FDA Grants EUA for Novavax’s COVID Vaccine
Opinion | On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax to distribute its experimental two-dose NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine for use by adults. The decision was expected, given the favorable recommendation by the FDA’s Vaccines and Related Biological Products Advisory […]
FDA Approves Fourth COVID Shot. Fifth Shot Considered.
On Mar. 29, 2022, the U.S. Food and Drug Administration (FDA) approved a second booster dose (a fourth shot) of the Pfizer/BioNTech messenger RNA (mRNA) biologic BNT162b2 (“Comirnaty”) and Moderna/NIAID mRNA-1273 (“Spikevax”) for people 50 years of age and older, as well as younger individuals who are immunocompromised. The second booster would be given no […]
CDC Opts for mRNA Biologics Over J&J COVID Vaccine Following Nine Blood Clotting Deaths
Based on concerns over a growing number of reports of a blood clotting disorder known as thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Johnson & Johnson/Janssen’s experimental human adenovirus vectored Ad26.COV2.S vaccine, the Advisory Committee on Immunization Practices (ACIP) voted 15-0 on Dec. 16, 2021 to recommend the experimental messenger RNA (mRNA) COVID-19 biologics […]
Washington Mom Dies of Blood Clotting Syndrome 12 Days After J&J COVID Vaccination
A 37-year-old woman in King County, Washington died unexpectedly on Sept. 7, 2021, just 12 days after receiving Johnson & Johnson/Janssen’s experimental Ad26.COV2.S vaccine for COVID-19. Jessica Berg Wilson, the mother of two young daughters, was vaccinated on Aug. 26 and subsequently developed a blood clotting syndrome, known as “thrombosis with thrombocytopenia syndrome” (TTS), that […]