Today an advisory panel of the Food and Drug Administration (FDA) recommended Pfizer COVID-19 booster shots for certain groups of people in a vote today, including people over age 65 and people who have an elevated risk for severe COVID-19. But the panel voted against Pfizer’s original proposal of approving the additional shots for people over the age of 16.
In a 16-to-2 vote, the FDA Vaccines and Related Biological Products Advisory Committee initially voted against the approval of a third dose of Comirnaty (the Pfizer/BioNTech COVID-19 vaccine) for people aged 16 and older. However, the panel voted unanimously to approve an emergency use authorization (EUA) for the shots for people over age 65 and those who are at high risk for severe COVID-19 complications, such as people with certain underlying health conditions, and agreed that the benefits of a booster shot outweigh the risks for people in these groups. In a poll rather than a formal vote, the committee also voted to include people who have a “high risk for occupational exposure,” such as health care workers and teachers, in the EUA. These votes do not mean that the vaccine has this authorization, but the FDA is expected to accept the recommendation and release an official EUA soon.
The decision comes about a month after the White House first announced an upcoming plan to offer third COVID-19 vaccine doses to the general public. That’s due in large part to data from Israel suggesting the vaccines may lose some of their effectiveness (at preventing infection, but not necessarily hospitalizations or deaths due to COVID-19) over time and that administration of a third dose can help bring that protection back.
When the White House plan was announced, experts were divided on whether or not booster shots are necessary for most people—especially at a time when so much of the world still hasn’t had great access to the initial doses. In the following weeks, the general consensus seemed to be that some people will inevitably need third doses at some point, particularly those who are significantly immunocompromised (for whom the FDA authorized the third shot in early August) and/or elderly. But whether or not the general public would get much of a benefit from booster shots—and whether or not now is really the time to be thinking about that at all—was still an open question.
In making its decision, the FDA advisory panel sorted through the current evidence and found that the benefits of a third Pfizer COVID-19 dose outweigh the potential risks for older adults and those who may be more vulnerable to serious complications of COVID-19. The panel also weighed any potential benefit of a booster shot against the potentially increased risk for side effects from the shots, including myocarditis and pericarditis, two types of heart inflammation that have been reported after people received the mRNA COVID-19 vaccines. Myocarditis and pericarditis have most often been reported in younger people getting the vaccines, the Centers for Disease Control and Prevention explain.
People who are immunocompromised can already receive their third COVID-19 dose. Those who fall into the other categories—older adults and those who are at a high risk for severe COVID-19—will have to wait for the FDA’s official EUA and the CDC’s Advisory Committee on Immunization Practices (ACIP) to make their own fine-tuned recommendations about the roll-out of the boosters. They’ll likely offer more specific recommendations around who qualifies as “high risk” and who has an elevated risk for occupational exposure to the virus.
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