FDA Says It's Working As Fast As It Can To Fully Approve COVID-19 Vaccines

The agency previously said it would finish reviewing Pfizer's application by January, but full approval could come before then.

The Food and Drug Administration said it is working “as quickly as possible” to grant full approval for the COVID-19 vaccines currently being distributed under emergency permits.

To date, the FDA has not said precisely when it will complete the process, but an agency official told CNN, and confirmed to HuffPost, that it was urgently reviewing the drugmakers’ applications.

“Although an authorization is not an FDA approval, the FDA conducted a thorough scientific evaluation of each of the authorized vaccines and can assure the public and medical community that the vaccines meet FDA’s rigorous standards for safety, effectiveness, and manufacturing quality,” the official said.

Full approval will hinge on several months of additional data.

The Pfizer and Moderna vaccines were each granted an Emergency Use Authorization from the agency in December, while the Johnson & Johnson shot was granted its EUA in February.

The FDA announced earlier this month that it was prioritizing review of Pfizer’s COVID-19 vaccine (which was the first to be approved for distribution in the United States) and aims to be done by January 2022. However, as FDA Acting Commissioner Janet Woodcock noted on Twitter, that does not mean it will not be approved before that target.

“Quite to the contrary, the review of [Pfizer’s application] has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [goal date],” Woodcock said.

Since December, more than 340 million doses of the vaccine have been distributed across the country, according to the Centers for Disease Control and Prevention.

But less than half of the U.S. population is fully vaccinated, and the nation has seen a spike in COVID-19 cases due to the delta variant. The new cases are concentrated in areas with low vaccination rates. When viruses are allowed to spread unchecked, they have more opportunity to mutate, and those mutations could make them more dangerous to humans.

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