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 […]
Guillain-Barré Syndrome Linked to COVID-19 Shots
A study by the University College London showed that serious Guillain-Barré syndrome (GBS), which can result in temporary or permanent paralysis, is a “small but significant” risk associated with AstraZeneca/Oxford University’s AZD1222 (or “Vaxzevria”) vaccine. Of the 996 cases of GBS that were recorded in the United Kingdoms’ National Immunisation Management System database between January […]
FDA Releases First Set of Pfizer COVID-19 Shot Safety Data
By the end of February 2021, there had been 1,291 reports of adverse events as a result of Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 biologic (also known as “Comirnaty”). The long list of adverse events associated with receipt of BNT162b2 shots were listed as an appendix to a 38-page report reluctantly released by the U.S. […]
Vaccine Damage Claims Related to COVID Vaccinations Reach $146 Million in U.K.
Some 920 applications have been filed in the United Kingdom for compensation related to injuries and deaths of people following COVID-19 vaccinations. Those applications are for financial payouts under the U.K. National Health Service’s (NHS) Vaccine Damage Payment Scheme (VDPS), which allows an individual who has allegedly been left severely disabled by a vaccine to […]
Are Adverse Events in COVID-19 Vaccine Trials Under-Reported?
Phase III controlled trials are considered the ‘gold standard’ for assessing vaccine efficacy and safety in humans. These are the trials upon which authorities have assured the public that COVID-19 vaccines are “safe and effective.” The benefits of the vaccines in reducing disease severity and hospitalizations are well-known, but what do we know about the adverse events?Data on adverse events is vital for effective decision-making by regulators, policy makers, doctors, and patients.
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 […]
