Three Reasons the FDA Rejected Pfizer Booster for the General Population

 

Three Reasons the FDA Rejected Pfizer Booster Injection for the General Population

The FDA rejected the Pfizer (PFE)/BioNTX (BNTX) booster dose recommendation for the general public to focus more on vaccinating the unvaccinated population and collect more data on booster doses.

Although the FDA rejected the booster for the general public by a large margin (16-2), the dose was unanimously approved for the elderly and immunocompromised population in the United States.

Fitzgerald said there are three reasons behind these decisions. "First, the evidence was lacking. A lot of the evidence was in that age group of the population that she directed. She noted that the data on the efficacy and necessity of booster doses is not yet complete, and it may take several more months before they are recommended for the general public."

Second, the vaccines that have already been distributed to the public effectively reached public health standards. "The primary task was to prevent hospitalizations and deaths, and we still see that in the north of 90% for most of the vaccine. So I think they also felt that those at risk were the group they wanted to focus on."

The third interrelated reason behind the FDA's decision, according to Fitzgerald, is to choose to focus more on vaccinating the unvaccinated population rather than improving the immunity of those who have already been vaccinated.

 Dr. Anthony Fauci supported the FDA's decision not to authorize booster doses for the general population, citing less severe symptoms in young adults as the leading cause. As the data comes out, Fauci said, the Food and Drug Administration can continue further investigations.

Children are generally less likely to get seriously ill when infected with the coronavirus, but they are still susceptible to getting sick. Schools that have returned to in-person learning have taken extra precautions to limit the spread of COVID, especially with the advent of flu season and the emergence of the threat of a "pandemic."

"I think it's major news," Fitzgerald said of the announcement. "Now, I don't know what kind of review this is going to have, it's either going to be four or six weeks, but we can get an emergency use permit for this kit by Halloween, which will be huge."

"I think what we're seeing is a transparent process, which is what the American public would like to see," Fitzgerald added.