Almost eleven months after the first confirmed coronavirus patient in the State of Washington (HL Pulse post here), the first dose of Pfizer and BioNTech’s COVID-19 vaccine was administered in the U.S. to a critical care nurse a little after 9:00 a.m. ET.  This happened just three days after the U.S. Food and Drug Administration (“FDA”) issued an emergency use authorization for the vaccine.  Pfizer had submitted its EUA on November 9, 2020 (HL Pulse post here.)  A press release from the FDA stated that:

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.

This exciting development comes almost one week after Great Britain began inoculating citizens, beginning with a 90 year-old woman named Margaret Keenan.  The U.S. is the sixth country to approve Pfizer’s vaccine, following Britain, Bahrain, Canada, Saudi Arabia and Mexico.

Today signifies the first of several exciting developments in combatting the coronavirus.  On December 17, 2020, the FDA will host a meeting of its Vaccines and Related Biological Products Advisory Committee to discuss Moderna’s EUA request for its COVID-19 vaccine candidate, which it is expected to promptly approve.  Operation Warp Speed Chief Medical Adviser, Dr. Moncef Slaoui, stated on Sunday that he believes the U.S. government will meet its goal of vaccinating more than 100 million people by the close of March.

U.S. President Donald Trump celebrated the news on Twitter.  The U.S. Centers for Disease Control has frequently asked questions that provide additional information about the distribution of vaccines in the U.S.

Norton Rose Fulbright attorneys will continue to provide relevant updates on the COVID-19 PHE on the Health Law Pulse.