US FDA: No Pfizer Booster Shots For 16 And Above, Approved Only For People Over 65

Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of September 20, pending signoff from the FDA and US Centers for Disease Control.

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The US Food and Drug Administration advisory (FDA) committee on Friday (local time) voted unanimously to approve Pfizer booster shots for use in people aged 65-plus and high-risk patients following a prior failed vote to approve third shots for all people aged from 16 and above.

Dr Ofer Levy, a vaccine and infectious disease specialist at Boston Children’s Hospital said, “It’s likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don’t think we’re there yet in terms of the data.”

To discuss boosters the Vaccines and Related Biological Products Advisory Committee met for more than eight hours on Friday and the final vote could be corrected to include health care workers and other workers who face a high risk of exposure.

Before unanimously embracing an alternate plan to give boosters to older Americans, the panel voted 16-2 against distributing the vaccines to Americans 16 and older and those who are vulnerable of suffering from severe illness if they get the virus. That’s previously included people with diabetes, heart disease, obesity and other so-called comorbidities.

The earlier question put by Pfizer would have made the booster available to everyone aged between 16 and above.

The committee decided to first hold an up-or-down vote on the question of whether to recommend a third dose of vaccine for everyone 16 and older to show some extraordinary move, because of its reservations around the question of boosters.

Biden administration officials have previously announced a plan to begin administering booster doses to the general population during the week of September 20, pending signoff from the FDA and US Centers for Disease Control.

Some of the advisers and a group of vaccine experts, immunologists, paediatricians, infectious disease specialists and public health experts — have said that the process was rushed because of that target date. For certain immuno-compromised people third doses are already approved for certain immuno-compromised people, but not for the general public.

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