The Food and Drug Administration signaled Tuesday that it is likely to approve emergency use authorization for the Pfizer/BioNTech coronavirus vaccine.
In a detailed analysis released Tuesday morning, the FDA said that it could find “no specific safety concerns identified that would preclude issuance of an EUA.”
A majority did experience side effects commonly associated with vaccines, including fatigue, headaches, and pain at the injection site.
On Thursday, the FDA will hold a meeting of its Vaccines and Related Biological Products Advisory Committee, known as VRBPAC, to determine whether the Pfizer/BioNTech vaccine should receive an EUA. The committee will have to decide if the known benefits of the vaccine outweigh the risks for people aged 16 and older.
If VRBPAC approves, then the final decision moves to the full FDA, which usually follows VRBPAC’s recommendations.
Under an EUA, the FDA will allow people to receive the vaccine while the agency continues to review the data. An EUA for a coronavirus vaccine could be a turning point in the pandemic as many public health officials are predicting a severe COVID-19 crisis in the coming winter months.
The earliest it would be available would be 24 hours after the FDA makes a decision to approve the authorization, which could be on Dec. 10. The VRBPAC will then meet again on Dec. 17 to discuss the Moderna vaccine.
That is what likely prompted Health and Human Services Secretary Alex Azar to say Monday, “We hope that if everything goes well, we could be seeing Pfizer vaccine distributed within days and the Moderna vaccine distributed within days after their hearing a week from Thursday.”
The first people to be vaccinated will be healthcare workers and long-term care facility staff and residents, based on recommendations made last week by the Advisory Committee on Immunization Practices, the body within the Centers for Disease Control and Prevention charged with constructing a plan for allocating the vaccine. While the decision on whom to prioritize for vaccination is left to state governments, all states appear to be following the committee’s recommendation.
While the committee has not made a recommendation on which group should be vaccinated next, its documents suggest that essential workers will be next.
