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.
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 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 […]
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 […]
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.
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 […]
Opinion | The experimental COVID-19 vaccines are being released first to a designated group of health care workers and residents of senior living facilities. As more of the vaccines becomes available, people at high-risk to the SARS-CoV-2 virus due to their medical conditions will be given an opportunity to get vaccines. Finally, the general public […]
On Dec. 11, 2020, Peru’s National Institute of Health (INS) said it was temporarily suspending the Phase 1 clinical trial of an experimental COVID-19 vaccine developed by Sinopharm Group Co. Ltd. of Shanghai, China after one of the participants in the trial who got the vaccine showed difficulty in moving his arms and legs—symptoms of […]
Sahara Walker was only 11 years old in 2013 when she received the Gardasil vaccine that drastically changed her life, according to the attorneys who filed a lawsuit in U.S. District Court for the Western District of Wisconsin against the New Jersey based pharmaceutical giant, Merck on Nov. 18, 2020. Prior to Gardasil, Sahara was […]
