The FDA Authorized Pfizer COVID-19 Booster Shots for Some People

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UPDATE—September 23, 2021: 

The Food and Drug Administration (FDA) authorized COVID-19 booster shots for some people. Specifically, the FDA updated the emergency use authorization for Pfizer’s COVID-19 vaccine to allow third doses of the vaccine to be administered to people over age 65, as well as those between the ages of 18 and 24 who have a high risk for severe COVID-19 complications or who may have an elevated risk for COVID-19 exposure due to their jobs.

It’s not clear exactly who is in those high-risk risk categories. But Janet Woodcock, M.D., the acting FDA commissioner, specifically mentioned “health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons” in a statement. Ultimately, it will be up to a Centers for Disease Control and Prevention (CDC) advisory panel, which is scheduled to meet today to discuss the authorization, to make that call.

The vaccine, now known as Comirnaty, first received authorization in December 2020 and full FDA approval in August 2021. A little over a month ago, the FDA also authorized booster shots of Pfizer’s COVID-19 vaccine for people who are immunocompromised. The new FDA authorization on booster shots is based, in part, on data from 200 clinical trial participants who received the third dose about six months after their initial shots. To learn more about the research behind booster shots for these populations and the controversy around their authorization, continue to our original report below.

ORIGINAL STORY—September 17, 2021:

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. 

https://www.self.com/story/fda-advisory-panel-covid-19-booster-shots, GO TO SAUBIO DIGITAL FOR MORE ANSWERS AND INFORMATION ON ANY TOPIC




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