Pfizer says third Covid-19 shot warranted in FDA document
Pfizer said the totality of the available data supports the public health need for a third dose of the shot in individuals 16 years of age and older about six months after they received their second dose
FILE PHOTO: Vials labelled "COVID-19 Coronavirus Vaccine" and a syringe are seen in front of the Pfizer logo in this illustration taken February 9, 2021. REUTERS/Dado Ruvic/Illustration/File Photo
Pfizer Inc said that US regulators should approve a third booster dose of the Covid-19 vaccine it developed with Germany's BioNTech SA due to waning effectiveness of the shot over time, according to documents the drugmaker submitted to the US Food and Drug Administration.
Pfizer said the totality of the available data supports the public health need for a third dose of the shot in individuals 16 years of age and older about six months after they received their second dose.
The FDA released the documents on Wednesday ahead of a meeting by an outside panel of experts on Friday to vote on whether or not to recommend US regulators approve the extra shots. The FDA has not yet published the briefing with its view on the issue.
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