatology that women with ILD are often advised by obstetricians or rheumatologists to avoid conception or terminate their pregnancies, though evidence for that has been based on small studies of 9-15 patients that have had mixed results.
“Many of these pregnancies were delivered 20-30 years ago, definitely with different rheumatic and obstetric care than we can provide now,” she said. “It’s really time to rethink our approach to interstitial lung disease and pregnancy.”
This study showed that while adverse pregnancy outcomes are common in these women, overall maternal morbidity and mortality are low.
ILD may be a secondary disease in people who have scleroderma, lupus, and sarcoidosis.
Largest study to date
This Pfizer-sponsored retrospective study of 67 pregnant women is the largest to date, and it analyzed 94 pregnancies (including five sets of twins).
Sarah Rae Easter, MD, maternal-fetal medicine doctor in the department of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, called the work “exciting” as the researchers were able to look back at a large number of cases for a rare condition for more than 20 years.
“Their data provides much-needed evidence to provide some reassurance for women affected by this type of pulmonary disease regarding the relative safety of pregnancy,” she said in an interview.
Study spanned 23 years
The researchers reviewed pregnancy records in patients diagnosed with ILD secondary to autoimmune disease at Duke University Health System from January 1996 to July 2019.
They classified the severity of ILD based on two standard breathing tests – forced vital capacity and diffusion capacity for carbon monoxide.
Overall, 69% of the women were diagnosed with sarcoidosis and the remaining 31% had a connective tissue disease associated with ILD (CTD-ILD). Of those measured for ILD severity, 11% were severe, 25% were moderate, 50% were mild, and 14% were normal. Their average maternal age was 32.1 and 83% were Black.
While 70% of the pregnancies resulted in live births, 9% were terminated. The remainder resulted in miscarriage or stillbirth.
Researchers reported a 15% rate of preeclampsia, a 34% rate of the composite measure PROMISSE-Adverse Pregnancy Outcome (APO), and a 15% rate of PROMISSE-APO SEVERE. Patients with severe disease had the highest rates of PROMISSE-APO (P = .03 across groups).
(PROMISSE stands for the Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus study.)
None of the women died
Dr. Clowse said it was a pleasant surprise to find that none of the women died, though patients with severe ILD had more adverse outcomes. Only 2.1% were treated in an intensive care unit during or soon after delivery. In 4.2%, ILD patients had significant shortness of breath due to fluid volume overload around the time of delivery.
For the women who had normal-to-moderate lung disease, Dr. Clowse said, “they really had remarkably good outcomes, really pretty comparable to the general population. About 15% delivered preterm and about 20% suffered a pregnancy loss.”
Dr. Easter, who was not involved with the study, noted the large number of Black women in the cohort.
“Focusing in on improving outcomes for Black and Brown women related to pregnancy in our country is a much-needed undertaking,” Dr. Easter said.
Being able to quote percentages from this research, based on a good-sized study “at least gives people a benchmark about what kind of risk they are willing to assume for themselves,” she said.
For providers, being able to place this rare disease within the spectrum of other diseases where there is more data is also very helpful, she said.
Dr. Clowse said in an interview that the preponderance of Black women in the study was a surprise but may be explained by two factors: Sarcoidosis is seen more frequently in Black women and in the study area in North Carolina there is a large population of Black women.
“Also, our patients with more severe lupus, the ones who are more likely to have interstitial lung disease, are often Black and that’s likely contributing as well,” she said.
Multidisciplinary teams advised
Dr. Clowse emphasized that women with ILD need multidisciplinary teams in pregnancy and should be managed at tertiary care centers where there is a full complement of obstetric and internal medicine experts.
“We do recommend evaluating the severity of their lungs and their heart disease around the time of pregnancy and during pregnancy if they have shortness of breath,” she said.
“We currently recommend that these patients with moderate or severe disease stay in the hospital for up to a week, just for monitoring,” she said.
Dr. Easter said having that kind of access to a large academic healthcare center should be an important part of the decision-making.
Patients need to think about whether they would have access to care similar to what the researchers are describing when they are making the decision to pursue or continue pregnancy, she said.
The study was sponsored by Pfizer Inc. Dr. Clowse reported relationships with UCB, GlaxoSmithKline, AstraZeneca, and Pfizer. Dr. Easter has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Pregnant women with interstitial lung disease (ILD) related to autoimmune disease may not need to terminate their pregnancies if they have close monitoring before, during, and after pregnancy with a multidisciplinary team of physicians, new research suggests.
Senior author Megan Clowse, MD, MPH, associate professor of medicine in the division of rheumatology at Duke University, Durham, N.C., explained during a press conference at the virtual annual meeting of the American College of Rheumatology that women with ILD are often advised by obstetricians or rheumatologists to avoid conception or terminate their pregnancies, though evidence for that has been based on small studies of 9-15 patients that have had mixed results.
“Many of these pregnancies were delivered 20-30 years ago, definitely with different rheumatic and obstetric care than we can provide now,” she said. “It’s really time to rethink our approach to interstitial lung disease and pregnancy.”
This study showed that while adverse pregnancy outcomes are common in these women, overall maternal morbidity and mortality are low.
ILD may be a secondary disease in people who have scleroderma, lupus, and sarcoidosis.
Largest study to date
This Pfizer-sponsored retrospective study of 67 pregnant women is the largest to date, and it analyzed 94 pregnancies (including five sets of twins).
Sarah Rae Easter, MD, maternal-fetal medicine doctor in the department of obstetrics and gynecology at Brigham and Women’s Hospital, Boston, called the work “exciting” as the researchers were able to look back at a large number of cases for a rare condition for more than 20 years.
“Their data provides much-needed evidence to provide some reassurance for women affected by this type of pulmonary disease regarding the relative safety of pregnancy,” she said in an interview.
Study spanned 23 years
The researchers reviewed pregnancy records in patients diagnosed with ILD secondary to autoimmune disease at Duke University Health System from January 1996 to July 2019.
They classified the severity of ILD based on two standard breathing tests – forced vital capacity and diffusion capacity for carbon monoxide.
Overall, 69% of the women were diagnosed with sarcoidosis and the remaining 31% had a connective tissue disease associated with ILD (CTD-ILD). Of those measured for ILD severity, 11% were severe, 25% were moderate, 50% were mild, and 14% were normal. Their average maternal age was 32.1 and 83% were Black.
While 70% of the pregnancies resulted in live births, 9% were terminated. The remainder resulted in miscarriage or stillbirth.
Researchers reported a 15% rate of preeclampsia, a 34% rate of the composite measure PROMISSE-Adverse Pregnancy Outcome (APO), and a 15% rate of PROMISSE-APO SEVERE. Patients with severe disease had the highest rates of PROMISSE-APO (P = .03 across groups).
(PROMISSE stands for the Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus study.)
None of the women died
Dr. Clowse said it was a pleasant surprise to find that none of the women died, though patients with severe ILD had more adverse outcomes. Only 2.1% were treated in an intensive care unit during or soon after delivery. In 4.2%, ILD patients had significant shortness of breath due to fluid volume overload around the time of delivery.
For the women who had normal-to-moderate lung disease, Dr. Clowse said, “they really had remarkably good outcomes, really pretty comparable to the general population. About 15% delivered preterm and about 20% suffered a pregnancy loss.”
Dr. Easter, who was not involved with the study, noted the large number of Black women in the cohort.
“Focusing in on improving outcomes for Black and Brown women related to pregnancy in our country is a much-needed undertaking,” Dr. Easter said.
Being able to quote percentages from this research, based on a good-sized study “at least gives people a benchmark about what kind of risk they are willing to assume for themselves,” she said.
For providers, being able to place this rare disease within the spectrum of other diseases where there is more data is also very helpful, she said.
Dr. Clowse said in an interview that the preponderance of Black women in the study was a surprise but may be explained by two factors: Sarcoidosis is seen more frequently in Black women and in the study area in North Carolina there is a large population of Black women.
“Also, our patients with more severe lupus, the ones who are more likely to have interstitial lung disease, are often Black and that’s likely contributing as well,” she said.
Multidisciplinary teams advised
Dr. Clowse emphasized that women with ILD need multidisciplinary teams in pregnancy and should be managed at tertiary care centers where there is a full complement of obstetric and internal medicine experts.
“We do recommend evaluating the severity of their lungs and their heart disease around the time of pregnancy and during pregnancy if they have shortness of breath,” she said.
“We currently recommend that these patients with moderate or severe disease stay in the hospital for up to a week, just for monitoring,” she said.
Dr. Easter said having that kind of access to a large academic healthcare center should be an important part of the decision-making.
Patients need to think about whether they would have access to care similar to what the researchers are describing when they are making the decision to pursue or continue pregnancy, she said.
The study was sponsored by Pfizer Inc. Dr. Clowse reported relationships with UCB, GlaxoSmithKline, AstraZeneca, and Pfizer. Dr. Easter has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.