FDA Grants EUA for Novavax’s COVID Vaccine

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.

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

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

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

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 […]

More Deaths Reported to VAERS Following COVID-19 Vaccinations Than for Any Other Vaccine

More Deaths Reported to VAERS Following COVID-19 Vaccinations Than for Any Other Vaccine

Last week, the U.S. Centers for Disease Control and Prevention (CDC) released data containing reports of health problems, including deaths, following receipt of federally recommended vaccines that have been filed with the federal Vaccine Adverse Event Reporting System (VAERS).1 2 The latest release of VAERS data included descriptions of 438,441 adverse event reports following COVID-19 […]

With Little Safety Data, CDC Recommends Pfizer COVID Vaccine for 12-Year-Old Children

With Little Safety Data, CDC Recommends Pfizer COVID Vaccine for 12-Year-Old Children

Opinion | I monitor meetings of the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control and Prevention (CDC) for the National Vaccine Information Center (NVIC). On May 10, 2021, the U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) granted Pfizer/BioNTech to distribute its experimental mRNA vaccine in […]