The U.S. Food and Drug Administration (FDA) is expanding authorization for COVID-19 booster doses to include all adults. The decision, announced November 19, expands existing emergency use rights to include anyone who has been previously immunized with two doses of Pfizer-BioNTech or Moderna COVID-19. (The previous license had covered people who had received a single dose of Johnson & Johnson-Janssen.)
The Centers for Disease Control (CDC) will now decide whether to follow that recommendation and give booster drug advice to all adults, or whether to further tailor the advice.
In September, the FDA and CDC authorized booster doses of the Pfizer-BioNTech vaccine only for people at higher risk for COVID-19, including people over 65 years of age who have medical conditions certain people and people who work or live in places where there is an increased risk of this disease. more likely they will be exposed to the virus. In October, the agencies issued a similar license for Moderna footage. At that time, the authorization was extended to all people who received a single dose of J&J-Janssen, with data showing lower initial immunity to the vaccine. For people initially vaccinated with Pfizer-BioNTech or Moderna shots, the agencies recommend a booster shot six months after the second dose; for those vaccinated with J&J, two months after that single dose regimen. Currently, that eligible population includes a large portion of the U.S. population, and because injectors do not require documentation of their eligibility, most people who want a booster shot have can receive.
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In the two months since that recommendation, Pfizer and Moderna have provided more data to the FDA, raising concerns about breakthrough infections among immunized people, mostly among those with pre-existing medical conditions. compromised immune systems, as well as studies showing that people who are vaccinated earlier – mainly the elderly – are at an increasing rate of initiation of hospitalization.
Studies by both companies show that immunity from vaccines can wane after six months or so, from more than 90% protection against COVID-19 disease, to 50%. That protection is brought back up to 90% or so a month after the booster dose. And although further studies are needed, there are encouraging signs that vaccines, including booster doses, can help limit the spread of the virus in the community. The FDA weighed that evidence against additional data on vaccine risks, including myocarditis, and concluded that with current rates of infection in the United States continuing to increase, the benefits of a booster dose for all adults — especially if they can both prevent serious illness and help limit the spread of the virus — outweigh the small risks.
If the CDC upheld FDA authorization, all adults would now be eligible to receive a booster dose. The extra footage could offer more reassurance, especially in light of what is expected to be a busier holiday travel season, where more people will gather and celebrate in larger groups.
