An FDA advisory committee has endorsed Paxlovid for full approval, a study finds significant disparities in COVID-19 death rates among children, and more in this week's roundup of COVID-19 news.
- FDA on Tuesday released briefing documents on Paxlovid's efficacy, interactions, and more ahead of a meeting of the agency's Antimicrobial Drugs Advisory Committee (ADAC). During the meeting, experts will consider the strength of evidence for the drug's use in patients, discuss any concerns, and recommend whether an overall risk-benefit assessment would support full approval. Currently, Paxlovid has only been granted emergency use authorization. In the documents, FDA staff said clinical trial data supports "the efficacy of Paxlovid for the treatment of mild-to-moderate COVID-19 in high-risk adults regardless of COVID-19 vaccination status or evidence of prior SARS-CoV-2 infection." They also noted that the drug is one of the few COVID-19 treatments still available in outpatient settings. Based on data from January, FDA estimated that Paxlovid helped avert 13,000 hospitalizations and 1,500 deaths, with a "conservative estimate of benefit" at a 50% reduction in relative risk. When it came to potential rebound with Paxlovid, FDA said it was not able to find clear evidence that the drug was associated with the condition, instead concluding that rebound may "occur as part of the natural progression and resolution of COVID-19." However, reviewers said potential drug-drug interactions (DDIs) were a "key safety concern" with Paxlovid, and the "the risk could outweigh the benefit particularly if the DDIs are not adequately managed." On Thursday, ADAC voted 16-1 to endorse a full approval of Paxlovid for adults. FDA will take the committee's vote into consideration while it makes its final decision, which is expected in May. (Hein, MedPage Today, 3/15; Moreno, Axios, 3/14; Feller, Healio, 3/16; Hein, MedPage Today, 3/16)
- Last week, both the Senate and House of Representatives passed a bill requiring the Director of National Intelligence (DNI) to declassify information on COVID-19's origins. The bill has been sent to President Joe Biden, and since he has not indicated a veto of the bill, it will likely soon become law. After the bill becomes law, the DNI will have 90 days to declassify information on the origin of COVID-19 and send an unclassified report to Congress. In particular, the bill requests details on coronavirus research at the Wuhan Institute of Virology before the initial outbreak, researchers who may have fallen sick in fall 2019, and more. According to Axios, the push to declassify information on COVID-19's origins comes after the Department of Energy concluded with "low confidence" that the pandemic was the result of an accidental lab leak. Testifying before Congress last week, DNI Avril Haines said that it has been "extremely challenging" to investigate COVID-19's origins. (Goldman, Axios, 3/10)
- The omicron variant may be less likely to cause long COVID compared to the original coronavirus strain, according to a new preprint study. For the study, researchers analyzed data from 1,201 healthcare workers in Switzerland and found that those who were infected by the original coronavirus strain were 67% more likely to have long-term symptoms. In comparison, those who had an omicron infection were no more likely to have long-term symptoms than people who were not infected. The researchers also found that having an omicron infection after an original infection did not increase a person's risk of long COVID or fatigue than just one infection with the original strain. "With the emergence of omicron, its ongoing global dominance and the accompanying explosion of infections, it is vital to find out more about who is at risk of long COVID and why," said Carol Strahm, one of study's authors from Cantonal Hospital St. Gallen in Switzerland. Although it's currently unclear why an omicron infection might have a lower risk of long COVID, Strahm said that it's "probably due to a combination of the omicron variant being less likely to cause severe illness than the [original] virus — we know that long COVID is more common after severe illness — and immunity acquired through previous exposure to the virus through, for example, a sub-clinical infection without seroconversion." (Twenter, Becker's Hospital Review, 3/10)
- During the pandemic, Black children had COVID-19 death rates that were almost three times higher than that of white children, according to a new study from the Morehouse School of Medicine. The study, which was commissioned by the Black Coalition Against Covid, found that COVID-19 death rates among Black children were 13.8 per 100,000 compared to 5.1 per 100,000 among white children — or 2.7 times higher. In addition, both Hispanic and Black children were more likely to be hospitalized with COVID-19 than white children. According to the researchers, Black children were also more likely to lose a parent or caregiver to COVID-19, and Black and Latino families were more likely to have economic and health struggles. "All of these social and political determinants that had been driving the inequities in health and health status came to play when the pandemic hit," said Aye Joana Obe, a legal research fellow at Morehouse's Satcher Health Leadership Institute and one of the study's authors. "There were always problems of access for minorities." (Peng, Bloomberg, 3/14)
- FDA on Wednesday updated its fact sheet on Johnson & Johnson's (J&J) COVID-19 vaccine to include warnings for myocarditis and pericarditis. Myocarditis refers to inflammation of the heart, and pericarditis is inflammation of the lining outside the heart. Currently, both conditions are listed as potential risks of the vaccine, although FDA has noted that the overall risk is very low. Symptoms will usually occur within eight days of vaccination. Anyone who receives the vaccine and begins to experience chest pain, shortness of breath, or a fast-beating, fluttering, or pounding heart should seek immediate medical attention, the agency said. Overall, J&J's vaccine only makes up a small portion of all COVID-19 vaccinations. Roughly 19 million J&J vaccines have been administered compared to 475 million Pfizer-BioNTech and Moderna vaccines. (Twenter, Becker's Hospital Review, 3/15)