The U.S. rollout of the first coronavirus vaccine began this morning as the first doses of Pfizer-BioNTech's BNT162b2 were administered to health care workers and nursing home staffers.
The U.S. FDA granted the drug emergency use authorization on Friday, just one day after the FDA's Vaccines and Related Biological Products Advisory Committee voted in favor of the EUA. Pfizer and BioNTech are now gathering additional data and preparing to file a planned Biologics License Application (BLA) with the FDA for a possible full regulatory approval in 2021.
The first truck carrying the COVID-19 vaccine pulled out of Pfizer's Portage, Michigan manufacturing plant Sunday morning. According to the companies, to assure product quality, the partners have developed specially designed, temperature-controlled shippers for the vaccine, which can maintain recommended storage conditions 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 open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions 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.
The Department of Defense in partnership with agencies within HHS, including the CDC, will manage allocation and distribution of the vaccine in the U.S. This will be prioritized according to the populations identified by the CDC’s Advisory Committee on Immunization Practices guidelines.
Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine makers are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021. FDA's VRBPAC plans to meet in open session on Dec. 17 to discuss EUA for Moderna's vaccine in individuals 18 years and older.
Pfizer CEO Albert Bourla told CNN he hasn't taken the vaccine yet, but only because he doesn't want to "cut the queue." But Bourla said if it will help the public trust in the vaccine, he will absolutely get the vaccination.
Read the Pfizer press release