The potential risk of Guillain-Barré syndrome (GBS) developing after receipt of Pfizer’s respiratory experimental syncytial virus (RSV) vaccine have prompted the U.S. Food and Drug Administration (FDA) to request that Pfizer conduct a post-marketing safety study if the vaccine is approved for use in the United States this spring.1 The RSV vaccine manufactured by GlaxoSmithKline […]
In July 2020, the U.S. government ordered 100 million doses of Pfizer/BioNTech’s experimental BNT162b2 (now known as Comirnaty) messenger RNA (mRNA) COVID-19 biologic for $1.95 billion, or $19.50 per dose. A few months later in December, it followed up with a second order for another 100 million doses of the shot for the same price.1 […]
The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) said last week that they are investigating a possible link between Pfizer/BioNTech’s bivalent messenger RNA (mRNA) Comirnaty COVID biologic and an increased risk of a type of ischemic stroke among people 65 years of age and older. Data from the […]
The South African Health Products Regulatory Authority (SAHPRA) confirmed on Sept. 12, 2022 that another person in South Africa has died of a polio-like neurological disorder that causes paralysis known as Guillain-Barré syndrome (GBS) due to receiving Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S COVID-19 vaccine. SAHPRA said the National Immunization Safety Expert Committee (NISEC) performed […]
Techniker Krankenkasse, Germany’s largest health insurance company, reported that 437,593 of 11 million (1 in 25) insured individuals in 2021 had to undergo medical treatment as a result of adverse reactions from COVID-19 shots.1 COVID shots currently approved for use in Germany include Novavax’s Nuvaxovid, Moderna’s Spikevax, Pfizer/BioNTech’s Comirnaty, Johnson & Johnson/Janssen’s Ad26.COV2.S, AstraZeneca/Oxford University’s […]
On Aug. 4, 2022, the South African Health Products Regulatory Authority (SAHPRA) reported the death of an individual in South Africa shortly after receiving Johnson & Johnson/Janssen’s adenovirus vectored Ad26.COV2.S COVID-19 vaccine. The agency stated that the death was causally linked to the vaccine.1 2 3 4 5 The name and age of the person […]
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 […]
Despite concerns about the risk of developing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) following vaccination with Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on June 6, […]
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 […]
A U.S. cohort study assessing the effect of COVID-19 shots on menstrual cycles was peer reviewed and published in the journal Obstetrics & Gynecology on Jan. 5, 20221 after many women spoke out about changes to their menstrual cycles after receiving COVID shots. The U.S. National Institutes of Health (NIH) provided $1.6 million to fund […]