A committee of outside experts advising the Food and Drug Administration has convened this morning and is now publicly deliberating whether the agency should grant an Emergency Use Authorization for the COVID-19 vaccine developed by pharmaceutical giant Pfizer and its partner, German biotech firm BioNTech.
If the committee votes to grant an authorization—and the FDA agrees—the federal government’s Operation Warp Speed has said it will begin shipping vaccine allotments to states and jurisdictions within hours.
So far, the Pfizer/BioNTech vaccine has already been approved in the United Kingdom—after a remarkably speedy 10-day review. The country began a mass vaccination campaign this week. On Wednesday, Canadian health officials announced that they, too, had authorized the vaccine.
The FDA has repeatedly defended its thorough, slower review process for the vaccine, particularly in the face of political pressure from the Trump administration. The agency’s review began on November 20, when Pfizer and BioNTech filed a request for the Emergency Use Authorization for its vaccine, BNT162b2.
The companies filed a request for an EUA after announcing that Phase III clinical trial results found the vaccine to be 95-percent effective at preventing symptomatic COVID-19.
On Tuesday, the FDA released a briefing of its review of more detailed data on BNT162b2. The agency found it to be “highly effective” at preventing symptomatic COVID-19 and noted that “efficacy findings were also consistent across various subgroups, including racial and ethnic minorities, participants aged 65 years and older, and those with one or more of the following conditions: obesity, diabetes, hypertension, and chronic cardiopulmonary diseases.”
Additionally, the agency noted that the data so far on the vaccine suggests a “favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.”
The advisory committee meeting today—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—is expected to recommend granting an EUA. Today, they will go over the clinical trial data, issues related to issuing an EUA (which is different from a full FDA approval), and safety and efficacy monitoring. They will also address two specific discussion questions:
- Pfizer has proposed a plan for continuation of blinded, placebo-controlled follow-up in ongoing trials if the vaccine were made available under EUA. Please discuss Pfizer’s plan, including how loss of blinded, placebo controlled follow-up in ongoing trials should be addressed.
- Please discuss any gaps in plans described today and in the briefing documents for further evaluation of vaccine safety and effectiveness in populations who receive the Pfizer-BioNTech Vaccine under an EUA.
According to the draft agenda, the committee plans to hold a vote on the EUA between 3pm and 5pm today.