FDA Advisory Committee rejects booster vaccinations for general population

by mcardinal

Lauren Moye, FISM NEWS


President Joe Biden’s plan to provide a third round of Pfizer vaccinations to the general population has been rejected by the Food and Drug Administration’s own advisory committee. On Friday, the committee voted 16-2 against recommending Pfizer booster shots to the general population on the grounds that there were not enough studies determining the potential health risks and benefits.

This is in contradiction to the president’s plan which he announced on August 18. At the time, Biden shared Israeli information about waning efficacy of the vaccinations against the COVID-19 Delta variant.

Biden had previously recommended beginning booster shots on Sept. 20.  “This will boost your immune response. It will increase your protection from COVID-19. That’s the best way to protect ourselves from new variants that could arise,” Biden said of boosters at the time.

Top US doctors seemed to agree when they released a joint statement about the need for boosters: “Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.”

Dr. Janet Woodcock, Acting Commissioner of the FDA, placed her name on this statement.

However, her own doctors appear to be less supportive of this plan. In the documents released in preparation for Friday’s meeting, these same scientists stated that “data indicates that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States.”

On Friday, the advisory committee listened to evidence both for and against the need for boosters. They considered unknown health risks, like potential inflammation of hearts. They also heard from Israeli scientists about the waning efficacy of the vaccines. In light of these presentations, the committee ultimately recommended boosters only for individuals over age 65 or front-line workers.

It was an apparent critique to the necessity of the White House’s announced plan. White House Chief Medical Advisor Dr. Anthony Fauci stated on CNN’s State of the Union, “While we said we are planning to do this, it was always said in his official statements, in the official written statement from all of us, including the FDA and the CDC, that [it] was pending and on the condition of the examination of all of the data by the FDA.”

Fauci also discussed the relevance of new data to impact the FDA’s decision. He said, “…I think people need to understand that this is not the end of the story.”

The FDA and CDC both need to agree on a plan to expand the usage of booster vaccine doses. Since the vote of the advisory panel is non-binding, the FDA in theory could still approve boosters for the general population, but to do so it would have to do this against the vote of its own scientists. The FDA plans to release their official recommendation on booster shots later this week.