News from the FDA/CDC

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control and Prevention has recommended that everyone get a COVID-19 vaccine, even if they’ve had the virus before. Yet many skeptics have held off getting the shots, believing that immunity generated by their previous infection will protect them if they should encounter the virus again. 

A new study published in the CDC’s Morbidity and Mortality Weekly Report pokes holes in this notion. It shows people who have recovered from COVID-19 but haven’t been vaccinated have more than double the risk of testing positive for the virus again, compared with someone who was vaccinated after an initial infection.

The study looked at 738 Kentucky residents who had an initial bout of COVID-19 in 2020. About 250 of them tested positive for COVID-19 a second time between May and July of 2021, when the Delta variant became dominant in the United States. 

The study matched each person who’d been reinfected with two people of the same sex and roughly the same age who had caught their initial COVID infection within the same week. The researchers then cross-matched those cases with data from Kentucky’s Immunization Registry.

They found that those who were unvaccinated had more than double the risk of being reinfected during the Delta wave. Partial vaccination appeared to have no significant impact on the risk of reinfection.

Among those who were reinfected, 20% were fully vaccinated, while 34% of those who did not get reinfected were fully vaccinated.

The study is observational, meaning it can’t show cause and effect; and the researchers had no information on the severity of the infections. Alyson Cavanaugh, PhD, a member of the CDC’s Epidemic Intelligence Service who led the study, said it is possible that some of the people who tested positive a second time had asymptomatic infections that were picked up through routine screening.

Still, the study backs up previous research and suggests that vaccination offers important additional protection.

“Our laboratory studies have shown that there’s an added benefit of vaccine for people who’ve had previous COVID-19. This is a real-world, epidemiologic study that found that among people who’d previously already had COVID-19, those who were vaccinated had lower odds of being reinfected,” Dr. Cavanaugh said.

“If you have had COVID-19 before, please still get vaccinated,” said CDC Director Rochelle Walensky, MD, in a written media statement. “This study shows you are twice as likely to get infected again if you are unvaccinated. Getting the vaccine is the best way to protect yourself and others around you, especially as the more contagious Delta variant spreads around the country.”

In a White House COVID-19 Response Team briefing in May, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Disease, explained why vaccines create stronger immunity than infection. He highlighted new research showing that two doses of an mRNA vaccine produce levels of neutralizing antibodies that are up to 10 times higher than the levels found in the blood of people who’ve recovered from COVID-19. Vaccines also enhance B cells and T cells in people who’ve recovered from COVID-19, which broadens the spectrum of protection and helps to fend off variants.

The study has some important limitations, which the authors acknowledged. The first is that second infections weren’t confirmed with genetic sequencing, so the researchers couldn’t definitively tell if a person tested positive a second time because they caught a new virus, or if they were somehow still shedding virus from their first infection. Given that the tests were at least 5 months apart, though, the researchers think reinfection is the most likely explanation.

Another bias in the study could have something to do with vaccination. Vaccinated people may have been less likely to be tested for COVID-19 after their vaccines, so the association or reinfection with a lack of vaccination may be overestimated. 

Also, people who were vaccinated at federal sites or in another state were not logged in the state’s immunization registry, which may have skewed the data.

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

The Centers for Disease Control has issued the first recommendations for the prevention and treatment of plague since 2000. The new guidelines focus on the possibility of bioterrorism with mass casualty events from an intentional release of Yersinia pestis.

Plague, a deadly infection caused by Y. pestis, has been feared throughout history because of large pandemics. The most well-known pandemic was the so-called Black Death in the fourteenth century, during which more than 50 million Europeans died. The biggest concern now is the spread of the bacteria by bioterrorism.

The CDC based their revised guidelines on an extensive systematic review of the literature and multiple sessions with about 90 experts in infectious disease, public health, emergency medicine, obgyn, maternal-fetal health, and pediatrics, in addition to representatives from a wide range of federal agencies.
 

Key changes

Christina Nelson, a medical officer with the CDC’s Division of Vector-Borne Diseases, told this news organization that now “we have been fortunate to have extended options for treatment.” Previously, “streptomycin and gentamicin were the first-line options for adults,” she said. Now, on the basis of additional evidence, “[we’re] able to … elevate the fluoroquinolones to first-line treatments.”

On the basis of the Animal Rule, which allows approval of antibiotics without human testing if such testing is not possible, the U.S. Food and Drug Administration has approved several quinolones for both treatment and prophylaxis of plague.

The guidelines offer same-class alternative antibiotics to meet surge capacity. Similarly, trimethoprim-sulfamethoxazole is now an alternative for prophylaxis.

There are additional oral options to conserve IV medications and supplies in a mass casualty event.

For the first time, the CDC added specific recommendations for pregnant women. Gigi Kwik Gronvall, PhD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, told this news organization that she was pleased to see this addition, because “effects on women and during pregnancy are not fully addressed, and it leads to problems down the road, like with COVID, [for which] they didn’t include pregnant people in their clinical trials for the vaccines [and] don’t have enough data to convince pregnant women to actually get the vaccine.”
 

Bubonic plague

Plague occurs globally, with natural sylvatic (wild animal) outbreaks occurring among rodents and small mammals. It is spread by fleas. When an infected flea bites a human, the person can become infected, most commonly as “bubonic” plague, with swollen lymph nodes, called buboes. Transmission can also occur between people by contact with infected fluids or inhalation of infectious droplets.

Gentamicin or streptomycin remain first-line agents for treating bubonic plague. When used as monotherapy, the survival rate is 91%. They have to be given parenterally and are associated with both nephroroxicity and ototoxicity; patients require monitoring.

Alternative first-line drugs now include high-dose ciprofloxicin, levofloxacin, moxifloxacin, and doxycycline. Each is administered either intravenously or orally.

Physicians should consider dual therapy and drainage for patients with large buboes. Treatment is for 10 to 14 days.
 

Pneumonic and septicemic plague

The pneumonic and septicemic forms of infection are deadlier than the bubonic. Pneumonic plague can be acquired from inhalation of infected bacteria from animals or people, from lab accidents, or from intentional aerosolization. Without treatment, these forms are almost always fatal. With treatment with aminoglycosides, fluoroquinolones, or tetracyclines, alone or in combination, survival is 82% to 83%. With naturally occurring pneumonic plague, the CDC now recommends levofloxacin or moxifloxacin to cover for community-acquired pneumonia if the source of the infection is uncertain.

Because plague is life threatening, doxycycline is not considered contraindicated in children. It has not been shown to cause tooth staining, unlike other tetracyclines, which should still be avoided if possible.
 

Meningitis

About 10% of people infected with bubonic plague develop plague meningitis. Symptoms are stiff neck, fever, headache, and coma. The current recommendation for treating plague meningitis is chloramphenicol and moxifloxacin or levofloxacin. However, quinolones can cause seizures, and clinicians should take that into account.

Infection control

Plague is transmitted between people by droplets, so caretakers should wear a mask in addition to taking standard precautions. They should add eye protection and a face shield if splashing is likely. Airborne precautions are not needed. Plague is not very transmissible from person to person; each infected person on average infects only 1.18 other people. In comparison, someone with chicken pox infects 9 to 10 people on average.

Bioterrorism

A deliberate attack would likely go undetected until a cluster or unusual pattern of disease became evident. With Y. pestis, the infectious dose is low. According to the guidelines, modeling suggests that a “release of 50 kg of Y. pestis into the air over a city of 5 million persons could result in 150,000 cases of pneumonic plague and 36,000 deaths.”

Because the former Union of the Soviet Socialist Republics (USSR) engineered antibiotic-resistant Y. pestis, antibiotics from two different classes should be used empirically until sensitivity tests become available.

Antibiotic prophylaxis would also have to be considered for exposed individuals. Recommendations would be developed at the time by federal and state experts, based in part on the magnitude of the event and the availability of masks and different classes of antibiotics.

Dr. Gronvall stressed the need for awareness, saying, “It’s important for people to remember that the first sign of the potential attack could be somebody coming into your hospital.”

Dr. Nelson added, “One of the main take-home messages ... is that plague still happens, it still happens in the western United States, it still happens around the world ... It’s not just a relic of history.” She emphasized that clinicians need to be thinking about it, because “it’s very important to get antibiotics on board early ... Then patients generally have a good prognosis.”

Dr. Nelson and Dr. Gronvall have disclosed no relevant financial relationships.

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

The Centers for Disease Control has issued the first recommendations for the prevention and treatment of plague since 2000. The new guidelines focus on the possibility of bioterrorism with mass casualty events from an intentional release of Yersinia pestis.

Plague, a deadly infection caused by Y. pestis, has been feared throughout history because of large pandemics. The most well-known pandemic was the so-called Black Death in the fourteenth century, during which more than 50 million Europeans died. The biggest concern now is the spread of the bacteria by bioterrorism.

The CDC based their revised guidelines on an extensive systematic review of the literature and multiple sessions with about 90 experts in infectious disease, public health, emergency medicine, obgyn, maternal-fetal health, and pediatrics, in addition to representatives from a wide range of federal agencies.
 

Key changes

Christina Nelson, a medical officer with the CDC’s Division of Vector-Borne Diseases, told this news organization that now “we have been fortunate to have extended options for treatment.” Previously, “streptomycin and gentamicin were the first-line options for adults,” she said. Now, on the basis of additional evidence, “[we’re] able to … elevate the fluoroquinolones to first-line treatments.”

On the basis of the Animal Rule, which allows approval of antibiotics without human testing if such testing is not possible, the U.S. Food and Drug Administration has approved several quinolones for both treatment and prophylaxis of plague.

The guidelines offer same-class alternative antibiotics to meet surge capacity. Similarly, trimethoprim-sulfamethoxazole is now an alternative for prophylaxis.

There are additional oral options to conserve IV medications and supplies in a mass casualty event.

For the first time, the CDC added specific recommendations for pregnant women. Gigi Kwik Gronvall, PhD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, told this news organization that she was pleased to see this addition, because “effects on women and during pregnancy are not fully addressed, and it leads to problems down the road, like with COVID, [for which] they didn’t include pregnant people in their clinical trials for the vaccines [and] don’t have enough data to convince pregnant women to actually get the vaccine.”
 

Bubonic plague

Plague occurs globally, with natural sylvatic (wild animal) outbreaks occurring among rodents and small mammals. It is spread by fleas. When an infected flea bites a human, the person can become infected, most commonly as “bubonic” plague, with swollen lymph nodes, called buboes. Transmission can also occur between people by contact with infected fluids or inhalation of infectious droplets.

Gentamicin or streptomycin remain first-line agents for treating bubonic plague. When used as monotherapy, the survival rate is 91%. They have to be given parenterally and are associated with both nephroroxicity and ototoxicity; patients require monitoring.

Alternative first-line drugs now include high-dose ciprofloxicin, levofloxacin, moxifloxacin, and doxycycline. Each is administered either intravenously or orally.

Physicians should consider dual therapy and drainage for patients with large buboes. Treatment is for 10 to 14 days.
 

Pneumonic and septicemic plague

The pneumonic and septicemic forms of infection are deadlier than the bubonic. Pneumonic plague can be acquired from inhalation of infected bacteria from animals or people, from lab accidents, or from intentional aerosolization. Without treatment, these forms are almost always fatal. With treatment with aminoglycosides, fluoroquinolones, or tetracyclines, alone or in combination, survival is 82% to 83%. With naturally occurring pneumonic plague, the CDC now recommends levofloxacin or moxifloxacin to cover for community-acquired pneumonia if the source of the infection is uncertain.

Because plague is life threatening, doxycycline is not considered contraindicated in children. It has not been shown to cause tooth staining, unlike other tetracyclines, which should still be avoided if possible.
 

Meningitis

About 10% of people infected with bubonic plague develop plague meningitis. Symptoms are stiff neck, fever, headache, and coma. The current recommendation for treating plague meningitis is chloramphenicol and moxifloxacin or levofloxacin. However, quinolones can cause seizures, and clinicians should take that into account.

Infection control

Plague is transmitted between people by droplets, so caretakers should wear a mask in addition to taking standard precautions. They should add eye protection and a face shield if splashing is likely. Airborne precautions are not needed. Plague is not very transmissible from person to person; each infected person on average infects only 1.18 other people. In comparison, someone with chicken pox infects 9 to 10 people on average.

Bioterrorism

A deliberate attack would likely go undetected until a cluster or unusual pattern of disease became evident. With Y. pestis, the infectious dose is low. According to the guidelines, modeling suggests that a “release of 50 kg of Y. pestis into the air over a city of 5 million persons could result in 150,000 cases of pneumonic plague and 36,000 deaths.”

Because the former Union of the Soviet Socialist Republics (USSR) engineered antibiotic-resistant Y. pestis, antibiotics from two different classes should be used empirically until sensitivity tests become available.

Antibiotic prophylaxis would also have to be considered for exposed individuals. Recommendations would be developed at the time by federal and state experts, based in part on the magnitude of the event and the availability of masks and different classes of antibiotics.

Dr. Gronvall stressed the need for awareness, saying, “It’s important for people to remember that the first sign of the potential attack could be somebody coming into your hospital.”

Dr. Nelson added, “One of the main take-home messages ... is that plague still happens, it still happens in the western United States, it still happens around the world ... It’s not just a relic of history.” She emphasized that clinicians need to be thinking about it, because “it’s very important to get antibiotics on board early ... Then patients generally have a good prognosis.”

Dr. Nelson and Dr. Gronvall have disclosed no relevant financial relationships.

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

The Centers for Disease Control has issued the first recommendations for the prevention and treatment of plague since 2000. The new guidelines focus on the possibility of bioterrorism with mass casualty events from an intentional release of Yersinia pestis.

Plague, a deadly infection caused by Y. pestis, has been feared throughout history because of large pandemics. The most well-known pandemic was the so-called Black Death in the fourteenth century, during which more than 50 million Europeans died. The biggest concern now is the spread of the bacteria by bioterrorism.

The CDC based their revised guidelines on an extensive systematic review of the literature and multiple sessions with about 90 experts in infectious disease, public health, emergency medicine, obgyn, maternal-fetal health, and pediatrics, in addition to representatives from a wide range of federal agencies.
 

Key changes

Christina Nelson, a medical officer with the CDC’s Division of Vector-Borne Diseases, told this news organization that now “we have been fortunate to have extended options for treatment.” Previously, “streptomycin and gentamicin were the first-line options for adults,” she said. Now, on the basis of additional evidence, “[we’re] able to … elevate the fluoroquinolones to first-line treatments.”

On the basis of the Animal Rule, which allows approval of antibiotics without human testing if such testing is not possible, the U.S. Food and Drug Administration has approved several quinolones for both treatment and prophylaxis of plague.

The guidelines offer same-class alternative antibiotics to meet surge capacity. Similarly, trimethoprim-sulfamethoxazole is now an alternative for prophylaxis.

There are additional oral options to conserve IV medications and supplies in a mass casualty event.

For the first time, the CDC added specific recommendations for pregnant women. Gigi Kwik Gronvall, PhD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, told this news organization that she was pleased to see this addition, because “effects on women and during pregnancy are not fully addressed, and it leads to problems down the road, like with COVID, [for which] they didn’t include pregnant people in their clinical trials for the vaccines [and] don’t have enough data to convince pregnant women to actually get the vaccine.”
 

Bubonic plague

Plague occurs globally, with natural sylvatic (wild animal) outbreaks occurring among rodents and small mammals. It is spread by fleas. When an infected flea bites a human, the person can become infected, most commonly as “bubonic” plague, with swollen lymph nodes, called buboes. Transmission can also occur between people by contact with infected fluids or inhalation of infectious droplets.

Gentamicin or streptomycin remain first-line agents for treating bubonic plague. When used as monotherapy, the survival rate is 91%. They have to be given parenterally and are associated with both nephroroxicity and ototoxicity; patients require monitoring.

Alternative first-line drugs now include high-dose ciprofloxicin, levofloxacin, moxifloxacin, and doxycycline. Each is administered either intravenously or orally.

Physicians should consider dual therapy and drainage for patients with large buboes. Treatment is for 10 to 14 days.
 

Pneumonic and septicemic plague

The pneumonic and septicemic forms of infection are deadlier than the bubonic. Pneumonic plague can be acquired from inhalation of infected bacteria from animals or people, from lab accidents, or from intentional aerosolization. Without treatment, these forms are almost always fatal. With treatment with aminoglycosides, fluoroquinolones, or tetracyclines, alone or in combination, survival is 82% to 83%. With naturally occurring pneumonic plague, the CDC now recommends levofloxacin or moxifloxacin to cover for community-acquired pneumonia if the source of the infection is uncertain.

Because plague is life threatening, doxycycline is not considered contraindicated in children. It has not been shown to cause tooth staining, unlike other tetracyclines, which should still be avoided if possible.
 

Meningitis

About 10% of people infected with bubonic plague develop plague meningitis. Symptoms are stiff neck, fever, headache, and coma. The current recommendation for treating plague meningitis is chloramphenicol and moxifloxacin or levofloxacin. However, quinolones can cause seizures, and clinicians should take that into account.

Infection control

Plague is transmitted between people by droplets, so caretakers should wear a mask in addition to taking standard precautions. They should add eye protection and a face shield if splashing is likely. Airborne precautions are not needed. Plague is not very transmissible from person to person; each infected person on average infects only 1.18 other people. In comparison, someone with chicken pox infects 9 to 10 people on average.

Bioterrorism

A deliberate attack would likely go undetected until a cluster or unusual pattern of disease became evident. With Y. pestis, the infectious dose is low. According to the guidelines, modeling suggests that a “release of 50 kg of Y. pestis into the air over a city of 5 million persons could result in 150,000 cases of pneumonic plague and 36,000 deaths.”

Because the former Union of the Soviet Socialist Republics (USSR) engineered antibiotic-resistant Y. pestis, antibiotics from two different classes should be used empirically until sensitivity tests become available.

Antibiotic prophylaxis would also have to be considered for exposed individuals. Recommendations would be developed at the time by federal and state experts, based in part on the magnitude of the event and the availability of masks and different classes of antibiotics.

Dr. Gronvall stressed the need for awareness, saying, “It’s important for people to remember that the first sign of the potential attack could be somebody coming into your hospital.”

Dr. Nelson added, “One of the main take-home messages ... is that plague still happens, it still happens in the western United States, it still happens around the world ... It’s not just a relic of history.” She emphasized that clinicians need to be thinking about it, because “it’s very important to get antibiotics on board early ... Then patients generally have a good prognosis.”

Dr. Nelson and Dr. Gronvall have disclosed no relevant financial relationships.

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

The CDC has reported two clusters of Candida auris infections resistant to all antifungal medications in long-term care facilities in 2021. Because these panresistant infections occurred without any exposure to antifungal drugs, the cases are even more worrisome. These clusters are the first time such nosocomial transmission has been detected.

In the District of Columbia, three panresistant isolates were discovered through screening for skin colonization with resistant organisms at a long-term acute care facility (LTAC) that cares for patients who are seriously ill, often on mechanical ventilation.

In Texas, the resistant organisms were found both by screening and in specimens from ill patients at an LTAC and a short-term acute care hospital that share patients. Two were panresistant, and five others were resistant to fluconazole and echinocandins.

These clusters occurred simultaneously and independently of each other; there were no links between the two institutions.

Colonization of skin with C. auris can lead to invasive infections in 5%-10% of affected patients. Routine skin surveillance cultures are not commonly done for Candida, although perirectal cultures for vancomycin-resistant enterococci and nasal swabs for MRSA have been done for years. Some areas, like Los Angeles, have recommended screening for C. auris in high-risk patients – defined as those who were on a ventilator or had a tracheostomy admitted from an LTAC or skilled nursing facility in Los Angeles County, New York, New Jersey, or Illinois.

In the past, about 85% of C. auris isolates in the United States have been resistant to azoles (for example, fluconazole), 33% to amphotericin B, and 1% to echinocandins. Because of generally strong susceptibility, an echinocandin such as micafungin or caspofungin has been the drug of choice for an invasive Candida infection.

C. auris is particularly difficult to deal with for several reasons. First, it can continue to live in the environment, on both dry or moist surfaces, for up to 2 weeks. Outbreaks have occurred both from hand (person-to-person) transmission or via inanimate surfaces that have become contaminated. Equally troublesome is that people become colonized with the yeast indefinitely.

Meghan Lyman, MD, of the fungal diseases branch of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said in an interview that facilities might be slow in recognizing the problem and in identifying the organism. “We encounter problems in noninvasive specimens, especially urine,” Dr. Lyman added.

“Sometimes ... they consider Candida [to represent] colonization so they will often not speciate it.” She emphasized the need for facilities that care for ventilated patients to consider screening. “Higher priority ... are places in areas where there’s a lot of C. auris transmission or in nearby areas that are likely to get introductions.” Even those that do speciate may have difficulty identifying C. auris.

Further, Dr. Lyman stressed “the importance of antifungal susceptibility testing and testing for resistance. Because that’s also something that’s not widely available at all hospitals and clinical labs ... you can send it to the [CDC’s] antimicrobial resistance lab network” for testing.

COVID-19 has brought particular challenges. Rodney E. Rohde, PhD, MS, professor and chair, clinical lab science program, Texas State University, San Marcos, said in an interview that he is worried about all the steroids and broad-spectrum antibiotics patients receive.

They’re “being given medical interventions, whether it’s ventilators or [extracorporeal membrane oxygenation] or IVs or central lines or catheters for UTIs and you’re creating highways, right for something that may be right there,” said Dr. Rohde, who was not involved in the CDC study. “It’s a perfect storm, not just for C. auris, but I worry about bacterial resistance agents, too, like MRSA and so forth, having kind of a spike in those types of infections with COVID. So, it’s kind of a doubly dangerous time, I think.”

Multiresistant bacteria are a major health problem, causing illnesses in 2.8 million people annually in the United States, and causing about 35,000 deaths.

Dr. Rohde raised another, rarely mentioned concern. “We’re in crisis mode. People are leaving our field more than they ever had before. The medical laboratory is being decimated because people have burned out after these past 14 months. And so I worry just about competent medical laboratory professionals that are on board to deal with these types of other crises that are popping up within hospitals and long-term care facilities. It kind of keeps me awake.”

Dr. Rohde and Dr. Lyman shared their concern that COVID caused a decrease in screening for other infections and drug-resistant organisms. Bare-bones staffing and shortages of personal protective equipment have likely fueled the spread of these infections as well.

In an outbreak of C. auris in a Florida hospital’s COVID unit in 2020, 35 of 67 patients became colonized, and 6 became ill. The epidemiologists investigating thought that contaminated gowns or gloves, computers, and other equipment were likely sources of transmission.

Low pay, especially in nursing homes, is another problem Dr. Rohde mentioned. It’s an additional problem in both acute and long-term care that “some of the lowest-paid people are the environmental services people, and so the turnover is crazy.” Yet, we rely on them to keep everyone safe. He added that, in addition to pay, he “tries to give them the appreciation and the recognition that they really deserve.”

There are a few specific measures that can be taken to protect patients. Dr. Lyman concluded. “The best way is identifying cases and really ensuring good infection control to prevent the spread.” It’s back to basics – limiting broad-spectrum antibiotics and invasive medical devices, and especially good handwashing and thorough cleaning.

Dr. Lyman and Dr. Rohde have disclosed no relevant financial relationships.

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

The CDC has reported two clusters of Candida auris infections resistant to all antifungal medications in long-term care facilities in 2021. Because these panresistant infections occurred without any exposure to antifungal drugs, the cases are even more worrisome. These clusters are the first time such nosocomial transmission has been detected.

In the District of Columbia, three panresistant isolates were discovered through screening for skin colonization with resistant organisms at a long-term acute care facility (LTAC) that cares for patients who are seriously ill, often on mechanical ventilation.

In Texas, the resistant organisms were found both by screening and in specimens from ill patients at an LTAC and a short-term acute care hospital that share patients. Two were panresistant, and five others were resistant to fluconazole and echinocandins.

These clusters occurred simultaneously and independently of each other; there were no links between the two institutions.

Colonization of skin with C. auris can lead to invasive infections in 5%-10% of affected patients. Routine skin surveillance cultures are not commonly done for Candida, although perirectal cultures for vancomycin-resistant enterococci and nasal swabs for MRSA have been done for years. Some areas, like Los Angeles, have recommended screening for C. auris in high-risk patients – defined as those who were on a ventilator or had a tracheostomy admitted from an LTAC or skilled nursing facility in Los Angeles County, New York, New Jersey, or Illinois.

In the past, about 85% of C. auris isolates in the United States have been resistant to azoles (for example, fluconazole), 33% to amphotericin B, and 1% to echinocandins. Because of generally strong susceptibility, an echinocandin such as micafungin or caspofungin has been the drug of choice for an invasive Candida infection.

C. auris is particularly difficult to deal with for several reasons. First, it can continue to live in the environment, on both dry or moist surfaces, for up to 2 weeks. Outbreaks have occurred both from hand (person-to-person) transmission or via inanimate surfaces that have become contaminated. Equally troublesome is that people become colonized with the yeast indefinitely.

Meghan Lyman, MD, of the fungal diseases branch of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said in an interview that facilities might be slow in recognizing the problem and in identifying the organism. “We encounter problems in noninvasive specimens, especially urine,” Dr. Lyman added.

“Sometimes ... they consider Candida [to represent] colonization so they will often not speciate it.” She emphasized the need for facilities that care for ventilated patients to consider screening. “Higher priority ... are places in areas where there’s a lot of C. auris transmission or in nearby areas that are likely to get introductions.” Even those that do speciate may have difficulty identifying C. auris.

Further, Dr. Lyman stressed “the importance of antifungal susceptibility testing and testing for resistance. Because that’s also something that’s not widely available at all hospitals and clinical labs ... you can send it to the [CDC’s] antimicrobial resistance lab network” for testing.

COVID-19 has brought particular challenges. Rodney E. Rohde, PhD, MS, professor and chair, clinical lab science program, Texas State University, San Marcos, said in an interview that he is worried about all the steroids and broad-spectrum antibiotics patients receive.

They’re “being given medical interventions, whether it’s ventilators or [extracorporeal membrane oxygenation] or IVs or central lines or catheters for UTIs and you’re creating highways, right for something that may be right there,” said Dr. Rohde, who was not involved in the CDC study. “It’s a perfect storm, not just for C. auris, but I worry about bacterial resistance agents, too, like MRSA and so forth, having kind of a spike in those types of infections with COVID. So, it’s kind of a doubly dangerous time, I think.”

Multiresistant bacteria are a major health problem, causing illnesses in 2.8 million people annually in the United States, and causing about 35,000 deaths.

Dr. Rohde raised another, rarely mentioned concern. “We’re in crisis mode. People are leaving our field more than they ever had before. The medical laboratory is being decimated because people have burned out after these past 14 months. And so I worry just about competent medical laboratory professionals that are on board to deal with these types of other crises that are popping up within hospitals and long-term care facilities. It kind of keeps me awake.”

Dr. Rohde and Dr. Lyman shared their concern that COVID caused a decrease in screening for other infections and drug-resistant organisms. Bare-bones staffing and shortages of personal protective equipment have likely fueled the spread of these infections as well.

In an outbreak of C. auris in a Florida hospital’s COVID unit in 2020, 35 of 67 patients became colonized, and 6 became ill. The epidemiologists investigating thought that contaminated gowns or gloves, computers, and other equipment were likely sources of transmission.

Low pay, especially in nursing homes, is another problem Dr. Rohde mentioned. It’s an additional problem in both acute and long-term care that “some of the lowest-paid people are the environmental services people, and so the turnover is crazy.” Yet, we rely on them to keep everyone safe. He added that, in addition to pay, he “tries to give them the appreciation and the recognition that they really deserve.”

There are a few specific measures that can be taken to protect patients. Dr. Lyman concluded. “The best way is identifying cases and really ensuring good infection control to prevent the spread.” It’s back to basics – limiting broad-spectrum antibiotics and invasive medical devices, and especially good handwashing and thorough cleaning.

Dr. Lyman and Dr. Rohde have disclosed no relevant financial relationships.

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

The CDC has reported two clusters of Candida auris infections resistant to all antifungal medications in long-term care facilities in 2021. Because these panresistant infections occurred without any exposure to antifungal drugs, the cases are even more worrisome. These clusters are the first time such nosocomial transmission has been detected.

In the District of Columbia, three panresistant isolates were discovered through screening for skin colonization with resistant organisms at a long-term acute care facility (LTAC) that cares for patients who are seriously ill, often on mechanical ventilation.

In Texas, the resistant organisms were found both by screening and in specimens from ill patients at an LTAC and a short-term acute care hospital that share patients. Two were panresistant, and five others were resistant to fluconazole and echinocandins.

These clusters occurred simultaneously and independently of each other; there were no links between the two institutions.

Colonization of skin with C. auris can lead to invasive infections in 5%-10% of affected patients. Routine skin surveillance cultures are not commonly done for Candida, although perirectal cultures for vancomycin-resistant enterococci and nasal swabs for MRSA have been done for years. Some areas, like Los Angeles, have recommended screening for C. auris in high-risk patients – defined as those who were on a ventilator or had a tracheostomy admitted from an LTAC or skilled nursing facility in Los Angeles County, New York, New Jersey, or Illinois.

In the past, about 85% of C. auris isolates in the United States have been resistant to azoles (for example, fluconazole), 33% to amphotericin B, and 1% to echinocandins. Because of generally strong susceptibility, an echinocandin such as micafungin or caspofungin has been the drug of choice for an invasive Candida infection.

C. auris is particularly difficult to deal with for several reasons. First, it can continue to live in the environment, on both dry or moist surfaces, for up to 2 weeks. Outbreaks have occurred both from hand (person-to-person) transmission or via inanimate surfaces that have become contaminated. Equally troublesome is that people become colonized with the yeast indefinitely.

Meghan Lyman, MD, of the fungal diseases branch of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said in an interview that facilities might be slow in recognizing the problem and in identifying the organism. “We encounter problems in noninvasive specimens, especially urine,” Dr. Lyman added.

“Sometimes ... they consider Candida [to represent] colonization so they will often not speciate it.” She emphasized the need for facilities that care for ventilated patients to consider screening. “Higher priority ... are places in areas where there’s a lot of C. auris transmission or in nearby areas that are likely to get introductions.” Even those that do speciate may have difficulty identifying C. auris.

Further, Dr. Lyman stressed “the importance of antifungal susceptibility testing and testing for resistance. Because that’s also something that’s not widely available at all hospitals and clinical labs ... you can send it to the [CDC’s] antimicrobial resistance lab network” for testing.

COVID-19 has brought particular challenges. Rodney E. Rohde, PhD, MS, professor and chair, clinical lab science program, Texas State University, San Marcos, said in an interview that he is worried about all the steroids and broad-spectrum antibiotics patients receive.

They’re “being given medical interventions, whether it’s ventilators or [extracorporeal membrane oxygenation] or IVs or central lines or catheters for UTIs and you’re creating highways, right for something that may be right there,” said Dr. Rohde, who was not involved in the CDC study. “It’s a perfect storm, not just for C. auris, but I worry about bacterial resistance agents, too, like MRSA and so forth, having kind of a spike in those types of infections with COVID. So, it’s kind of a doubly dangerous time, I think.”

Multiresistant bacteria are a major health problem, causing illnesses in 2.8 million people annually in the United States, and causing about 35,000 deaths.

Dr. Rohde raised another, rarely mentioned concern. “We’re in crisis mode. People are leaving our field more than they ever had before. The medical laboratory is being decimated because people have burned out after these past 14 months. And so I worry just about competent medical laboratory professionals that are on board to deal with these types of other crises that are popping up within hospitals and long-term care facilities. It kind of keeps me awake.”

Dr. Rohde and Dr. Lyman shared their concern that COVID caused a decrease in screening for other infections and drug-resistant organisms. Bare-bones staffing and shortages of personal protective equipment have likely fueled the spread of these infections as well.

In an outbreak of C. auris in a Florida hospital’s COVID unit in 2020, 35 of 67 patients became colonized, and 6 became ill. The epidemiologists investigating thought that contaminated gowns or gloves, computers, and other equipment were likely sources of transmission.

Low pay, especially in nursing homes, is another problem Dr. Rohde mentioned. It’s an additional problem in both acute and long-term care that “some of the lowest-paid people are the environmental services people, and so the turnover is crazy.” Yet, we rely on them to keep everyone safe. He added that, in addition to pay, he “tries to give them the appreciation and the recognition that they really deserve.”

There are a few specific measures that can be taken to protect patients. Dr. Lyman concluded. “The best way is identifying cases and really ensuring good infection control to prevent the spread.” It’s back to basics – limiting broad-spectrum antibiotics and invasive medical devices, and especially good handwashing and thorough cleaning.

Dr. Lyman and Dr. Rohde have disclosed no relevant financial relationships.

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

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

[email protected]

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

[email protected]

New COVID-19 cases in children soared by almost 86% over the course of just 1 week, while the number of 12- to 17-year-old children who have received at least one dose of vaccine rose by 5.4%, according to two separate sources.

There were 71,726 new cases reported during the week of July 23-29, compared with 38,654 the previous week, an increase of 85.6%. Meanwhile, the increase over the past 2 weeks – from 23,551 new cases for July 16-22 to almost 72,000 – works out to almost 205%, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Children represented 19.0% of the cases reported during the week of July 23-29, and they have made up 14.3% of all cases since the pandemic began, with the total number of cases in children now approaching 4.2 million, the AAP and CHA said in their weekly COVID report. About 22% of the U.S. population is under the age of 18 years.

As of Aug. 2, just over 9.8 million children aged 12-17 years had received at least one dose of the COVID vaccine, which was up by about 500,000, or 5.4%, from a week earlier, based on data from the Centers for Disease Control and Prevention.

Children aged 16-17 have reached a notable milestone on the journey that started with vaccine approval in December: 50.2% have gotten at least one dose and 40.3% are fully vaccinated. Among children aged 12-15 years, the proportion with at least one dose of vaccine is up to 39.5%, compared with 37.1% the previous week, while 29.0% are fully vaccinated (27.8% the week before), the CDC said on its COVID Data Tracker.

The national rates for child vaccination, however, tend to hide the disparities between states. There is a gap between Mississippi (lowest), where just 17% of children aged 12-17 years have gotten at least one dose, and Vermont (highest), which is up to 69%. Vermont also has the highest rate of vaccine completion (60%), while Alabama and Mississippi have the lowest (10%), according to a solo report from the AAP.

[email protected]

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

In announcing new guidance on July 27, the CDC said vaccinated people should wear face masks in indoor public places with “high” or “substantial” community transmission rates of COVID-19.

Data from the CDC shows that designation covers 69.3% of all counties in the United States – 52.2% (1,680 counties) with high community transmission rates and 17.1% (551 counties) with substantial rates.

A county has “high transmission” if it reports 100 or more weekly cases per 100,000 residents or a 10% or higher test positivity rate in the last 7 days, the CDC said. “Substantial transmission” means a county reports 50-99 weekly cases per 100,000 residents or has a positivity rate between 8% and 9.9% in the last 7 days.

About 23% of U.S. counties had moderate rates of community transmission, and 7.67% had low rates.

To find out the transmission rate in your county, go to the CDC COVID data tracker.
 

Smithsonian requiring masks again

The Smithsonian now requires all visitors over age 2, regardless of vaccination status, to wear face masks indoors and in all museum spaces.

The Smithsonian said in a news release that fully vaccinated visitors won’t have to wear masks at the National Zoo or outdoor gardens for museums.

The new rule goes into effect Aug. 6. It reverses a rule that said fully vaccinated visitors didn’t have to wear masks indoors beginning June 28.

Indoor face masks will be required throughout the District of Columbia beginning July 31., D.C. Mayor Muriel Bowser.
 

House Republicans protest face mask policy

About 40 maskless Republican members of the U.S. House of Representatives filed onto the Senate floor on July 29 to protest a new rule requiring House members to wear face masks, the Hill reported.

Congress’s attending doctor said in a memo that the 435 members of the House, plus workers, must wear masks indoors, but not the 100 members of the Senate. The Senate is a smaller body and has had better mask compliance than the House.

Rep. Ronny Jackson (R-Tex.), told the Hill that Republicans wanted to show “what it was like on the floor of the Senate versus the floor of the House. Obviously, it’s vastly different.”

Among the group of Republicans who filed onto the Senate floor were Rep. Lauren Boebert of Colorado, Rep. Matt Gaetz and Rep. Byron Donalds of Florida, Rep. Marjorie Taylor Greene of Georgia, Rep. Chip Roy and Rep. Louie Gohmert of Texas, Rep. Madison Cawthorn of North Carolina, Rep. Warren Davidson of Ohio, and Rep. Andy Biggs of Arizona.

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

Internal Centers for Disease Control and Prevention documents support the high transmission rate of the Delta variant and put the risk in easier to understand terms.

In addition, the agency released a new study that shows that breakthrough infections in the vaccinated make people about as contagious as those who are unvaccinated. The new report, published July 30 in Morbidity and Mortality Weekly Report (MMWR), also reveals that the Delta variant likely causes more severe COVID-19 illness.

Given these recent findings, the internal CDC slide show advises that the agency  should “acknowledge the war has changed.”
 

A ‘pivotal discovery’

CDC Director Rochelle Walensky, MD, MPH, said in a statement that the MMWR report demonstrates “that [D]elta infection resulted in similarly high SARS-CoV-2 viral loads in vaccinated and unvaccinated people.

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with [D]elta can transmit the virus,” she added. “This finding is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation.”

The investigators analyzed 469 COVID-19 cases reported in Massachusetts residents July 3 through 17, 2021. The infections were associated with an outbreak following multiple events and large gatherings in Provincetown in that state’s easternmost Barnstable County, also known as Cape Cod.

Notably, 346 infections, or 74%, of the cases occurred in fully vaccinated individuals. This group had a median age of 42, and 87% were male. Also, 79% of the breakthrough infections were symptomatic.

Researchers also identified the Delta variant in 90% of 133 specimens collected for analysis. Furthermore, viral loads were about the same between samples taken from people who were fully vaccinated and those who were not.

Four of the five people hospitalized were fully vaccinated. No deaths were reported. 

The publication of these results was highly anticipated following the CDC’s updated mask recommendations on July 27.

Outside the scope of the MMWR report is the total number of cases associated with the outbreak, including visitors from outside Massachusetts, which now approach 900 infections, NBC Boston reported.
 

‘Very sobering’ data

“The new information from the CDC around the [D]elta variant is very sobering,” David Hirschwerk, MD, infectious disease specialist at Northwell Health in New Hyde Park, N.Y., said in an interview.

“The CDC is trying to convey and present this uncertain situation clearly to the public based on new, accumulated data,” he said. For example, given the evidence for higher contagiousness of the Delta variant, Dr. Hirschwerk added, “there will be situations where vaccinated people get infected, because the amount of the virus overwhelms the immune protection.

“What is new that is concerning is that people who are vaccinated still have the potential to transmit the virus to the same degree,” he said.

The MMWR study “helps us better understand the question related to whether or not a person who has completed a COVID-19 series can spread the infection,” agreed Michelle Barron, MD, a professor in the division of infectious disease at the University of Colorado, Aurora.

“The message is that, because the [D]elta variant is much more contagious than the original strain, unvaccinated persons need to get vaccinated because it is nearly impossible to avoid the virus indefinitely,” Michael Lin, MD, MPH, infectious diseases specialist and epidemiologist at Rush University Medical Center, Chicago, said when asked to comment.

The new data highlight “that vaccinated persons, if they become sick, should still seek COVID-19 testing and should still isolate, as they are likely contagious,” Dr. Lin added.
 

More contagious than other infections

The internal CDC slide presentation also puts the new transmission risk in simple terms. Saying that the Delta variant is about as contagious as chicken pox, for example, immediately brings back vivid memories for some of staying indoors and away from friends during childhood or teenage outbreaks.

“A lot of people will remember getting chicken pox and then having their siblings get it shortly thereafter,” Dr. Barron said. “The only key thing to note is that this does not mean that the COVID-19 [D]elta variant mechanism of spread is the same as chicken pox and Ebola. The primary means of spread of COVID-19, even the Delta variant, is via droplets.”

This also means each person infected with the Delta variant could infect an average of eight or nine others.

In contrast, the original strain of the SARS-CoV-2 virus was about as infectious as the common cold. In other words, someone was likely to infect about two other people on average.

In addition to the cold, the CDC notes that the Delta variant is now more contagious than Ebola, the seasonal flu, or small pox.

These Delta variant comparisons are one tangible way of explaining why the CDC on July 27 recommended a return to masking in schools and other indoor spaces for people – vaccinated and unvaccinated – in about 70% of the counties across the United States.

In comparing the Delta variant with other infections, “I think the CDC is trying to help people understand a little bit better the situation we now face since the information is so new. We are in a very different position now than just a few weeks ago, and it is hard for people to accept this,” Dr. Hirschwerk said.

The Delta variant is so different that the CDC considers it almost acting like a new virus altogether.

The CDC’s internal documents were first released by The Washington Post on July 29. The slides cite communication challenges for the agency to continue promoting vaccination while also acknowledging that breakthrough cases are occurring and therefore the fully vaccinated, in some instances, are likely infecting others.

Moving back to science talk, the CDC used the recent outbreak in Barnstable County as an example. The cycle threshold, or Ct values, a measure of viral load, were about the same between 80 vaccinated people linked to the outbreak who had a mean Ct value of 21.9, compared with 65 other unvaccinated people with a Ct of 21.5.

Many experts are quick to note that vaccination remains essential, in part because a vaccinated person also walks around with a much lower risk for severe outcomes, hospitalization, and death. In the internal slide show, the CDC points out that vaccination reduces the risk for infection threefold.

“Even with this high amount of virus, [the Delta variant] did not necessarily make the vaccinated individuals as sick,” Dr. Barron said.

In her statement, Dr. Walensky credited collaboration with the Commonwealth of Massachusetts Department of Public Health and the CDC for the new data. She also thanked the residents of Barnstable County for participating in interviews done by contact tracers and their willingness to get tested and adhere to safety protocols after learning of their exposure.
 

Next moves by CDC?

The agency notes that next steps include consideration of prevention measures such as vaccine mandates for healthcare professionals to protect vulnerable populations, universal masking for source control and prevention, and reconsidering other community mitigation strategies.

Asked if this potential policy is appropriate and feasible, Dr. Lin said, “Yes, I believe that every person working in health care should be vaccinated for COVID-19, and it is feasible.”

Dr. Barron agreed as well. “We as health care providers choose to work in health care, and we should be doing everything feasible to ensure that we are protecting our patients and keeping our coworkers safe.”

“Whether you are a health care professional or not, I would urge everyone to get the COVID-19 vaccine, especially as cases across the country continue to rise,” Dr. Hirschwerk said. “Unequivocally vaccines protect you from the virus.”

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

The Centers for Disease Control and Prevention is expected to announce in early August that new data shows people vaccinated against COVID-19 who become infected with the Delta variant can spread it and infect others, the New York Times reported on July 29.

The revelation is one reason the agency reversed course this week and said fully vaccinated people should go back to wearing masks in many cases.

The new findings also are a reversal from what scientists had believed to be true about other variants of the virus, the New York Times said. The bottom line is that the CDC data shows people with so-called breakthrough cases of the Delta variant may be just as contagious as unvaccinated people, even if they do not show symptoms.

ABC News reported earlier on Jul 29 that the CDC’s updated mask guidance followed an outbreak on Cape Cod, where crowds gathered for the Fourth of July.

As of July 29, 882 people were tied to the outbreak centered in Provincetown, Mass. Of those who live in Massachusetts, 74% were unvaccinated. ABC said the majority were showing symptoms of COVID-19.

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

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

Anifrolumab, an inhibitor of type 1 interferons, received approval from the Food and Drug Administration for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy, according to a statement released Aug. 2 from its manufacturer, AstraZeneca.

Courtesy AstraZeneca

Anifrolumab will be marketed as Saphnelo. It is a fully human monoclonal antibody against subunit 1 of the type 1 interferon receptor, and its approval represents the only new treatment approved for patients with SLE in a decade. The recommended dosage is 300 mg as an intravenous infusion over a 30-minute period every 4 weeks, according to its prescribing information, and it will be sold in a single-dose vial containing 300 mg/2 mL (150 mg/mL).

Wikimedia Commons/FitzColinGerald/ Creative Commons License

Increased type I interferon (IFN) signaling is associated with increased disease activity in patients with SLE, and the option of a type I IFN receptor antagonist may allow physicians to treat patients with fewer corticosteroids, according to the statement.

The approval was based on data from three trials. The TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) phase 3 research included two randomized, double-blind, placebo-controlled studies, TULIP-1 and TULIP-2. The TULIP trials each enrolled seropositive patients with moderate to severe active disease despite standard-of-care therapy (SOC), which included oral corticosteroids, antimalarials, and immunosuppressants (methotrexate, azathioprine, or mycophenolate mofetil). All patients met American College of Rheumatology criteria and had an SLE Disease Activity Index (SLEDAI)-2K of 6 or greater, as well as British Isles Lupus Assessment Group (BILAG) index scoring showing one or more organ systems with grade A involvement or two or more with grade B. Both trials required stable SOC therapy throughout the study except for mandatory attempts at oral corticosteroid tapering for patients who were receiving 10 mg/day or more of prednisone or its equivalent at study entry.

TULIP-1 failed to meet its primary endpoint of SLE Responder Index (SRI) at 52 weeks, but investigators determined after the trial that some patients taking anifrolumab had been inappropriately labeled as nonresponders because the trial automatically required any patient who used a restricted drug, including NSAIDs, to be classified as a nonresponder even if they used the medication for something unrelated to SLE. When these rules were amended in a post hoc analysis, differences between the groups treated with anifrolumab and placebo widened in secondary endpoints for oral corticosteroid dose reduction, Cutaneous Lupus Erythematosus Disease Activity Severity Index response, and BILAG-Based Composite Lupus Assessment (BICLA) response.

The TULIP-2 trial included 362 patients who received a fixed dose of 300 mg anifrolumab or a placebo intravenously every 4 weeks for 48 weeks. In this study, anifrolumab patients showed significant improvement in disease activity on the BICLA scale, compared with placebo patients. The BICLA response was 47.8% in patients taking anifrolumab and 31.5% in placebo-treated patients (P = .001).

In the MUSE phase 2 trial, 305 adults with SLE were randomized to a fixed-dose intravenous infusion of 300 mg or 1,000 mg of anifrolumab or a placebo every 4 weeks, plus SOC, for 48 weeks. Patients in this study showed significant improvement on either dose, compared with placebo.

The results from the MUSE trial were published online in Arthritis & Rheumatology Nov. 7, 2016, followed by the TULIP-1 trial in The Lancet Rheumatology Nov. 11, 2019, and the TULIP-2 trial in the New England Journal of Medicine Jan. 16, 2020.

The most common treatment-related adverse events in all three studies were nasopharyngitis, upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, and cough. Infusion-related reactions in the trials were similar in anifrolumab and placebo patients, and included headache, nausea, vomiting, fatigue, and dizziness.

Anifrolumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus and is not recommended for these patients, according to the statement.

AstraZeneca said in its statement that anifrolumab is also under regulatory review in Japan and the European Union, and it continues to evaluate anifrolumab in patients with SLE in a long-term extension phase 3 trial and a phase 3 trial assessing subcutaneous delivery. The company said it “is exploring the potential of Saphnelo in a variety of diseases where type I IFN plays a key role, including lupus nephritis, cutaneous lupus erythematosus, and myositis.”

COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.

The new-case count was 38,654 for the week of July 16-22, an increase of 64% over the 23,551 child cases reported during the week of July 9-15, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.

As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.

Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.

Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.

Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.

[email protected]

COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.

The new-case count was 38,654 for the week of July 16-22, an increase of 64% over the 23,551 child cases reported during the week of July 9-15, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.

As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.

Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.

Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.

Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.

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COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.

The new-case count was 38,654 for the week of July 16-22, an increase of 64% over the 23,551 child cases reported during the week of July 9-15, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.

“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.

As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.

Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.

Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.

Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.

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Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine, independent experts who advise the Centers for Disease Control and Prevention on the use of vaccines agree that the benefits of the one-dose shot still outweigh its risks.

Johnson & Johnson

The company also presented new data suggesting that the shots generate strong immune responses against circulating variants and that antibodies generated by the vaccine stay elevated for at least 8 months.

Members of the Advisory Committee on Immunization Practices (ACIP) did not vote, but discussed and affirmed their support for recent decisions by the Food and Drug Administration and CDC to update patient information about the very low risk of GBS that appears to be associated with the vaccine, but to continue offering the vaccine to people in the United States.

The Johnson & Johnson shot has been a minor player in the U.S. vaccination campaign, accounting for less than 4% of all vaccine doses given in this country. Still, the single-dose inoculation, which doesn’t require ultra-cold storage, has been important for reaching people in rural areas, through mobile clinics, at colleges and primary care offices, and in vulnerable populations – those who are incarcerated or homeless.

The FDA says it has received reports of 100 cases of GBS after the Johnson & Johnson vaccine in its Vaccine Adverse Event Reporting System database through the end of June. The cases are still under investigation.

To date, more than 12 million doses of the vaccine have been administered, making the rate of GBS 8.1 cases for every million doses administered.

Although it is still extremely rare, that’s above the expected background rate of GBS of 1.6 cases for every million people, said Grace Lee, MD, a Stanford, Calif., pediatrician who chairs the ACIP’s Vaccine Safety Technical Work Group. 

So far, most GBS cases (61%) have been among men. The midpoint age of the cases was 57 years. The average time to onset was 14 days, and 98% of cases occurred within 42 days of the shot.  Facial paralysis has been associated with an estimated 30%-50% of cases. One person, who had heart failure, high blood pressure, and diabetes, has died.

Still, the benefits of the vaccine far outweigh its risks. For every million doses given to people over age 50, the vaccine prevents nearly 7,500 COVID-19 hospitalizations and nearly 100 deaths in women, and more than 13,000 COVID-19 hospitalizations and more than 2,400 deaths in men. 

Rates of GBS after the mRNA vaccines made by Pfizer and Moderna were around 1 case for every 1 million doses given, which is not above the rate that would be expected without vaccination.

The link to the Johnson & Johnson vaccine prompted the FDA to add a warning to the vaccine’s patient safety information on July 12.

Also in July, the European Medicines Agency recommended a similar warning for the product information of the AstraZeneca vaccine Vaxzevria, which relies on similar technology.
 

Good against variants

Johnson & Johnson also presented new information showing its vaccine maintained high levels of neutralizing antibodies against four of the so-called “variants of concern” – Alpha, Gamma, Beta, and Delta. The protection generated by the vaccine lasted for at least 8 months after the shot, the company said.

“We’re still learning about the duration of protection and the breadth of coverage against this evolving variant landscape for each of the authorized vaccines,” said Mathai Mammen, MD, PhD, global head of research and development at Janssen, the company that makes the vaccine for J&J.

The company also said that its vaccine generated very strong T-cell responses. T cells destroy infected cells and, along with antibodies, are an important part of the body’s immune response.

Antibody levels and T-cell responses are markers for immunity. Measuring these levels isn’t the same as proving that shots can fend off an infection. 

It’s still unclear exactly which component of the immune response is most important for fighting off COVID-19.

Dr. Mammen said the companies are still gathering that clinical data, and would present it soon.

“We will have a better view of the clinical efficacy in the coming weeks,” he said.


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

Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine, independent experts who advise the Centers for Disease Control and Prevention on the use of vaccines agree that the benefits of the one-dose shot still outweigh its risks.

Johnson & Johnson

The company also presented new data suggesting that the shots generate strong immune responses against circulating variants and that antibodies generated by the vaccine stay elevated for at least 8 months.

Members of the Advisory Committee on Immunization Practices (ACIP) did not vote, but discussed and affirmed their support for recent decisions by the Food and Drug Administration and CDC to update patient information about the very low risk of GBS that appears to be associated with the vaccine, but to continue offering the vaccine to people in the United States.

The Johnson & Johnson shot has been a minor player in the U.S. vaccination campaign, accounting for less than 4% of all vaccine doses given in this country. Still, the single-dose inoculation, which doesn’t require ultra-cold storage, has been important for reaching people in rural areas, through mobile clinics, at colleges and primary care offices, and in vulnerable populations – those who are incarcerated or homeless.

The FDA says it has received reports of 100 cases of GBS after the Johnson & Johnson vaccine in its Vaccine Adverse Event Reporting System database through the end of June. The cases are still under investigation.

To date, more than 12 million doses of the vaccine have been administered, making the rate of GBS 8.1 cases for every million doses administered.

Although it is still extremely rare, that’s above the expected background rate of GBS of 1.6 cases for every million people, said Grace Lee, MD, a Stanford, Calif., pediatrician who chairs the ACIP’s Vaccine Safety Technical Work Group. 

So far, most GBS cases (61%) have been among men. The midpoint age of the cases was 57 years. The average time to onset was 14 days, and 98% of cases occurred within 42 days of the shot.  Facial paralysis has been associated with an estimated 30%-50% of cases. One person, who had heart failure, high blood pressure, and diabetes, has died.

Still, the benefits of the vaccine far outweigh its risks. For every million doses given to people over age 50, the vaccine prevents nearly 7,500 COVID-19 hospitalizations and nearly 100 deaths in women, and more than 13,000 COVID-19 hospitalizations and more than 2,400 deaths in men. 

Rates of GBS after the mRNA vaccines made by Pfizer and Moderna were around 1 case for every 1 million doses given, which is not above the rate that would be expected without vaccination.

The link to the Johnson & Johnson vaccine prompted the FDA to add a warning to the vaccine’s patient safety information on July 12.

Also in July, the European Medicines Agency recommended a similar warning for the product information of the AstraZeneca vaccine Vaxzevria, which relies on similar technology.
 

Good against variants

Johnson & Johnson also presented new information showing its vaccine maintained high levels of neutralizing antibodies against four of the so-called “variants of concern” – Alpha, Gamma, Beta, and Delta. The protection generated by the vaccine lasted for at least 8 months after the shot, the company said.

“We’re still learning about the duration of protection and the breadth of coverage against this evolving variant landscape for each of the authorized vaccines,” said Mathai Mammen, MD, PhD, global head of research and development at Janssen, the company that makes the vaccine for J&J.

The company also said that its vaccine generated very strong T-cell responses. T cells destroy infected cells and, along with antibodies, are an important part of the body’s immune response.

Antibody levels and T-cell responses are markers for immunity. Measuring these levels isn’t the same as proving that shots can fend off an infection. 

It’s still unclear exactly which component of the immune response is most important for fighting off COVID-19.

Dr. Mammen said the companies are still gathering that clinical data, and would present it soon.

“We will have a better view of the clinical efficacy in the coming weeks,” he said.


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

Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine, independent experts who advise the Centers for Disease Control and Prevention on the use of vaccines agree that the benefits of the one-dose shot still outweigh its risks.

Johnson & Johnson

The company also presented new data suggesting that the shots generate strong immune responses against circulating variants and that antibodies generated by the vaccine stay elevated for at least 8 months.

Members of the Advisory Committee on Immunization Practices (ACIP) did not vote, but discussed and affirmed their support for recent decisions by the Food and Drug Administration and CDC to update patient information about the very low risk of GBS that appears to be associated with the vaccine, but to continue offering the vaccine to people in the United States.

The Johnson & Johnson shot has been a minor player in the U.S. vaccination campaign, accounting for less than 4% of all vaccine doses given in this country. Still, the single-dose inoculation, which doesn’t require ultra-cold storage, has been important for reaching people in rural areas, through mobile clinics, at colleges and primary care offices, and in vulnerable populations – those who are incarcerated or homeless.

The FDA says it has received reports of 100 cases of GBS after the Johnson & Johnson vaccine in its Vaccine Adverse Event Reporting System database through the end of June. The cases are still under investigation.

To date, more than 12 million doses of the vaccine have been administered, making the rate of GBS 8.1 cases for every million doses administered.

Although it is still extremely rare, that’s above the expected background rate of GBS of 1.6 cases for every million people, said Grace Lee, MD, a Stanford, Calif., pediatrician who chairs the ACIP’s Vaccine Safety Technical Work Group. 

So far, most GBS cases (61%) have been among men. The midpoint age of the cases was 57 years. The average time to onset was 14 days, and 98% of cases occurred within 42 days of the shot.  Facial paralysis has been associated with an estimated 30%-50% of cases. One person, who had heart failure, high blood pressure, and diabetes, has died.

Still, the benefits of the vaccine far outweigh its risks. For every million doses given to people over age 50, the vaccine prevents nearly 7,500 COVID-19 hospitalizations and nearly 100 deaths in women, and more than 13,000 COVID-19 hospitalizations and more than 2,400 deaths in men. 

Rates of GBS after the mRNA vaccines made by Pfizer and Moderna were around 1 case for every 1 million doses given, which is not above the rate that would be expected without vaccination.

The link to the Johnson & Johnson vaccine prompted the FDA to add a warning to the vaccine’s patient safety information on July 12.

Also in July, the European Medicines Agency recommended a similar warning for the product information of the AstraZeneca vaccine Vaxzevria, which relies on similar technology.
 

Good against variants

Johnson & Johnson also presented new information showing its vaccine maintained high levels of neutralizing antibodies against four of the so-called “variants of concern” – Alpha, Gamma, Beta, and Delta. The protection generated by the vaccine lasted for at least 8 months after the shot, the company said.

“We’re still learning about the duration of protection and the breadth of coverage against this evolving variant landscape for each of the authorized vaccines,” said Mathai Mammen, MD, PhD, global head of research and development at Janssen, the company that makes the vaccine for J&J.

The company also said that its vaccine generated very strong T-cell responses. T cells destroy infected cells and, along with antibodies, are an important part of the body’s immune response.

Antibody levels and T-cell responses are markers for immunity. Measuring these levels isn’t the same as proving that shots can fend off an infection. 

It’s still unclear exactly which component of the immune response is most important for fighting off COVID-19.

Dr. Mammen said the companies are still gathering that clinical data, and would present it soon.

“We will have a better view of the clinical efficacy in the coming weeks,” he said.


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