FDA races to finalize vaccine authorization as Trump rages, issues threat

Enlarge / Stephen Hahn, commissioner of the US Food and Drug Administration. (credit: Getty | Bloomberg)

The US Food and Drug Administration may finalize authorization for the first COVID-19 vaccine later today, Friday, which would accelerate an already breakneck regulatory pace in the wake of intense pressure and threats from the Trump Administration.

According to multiple reports, the FDA was expecting to finalize the Emergency Use Authorization for the two-dose Pfizer/BioNTech COVID-19 vaccine early Saturday. That final sign off would land less than 48 hours after the agency’s independent advisory committee endorsed granting the EUA in a vote late Thursday of 17 to 4, with one abstention.

Earlier this week, the FDA released a briefing of its own review of the Pfizer/BioNTech mRNA vaccine, finding it “highly effective” and with a “favorable safety profile.”