Damian McNamara

If you, a friend, or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk of dying if you become infected.

That’s the conclusion of a new report released by the Associated Press looking at COVID-19 deaths during May 2021.

Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That’s less than 1%.

“Recently, I was working in the emergency room [and] I saw a 21-year-old African American who came in with shortness of breath,” said Vino K. Palli, MD, MPH, a physician specializing in emergency medicine, internal medicine, and urgent care.

The patient rapidly deteriorated and required intubation and ventilation. She was transferred to a specialized hospital for possible extracorporeal membrane oxygenation (ECMO) treatment.

“This patient was unvaccinated, along with her entire family. This would have been easily preventable,” added Dr. Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City.

“Vaccine misinformation, compounded with vaccine inertia and vaccine access, have contributed to this,” he added. “Even though we have a surplus amount of vaccines at this time, we are only seeing 50% to 55% of completely vaccinated patients.”

Authors of the Associated Press report also acknowledge that some people who are fully vaccinated can get a breakthrough infection. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%.

The Associated Press came up with these numbers using data from the Centers for Disease Control and Prevention. The CDC tracks the numbers of cases, hospitalizations, and deaths but does not breakdown rates by vaccination status.  
 

Stronger argument for vaccination?

“The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination,” said Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, New York.

Stuart C. Ray, MD, professor of medicine and oncology in the Division of Infectious Diseases at Johns Hopkins University, Baltimore, agreed. “It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19 when they represent less than 50% of the adult population in the United States.”

The findings from the study could be more persuasive than previous arguments made in favor of immunization, Dr. Ray said. “These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss.”

Brian Labus, PhD, MPH, of the University of Nevada Las Vegas (UNLV) is less convinced. “While this might change some peoples’ minds, it probably won’t make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider.”

The study adds information that was not available before, said Dr. Labus, assistant professor in the Department of Epidemiology and Biostatistics at the UNLV School of Public Health. “We study the vaccine under tightly controlled, ideal conditions. This is the evidence that it works as well in the real world as it did in the trials, and that is what is most important in implementing a vaccination program,” added Dr. Labus.

“The scientific data has honed in on one thing: Vaccines are effective in preventing hospitalizations, ICU admissions, ventilations, and deaths,” agreed Dr. Palli.

“We now know that almost all deaths occurred in patients who were not vaccinated. We also know that all vaccines are effective against various strains that are in circulation right now, including the Delta variant, which is rapidly spreading,” Dr. Palli said.

Dr. Cassiere pointed out that the unvaccinated are not only at higher risk of developing COVID-19 but also of spreading, being hospitalized for, and dying from the infection. Avoiding “long hauler” symptoms is another argument in favor of immunization, he added.

As of June 28, the CDC reports that 63% of Americans 12 years and older have received at least one dose of a COVID-19 vaccine, and 54% are fully vaccinated.
 

Worldwide worry?

Although overall rates of U.S. COVID-19 hospitalizations and deaths are down, the outlook may not remain as encouraging. “I hope I’m wrong about this, but I anticipate that the coming fall and winter will bring increasingly localized versions of similar findings – severe disease and death due to SARS-CoV-2 infection in regions or groups with lower vaccination rates,” Dr. Ray said.

There could be a silver lining, he added: “If this unfortunate surge occurs, the health and economic consequences seem likely to erode much of the remaining hesitancy regarding vaccination.”

The rise of more infectious SARS-CoV-2 variants, such as the Delta variant, could also throw a wrench in controlling COVID-19. “This isn’t just a domestic issue,” Dr. Ray said. “We have learned that the world is a small place in pandemic times.”

The Associated Press investigators state that their findings support the high efficacy of the vaccine. Also, given the current widespread availability of COVID-19 vaccines in the United States, they believe many of the COVID-19 deaths now occurring are preventable.

Public health measures should have continued longer to protect unvaccinated individuals, especially Black Americans, Hispanic Americans, and other minorities, Dr. Palli said. “Only time will tell if re-opening and abandoning all public health measures by the CDC was premature.”

A version of this article first appeared on Medscape.com.

If you, a friend, or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk of dying if you become infected.

That’s the conclusion of a new report released by the Associated Press looking at COVID-19 deaths during May 2021.

Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That’s less than 1%.

“Recently, I was working in the emergency room [and] I saw a 21-year-old African American who came in with shortness of breath,” said Vino K. Palli, MD, MPH, a physician specializing in emergency medicine, internal medicine, and urgent care.

The patient rapidly deteriorated and required intubation and ventilation. She was transferred to a specialized hospital for possible extracorporeal membrane oxygenation (ECMO) treatment.

“This patient was unvaccinated, along with her entire family. This would have been easily preventable,” added Dr. Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City.

“Vaccine misinformation, compounded with vaccine inertia and vaccine access, have contributed to this,” he added. “Even though we have a surplus amount of vaccines at this time, we are only seeing 50% to 55% of completely vaccinated patients.”

Authors of the Associated Press report also acknowledge that some people who are fully vaccinated can get a breakthrough infection. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%.

The Associated Press came up with these numbers using data from the Centers for Disease Control and Prevention. The CDC tracks the numbers of cases, hospitalizations, and deaths but does not breakdown rates by vaccination status.  
 

Stronger argument for vaccination?

“The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination,” said Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, New York.

Stuart C. Ray, MD, professor of medicine and oncology in the Division of Infectious Diseases at Johns Hopkins University, Baltimore, agreed. “It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19 when they represent less than 50% of the adult population in the United States.”

The findings from the study could be more persuasive than previous arguments made in favor of immunization, Dr. Ray said. “These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss.”

Brian Labus, PhD, MPH, of the University of Nevada Las Vegas (UNLV) is less convinced. “While this might change some peoples’ minds, it probably won’t make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider.”

The study adds information that was not available before, said Dr. Labus, assistant professor in the Department of Epidemiology and Biostatistics at the UNLV School of Public Health. “We study the vaccine under tightly controlled, ideal conditions. This is the evidence that it works as well in the real world as it did in the trials, and that is what is most important in implementing a vaccination program,” added Dr. Labus.

“The scientific data has honed in on one thing: Vaccines are effective in preventing hospitalizations, ICU admissions, ventilations, and deaths,” agreed Dr. Palli.

“We now know that almost all deaths occurred in patients who were not vaccinated. We also know that all vaccines are effective against various strains that are in circulation right now, including the Delta variant, which is rapidly spreading,” Dr. Palli said.

Dr. Cassiere pointed out that the unvaccinated are not only at higher risk of developing COVID-19 but also of spreading, being hospitalized for, and dying from the infection. Avoiding “long hauler” symptoms is another argument in favor of immunization, he added.

As of June 28, the CDC reports that 63% of Americans 12 years and older have received at least one dose of a COVID-19 vaccine, and 54% are fully vaccinated.
 

Worldwide worry?

Although overall rates of U.S. COVID-19 hospitalizations and deaths are down, the outlook may not remain as encouraging. “I hope I’m wrong about this, but I anticipate that the coming fall and winter will bring increasingly localized versions of similar findings – severe disease and death due to SARS-CoV-2 infection in regions or groups with lower vaccination rates,” Dr. Ray said.

There could be a silver lining, he added: “If this unfortunate surge occurs, the health and economic consequences seem likely to erode much of the remaining hesitancy regarding vaccination.”

The rise of more infectious SARS-CoV-2 variants, such as the Delta variant, could also throw a wrench in controlling COVID-19. “This isn’t just a domestic issue,” Dr. Ray said. “We have learned that the world is a small place in pandemic times.”

The Associated Press investigators state that their findings support the high efficacy of the vaccine. Also, given the current widespread availability of COVID-19 vaccines in the United States, they believe many of the COVID-19 deaths now occurring are preventable.

Public health measures should have continued longer to protect unvaccinated individuals, especially Black Americans, Hispanic Americans, and other minorities, Dr. Palli said. “Only time will tell if re-opening and abandoning all public health measures by the CDC was premature.”

A version of this article first appeared on Medscape.com.

If you, a friend, or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk of dying if you become infected.

That’s the conclusion of a new report released by the Associated Press looking at COVID-19 deaths during May 2021.

Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That’s less than 1%.

“Recently, I was working in the emergency room [and] I saw a 21-year-old African American who came in with shortness of breath,” said Vino K. Palli, MD, MPH, a physician specializing in emergency medicine, internal medicine, and urgent care.

The patient rapidly deteriorated and required intubation and ventilation. She was transferred to a specialized hospital for possible extracorporeal membrane oxygenation (ECMO) treatment.

“This patient was unvaccinated, along with her entire family. This would have been easily preventable,” added Dr. Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City.

“Vaccine misinformation, compounded with vaccine inertia and vaccine access, have contributed to this,” he added. “Even though we have a surplus amount of vaccines at this time, we are only seeing 50% to 55% of completely vaccinated patients.”

Authors of the Associated Press report also acknowledge that some people who are fully vaccinated can get a breakthrough infection. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%.

The Associated Press came up with these numbers using data from the Centers for Disease Control and Prevention. The CDC tracks the numbers of cases, hospitalizations, and deaths but does not breakdown rates by vaccination status.  
 

Stronger argument for vaccination?

“The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination,” said Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, New York.

Stuart C. Ray, MD, professor of medicine and oncology in the Division of Infectious Diseases at Johns Hopkins University, Baltimore, agreed. “It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19 when they represent less than 50% of the adult population in the United States.”

The findings from the study could be more persuasive than previous arguments made in favor of immunization, Dr. Ray said. “These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss.”

Brian Labus, PhD, MPH, of the University of Nevada Las Vegas (UNLV) is less convinced. “While this might change some peoples’ minds, it probably won’t make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider.”

The study adds information that was not available before, said Dr. Labus, assistant professor in the Department of Epidemiology and Biostatistics at the UNLV School of Public Health. “We study the vaccine under tightly controlled, ideal conditions. This is the evidence that it works as well in the real world as it did in the trials, and that is what is most important in implementing a vaccination program,” added Dr. Labus.

“The scientific data has honed in on one thing: Vaccines are effective in preventing hospitalizations, ICU admissions, ventilations, and deaths,” agreed Dr. Palli.

“We now know that almost all deaths occurred in patients who were not vaccinated. We also know that all vaccines are effective against various strains that are in circulation right now, including the Delta variant, which is rapidly spreading,” Dr. Palli said.

Dr. Cassiere pointed out that the unvaccinated are not only at higher risk of developing COVID-19 but also of spreading, being hospitalized for, and dying from the infection. Avoiding “long hauler” symptoms is another argument in favor of immunization, he added.

As of June 28, the CDC reports that 63% of Americans 12 years and older have received at least one dose of a COVID-19 vaccine, and 54% are fully vaccinated.
 

Worldwide worry?

Although overall rates of U.S. COVID-19 hospitalizations and deaths are down, the outlook may not remain as encouraging. “I hope I’m wrong about this, but I anticipate that the coming fall and winter will bring increasingly localized versions of similar findings – severe disease and death due to SARS-CoV-2 infection in regions or groups with lower vaccination rates,” Dr. Ray said.

There could be a silver lining, he added: “If this unfortunate surge occurs, the health and economic consequences seem likely to erode much of the remaining hesitancy regarding vaccination.”

The rise of more infectious SARS-CoV-2 variants, such as the Delta variant, could also throw a wrench in controlling COVID-19. “This isn’t just a domestic issue,” Dr. Ray said. “We have learned that the world is a small place in pandemic times.”

The Associated Press investigators state that their findings support the high efficacy of the vaccine. Also, given the current widespread availability of COVID-19 vaccines in the United States, they believe many of the COVID-19 deaths now occurring are preventable.

Public health measures should have continued longer to protect unvaccinated individuals, especially Black Americans, Hispanic Americans, and other minorities, Dr. Palli said. “Only time will tell if re-opening and abandoning all public health measures by the CDC was premature.”

A version of this article first appeared on Medscape.com.

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

Ustekinumab (Stelara, Janssen) appears superior to vedolizumab (Entyvio, Takeda) on multiple measures of response and remission among patients with Crohn’s disease who failed at least one anti–tumor necrosis factor (TNF) therapy, in a retrospective analysis.

Of patients taking ustekinumab, a higher proportion (51%) met the primary endpoint of corticosteroid-free clinical remission at week 54. In the vedolizumab group, only 41% achieved the same outcome.

“Failure to anti-TNF therapy is a major concern in Crohn’s disease,” Anthony Buisson, MD, PhD, head of the Inflammatory Bowel Disease Unit, University Hospital Estaing, Clermont-Ferrand, France, said during the Digestive Disease Week 2021 virtual meeting.

Dr. Buisson estimated that 15% of patients with Crohn’s disease experience primary failure from an anti-TNF agent. Also, only slightly more than one-third (37%) remain in clinical remission at 1 year.

With that in mind, Dr. Buisson and his colleagues conducted the VENUS study to evaluate outcomes between ustekinumab and vedolizumab. These two biologic agents are indicated for Crohn’s disease and feature different mechanisms of action, compared with anti-TNF agents.

They assessed 312 adults with Crohn’s disease from two patient cohorts in France. All participants failed prior treatment with at least one anti-TNF agent, including approximately 20% who experienced a primary nonresponse.

The retrospective analysis included 224 patients treated with ustekinumab and another 88 with vedolizumab between July 2014 and May 2020. The two groups were comparable based on a propensity analysis. Other medications were allowed at the physician’s discretion.
 

Nonresponders and other outcomes

“Vedolizumab patients were more likely to be primary nonresponders than ustekinumab patients,” Dr. Buisson said. This group included 6% of patients taking ustekinumab versus 14% of those taking vedolizumab.

In contrast, regarding secondary loss of response, “we did not observe any [significant] difference between two groups,” he added.

The investigators defined corticosteroid-free remission as a Crohn’s Disease Activity Index less than 150 at week 54. They also assessed “deep remission” at 14 weeks, which was defined as meeting corticosteroid-free remission and a fecal calprotectin of less than 100 mcg/g.

They found that 26% of patients who received ustekinumab met the deep remission criteria versus 4% of those who received vedolizumab.

Dr. Buisson and colleagues also looked at time to drug escalation. A Kaplan Meier curve revealed that patients taking vedolizumab were more likely to be escalated, compared with those taking ustekinumab (hazard ratio, 1.35).

Furthermore, those treated with vedolizumab also featured a higher risk for drug discontinuation because of therapeutic failure (HR, 1.53).

“This is an interesting study comparing ustekinumab with vedolizumab in Crohn’s disease patients who have failed prior anti-TNF therapy,” Farah Monzur, MD, who was not affiliated with the study, told this news organization. “Although the researchers assessed corticosteroid-free remission and ‘deep remission,’ ” she said, endoscopic and histologic remission were not studied, “which have become the new targets to achieve.”

“Even so, this study adds to the literature, aiming to position these newer biologics in the treatment algorithm,” added Dr. Monzur, assistant professor of medicine and medical director of ambulatory GI at Stony Brook (N.Y.) Medicine.
 

Superior in subgroup analyses as well

“No subgroups were identified where vedolizumab was more effective than ustekinumab,” Dr. Buisson said. “In contrast, ustekinumab was more effective in five subgroups.”

The subgroups favoring ustekinumab included those patients not taking steroids at baseline, with no prior bowel resection, with a noncomplicated phenotype, with upper gastrointestinal involvement, and older than 35 years of age.

The retrospective analysis design was a limitation. The long follow-up and large sample size were strengths.

The authors concluded that ustekinumab was more effective to achieve early and long-term efficacy than vedolizumab in patients with Crohn’s disease who previously failed to anti-TNF agents.

“However, these data should be confirmed in a head-to-head randomized controlled trial,” Dr. Buisson said.

Dr. Buisson disclosed that he is a consultant for Janssen and Takeda. Dr. Monzur has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com..

Ustekinumab (Stelara, Janssen) appears superior to vedolizumab (Entyvio, Takeda) on multiple measures of response and remission among patients with Crohn’s disease who failed at least one anti–tumor necrosis factor (TNF) therapy, in a retrospective analysis.

Of patients taking ustekinumab, a higher proportion (51%) met the primary endpoint of corticosteroid-free clinical remission at week 54. In the vedolizumab group, only 41% achieved the same outcome.

“Failure to anti-TNF therapy is a major concern in Crohn’s disease,” Anthony Buisson, MD, PhD, head of the Inflammatory Bowel Disease Unit, University Hospital Estaing, Clermont-Ferrand, France, said during the Digestive Disease Week 2021 virtual meeting.

Dr. Buisson estimated that 15% of patients with Crohn’s disease experience primary failure from an anti-TNF agent. Also, only slightly more than one-third (37%) remain in clinical remission at 1 year.

With that in mind, Dr. Buisson and his colleagues conducted the VENUS study to evaluate outcomes between ustekinumab and vedolizumab. These two biologic agents are indicated for Crohn’s disease and feature different mechanisms of action, compared with anti-TNF agents.

They assessed 312 adults with Crohn’s disease from two patient cohorts in France. All participants failed prior treatment with at least one anti-TNF agent, including approximately 20% who experienced a primary nonresponse.

The retrospective analysis included 224 patients treated with ustekinumab and another 88 with vedolizumab between July 2014 and May 2020. The two groups were comparable based on a propensity analysis. Other medications were allowed at the physician’s discretion.
 

Nonresponders and other outcomes

“Vedolizumab patients were more likely to be primary nonresponders than ustekinumab patients,” Dr. Buisson said. This group included 6% of patients taking ustekinumab versus 14% of those taking vedolizumab.

In contrast, regarding secondary loss of response, “we did not observe any [significant] difference between two groups,” he added.

The investigators defined corticosteroid-free remission as a Crohn’s Disease Activity Index less than 150 at week 54. They also assessed “deep remission” at 14 weeks, which was defined as meeting corticosteroid-free remission and a fecal calprotectin of less than 100 mcg/g.

They found that 26% of patients who received ustekinumab met the deep remission criteria versus 4% of those who received vedolizumab.

Dr. Buisson and colleagues also looked at time to drug escalation. A Kaplan Meier curve revealed that patients taking vedolizumab were more likely to be escalated, compared with those taking ustekinumab (hazard ratio, 1.35).

Furthermore, those treated with vedolizumab also featured a higher risk for drug discontinuation because of therapeutic failure (HR, 1.53).

“This is an interesting study comparing ustekinumab with vedolizumab in Crohn’s disease patients who have failed prior anti-TNF therapy,” Farah Monzur, MD, who was not affiliated with the study, told this news organization. “Although the researchers assessed corticosteroid-free remission and ‘deep remission,’ ” she said, endoscopic and histologic remission were not studied, “which have become the new targets to achieve.”

“Even so, this study adds to the literature, aiming to position these newer biologics in the treatment algorithm,” added Dr. Monzur, assistant professor of medicine and medical director of ambulatory GI at Stony Brook (N.Y.) Medicine.
 

Superior in subgroup analyses as well

“No subgroups were identified where vedolizumab was more effective than ustekinumab,” Dr. Buisson said. “In contrast, ustekinumab was more effective in five subgroups.”

The subgroups favoring ustekinumab included those patients not taking steroids at baseline, with no prior bowel resection, with a noncomplicated phenotype, with upper gastrointestinal involvement, and older than 35 years of age.

The retrospective analysis design was a limitation. The long follow-up and large sample size were strengths.

The authors concluded that ustekinumab was more effective to achieve early and long-term efficacy than vedolizumab in patients with Crohn’s disease who previously failed to anti-TNF agents.

“However, these data should be confirmed in a head-to-head randomized controlled trial,” Dr. Buisson said.

Dr. Buisson disclosed that he is a consultant for Janssen and Takeda. Dr. Monzur has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com..

Ustekinumab (Stelara, Janssen) appears superior to vedolizumab (Entyvio, Takeda) on multiple measures of response and remission among patients with Crohn’s disease who failed at least one anti–tumor necrosis factor (TNF) therapy, in a retrospective analysis.

Of patients taking ustekinumab, a higher proportion (51%) met the primary endpoint of corticosteroid-free clinical remission at week 54. In the vedolizumab group, only 41% achieved the same outcome.

“Failure to anti-TNF therapy is a major concern in Crohn’s disease,” Anthony Buisson, MD, PhD, head of the Inflammatory Bowel Disease Unit, University Hospital Estaing, Clermont-Ferrand, France, said during the Digestive Disease Week 2021 virtual meeting.

Dr. Buisson estimated that 15% of patients with Crohn’s disease experience primary failure from an anti-TNF agent. Also, only slightly more than one-third (37%) remain in clinical remission at 1 year.

With that in mind, Dr. Buisson and his colleagues conducted the VENUS study to evaluate outcomes between ustekinumab and vedolizumab. These two biologic agents are indicated for Crohn’s disease and feature different mechanisms of action, compared with anti-TNF agents.

They assessed 312 adults with Crohn’s disease from two patient cohorts in France. All participants failed prior treatment with at least one anti-TNF agent, including approximately 20% who experienced a primary nonresponse.

The retrospective analysis included 224 patients treated with ustekinumab and another 88 with vedolizumab between July 2014 and May 2020. The two groups were comparable based on a propensity analysis. Other medications were allowed at the physician’s discretion.
 

Nonresponders and other outcomes

“Vedolizumab patients were more likely to be primary nonresponders than ustekinumab patients,” Dr. Buisson said. This group included 6% of patients taking ustekinumab versus 14% of those taking vedolizumab.

In contrast, regarding secondary loss of response, “we did not observe any [significant] difference between two groups,” he added.

The investigators defined corticosteroid-free remission as a Crohn’s Disease Activity Index less than 150 at week 54. They also assessed “deep remission” at 14 weeks, which was defined as meeting corticosteroid-free remission and a fecal calprotectin of less than 100 mcg/g.

They found that 26% of patients who received ustekinumab met the deep remission criteria versus 4% of those who received vedolizumab.

Dr. Buisson and colleagues also looked at time to drug escalation. A Kaplan Meier curve revealed that patients taking vedolizumab were more likely to be escalated, compared with those taking ustekinumab (hazard ratio, 1.35).

Furthermore, those treated with vedolizumab also featured a higher risk for drug discontinuation because of therapeutic failure (HR, 1.53).

“This is an interesting study comparing ustekinumab with vedolizumab in Crohn’s disease patients who have failed prior anti-TNF therapy,” Farah Monzur, MD, who was not affiliated with the study, told this news organization. “Although the researchers assessed corticosteroid-free remission and ‘deep remission,’ ” she said, endoscopic and histologic remission were not studied, “which have become the new targets to achieve.”

“Even so, this study adds to the literature, aiming to position these newer biologics in the treatment algorithm,” added Dr. Monzur, assistant professor of medicine and medical director of ambulatory GI at Stony Brook (N.Y.) Medicine.
 

Superior in subgroup analyses as well

“No subgroups were identified where vedolizumab was more effective than ustekinumab,” Dr. Buisson said. “In contrast, ustekinumab was more effective in five subgroups.”

The subgroups favoring ustekinumab included those patients not taking steroids at baseline, with no prior bowel resection, with a noncomplicated phenotype, with upper gastrointestinal involvement, and older than 35 years of age.

The retrospective analysis design was a limitation. The long follow-up and large sample size were strengths.

The authors concluded that ustekinumab was more effective to achieve early and long-term efficacy than vedolizumab in patients with Crohn’s disease who previously failed to anti-TNF agents.

“However, these data should be confirmed in a head-to-head randomized controlled trial,” Dr. Buisson said.

Dr. Buisson disclosed that he is a consultant for Janssen and Takeda. Dr. Monzur has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com..

A prebiotic therapy in development significantly reduced the number of days per month that people with gastroesophageal reflux disease (GERD) experienced heartburn.

The prebiotic treatment, maltosyl-isomalto-oligosaccharides (MIMO, ISOT-101), under development by ISOThrive, was also associated with reduced symptom severity and improved quality of life, John Selling, MD, chief medical officer at ISOThrive, said during the presentation of his study at the virtual Digestive Disease Week (DDW) 2021.

ISOT-101 is a nondigestible, nonabsorbable prebiotic carbohydrate produced by bacterial fermentation of sucrose and maltose. It was “possibly a staple of the bacterial diet that was present in the human diet during the past 10,000 years,” Dr. Selling said. He is a clinical associate professor of medicine and gastroenterology at Stanford (Calif.) University.

The prebiotic, however, “has been absent in our diet for about 50 to 100 years, driven by changes in agriculture, food production, food preservation, and dietary preferences,” he added.

Acid suppression treatments, such as proton pump inhibitors (PPIs), have long been a staple of treating GERD. However, about 40% of people taking PPIs still have symptoms, Dr. Selling said. He noted that there are concerns about the health risks associated with long-term PPI use.

A prebiotic could work because the distal esophageal microbiome in people with GERD “differs greatly” from that of healthy persons, Dr. Selling said. The prebiotic could help reduce an abnormal increase in gram-negative bacteria in these patients, for example. These bacterial strains express lipopolysaccharides on their outer cell membranes, which, in turn, alter cytokine signaling. This mechanism could lead to the hyperinflammatory state associated with GERD.

Dr. Selling and colleagues hypothesized that this treatment could help resolve GERD symptoms in two ways. The prebiotic could selectively feed the beneficial gram-positive bacteria in the distal esophagus, thereby helping to restore a healthy balance of bacteria. ISOT-101 could also produce bacteriocins that help kill the harmful gram-negative bacteria and control inflammation.

To assess the efficacy and tolerability of ISOT-101, Dr. Selling and colleagues plan to evaluate use of the agent in 110 people with GERD. The data presented at this year’s DDW are based on the first 44 participants to complete the study protocol.

Participants had to have active symptoms four or more days a week. They verbally reported symptoms to investigators and completed a daily ReQuest validated GERD symptom questionnaire.

After a week of baseline screening, participants consumed about a quarter teaspoon of ISOT-101 as the last substance swallowed before bed every night. The investigators asked participants to rate their GI symptoms, general well-being including any sleep disturbances, and quality of life on the Short Form 36 (SF-36) health survey. Participants also recorded use of any other medications during the 4-week study.

“I thought this was a very interesting study, as it proposes an alternative approach to manage patients with GERD,” Richa Shukla, MD, who was not affiliated with the research, said in an interview when asked to comment. “We see many patients with typical GERD symptoms who do not respond to PPI therapy, and perhaps considering an alternative cause and treatment may help with these patients.”

Dr. Shukla shared a couple of caveats. “This is a relatively small study, and it has not yet completed its enrollment target, so it will be helpful to see what the results are with the full study.” Also, it would be useful to know how many participants also took a PPI during the study, she said.

“Essentially, a lot remains unknown, but the study holds promise for patients,” added Dr. Shukla, assistant professor in the section of gastroenterology and hepatology at Baylor College of Medicine, Houston. “I think there is a lot of interest in the microbiome and how modulating it can impact inflammatory conditions.”
 

Key findings

The increase in heartburn-free days translated to more than eight additional days a month in which patients had no complaints of acid or heartburn. The difference from baseline was statistically significant (P < .001).

About two-thirds (66%) of participants were classified as “strong responders” to treatment, meaning they experienced an improvement of >50% in their ReQuest symptom scores over the 4 weeks. Again, the difference compared to baseline was statistically significant (P < .001).

The researchers also reported statistically significant improvements in quality-of-life indicators, such as well-being and sleep (P < .001).

The primary endpoint of the study was tolerability. The prebiotic was defined as tolerable if the ReQuest symptom scores and SF-36 scores remained constant or improved by the fourth week. ReQuest symptom scores improved for 89% of participants.

Two participants experienced nausea. No other adverse events related to ISOT-101 were reported. For five participants, ReQuest GI subscores worsened over time. For four participants, ReQuest total symptom scores worsened over time; that score represents a sum of GI and general well-being scores.
 

Unanswered questions

Inflammation in GERD is likely due to bacterial dysbiosis and acid-induced injury, Dr. Selling said.

If development of the prebiotic continues successfully, it could represent a paradigm shift in this clinical area, he said. “It suggests moving from acid reduction to also reducing dysbiosis as a treatment modality.”

But it remains unclear whether ISOT-101 would be indicated as monotherapy or for use in combination with other therapies for GERD.

Another unanswered question is whether the agent could be used to treat progressive disease. “This type of bacterial dysbiosis remains throughout the disease progression, from GERD to Barrett’s esophagus to esophageal adenocarcinoma,” Dr. Selling said.

The investigators reported that further controlled studies are forthcoming.

Dr. Selling is a co-founder and chief medical officer at ISOThrive. Dr. Shukla has disclosed no relevant financial relationships. David Johnson, MD, one of the authors of the abstract, is an advisor and contributor to Medscape.

A version of this article first appeared on Medscape.com.

A prebiotic therapy in development significantly reduced the number of days per month that people with gastroesophageal reflux disease (GERD) experienced heartburn.

The prebiotic treatment, maltosyl-isomalto-oligosaccharides (MIMO, ISOT-101), under development by ISOThrive, was also associated with reduced symptom severity and improved quality of life, John Selling, MD, chief medical officer at ISOThrive, said during the presentation of his study at the virtual Digestive Disease Week (DDW) 2021.

ISOT-101 is a nondigestible, nonabsorbable prebiotic carbohydrate produced by bacterial fermentation of sucrose and maltose. It was “possibly a staple of the bacterial diet that was present in the human diet during the past 10,000 years,” Dr. Selling said. He is a clinical associate professor of medicine and gastroenterology at Stanford (Calif.) University.

The prebiotic, however, “has been absent in our diet for about 50 to 100 years, driven by changes in agriculture, food production, food preservation, and dietary preferences,” he added.

Acid suppression treatments, such as proton pump inhibitors (PPIs), have long been a staple of treating GERD. However, about 40% of people taking PPIs still have symptoms, Dr. Selling said. He noted that there are concerns about the health risks associated with long-term PPI use.

A prebiotic could work because the distal esophageal microbiome in people with GERD “differs greatly” from that of healthy persons, Dr. Selling said. The prebiotic could help reduce an abnormal increase in gram-negative bacteria in these patients, for example. These bacterial strains express lipopolysaccharides on their outer cell membranes, which, in turn, alter cytokine signaling. This mechanism could lead to the hyperinflammatory state associated with GERD.

Dr. Selling and colleagues hypothesized that this treatment could help resolve GERD symptoms in two ways. The prebiotic could selectively feed the beneficial gram-positive bacteria in the distal esophagus, thereby helping to restore a healthy balance of bacteria. ISOT-101 could also produce bacteriocins that help kill the harmful gram-negative bacteria and control inflammation.

To assess the efficacy and tolerability of ISOT-101, Dr. Selling and colleagues plan to evaluate use of the agent in 110 people with GERD. The data presented at this year’s DDW are based on the first 44 participants to complete the study protocol.

Participants had to have active symptoms four or more days a week. They verbally reported symptoms to investigators and completed a daily ReQuest validated GERD symptom questionnaire.

After a week of baseline screening, participants consumed about a quarter teaspoon of ISOT-101 as the last substance swallowed before bed every night. The investigators asked participants to rate their GI symptoms, general well-being including any sleep disturbances, and quality of life on the Short Form 36 (SF-36) health survey. Participants also recorded use of any other medications during the 4-week study.

“I thought this was a very interesting study, as it proposes an alternative approach to manage patients with GERD,” Richa Shukla, MD, who was not affiliated with the research, said in an interview when asked to comment. “We see many patients with typical GERD symptoms who do not respond to PPI therapy, and perhaps considering an alternative cause and treatment may help with these patients.”

Dr. Shukla shared a couple of caveats. “This is a relatively small study, and it has not yet completed its enrollment target, so it will be helpful to see what the results are with the full study.” Also, it would be useful to know how many participants also took a PPI during the study, she said.

“Essentially, a lot remains unknown, but the study holds promise for patients,” added Dr. Shukla, assistant professor in the section of gastroenterology and hepatology at Baylor College of Medicine, Houston. “I think there is a lot of interest in the microbiome and how modulating it can impact inflammatory conditions.”
 

Key findings

The increase in heartburn-free days translated to more than eight additional days a month in which patients had no complaints of acid or heartburn. The difference from baseline was statistically significant (P < .001).

About two-thirds (66%) of participants were classified as “strong responders” to treatment, meaning they experienced an improvement of >50% in their ReQuest symptom scores over the 4 weeks. Again, the difference compared to baseline was statistically significant (P < .001).

The researchers also reported statistically significant improvements in quality-of-life indicators, such as well-being and sleep (P < .001).

The primary endpoint of the study was tolerability. The prebiotic was defined as tolerable if the ReQuest symptom scores and SF-36 scores remained constant or improved by the fourth week. ReQuest symptom scores improved for 89% of participants.

Two participants experienced nausea. No other adverse events related to ISOT-101 were reported. For five participants, ReQuest GI subscores worsened over time. For four participants, ReQuest total symptom scores worsened over time; that score represents a sum of GI and general well-being scores.
 

Unanswered questions

Inflammation in GERD is likely due to bacterial dysbiosis and acid-induced injury, Dr. Selling said.

If development of the prebiotic continues successfully, it could represent a paradigm shift in this clinical area, he said. “It suggests moving from acid reduction to also reducing dysbiosis as a treatment modality.”

But it remains unclear whether ISOT-101 would be indicated as monotherapy or for use in combination with other therapies for GERD.

Another unanswered question is whether the agent could be used to treat progressive disease. “This type of bacterial dysbiosis remains throughout the disease progression, from GERD to Barrett’s esophagus to esophageal adenocarcinoma,” Dr. Selling said.

The investigators reported that further controlled studies are forthcoming.

Dr. Selling is a co-founder and chief medical officer at ISOThrive. Dr. Shukla has disclosed no relevant financial relationships. David Johnson, MD, one of the authors of the abstract, is an advisor and contributor to Medscape.

A version of this article first appeared on Medscape.com.

A prebiotic therapy in development significantly reduced the number of days per month that people with gastroesophageal reflux disease (GERD) experienced heartburn.

The prebiotic treatment, maltosyl-isomalto-oligosaccharides (MIMO, ISOT-101), under development by ISOThrive, was also associated with reduced symptom severity and improved quality of life, John Selling, MD, chief medical officer at ISOThrive, said during the presentation of his study at the virtual Digestive Disease Week (DDW) 2021.

ISOT-101 is a nondigestible, nonabsorbable prebiotic carbohydrate produced by bacterial fermentation of sucrose and maltose. It was “possibly a staple of the bacterial diet that was present in the human diet during the past 10,000 years,” Dr. Selling said. He is a clinical associate professor of medicine and gastroenterology at Stanford (Calif.) University.

The prebiotic, however, “has been absent in our diet for about 50 to 100 years, driven by changes in agriculture, food production, food preservation, and dietary preferences,” he added.

Acid suppression treatments, such as proton pump inhibitors (PPIs), have long been a staple of treating GERD. However, about 40% of people taking PPIs still have symptoms, Dr. Selling said. He noted that there are concerns about the health risks associated with long-term PPI use.

A prebiotic could work because the distal esophageal microbiome in people with GERD “differs greatly” from that of healthy persons, Dr. Selling said. The prebiotic could help reduce an abnormal increase in gram-negative bacteria in these patients, for example. These bacterial strains express lipopolysaccharides on their outer cell membranes, which, in turn, alter cytokine signaling. This mechanism could lead to the hyperinflammatory state associated with GERD.

Dr. Selling and colleagues hypothesized that this treatment could help resolve GERD symptoms in two ways. The prebiotic could selectively feed the beneficial gram-positive bacteria in the distal esophagus, thereby helping to restore a healthy balance of bacteria. ISOT-101 could also produce bacteriocins that help kill the harmful gram-negative bacteria and control inflammation.

To assess the efficacy and tolerability of ISOT-101, Dr. Selling and colleagues plan to evaluate use of the agent in 110 people with GERD. The data presented at this year’s DDW are based on the first 44 participants to complete the study protocol.

Participants had to have active symptoms four or more days a week. They verbally reported symptoms to investigators and completed a daily ReQuest validated GERD symptom questionnaire.

After a week of baseline screening, participants consumed about a quarter teaspoon of ISOT-101 as the last substance swallowed before bed every night. The investigators asked participants to rate their GI symptoms, general well-being including any sleep disturbances, and quality of life on the Short Form 36 (SF-36) health survey. Participants also recorded use of any other medications during the 4-week study.

“I thought this was a very interesting study, as it proposes an alternative approach to manage patients with GERD,” Richa Shukla, MD, who was not affiliated with the research, said in an interview when asked to comment. “We see many patients with typical GERD symptoms who do not respond to PPI therapy, and perhaps considering an alternative cause and treatment may help with these patients.”

Dr. Shukla shared a couple of caveats. “This is a relatively small study, and it has not yet completed its enrollment target, so it will be helpful to see what the results are with the full study.” Also, it would be useful to know how many participants also took a PPI during the study, she said.

“Essentially, a lot remains unknown, but the study holds promise for patients,” added Dr. Shukla, assistant professor in the section of gastroenterology and hepatology at Baylor College of Medicine, Houston. “I think there is a lot of interest in the microbiome and how modulating it can impact inflammatory conditions.”
 

Key findings

The increase in heartburn-free days translated to more than eight additional days a month in which patients had no complaints of acid or heartburn. The difference from baseline was statistically significant (P < .001).

About two-thirds (66%) of participants were classified as “strong responders” to treatment, meaning they experienced an improvement of >50% in their ReQuest symptom scores over the 4 weeks. Again, the difference compared to baseline was statistically significant (P < .001).

The researchers also reported statistically significant improvements in quality-of-life indicators, such as well-being and sleep (P < .001).

The primary endpoint of the study was tolerability. The prebiotic was defined as tolerable if the ReQuest symptom scores and SF-36 scores remained constant or improved by the fourth week. ReQuest symptom scores improved for 89% of participants.

Two participants experienced nausea. No other adverse events related to ISOT-101 were reported. For five participants, ReQuest GI subscores worsened over time. For four participants, ReQuest total symptom scores worsened over time; that score represents a sum of GI and general well-being scores.
 

Unanswered questions

Inflammation in GERD is likely due to bacterial dysbiosis and acid-induced injury, Dr. Selling said.

If development of the prebiotic continues successfully, it could represent a paradigm shift in this clinical area, he said. “It suggests moving from acid reduction to also reducing dysbiosis as a treatment modality.”

But it remains unclear whether ISOT-101 would be indicated as monotherapy or for use in combination with other therapies for GERD.

Another unanswered question is whether the agent could be used to treat progressive disease. “This type of bacterial dysbiosis remains throughout the disease progression, from GERD to Barrett’s esophagus to esophageal adenocarcinoma,” Dr. Selling said.

The investigators reported that further controlled studies are forthcoming.

Dr. Selling is a co-founder and chief medical officer at ISOThrive. Dr. Shukla has disclosed no relevant financial relationships. David Johnson, MD, one of the authors of the abstract, is an advisor and contributor to Medscape.

A version of this article first appeared on Medscape.com.

A “smart toilet” in development uses artificial intelligence (AI) to scan stool for consistency and presence of blood – and early evidence suggests it is more accurate than patient self-reporting, a study reveals.

The remote, automated, real-time analysis and reporting increase the likelihood of physicians detecting gastrointestinal issues earlier, investigators reported.

In a proof-of-concept study, the smart toilet was 85% accurate in categorizing stool consistency as loose, normal, or constipated. The findings were presented at the annual Digestive Disease Week® (DDW).

“This study highlights a very innovative and practical tool that could have major implications for patients and clinicians alike,” Andrea Shin, MD, who was not affiliated with the research, said in an interview.

“Stool form or consistency and signs of bleeding are some of the most important pieces of clinical history when it comes to GI or bowel symptoms,” added Dr. Shin, assistant professor of medicine in the department of gastroenterology and hepatology at Indiana University, Indianapolis.
 

Image analysis

The researchers tested their AI algorithm on 3,328 images. They assessed photos from the Internet and some submitted anonymously by participants in the study.

Two gastroenterologists also rated a subset of 552 images. The physicians showed “satisfactory agreement” on interrater reliability (the extent to which two or more “raters” [for example, observers, examiners] agree), the investigators noted.

The smart toilet also was 76% accurate for gross blood detection.

“It’s objective and more accurate,” study author Sonia Grego, PhD, said in an interview. In contrast to asking patients to keep a bowel movement diary or recall the frequency and consistency of their stool over time, “the system does it for you,” she added.

“Our technology – by automating the image acquisition – removes the burden of having to track your pattern for weeks or months,” added Dr. Grego, founding director of the Duke Smart Toilet Lab at Duke University in Durham, N.C.

Information provided by patients “can have a big impact on decision-making,” Dr. Shin said. “For example, if I am talking to an individual who suffers from irritable bowel syndrome [IBS], I commonly ask them about how loose or watery and hard or formed their stool is, because this information gives me clues as to the underlying problems that may be driving their symptoms.”

Dr. Shin agreed it can be challenging for people to know what is important to report to their doctor. “This tool has the potential to relieve patient burden and facilitate communication between a patient and their clinician. It’s a great example of how technology can be leveraged to enhance care.”
 

Working behind the scenes

Together with gastroenterologist Deborah Anne Fisher, MD, an associate professor of medicine at Duke, Dr. Grego and colleagues devised a prototype that positions the image analyzer in the pipes behind the toilet. So the analysis is done post flush.

“We are experts of toilets and toilet technology,” Dr. Grego said. “We have learned that people really don’t like to see anything weird around the toilet bowl.”

The smart toilet system is designed for multiple users in a residential or commercial setting. The technology could be used in hospitals or long-term care facilities, for example. A fingerprint scanner on the flush mechanism tracks each individual user.
 

Mixed reactions

Dr. Grego gets a range of reactions when she tells people she is developing smart toilet technology.

“Friends and family laugh about the concept of the smart toilet,” she said, “so all the possible jokes that have been done on poops, we know.”

In fact, the researchers also are collecting the jokes they hear. “We’re being very systematic.”

In contrast, gastroenterologists who learn of the technology in development are more enthusiastic, Dr. Grego said. “There is such a need for removing the uncertainty of the patient recall about bowel movement frequency and appearance.

“We are seeking to expand through collaboration with additional GI doctors. We want to develop a more advanced prototype and do further validation studies,” Dr. Grego said.
 

Digital health tool

There is an aversion among patients to handling stool “or even talking about it,” Dr. Grego said. Colleagues tell her that people are more willing to provide a blood sample, which requires a needle, than a stool sample.

“But a lot of health data is there [in the stool],” she added. “We think this will empower a lot of research as well as consumer data gathering.”

For example, Dr. Grego envisions pharmaceutical companies using the technology to detect or monitor any changes in stool or gut health based on a treatment in development during clinical trials.

Furthermore, the technology might empower health-conscious consumers who want to track their own gut health. “This technology will be a whole new entry in the digital health toolkit,” Dr. Grego said.

Although not included in the research presented at this year’s DDW, the developers plan to add a sampling capability. Biochemic analysis of stool samples could provide “metabolically relevant information,” including stool biomarkers and microbiome composition.

“We have demonstrated it in the laboratory. It will be part of the technology when developed into a product,” Dr. Grego said.

This proof-of-concept study “is the first step in a path we are aggressively pursuing,” Dr. Grego said. She estimated it will take about 12-18 months to develop a prototype for use with patients. “We hope to move to a product soon after that.”

“I’m looking forward to seeing future iterations of this tool,” Dr. Shin said. “It could have a role in monitoring important GI diseases and disorders, including IBS and inflammatory bowel disease, or even for the detection of ‘alarm symptoms’ that shouldn’t be ignored.

“I could even see it having a role in preventative health in the future,” Dr. Shin added. 

The technology has been licensed to the spin-off company Coprata to develop the product further.

“We hope to have an impact on people’s health very soon,” Dr. Grego said.  

Duke University funded the study. Dr. Grego holds a management position at Coprata. Dr. Shin disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A “smart toilet” in development uses artificial intelligence (AI) to scan stool for consistency and presence of blood – and early evidence suggests it is more accurate than patient self-reporting, a study reveals.

The remote, automated, real-time analysis and reporting increase the likelihood of physicians detecting gastrointestinal issues earlier, investigators reported.

In a proof-of-concept study, the smart toilet was 85% accurate in categorizing stool consistency as loose, normal, or constipated. The findings were presented at the annual Digestive Disease Week® (DDW).

“This study highlights a very innovative and practical tool that could have major implications for patients and clinicians alike,” Andrea Shin, MD, who was not affiliated with the research, said in an interview.

“Stool form or consistency and signs of bleeding are some of the most important pieces of clinical history when it comes to GI or bowel symptoms,” added Dr. Shin, assistant professor of medicine in the department of gastroenterology and hepatology at Indiana University, Indianapolis.
 

Image analysis

The researchers tested their AI algorithm on 3,328 images. They assessed photos from the Internet and some submitted anonymously by participants in the study.

Two gastroenterologists also rated a subset of 552 images. The physicians showed “satisfactory agreement” on interrater reliability (the extent to which two or more “raters” [for example, observers, examiners] agree), the investigators noted.

The smart toilet also was 76% accurate for gross blood detection.

“It’s objective and more accurate,” study author Sonia Grego, PhD, said in an interview. In contrast to asking patients to keep a bowel movement diary or recall the frequency and consistency of their stool over time, “the system does it for you,” she added.

“Our technology – by automating the image acquisition – removes the burden of having to track your pattern for weeks or months,” added Dr. Grego, founding director of the Duke Smart Toilet Lab at Duke University in Durham, N.C.

Information provided by patients “can have a big impact on decision-making,” Dr. Shin said. “For example, if I am talking to an individual who suffers from irritable bowel syndrome [IBS], I commonly ask them about how loose or watery and hard or formed their stool is, because this information gives me clues as to the underlying problems that may be driving their symptoms.”

Dr. Shin agreed it can be challenging for people to know what is important to report to their doctor. “This tool has the potential to relieve patient burden and facilitate communication between a patient and their clinician. It’s a great example of how technology can be leveraged to enhance care.”
 

Working behind the scenes

Together with gastroenterologist Deborah Anne Fisher, MD, an associate professor of medicine at Duke, Dr. Grego and colleagues devised a prototype that positions the image analyzer in the pipes behind the toilet. So the analysis is done post flush.

“We are experts of toilets and toilet technology,” Dr. Grego said. “We have learned that people really don’t like to see anything weird around the toilet bowl.”

The smart toilet system is designed for multiple users in a residential or commercial setting. The technology could be used in hospitals or long-term care facilities, for example. A fingerprint scanner on the flush mechanism tracks each individual user.
 

Mixed reactions

Dr. Grego gets a range of reactions when she tells people she is developing smart toilet technology.

“Friends and family laugh about the concept of the smart toilet,” she said, “so all the possible jokes that have been done on poops, we know.”

In fact, the researchers also are collecting the jokes they hear. “We’re being very systematic.”

In contrast, gastroenterologists who learn of the technology in development are more enthusiastic, Dr. Grego said. “There is such a need for removing the uncertainty of the patient recall about bowel movement frequency and appearance.

“We are seeking to expand through collaboration with additional GI doctors. We want to develop a more advanced prototype and do further validation studies,” Dr. Grego said.
 

Digital health tool

There is an aversion among patients to handling stool “or even talking about it,” Dr. Grego said. Colleagues tell her that people are more willing to provide a blood sample, which requires a needle, than a stool sample.

“But a lot of health data is there [in the stool],” she added. “We think this will empower a lot of research as well as consumer data gathering.”

For example, Dr. Grego envisions pharmaceutical companies using the technology to detect or monitor any changes in stool or gut health based on a treatment in development during clinical trials.

Furthermore, the technology might empower health-conscious consumers who want to track their own gut health. “This technology will be a whole new entry in the digital health toolkit,” Dr. Grego said.

Although not included in the research presented at this year’s DDW, the developers plan to add a sampling capability. Biochemic analysis of stool samples could provide “metabolically relevant information,” including stool biomarkers and microbiome composition.

“We have demonstrated it in the laboratory. It will be part of the technology when developed into a product,” Dr. Grego said.

This proof-of-concept study “is the first step in a path we are aggressively pursuing,” Dr. Grego said. She estimated it will take about 12-18 months to develop a prototype for use with patients. “We hope to move to a product soon after that.”

“I’m looking forward to seeing future iterations of this tool,” Dr. Shin said. “It could have a role in monitoring important GI diseases and disorders, including IBS and inflammatory bowel disease, or even for the detection of ‘alarm symptoms’ that shouldn’t be ignored.

“I could even see it having a role in preventative health in the future,” Dr. Shin added. 

The technology has been licensed to the spin-off company Coprata to develop the product further.

“We hope to have an impact on people’s health very soon,” Dr. Grego said.  

Duke University funded the study. Dr. Grego holds a management position at Coprata. Dr. Shin disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A “smart toilet” in development uses artificial intelligence (AI) to scan stool for consistency and presence of blood – and early evidence suggests it is more accurate than patient self-reporting, a study reveals.

The remote, automated, real-time analysis and reporting increase the likelihood of physicians detecting gastrointestinal issues earlier, investigators reported.

In a proof-of-concept study, the smart toilet was 85% accurate in categorizing stool consistency as loose, normal, or constipated. The findings were presented at the annual Digestive Disease Week® (DDW).

“This study highlights a very innovative and practical tool that could have major implications for patients and clinicians alike,” Andrea Shin, MD, who was not affiliated with the research, said in an interview.

“Stool form or consistency and signs of bleeding are some of the most important pieces of clinical history when it comes to GI or bowel symptoms,” added Dr. Shin, assistant professor of medicine in the department of gastroenterology and hepatology at Indiana University, Indianapolis.
 

Image analysis

The researchers tested their AI algorithm on 3,328 images. They assessed photos from the Internet and some submitted anonymously by participants in the study.

Two gastroenterologists also rated a subset of 552 images. The physicians showed “satisfactory agreement” on interrater reliability (the extent to which two or more “raters” [for example, observers, examiners] agree), the investigators noted.

The smart toilet also was 76% accurate for gross blood detection.

“It’s objective and more accurate,” study author Sonia Grego, PhD, said in an interview. In contrast to asking patients to keep a bowel movement diary or recall the frequency and consistency of their stool over time, “the system does it for you,” she added.

“Our technology – by automating the image acquisition – removes the burden of having to track your pattern for weeks or months,” added Dr. Grego, founding director of the Duke Smart Toilet Lab at Duke University in Durham, N.C.

Information provided by patients “can have a big impact on decision-making,” Dr. Shin said. “For example, if I am talking to an individual who suffers from irritable bowel syndrome [IBS], I commonly ask them about how loose or watery and hard or formed their stool is, because this information gives me clues as to the underlying problems that may be driving their symptoms.”

Dr. Shin agreed it can be challenging for people to know what is important to report to their doctor. “This tool has the potential to relieve patient burden and facilitate communication between a patient and their clinician. It’s a great example of how technology can be leveraged to enhance care.”
 

Working behind the scenes

Together with gastroenterologist Deborah Anne Fisher, MD, an associate professor of medicine at Duke, Dr. Grego and colleagues devised a prototype that positions the image analyzer in the pipes behind the toilet. So the analysis is done post flush.

“We are experts of toilets and toilet technology,” Dr. Grego said. “We have learned that people really don’t like to see anything weird around the toilet bowl.”

The smart toilet system is designed for multiple users in a residential or commercial setting. The technology could be used in hospitals or long-term care facilities, for example. A fingerprint scanner on the flush mechanism tracks each individual user.
 

Mixed reactions

Dr. Grego gets a range of reactions when she tells people she is developing smart toilet technology.

“Friends and family laugh about the concept of the smart toilet,” she said, “so all the possible jokes that have been done on poops, we know.”

In fact, the researchers also are collecting the jokes they hear. “We’re being very systematic.”

In contrast, gastroenterologists who learn of the technology in development are more enthusiastic, Dr. Grego said. “There is such a need for removing the uncertainty of the patient recall about bowel movement frequency and appearance.

“We are seeking to expand through collaboration with additional GI doctors. We want to develop a more advanced prototype and do further validation studies,” Dr. Grego said.
 

Digital health tool

There is an aversion among patients to handling stool “or even talking about it,” Dr. Grego said. Colleagues tell her that people are more willing to provide a blood sample, which requires a needle, than a stool sample.

“But a lot of health data is there [in the stool],” she added. “We think this will empower a lot of research as well as consumer data gathering.”

For example, Dr. Grego envisions pharmaceutical companies using the technology to detect or monitor any changes in stool or gut health based on a treatment in development during clinical trials.

Furthermore, the technology might empower health-conscious consumers who want to track their own gut health. “This technology will be a whole new entry in the digital health toolkit,” Dr. Grego said.

Although not included in the research presented at this year’s DDW, the developers plan to add a sampling capability. Biochemic analysis of stool samples could provide “metabolically relevant information,” including stool biomarkers and microbiome composition.

“We have demonstrated it in the laboratory. It will be part of the technology when developed into a product,” Dr. Grego said.

This proof-of-concept study “is the first step in a path we are aggressively pursuing,” Dr. Grego said. She estimated it will take about 12-18 months to develop a prototype for use with patients. “We hope to move to a product soon after that.”

“I’m looking forward to seeing future iterations of this tool,” Dr. Shin said. “It could have a role in monitoring important GI diseases and disorders, including IBS and inflammatory bowel disease, or even for the detection of ‘alarm symptoms’ that shouldn’t be ignored.

“I could even see it having a role in preventative health in the future,” Dr. Shin added. 

The technology has been licensed to the spin-off company Coprata to develop the product further.

“We hope to have an impact on people’s health very soon,” Dr. Grego said.  

Duke University funded the study. Dr. Grego holds a management position at Coprata. Dr. Shin disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

It’s more evidence that Americans drank more alcohol during the COVID-19 lockdown. Rates of liver and gastrointestinal diseases associated with drinking alcohol rose after the COVID-19 pandemic started, compared with the same period in 2019.

Interestingly, while the overall number of people seeking GI or liver specialist care dropped by 27%, the proportion of consults for alcohol-related GI and liver diseases jumped by nearly 60%, researchers reported.

“We do believe that the lockdown of the pandemic has a direct effect on patients’ alcohol consumption,” senior study author Waihong Chung, MD, said during Digestive Disease Week® (DDW) 2021 preview media briefing on May 13.

“We urge primary care physicians and GI doctors and hepatologists to double down on questioning patients about alcohol use and to identify people who might need help sooner rather than later,” added Dr. Chung, gastroenterologist at Lifespan/Brown University in Providence, R.I.

“You have to ask. If you don’t ask, you don’t know,” Dr. Chung said in an interview when asked how to broach the subject.

Symptoms of alcohol-related GI and liver diseases, especially acute alcoholic hepatitis, can include fatigue, abdominal pain, loss of appetite, and even jaundice in more severe cases. “I want to stress that some of these symptoms appear much later during the course of the disease,” Dr. Chung said. “At the early phase, people might be asymptomatic. By the time people develop symptoms it might be too late. That’s why it’s important to ask.”

“I really believe that physicians of all specialties should make it routine when you have a patient encounter to include assessment for alcohol use,” he added.

Creating a clinical environment where patients feel safe to disclose their alcohol use is likewise essential.

Suggested questions include: Do you drink alcohol? How much did you drink in the past week?

“A few people will be offended by me asking this way, but it helps people who might think they have an alcohol problem open up [about it],” he said.

After Dr. Chung and colleagues noticed an increase in patients with alcohol-related GI and liver diseases, they conducted a hospital system–wide audit. They evaluated 558 inpatient GI consults during a lockdown phase from March 23 to May 10, 2020, and another 713 consults during a reopening phase from June 1 to July 19, 2020. They also compared results with consults from similar periods in 2019.

At the same time, consults for non–alcohol-related liver diseases, such as biliary obstruction/injury, inflammatory bowel disease, and gastrointestinal bleeding, did not change significantly. Also, during reopening the total volume of consults rebounded to 101% of the volume during the same period in 2019.

However, reopening also saw the proportion of these alcohol-related conditions remain elevated by 79%. Patients diagnosed with alcoholic hepatitis increased by 127%, for example. At the same time, patients in this population requiring inpatient endoscopy nearly tripled from 14% to 35%.

Alcohol-related GI and liver diseases included acute alcoholic hepatitis, alcoholic cirrhosis, alcoholic gastritis, alcoholic esophagitis, and pancreatitis. Most patients (70%) were men. Median ages were 56 years during the lockdown phase and 51 years during the reopening phase.

“I think it’s interesting. It fits into what people have anecdotally been suggesting,” said Loren Laine, MD, chief of the section of digestive diseases at Yale University in New Haven, Conn., and moderator of the media briefing.

“It is [also] interesting to see how COVID has changed so many different things over the past year,” he added when asked his opinion of the findings.

Dr. Chung added that not all patients with alcohol use disorders are admitted to a hospital, “so we believe that the health problems related to increased alcohol use may be even higher in the community.”

Although the study was conducted in one health system in one state, Dr. Chung said, “we do believe that the result of our study is an accurate reflection of what’s happening in many other urban and suburban cities in the United States.”

A version of this article first appeared on Medscape.com.

It’s more evidence that Americans drank more alcohol during the COVID-19 lockdown. Rates of liver and gastrointestinal diseases associated with drinking alcohol rose after the COVID-19 pandemic started, compared with the same period in 2019.

Interestingly, while the overall number of people seeking GI or liver specialist care dropped by 27%, the proportion of consults for alcohol-related GI and liver diseases jumped by nearly 60%, researchers reported.

“We do believe that the lockdown of the pandemic has a direct effect on patients’ alcohol consumption,” senior study author Waihong Chung, MD, said during Digestive Disease Week® (DDW) 2021 preview media briefing on May 13.

“We urge primary care physicians and GI doctors and hepatologists to double down on questioning patients about alcohol use and to identify people who might need help sooner rather than later,” added Dr. Chung, gastroenterologist at Lifespan/Brown University in Providence, R.I.

“You have to ask. If you don’t ask, you don’t know,” Dr. Chung said in an interview when asked how to broach the subject.

Symptoms of alcohol-related GI and liver diseases, especially acute alcoholic hepatitis, can include fatigue, abdominal pain, loss of appetite, and even jaundice in more severe cases. “I want to stress that some of these symptoms appear much later during the course of the disease,” Dr. Chung said. “At the early phase, people might be asymptomatic. By the time people develop symptoms it might be too late. That’s why it’s important to ask.”

“I really believe that physicians of all specialties should make it routine when you have a patient encounter to include assessment for alcohol use,” he added.

Creating a clinical environment where patients feel safe to disclose their alcohol use is likewise essential.

Suggested questions include: Do you drink alcohol? How much did you drink in the past week?

“A few people will be offended by me asking this way, but it helps people who might think they have an alcohol problem open up [about it],” he said.

After Dr. Chung and colleagues noticed an increase in patients with alcohol-related GI and liver diseases, they conducted a hospital system–wide audit. They evaluated 558 inpatient GI consults during a lockdown phase from March 23 to May 10, 2020, and another 713 consults during a reopening phase from June 1 to July 19, 2020. They also compared results with consults from similar periods in 2019.

At the same time, consults for non–alcohol-related liver diseases, such as biliary obstruction/injury, inflammatory bowel disease, and gastrointestinal bleeding, did not change significantly. Also, during reopening the total volume of consults rebounded to 101% of the volume during the same period in 2019.

However, reopening also saw the proportion of these alcohol-related conditions remain elevated by 79%. Patients diagnosed with alcoholic hepatitis increased by 127%, for example. At the same time, patients in this population requiring inpatient endoscopy nearly tripled from 14% to 35%.

Alcohol-related GI and liver diseases included acute alcoholic hepatitis, alcoholic cirrhosis, alcoholic gastritis, alcoholic esophagitis, and pancreatitis. Most patients (70%) were men. Median ages were 56 years during the lockdown phase and 51 years during the reopening phase.

“I think it’s interesting. It fits into what people have anecdotally been suggesting,” said Loren Laine, MD, chief of the section of digestive diseases at Yale University in New Haven, Conn., and moderator of the media briefing.

“It is [also] interesting to see how COVID has changed so many different things over the past year,” he added when asked his opinion of the findings.

Dr. Chung added that not all patients with alcohol use disorders are admitted to a hospital, “so we believe that the health problems related to increased alcohol use may be even higher in the community.”

Although the study was conducted in one health system in one state, Dr. Chung said, “we do believe that the result of our study is an accurate reflection of what’s happening in many other urban and suburban cities in the United States.”

A version of this article first appeared on Medscape.com.

It’s more evidence that Americans drank more alcohol during the COVID-19 lockdown. Rates of liver and gastrointestinal diseases associated with drinking alcohol rose after the COVID-19 pandemic started, compared with the same period in 2019.

Interestingly, while the overall number of people seeking GI or liver specialist care dropped by 27%, the proportion of consults for alcohol-related GI and liver diseases jumped by nearly 60%, researchers reported.

“We do believe that the lockdown of the pandemic has a direct effect on patients’ alcohol consumption,” senior study author Waihong Chung, MD, said during Digestive Disease Week® (DDW) 2021 preview media briefing on May 13.

“We urge primary care physicians and GI doctors and hepatologists to double down on questioning patients about alcohol use and to identify people who might need help sooner rather than later,” added Dr. Chung, gastroenterologist at Lifespan/Brown University in Providence, R.I.

“You have to ask. If you don’t ask, you don’t know,” Dr. Chung said in an interview when asked how to broach the subject.

Symptoms of alcohol-related GI and liver diseases, especially acute alcoholic hepatitis, can include fatigue, abdominal pain, loss of appetite, and even jaundice in more severe cases. “I want to stress that some of these symptoms appear much later during the course of the disease,” Dr. Chung said. “At the early phase, people might be asymptomatic. By the time people develop symptoms it might be too late. That’s why it’s important to ask.”

“I really believe that physicians of all specialties should make it routine when you have a patient encounter to include assessment for alcohol use,” he added.

Creating a clinical environment where patients feel safe to disclose their alcohol use is likewise essential.

Suggested questions include: Do you drink alcohol? How much did you drink in the past week?

“A few people will be offended by me asking this way, but it helps people who might think they have an alcohol problem open up [about it],” he said.

After Dr. Chung and colleagues noticed an increase in patients with alcohol-related GI and liver diseases, they conducted a hospital system–wide audit. They evaluated 558 inpatient GI consults during a lockdown phase from March 23 to May 10, 2020, and another 713 consults during a reopening phase from June 1 to July 19, 2020. They also compared results with consults from similar periods in 2019.

At the same time, consults for non–alcohol-related liver diseases, such as biliary obstruction/injury, inflammatory bowel disease, and gastrointestinal bleeding, did not change significantly. Also, during reopening the total volume of consults rebounded to 101% of the volume during the same period in 2019.

However, reopening also saw the proportion of these alcohol-related conditions remain elevated by 79%. Patients diagnosed with alcoholic hepatitis increased by 127%, for example. At the same time, patients in this population requiring inpatient endoscopy nearly tripled from 14% to 35%.

Alcohol-related GI and liver diseases included acute alcoholic hepatitis, alcoholic cirrhosis, alcoholic gastritis, alcoholic esophagitis, and pancreatitis. Most patients (70%) were men. Median ages were 56 years during the lockdown phase and 51 years during the reopening phase.

“I think it’s interesting. It fits into what people have anecdotally been suggesting,” said Loren Laine, MD, chief of the section of digestive diseases at Yale University in New Haven, Conn., and moderator of the media briefing.

“It is [also] interesting to see how COVID has changed so many different things over the past year,” he added when asked his opinion of the findings.

Dr. Chung added that not all patients with alcohol use disorders are admitted to a hospital, “so we believe that the health problems related to increased alcohol use may be even higher in the community.”

Although the study was conducted in one health system in one state, Dr. Chung said, “we do believe that the result of our study is an accurate reflection of what’s happening in many other urban and suburban cities in the United States.”

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

About 2% of asymptomatic college students carried 90% of COVID-19 viral load levels on a Colorado campus last year, new research reveals. Furthermore, the viral loads in these students were as elevated as those seen in hospitalized patients.

“College campuses were one of the few places where people without any symptoms or suspicions of exposure were being screened for the virus. This allowed us to make some powerful comparisons between symptomatic vs healthy carriers of the virus,” senior study author Sara Sawyer, PhD, professor of virology at the University of Colorado, Boulder, said in an interview.

“It turns out, walking around a college campus can be as dangerous as walking through a COVID ward in the hospital, in that you will experience these viral ‘super carriers’ equally in both settings,” she said.

“This is an important study in advancing our understanding of how SARS-CoV-2 is distributed in the population,” Thomas Giordano, MD, MPH, professor and section chief of infectious diseases at Baylor College of Medicine, Houston, said in an interview.

The study “adds to the evidence that viral load is not too tightly correlated with symptoms.” In fact, Dr. Giordano added, “this study suggests viral load is not at all correlated with symptoms.”

Viral load may not be correlated with transmissibility either, said Raphael Viscidi, MD, when asked to comment. “This is not a transmissibility study. They did not show that viral load is the factor related to transmission.”

“It’s true that 2% of the population they studied carried 90% of the virus, but it does not establish any biological importance to that 2%,” added Dr. Viscidi, professor of pediatrics and oncology at Johns Hopkins University, Baltimore,.

The 2% could just be the upper tail end of a normal bell-shaped distribution curve, Dr. Viscidi said, or there could be something biologically unique about that group. But the study does not make that distinction, he said.

The study was published online May 10, 2021, in PNAS, the official journal of the National Academy of Sciences.
 

A similar picture in hospitalized patients

Out of more than 72,500 saliva samples taken during COVID-19 screening at the University of Colorado Boulder between Aug. 27 and Dec. 11, 2020, 1,405 were positive for SARS-CoV-2.

The investigators also compared viral loads from students with those of hospitalized patients based on published data. They found the distribution of viral loads between these groups “indistinguishable.”

“Strikingly, these datasets demonstrate dramatic differences in viral levels between individuals, with a very small minority of the infected individuals harboring the vast majority of the infectious virions,” the researchers wrote. The comparison “really represents two extremes: One group is mostly hospitalized, while the other group represents a mostly young and healthy (but infected) college population.”

“It would be interesting to adjust public health recommendations based on a person’s viral load,” Dr. Giordano said. “One could speculate that a person with a very high viral load could be isolated longer or more thoroughly, while someone with a very low viral load could be minimally isolated.

“This is speculation, and more data are needed to test this concept,” he added. Also, quantitative viral load testing would need to be standardized before it could be used to guide such decision-making
 

Preceding the COVID-19 vaccine era

It should be noted that the research was conducted in fall 2020, before access to COVID-19 immunization.

“The study was performed prior to vaccine availability in a cohort of young people. It adds further data to support prior observations that the majority of infections are spread by a much smaller group of individuals,” David Hirschwerk, MD, said in an interview.

“Now that vaccines are available, I think it is very likely that a repeat study of this type would show diminished transmission from vaccinated people who were infected yet asymptomatic,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in New Hyde Park, N.Y., who was not affiliated with the research.
 

Mechanism still a mystery

“This finding has been in the literature in piecemeal fashion since the beginning of the pandemic,” Dr. Sawyer said. “I just think we were the first to realize the bigger implications of these plots of viral load that we have all been seeing over and over again.”

How a minority of people walk around asymptomatic with a majority of virus remains unanswered. Are there special people who can harbor these extremely high viral loads? Or do many infected individuals experience a short period of time when they carry such elevated levels?

The highest observed viral load in the current study was more than 6 trillion virions per mL. “It is remarkable to consider that this individual was on campus and reported no symptoms at our testing site,” the researchers wrote.

In contrast, the lowest viral load detected was 8 virions per mL.

Although more research is needed, the investigators noted that “a strong implication is that these individuals who are viral ‘super carriers’ may also be ‘superspreaders.’ ”

Some of the study authors have financial ties to companies that offer commercial SARS-CoV-2 testing, including Darwin Biosciences, TUMI Genomics, Faze Medicines, and Arpeggio Biosciences.

A version of this article first appeared on Medscape.com.

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

A version of this article first appeared on Medscape.com.

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

A version of this article first appeared on Medscape.com.

The Moderna SARS-CoV-2 vaccine booster developed specifically with variant B.1.351 in mind shows efficacy against that strain and the P1 variant among people already vaccinated for COVID-19, according to first results released May 5.
 

Furthermore, data from the company’s ongoing phase 2 study show the variant-specific booster, known as mRNA-1273.351, achieved higher antibody titers against the B.1.351 variant than did a booster with the original Moderna vaccine.

“We are encouraged by these new data, which reinforce our confidence that our booster strategy should be protective against these newly detected variants. The strong and rapid boost in titers to levels above primary vaccination also clearly demonstrates the ability of mRNA-1273 to induce immune memory,” Stéphane Bancel, chief executive officer of Moderna, said in a statement.

The phase 2 study researchers also are evaluating a multivariant booster that is a 50/50 mix of mRNA-1273.351 and mRNA-1273, the initial vaccine given Food and Drug Administration emergency use authorization, in a single vial.

Unlike the two-dose regimen with the original vaccine, the boosters are administered as a single dose immunization.

The trial participants received a booster 6-8 months after primary vaccination. Titers to the wild-type SARS-CoV-2 virus remained high and detectable in 37 out of 40 participants. However, prior to the booster, titers against the two variants of concern, B.1.351 and P.1, were lower, with about half of participants showing undetectable levels.

In contrast, 2 weeks after a booster with the original vaccine or the B.1.351 strain-specific product, pseudovirus neutralizing titers were boosted in all participants and all variants tested.

“Following [the] boost, geometric mean titers against the wild-type, B.1.351, and P.1 variants increased to levels similar to or higher than the previously reported peak titers against the ancestral (D614G) strain following primary vaccination,” the company stated.

Both mRNA-1273.351 and mRNA-1273 booster doses were generally well tolerated, the company reported. Safety and tolerability were generally comparable to those reported after the second dose of the original vaccine. Most adverse events were mild to moderate, with injection site pain most common in both groups. Participants also reported fatigue, headache, myalgia, and arthralgia.

The company plans to release data shortly on the booster efficacy at additional time points beyond 2 weeks for mRNA-1273.351, a lower-dose booster with mRNA-1272/351, as well as data on the multivariant mRNA vaccine booster.

In addition to the company’s phase 2 study, the National Institute of Allergy and Infectious Diseases is conducting a separate phase 1 study of mRNA-1273.351.

A version of this article first appeared on Medscape.com.

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

A version of this article first appeared on Medscape.com.

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

A version of this article first appeared on Medscape.com.

COVID-19 is likely to follow a seasonal pattern – similar to some other respiratory viruses – with fewer cases come summer 2021 followed by a jump next winter, experts predicted in a Thursday briefing.

If that pattern holds, it could mean a need to reinforce the mask-wearing message as the weather gets colder and people once again congregate indoors.

“Right now, we are projecting the United States all the way to Aug. 1 [will have] 619,000 deaths from COVID-19, with 4.7 million globally,” said Ali H. Mokdad, PhD, professor of health metrics sciences at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle, during today’s media briefing sponsored by the Infectious Diseases Society of America and IHME.

The encouraging news is the vaccines appear to be working, and more Americans are getting them. “If you look at the data for these vaccines, they are extremely safe, they are extremely efficacious, and they make you basically impervious – for the most part – to getting serious disease, hospitalization, or death,” said Amesh Adalja, MD, senior scholar at Johns Hopkins University Center for Health Security in Baltimore.

“These vaccines do what they were meant to do: defang this virus,” said Dr. Adalja, who is an IDSA Fellow and adjunct assistant professor at Johns Hopkins Bloomberg School of Public Health. Emerging data out of Israel and other countries suggest a vaccinated person is less likely to transmit the virus as well, he added.
 

Still aiming for herd immunity

Furthermore, the U.S. Food and Drug Administration is likely to approve emergency use authorization (EUA) among teenagers 12-15 years old “imminently,” thereby expanding the pool of people potentially protected by vaccines.

Such authorization could help with overall public health efforts. “That’s simply a mathematical formula,” Dr. Adalja said. “The more people that are vaccinated, including children, the quicker we’ll get to herd immunity.”

In addition, with lower case numbers expected this summer, herd immunity might become more achievable, said Dr. Mokdad, who is also chief strategy officer for population health at the University of Washington.

As important as herd immunity is, so-called decoupling is “more important to me,” Dr. Adalja said. Decoupling refers to separating infections from the more severe outcomes, so people who get COVID-19 are less likely to need hospitalization or die from it.

Vaccines get the credit here, he added, including with the variants. “Even if you get a breakthrough infection with a variant, it’s not likely to land you in the hospital or cause serious disease or death,” Dr. Adalja said.
 

Masks and the uncommon cold

Wearing a mask until we reach herd immunity is important because it’s not possible to tell who is vaccinated and who isn’t, Dr. Mokdad said. “Remember, as many people are waiting to get a vaccine, all of us have access to a mask,” he said.

Dr. Adalja agreed, adding that public health guidance on masks will likely stay in place until we cross that herd immunity threshold and community circulation of the virus goes down.

“People are probably going to want to continue wearing masks, at least some proportion, because they see the benefit for other respiratory viruses,” Dr. Adalja said. “How many of you had a common cold this year?”
 

Variants: Some good news?

Experts are monitoring the spread of variants of concern in the United States and abroad. On a positive note, the B.1.1.7 variant first identified in the United Kingdom appears to be dominant in the United States at this time, which is potentially good for two reasons. One is that the available COVID-19 vaccines show sufficient efficacy against the strain, Dr. Mokdad said.

Second, a predominance of B.1.1.7 makes it more difficult for other emerging variants of concern like P1 [Brazil] or B.1.351 [South Africa] to gain control, Dr. Adalja said.

“B.1.1.7 is such an efficient transmitter,” he said. “That’s kind of an advantage … because the more B.1.1.7, you have the less opportunity B.1.351 and P1 have to set up shop.”
 

Hesitancy from misinformation

Vaccine hesitancy remains a concern, particularly at a time when some predict a drop in the number of Americans seeking vaccination. Although needle phobia plays a role in dissuading some from vaccination, the bigger issue is vaccine misinformation, Dr. Adalja said.

“Some people are just terrified when they see the needle. That’s a small part of the proportion of people who don’t want to get vaccinated,” Dr. Adalja said. In contrast, he attributed most hesitancy to misinformation about the vaccine, including reports that the vaccines are fake.

Even celebrities are getting drawn into the misinformation.

“I just had to answer something about Mariah Carey’s vaccination,” he said. Someone believed “that it was done with a retractable needle that didn’t really go into her arm.”

Vaccine hesitancy is more about people not understanding the risk-benefit analysis, taking side effects out of out of context if there are side effects, or being influenced by “arbitrary statements about microchips, infertility, or whatever it might be,” Dr. Adalja said.
 

The future is subject to change

“We’re expecting another rise in cases and more mortality in our winter season here in the United States,” Dr. Mokdad said, adding that the efficacy of the vaccines is likely to attenuate the mortality rate in particular.

However, as the epidemiology of the pandemic evolves, so too will the long-term predictions. Factors that could influence future numbers include the expansion of vaccination to teens 12-15 years old and (eventually) younger children, a need for booster vaccines, emerging variants, and the changing proportion of the population who are fully vaccinated or were previously infected.

Again, getting people to adhere to mask wearing come winter could be challenging if the scenario over the summer is “close to normal with less than 200 deaths a day in the United States,” he added. Asking people to wear masks again will be like “swimming upstream.”

“I think it’s a mistake to think that we’re going to get to ‘COVID zero,’ ” Dr. Adalja said. “This is not an eradicable disease. There’s only been one human infectious disease eradicated from the planet, and that’s smallpox, and it had very different characteristics.”

A version of this article first appeared on Medscape.com.