FDA advisers recommend authorization of vaccine
Vaccine advisers to the US Food and Drug Administration voted Thursday to recommend the agency grant emergency use authorization to Pfizer and BioNTech’s coronavirus vaccine. Seventeen members of the Vaccines and Related Biological Products Advisory Committee voted yes, four voted no and one abstained. Follow SpotLife Asia for the latest developments
Several committee members expressed concern about reports of allergic reactions in two people who were vaccinated in Britain, which authorized Pfizer’s vaccine ahead of the US.FDA staff said that, as with any vaccines, paperwork would accompany the Pfizer vaccine to warn against administering it to anyone with a history of severe allergic reactions to vaccines or allergies to any of the ingredients of the vaccine.
An EUA is short of a full approval. Pfizer would have to file a separate application for full FDA approval for its vaccine. Plus, Thursday’s vote doesn’t mean the vaccine will be authorized immediately. The FDA will now decide whether to accept the recommendation, but has signaled that it will issue the EUA for the vaccine.
Operation Warp Speed officials say they will start shipping the vaccine within 24 hours of FDA authorization.