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May 6, 2022

Covid-19 roundup: FDA restricts availability of J&J vaccine

Daily Briefing

    HHS finds that Covid-19 vaccination averted 107,000 Medicare hospitalizations, CDC data shows the prevalence of the omicron subvariant BA.2.12.1 continues to grow, and more in this week's roundup of Covid-19 news.

    Your top resources on the Covid-19 vaccines

        • FDA on Thursday announced that Johnson & Johnson's (J&J) Covid-19 vaccine would only be available to adults for whom other Covid-19 vaccines aren't "accessible or clinically appropriate." The decision comes after analysis from FDA determined the risk of thrombosis with thrombocytopenia syndrome (TTS)—a condition with rare and potentially life-threatening blood clots—as a side effect of J&J's vaccine "warrants limiting the authorized use of the vaccine." In a statement, J&J said it will continue working with regulators around the world to make sure consumers "are warned and fully informed about reports of TTS" and that it will "continue to focus its efforts on ensuring its vaccine is available during the pandemic where people are most in need." (Whyte/Loftus, Wall Street Journal, 5/5; Saric, Axios, 5/5; Dillinger, CNN, 5/6; Foley/Gardner, Politico, 5/5)
        • The World Health Organization (WHO) on Thursday announced that 14.9 million people died in 2020 and 2021 either directly or indirectly because of the Covid-19 pandemic, which is roughly 2.7 times more than the 5.42 million deaths previously reported by countries around the world. According to WHO, the Covid-19 pandemic indirectly killed millions of people as a result of its effect on health systems and general society. WHO director-general Tedros Adhanom Ghebreyesus said WHO's report shows "the need for all countries to invest in more resilient health systems that can sustain essential health services during crises, including stronger health information systems." (Chappell, "Goats and Soda," NPR, 5/5; Knutson, Axios, 5/5)
        • The United States may need to update its Covid-19 vaccines each year, and a "new normal" going forward could include an annual Covid-19 shot alongside seasonal flu shots, according to three top FDA officials. "Widespread vaccine- and infection-induced immunity, combined with the availability of effective therapeutics, could blunt the effects of future outbreaks. Nonetheless, it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal," wrote Peter Marks, director of FDA's Center for Biologics Evaluation and Research, Principal Deputy Commissioner Janet Woodcock, and FDA Commissioner Robert Califf in a paper published in JAMA. "It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates." According to the officials, a decision about the composition of Covid-19 vaccines for the fall and winter will be decided by June after the agency's vaccines advisory committee meets. Previously, some health experts have cautioned against deciding on annual Covid-19 boosters too soon, saying that the United States may be heading towards such a policy without sufficient evidence that they're necessary. "I'm distressed by the paucity … of data other than antibody data that we really need to design better vaccines or use these vaccines better. Know when to boost — things like that," said Jesse Goodman, a former chief scientist at FDA and a professor of medicine at Georgetown University. (Howard, CNN, 5/3; Branswell, STAT News, 4/26)
        • According to a new HHS report, Covid-19 vaccinations prevented approximately 107,000 hospitalizations among Medicare beneficiaries between January and May 2021, when the vaccines were first authorized. Overall, these averted hospitalizations reflect an estimated $2.6 billion in savings for Medicare and Medicare Advantage plans. In the future, HHS said it will examine how many hospitalizations Covid-19 vaccines helped prevent during the delta and omicron waves. (AHA News, 5/4)
        • Patients who are experiencing a "viral rebound" of Covid-19 symptoms after taking Pfizer's antiviral drug Paxlovid should take more of the treatment, Pfizer CEO Albert Bourla said in an interview. "Paxlovid does what it has to do: It reduces the viral load," Bourla said. "Then your body is supposed to do the job." In cases where Paxlovid does not completely eliminate the coronavirus, Bourla said patients should seek more of the pills. However, an FDA official on Wednesday contradicted Bourla, saying there is "no evidence" that a second course of Paxlovid would benefit patients experiencing a relapse in symptoms. "There is no evidence of benefit at this time for a longer course of treatment or repeating a treatment course of Paxlovid," said John Farley, director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research. Instead, Farley stated that the treatment "reduces the risk of hospitalization and death for patients with mild-to-moderate COVID-19 at high risk of disease progression" and is "expected to be effective against the Omicron variant." (Scribner, Axios, 5/3; Scribner, Axios, 5/4)
        • Lung transplant recipients may be at a higher risk of contracting Covid-19 from their donated organs than other transplant patients, according to a new study published in Open Forum Infectious Diseases. For the study, researchers examined data from the Organ Procurement and Transplantation Network, including laboratory and epidemiologic assessments and recent outcomes from solid organ transplant recipients. Overall, 140 organs from 40 donors who were associated with "potential donor-derived SARS-CoV-2 transmission events" were included in the analysis. The researchers found that between March 2020 and March 2021, nine donors who had been infected with Covid-19 donated their organs to 19 recipients. Of the recipients, three individuals who received bilateral lungs acquired coronavirus infections from the donor organs, but the other 16 individuals who received other organs did not. Among the three lung transplant recipients, one patient ultimately died, and the two others transmitted the coronavirus to others. "These findings suggest a higher risk of donor-derived SARS-CoV-2 infection among lung recipients than recipients of extrapulmonary organs," the researchers wrote. "While donor-derived SARS-CoV-2 infection is uncommon, it can result in recipient morbidity and mortality." (Walker, MedPage Today, 5/3)
        • The prevalence of the omicron subvariant BA.2.12.1, which is currently driving a surge in Covid-19 cases in New York state, has been steadily growing nationwide since the beginning of April, according to CDC data. In the week ending April 30, the subvariant made up 36.5% of all new Covid-19 cases, up from 26.6% the week prior. Across the United States, Covid-19 cases have increased 50% over the last two weeks as of May 3, according to HHS data tracked by the New York Times. Similarly, pediatric Covid-19 cases have increased significantly over the past few weeks, growing 61% in the two weeks leading up to April 28. Covid-19 hospitalizations have also increased 18% nationwide over the last two weeks, with 40 states and Washington, D.C., seeing increases. (Gleeson, Becker's Hospital Review, 5/4; Carbajal, Becker's Hospital Review, 5/4)

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