Pfizer requests FDA to approve booster vaccine for everyone 16+

FDA meets Friday to discuss data behind booster
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Posted at 7:44 AM, Sep 17, 2021

TAMPA, Fla. — The Federal Drug And Food Administration will discuss approving a booster shot for the Pfizer COVID-19 vaccine in a meeting Friday.

A third shot has been available for those with compromised immune systems, but Pfizer is asking to add the third shot for anyone 16 years and older to their official FDA approval.

The Biden Administration announced in August that they wanted booster shots of Moderna and Pfizer available for everyone 16 and up by next week, that’s if the FDA and CDC approved.

Even though this new data affirms that vaccine protection remains high against the worst outcomes of COVID, we are concerned that this pattern of decline we are seeing will continue in the months ahead,” U.S. Surgeon General Vivek Murphy said in a briefing on August 18.

Biopharmaceutical company Pfizer’s request references a number of studies, stating that their vaccine becomes less effective over time and contributes to breakthrough cases, regardless of variant.

One study shows efficacy goes from 96.2% seven days after the second dose, to 83.7% four months after.

What we do see is that there have been more symptomatic infections in vaccinated people recently, and what they're trying to do is to restore the level of vaccine effectiveness against symptomatic infection,” USF Professor of Medicine Michael Teng told ABC Action News.

Teng said he sees the value in boosters for those who are immunocompromised or elderly but doesn’t think 80% efficacy is time to start third doses for the masses. FDA approval required 50% efficacy.

“We really need to get more unvaccinated people vaccinated than have better immunity in those of us who have been vaccinated,” Teng expressed.

He’s not alone. Top scientists from the World Health Organization and two retiring members of the FDA contributed to an article in theLancetmedical journal stating:

"There is still high vaccine efficacy against both symptomatic and severe disease due to the delta variant. Current evidence does not, therefore, appear to show a need for boosting in the general population.”

They along with Teng say we should focus on getting first and second doses to everyone in the U.S. and abroad first.

“This pandemic doesn't end until we get immunity globally,” Teng said. “We have a contract to buy a certain number of doses, but once that contract is fulfilled, then… the vaccine will be available to other countries to purchase. And so that part, you can actually provide access to the vaccine for those countries that can afford to buy the vaccine, they can get it now rather than us, buying up lots of doses.”

The FDA panel will discuss the data in their meeting Friday- and then take a non-binding vote. From there, it will go to the CDC Advisory Committee, which is scheduled to meet next Wednesday and Thursday.