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

U.S. Food and Drug Administration (FDA), has expanded authorization for COVID-19 boost doses to all adults. The announcement was made Nov. 19 and expands the emergency use authorization. It will allow anyone who received two doses (or more) of Moderna COVID-19 shots or Pfizer BioNTech to apply for the expanded emergency use authorization. (The authorization had previously already included those who had received one dose of the Johnson&Johnson-Janssen shots.)

Now, the Centers for Disease Control will decide whether or not to implement that recommendation. They may also recommend boosters for adults.

In September, the FDA authorized booster doses from the Pfizer BioNTech vaccination for individuals at high risk. These include people over 65 and people with specific health conditions. The Moderna shot was authorized by the FDA and CDC in October. 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. The eligible population now comprises a significant portion of the U.S. and, because there is no documentation required to verify eligibility, almost everyone who wants a booster dose has been able obtain 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.

According to both companies, the protection against COVID-19 can decrease over six months. The vaccine’s immunity may drop from more than 90% to 50% after 6 months. After a booster dose, that protection can be restored to around 90% in a month. There are some encouraging signs, despite more research, that booster vaccines might be able to reduce the spread of the disease in the community. 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. This additional shot may provide additional security, particularly in the midst of a busy holiday season when more people are expected to gather and celebrate with larger groups.


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