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FDA to review request for Pfizer/BioNTech vaccine

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

Pfizer announced the two companies had filed for the EUA on Friday, Nov. 20.  Simultaneously, the two companies are also seeking use authorization in countries around the world, including Australia, Canada, Europe, Japan, and more.

The companies say their two-dose vaccine has an efficacy rate of  95% so far in the Phase 3 clinical trials.  Initial results showed 90%.   Participants in the Phase 3 clinical trials include children from age 12, people of diverse ethnic backgrounds, and people up to 85 years old.

The Pfizer-BioNGech vaccine requires extremely cold storage.  According to the companies, “Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 – 8oC) conditions.”

The FDA plans to livestream the Dec. 10 review meeting on its YouTube, Facebook and Twitter channels; the meeting will also be webcast from the FDA website.  The FDA is stressing that safety considerations for an Emergency Use Authorization are the primary concern, as well as efficacy.   The FDA says more details will be available this week.

 

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