The FDA's Vaccine Advisory Committee Will Evaluate Booster Shots

by Wall Street Rebel | Michael London | 09/17/2021 11:06 AM
The FDA's Vaccine Advisory Committee Will Evaluate Booster Shots

A major Food and Drug Administration vaccine advisory group will meet on Friday to discuss and vote on Pfizer and BioNTech's proposal to provide booster injections to the general population, submitted earlier this year.


Independent vaccine advisers from the Food and Drug Administration will meet on Friday to discuss the case for booster injections of the Pfizer-BioNTech coronavirus vaccine and vote on whether the agency should approve additional doses for anyone aged 16 and above.

The conference and decision, which may have significant consequences for government booster policy, are taking place in the middle of a heated debate inside the Biden administration about whether booster injections are still required today and for whom they should be administered.

Suppose the argument reflects the anger that exists inside the government. In that case, the expert panel may become divided, which would impact the Food and Drug Administration's decision-making process.

However, while the Food and Drug Administration is not obligated to follow the committee's recommendations, it does so in many cases.

Previous meetings conducted throughout the pandemic to review vaccine authorizations were mostly cordial, with unambiguous votes favoring the Food and Drug Administration's stated position on vaccine authorizations.

Several federal health officials, including Dr. Anthony S. Fauci, Vice President Joe Biden's senior medical advisor, have been warning for weeks that immunity to infection is eroding in properly vaccinated individuals and that there is evidence of reduced protection against more severe types of Covid-19.

A policy statement signed by eight of those officials in August stated that adult boosters could be delivered as early as the week beginning Sept. 20; however, some medical professionals believed this was premature given the fact that boosters were required but had not yet been delivered to adult patients.

Although the White House has already been compelled to postpone the administration of booster injections to recipients of the Moderna vaccine, it is only currently preparing third doses for individuals who received the Pfizer-BioNTech vaccine, assuming that the Food and Drug Administration approves the vaccine.

The use of boosters has been greeted with significant resistance from some federal career scientists and many immunization experts outside of the government, who are opposed to the practice.

A pair of top Food and Drug Administration experts wrote in The Lancet this week that, based on their assessment of data from hundreds of studies, there is no evidence that further injections for the general population are necessary at this time.

At the meeting on Friday, Marion Gruber, the head of the Food and Drug Administration's vaccination office, shared her thoughts.

As a consequence of Covid-19, experts believe that immunization continues to offer substantial protection against severe illness and hospitalization in the vast majority of people who have participated in all of the studies that have been reported so far.

As a consequence of the vaccines, people of all ages, particularly those exposed to the more contagious Delta form, seem to be less protected against infection.

The Global Health Organization has recommended that world leaders refrain from providing booster vaccinations until the end of the year to accomplish the goal of immunizing 40 percent of the world's population as a starting point for the vaccination campaign.

Some high-income countries, like the United Kingdom and the United States, have already begun to give boosters to their people, and others may follow their lead in the near future.

There are impartial scientific specialists, infectious disease physicians, and statisticians that make up the committee.

They had previously taken part in discussions regarding coronavirus vaccines, which several of them had attended.

Independent scientific experts, infectious disease physicians, and statisticians serve on the Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee, which advices on vaccines and related biological products.

CDC's vaccination advisory committee is scheduled to meet next week and suggest using the extra doses, assuming the Food and Drug Administration authorizes them.

Meanwhile, as administration officials dispute the need for the injections, many Americans are taking things into their own hands and looking for booster doses before the government formally authorizes the shots.



              LIVE: FDA committee meets to debate and vote on Covid booster shots





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