On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. The advisory committee was tasked with discussing Pfizer’s supplemental application for administration of this third dose for individuals aged 16 and older, and … Continue reading
On May 10, 2021 the U.S. Food and Drug Administration (“FDA”) announced that the Pfizer-BioNTech Emergency Use Authorization (“EUA”) would be expanded to include children ages 12-15. Previously, the vaccine had been approved for individuals 16 and older. The press release stated that between March 1, 2020 and April 30, 2021 there were approximately 1.5 … Continue reading
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 … Continue reading
On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading