FDA Gives Emergency Use Authorization to Pfizer’s/BioNTech’s COVID-19 Vaccine

By Patricia Van Arnum - DCAT Editorial Director

December 12, 2020

Pfizer and BioNTech, a Mainz, Germany-based immunotherapy company, have received emergency use authorization from the US Food and Drug Administration (FDA) for their COVID-19 vaccine, BNT162b2, in individuals 16 years of age or older, making it the first COVID-19 vaccine authorized for emergency use in the US.

The companies will begin delivering the first doses in the US immediately (as reported on December 11, 2020) with delivery fulfillment expected to be completed in 2021.The first vaccine supplies are being prepared to ship from Pfizer’s Kalamazoo, Michigan site. They will be distributed by the US Department of Defense (DoD) in partnership with agencies within the US Department of Health and Human Services (HHS), including the US Centers for Disease Control and Prevention (CDC), to government-designated facilities across the country. The DoD, HHS, and CDC will manage the allocation and distribution of the vaccine in the US. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices (ACIP) guidelines. The ACIP has recommended the use of the vaccine in individuals aged 16 or order. 

Pfizer and BioNTech previously formed a supply pact with the US government for its COVID-19 vaccine pending authorization of the vaccine. In July (July 2020), Pfizer and BioNTech announced an agreement with the HHS and the DoD for an initial order of 100 million doses of the vaccine for $1.95 billion with an option by the US government to acquire up to 500 million additional doses.

On a global basis, based on current projections (as of December 11, 2020), Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization). Pfizer is using three of its US manufacturing sites to produce the COVID-19 vaccine: Saint Louis, Missouri; Andover, Massachusetts; and Kalamazoo, Michigan. Pfizer’s sites in Pleasant Prairie, Wisconsin and Puurs, Belgium are also being used.

The distribution of the vaccine is built on a just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need to minimize the need for long-term storage. To assure product quality, the companies developed specially designed, temperature-controlled shippers for the vaccine, which can maintain recommended storage conditions (-70 degrees Celsius ± 10 degrees Celsius) for extended periods of time with dry ice. The shipper can maintain temperature for 10 days unopened, which allows for transportation to markets globally. Once opened, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions for up to 30 days with re-icing every five days in accordance with the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. Once thawed, the vaccine vial can be stored safely for up to five days at refrigerated conditions (2-8 degrees Celsius).

Other authorizations made or under review

The UK was the first country to authorize the vaccine for emergency use in early December (December 2020). The vaccine also has been authorized for emergency use in Canada, Bahrain, Saudi Arabia, and Mexico, and global filings and reviews are ongoing. Late last month (November 2020), the companies submitted an application for conditional marketing authorization with the European Medicines Agency (EMA). The EMA’s scientific committee for human medicines is scheduled to conclude its assessment for conditional marketing authorization by December 21, 2020; originally the meeting was scheduled for December 29, 2020 at the latest, but it was moved to an earlier date.  

After gaining emergency use authorization in the US, Pfizer and BioNTech say they will gather additional data and prepare to file a planned biologics license application for the vaccine with the FDA for a possible full regulatory approval in 2021.

Source: Pfizer (emergency use authorization), Pfizer (CDC recommendation), BioNTech, FDA,  HHS and CDC and European Medicines Agency

Note: This story was updated with information from the European Medicines Agency