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 […]
Two FDA Officials Resign Over White House Booster Shot Decision
Two senior officials of the U.S. Food and Drug Administration (FDA) have stepped down from the COVID vaccine review team at a critical time in the approval process. While the FDA did not cite a specific reason for the departure of two veteran officials, Endpoints News reports that widespread frustration in the regulatory agency began […]
Guillain-Barré Syndrome Warning Added to AstraZeneca’s Vaxzevria COVID Vaccine in Europe
The European Medicines Agency (EMA) last week added an autoimmune condition known as Guillain-Barré syndrome (GBS) as a possible side effect to the product information on AstraZeneca/Oxford University’s Vaxzevria (or “AZD1222”) experimental adenovirus vectored vaccine. GBS is a neurological disorder that causes pain, numbness, muscle weakness and sometimes paralysis.1 2 3 4 A total of […]
COVID-19 Vaccine Skeptics Have Many Concerns
With close to one-third of adults in the United States choosing to delay or forego the experimental COVID-19 vaccines, the medical industry is reportedly trying to understand the reasons behind the hesitancy and figure out how to persuade more Americans to get vaccinated.
FDA Adds Warning About Rare Reaction to J&J COVID-19 Vaccine
As the state sends mobile units from town to town to increase vaccination rates, the Johnson & Johnson shot is causing more worries. The FDA is now warning of a potential increased risk of a nerve complication called Guillain-Barré syndrome. Doctors say the roughly 100 cases reported after nearly 13 million shots should not be […]
