FDA panel unanimously endorses Moderna boosters for certain populations

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Members of the Food and Drug Administration’s vaccine expert panel on Thursday endorsed boosters for Moderna recipients who are at high risk of severe COVID-19, occupational exposure to COVID-19 or are 65 years old. and are older than that.

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why it matters: The unanimous decision reflects the FDA’s terms for those who qualify for the Pfizer booster.

Be smart: Despite the small data sample size and limited data, the agency noted several times that saying no to Modern Booster would require a strong justification when it had already approved these terms for Pfizer.

  • The group will discuss boosters for Johnson & Johnson recipients on Friday.
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By numbers: The company’s head of infectious disease therapeutics, Jacqueline Miller, told the FDA on Thursday that Moderna’s vaccine is 93% protective against virus-related illness and 98% protective against severe cases.

  • However, according to Miller, antibody levels fell six to eight months after vaccination. A half-dose booster at least six months after the initial vaccination restored those antibodies in one study of nearly 300 people.

big picture: Moderna has been in the hot seat for the past week over the distribution of vaccine doses around the world. David Kessler, the Biden administration’s chief science officer for the COVID-19 response, called on the company to “step up” its production for low-income countries.

  • However, the administration still wants boosters for all Americans – an ethical debate among public health experts, as much of Africa remains uninsured.
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Between the lines: Some FDA officials said Thursday that the booster would be needed, citing emerging data from Israel and expressing a desire to “reconcile” their decision with a previously agreed decision for Pfizer to avoid unnecessary public confusion. Of.

  • Data presented from Israel indicated that the booster for Pfizer reduced the rate of serious illness by 60-80%. However, the number of severe cases in people under 40 years of age was very small.

Reference: Up to this point, the agency has only voted on boosters for Americans who received the Pfizer vaccine, leaving Moderna and Johnson & Johnson recipients with little guidance as the data trickle in.

  • Moderna has applied for authorization for a booster for people 18 years of age and older and it proposes to give less vaccine in its boosters than in its original shot – 50 micrograms instead of 100 micrograms.
  • New data from the National Institutes of Health suggests that people who have received the Johnson & Johnson vaccine may benefit from getting a Pfizer or Moderna booster shot. But J&J has asked the FDA to approve a second shot for its own vaccine.

Peter Marx, At the beginning of the meeting, the director of the Center for Biologics Evaluation and Research said, “Vaccine effectiveness against mild and moderate disease appears to decrease over time for individual vaccines, and we need to take this fact into account.” that mild-to-moderate COVID-19 may be associated with adverse outcomes, such as blood clots and prolonged COVID-19, even in people who have a post-vaccination infection.”

  • yes but: Eric Rubin, an assistant professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, raised concerns about whether Moderna has enough data to show whether a booster shot will cause adverse side effects.

separately, The FDA is ready to make its determination on vaccines for children ages 5 to 11 in the next few weeks, President Biden said Thursday, and the federal government will be ready when that happens.

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