FDA Revokes EUA for Johnson & Johnson/Janssen’s COVID Vaccine
On June 1, 2023, the U.S. Food and Drug Administration (FDA) withdrew the Emergency Use Authorization (EUA) Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S (also known as JNJ-78436735) COVID-19 vaccine that had been granted to the companies on Feb. 27, 2021. The FDA noted that Janssen requested the voluntary withdrawal of the EUA in a letter […]
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 […]
Autoimmune Bleeding Disorder Diagnosed After COVID Shots
Four cases of an autoimmune bleeding disorder known as acquired hemophilia (AHA) were diagnosed in Italy’s northern province of Reggio Emilia weeks after the individuals received Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) biologic. The report about these four cases was published in a letter to the editors of journal Thrombosis Research […]
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 […]
