Pfizer to seek FDA approval for 3rd shot despite regulators' uncertainty about boosters

Pfizer and BioNTech on July 8 said they plan to seek FDA approval for a third shot of their COVID-19 vaccine.

The drugmakers said they are seeing "encouraging data" from their ongoing booster shot trial. They also said the shot provides five to 10 times more neutralizing antibodies when administered six months after the second dose, according to early analysis.

Pfizer and BioNTech said they plan to publish more definitive data in a peer-reviewed journal and will submit the data to regulatory authorities "in the coming weeks." They also said they plan to launch clinical trials in August testing an updated version of the vaccine designed to provide better protection against the delta variant first detected in India.

On the same day as Pfizer and BioNTech announced their plans, the CDC and FDA released a joint statement saying Americans who have been fully vaccinated against COVID-19 do not need booster shots at this time.

 

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