Booster Shots Still Await Official Approval - Who will the FDA deem eligible?
Contrary to the Biden administration’s plan to offer COVID booster shots to most adults, an independent expert panel, known as the Vaccine and Related Biological Products Advisory, has endorsed an alternative plan to only offer the shot to Americans who are 65 and older, or immunocompromised.
The panel has firmly rejected Pfizer’s request to provide their booster shot to Americans 16-years or older. “The vote by the committee of outside experts assembled by the Food and Drug Administration was 16-2, with members expressing frustration that Pfizer had provided little data on the safety of extra doses” according to the Associated Press.
With this decision, the White House’s proposed plan to offer all Americans booster shots eight months after their second dose seems more like a pipe dream that will not materialize in their predicted time frame.
This means that all Americans will not be offered the booster shot beginning September 20th, even though the CDC was prepared to do so.
“The available data make [it] very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination” according to a CDC media statement released last Wednesday.
Two months after the second dose of Pfizer, effectiveness is 96%, while it decreases to 84% after about six months, according to a Pfizer study of 44,000 people.
Therefore, the CDC has concluded “that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”
The million dollar question is: Who will have the option to receive the booster shot? Ultimately this decision is up to the FDA, which often elects to comply with the advice of medical experts.
Other countries like Israel have already acted upon the knowledge of time sensitive immunity by making the third dose available to virtually every citizen. Still, this safety data is only a month or so old.
While there is ample data proving that the COVID vaccine’s effectiveness wears over time, there is not enough data illustrating the safety concerns of the booster shot.
“You want to be careful about giving a third dose or any dose of a vaccine until you know that the benefits are going to outweigh any potential risks,” says NPR’s Joe Palca.
The Advisory Committee on Immunization Practices that advises the CDC will meet on Wednesday and Thursday this week to decide who they think should receive the booster shot.
In the coming weeks, the FDA is expected to make its official decision about who will be eligible and when.