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 […]

Guillain-Barré Syndrome Linked to COVID-19 Shots

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

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.

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?

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

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 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

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

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 […]

1 2 3