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FDA

FDA Approves Pfizer-BioNTech COVID Vaccine

The first COVID vaccine to get full approval opens doors for the rest

The US Food and Drug Administration (FDA) has approved the Pfizer-BioNTech COVID vaccine for patients over 16, making it the first of the three currently available vaccines to win full approval. Before August 23rd, all three were approved under emergency use authorization (EUA) for immediate distribution, and all three are still EUA approved for patients over 12.

In order for a vaccine to meet EUA standards, it must have evidence of efficacy and it must be proven that the known and potential benefits outweigh the known and potential risks. In other words, it must be demonstrably safer than the known risk of getting COVID.

Acting FDA Commissioner Janet Woodcock said that the Pfizer vaccine "meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."

For more, head to FDA.gov.