FDA to Decide on Pfizer Vaccine Booster Shots Without Hearing From Expert Panel
U.S. drug regulators will decide whether to approve booster doses of Pfizer’s COVID-19 vaccine for all Americans aged 16 or older without convening its expert vaccine advisory panel, the Food and Drug Administration (FDA) confirmed to The Epoch Times on Nov. 17.
The FDA’s acting head and other top Biden administration officials said earlier in 2021 that vaccine booster doses should be given to everyone because of waning vaccine efficacy against the virus that causes COVID-19. But the advisory panel recommended vaccine boosters for only certain groups, arguing that the data didn’t support the widespread administration of second and third vaccine doses.
However, that panel won’t get a chance to weigh in as regulators consider Pfizer’s Nov. 9 request.
“The FDA does not plan to hold a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Pfizer’s request to amend their emergency use authorization to include the use of a single booster dose for all individuals 18 years of age and older,” an FDA spokeswoman told The Epoch Times in an email.
“The agency has previously convened the VRBPAC for extensive discussions regarding the use of boosters for COVID-19 vaccines and, after review of the request, we have concluded that it does not raise questions that would benefit from additional discussion by the members of the committee.”
Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, sits on the advisory panel. He disagrees with the FDA’s decision to forgo hearing from members.
“I think it would have been of value for the public to hear an open discussion about the need for boosters. I wish we had had the chance to discuss this,” Offit told The Epoch Times in an email.
Two other panel members, Dr. Michael Kurilla and Dr. Steven Pergam, declined to comment.
In September, Offit and many of the other scientists on the panel expressed skepticism over the push COVID-19 vaccine booster shots for healthy, younger people and voted against advising the FDA to clear an additional Pfizer shot for everyone aged 16 or older.
The panel did recommend allowing everybody aged 65 or older and certain younger people to get a third vaccine dose and later recommended allowing them to receive booster doses of the Moderna and Johnson & Johnson vaccines as well. The FDA took up each recommendation.
Pfizer stated in its request that clinical trial data showing its vaccine booster dose increased efficacy against COVID-19 infections displayed the need for wider authorization.
All three COVID-19 vaccines in the United States have fallen in effectiveness against infection over time, studies show, with smaller drops in effectiveness occurring against severe disease. That motivated health officials to examine the possibility of authorizing vaccine booster shots.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, argued this week that making booster doses more widely available would help drive the CCP (Chinese Communist Party) virus to endemic levels.
“Look what other countries are doing now about adopting a booster campaign virtually for everybody,” Fauci said during a press conference. “I think if we do that, and we do it in earnest, I think by the spring we can have pretty good control of this.”
A growing number of states have also been telling residents that they can get a COVID-19 vaccine booster dose as long as six months have elapsed since their primary series of shots if they received a Pfizer or Moderna vaccine or as long as two months have gone by if they got a Johnson & Johnson vaccine.
New York City, Arkansas, and West Virginia have followed New Mexico, Colorado, and California in issuing the recommendations.
“Everybody should get the booster after six months. The data is incredibly clear that it increases your personal protection level,” Colorado Gov. Jared Polis said on CBS over the weekend.
The FDA declined to give a timeline for its decision on Pfizer’s request.
“While the FDA cannot predict how long its evaluation of the data and information will take, the agency will review the request as expeditiously as possible,” the spokeswoman said.