Pfizer to seek approval for booster shot to combat variants. FDA and CDC issue rare statement pushing back.


Pfizer announced Thursday that it would be seeking emergency authorization from the Federal Drug Administration for a booster shot but the Food and Drug Administration and the Centers for Disease Control and Prevention immediately issued a rare statement pushing back on the possibility.

The pharmaceutical giant cited early data from a small study that indicated a third booster shot could help stop the spread of the coronavirus variants that are threatening a resurgence of the pandemic. That study said that a booster could increase neutralizing antibody levels by a factor of 5 to 10 times the original.

A joint statement from the FDA and the CDC soon after the announcement from Pfizer made it clear that they would follow the science before approving a booster.

“Americans who have been fully vaccinated do not need a booster shot at this time,” read the statement.

“FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data — which can include data rom specific pharmaceutical companies, but does not rely on those data exclusively,” the statement continued.

“We continue to review any new data as it becomes available and will keep the public informed,” the statement concluded. “We are prepared for booster doses if and when the science demonstrates that they are needed.”

The emergence of the coronavirus variants with heightened transmissibility has threatened to undo much of the success from the campaign for vaccinations. While the vaccines remain highly effective against the variants, lower vaccination rates in some states and nations mean the possibility of another wave of infections.

Health officials in Los Angeles have already warned the public that people should consider wearing masks again when indoors in a public setting in order to get ahead of the spread of the delta variant.

“There is a lot of fear and concern” about variants, said Pfizer research leader Mikael Dolsten. “We are confident that such a boost will be highly effective against the delta variant.”

Here’s more about a possible Pfizer booster:

Pfizer Plans to Request FDA Nod for Covid Booster

Read More

Source: The Blaze

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