Sep 11, 2023 - Health

FDA approves updated COVID-19 vaccines amid late-summer wave

Photo Illustration: Nik Oiko/SOPA Images/LightRocket via Getty Images

The Food and Drug Administration approved updated versions of COVID-19 vaccines on Monday, a key step in getting the new shots to Americans as early as this week.

Why it matters: The Biden administration has faced increasing calls to make the reformulated vaccines available more quickly as infections and hospitalizations ticked up in recent weeks.

  • Health officials have largely urged people concerned about protecting themselves against the late-summer surge to wait until the new boosters are available.

Driving the news: The FDA greenlit shots from Pfizer and Moderna that are targeted against the XBB.1.5 variant, which was the dominant strain circulating in the United States earlier this summer.

  • Scientists believe that the shots will be protective against the now-dominant EG.5 variant and other newer strain, FL.1.5.1,, which are both XBB descendants.
  • Moderna and Pfizer also said their updated shots showed a strong antibody response against the BA.2.86 variant, which has raised some concern among scientists because of its many mutations.
  • An advisory committee to the Centers for Disease Control and Prevention will meet Sept. 12 to make recommendations about who should receive the shots.
  • CDC Director Mandy Cohen is expected to quickly sign off on recommendations, the final bureaucratic step in making the new shots available to the public.
  • The FDA is still reviewing another shot from Novavax, which unlike the mRNA vaccines from Pfizer and Moderna is a more traditional protein-based platform.

Of note: Health officials expect that COVID shots will be updated every fall to account for circulating variants, similar to the schedule for annual flu shots.

  • This is the first booster season in which the shots won't be fully covered by the federal government, but most people with insurance should be able to get them at no-cost.
  • People without insurance may be able to get the shots for free at community locations like health centers and through a temporary "bridge program" the Biden administration announced.
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