The U.S. FDA Expands Boosters Shots to All Adults

The U.S. Food and Drug Administration (FDA) is expanding authorization for COVID-19 booster doses to include all adults. The decision, announced Nov. 19, broadens the existing emergency use authorization to include anyone vaccinated previously with two doses of the Pfizer-BioNTech or Moderna COVID-19 shots. (The authorization had previously already included those who had received one dose of the Johnson&Johnson-Janssen shots.)

The Centers for Disease Control (CDC) will now decide whether to follow that recommendation and advise boosters for all adults, or whether to refine that advice further.

In September, the FDA and CDC authorized booster doses of the Pfizer-BioNTech vaccine only for people at higher risk of COVID-19, including those over 65 years, people with certain health conditions, and those who work or live in settings that make it more likely they would get exposed to the virus. In October, the agencies issued the same authorization for the Moderna shot. The authorization at that time extended to everyone who received the single dose J&J-Janssen shot, given the data showing lower initial immunity from the vaccine. For the people originally vaccinated with the Pfizer-BioNTech or Moderna shots, the agencies advised getting a booster six months after the second dose; for those vaccinated with the J&J shot, two months after that single dose regimen. Already, that eligible population includes a large portion of the U.S. population, and because vaccinators are not requiring documentation of their eligibility, most people who want a booster dose have been able to get one.
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In the two months since that recommendation, Pfizer and Moderna have provided additional data to the FDA raising concerns about breakthrough infections among the vaccinated, mostly among people with compromised immune systems, as well as studies suggesting that people vaccinated earlier—mostly the elderly—are starting to be hospitalized at increasing rates.

Studies by both companies show that the immunity from the vaccine can wane after six months or so, from over 90% protection from COVID-19 disease, to as low as 50%. That protection is brought back up to 90% or so a month after a booster dose. And although further research needs to be done, there are encouraging signs that the vaccines, including a booster dose, might help to curb spread of the virus in communities. The FDA weighed that evidence with additional data on the risks of the vaccines, which include an inflammation of the heart muscle, and concluded that with current infection rates in the U.S. continuing to rise, the benefits of a booster dose for all adults—especially if they can both prevent severe disease and help to dampen spread of the virus—outweighed the small risks.

If the CDC endorses the FDA’s authorization, then all adults would now be eligible to get a booster dose. The additional shot could bring additional peace of mind, especially before what is anticipated to be a busier holiday travel season where more people will be gathering and celebrating in larger groups.

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