On Oct. 20, 2021, the Biden administration outlined plans to begin giving COVID-19 vaccinations to children between five and 11 years old. Pending the results of reviews of the plan by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) over the […]
Following reports of an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) in young adults after receiving Moderna/NIAID’s experimental messenger RNA (mRNA) COVID-19 biologic known as “Spikevax,” the governments of Denmark, Norway and Sweden have suspended the shot or will not make it available for […]
by Vicky Pebsworth, PhD, RN and Theresa Wrangham on
Despite not convening the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) last month to vote on effectiveness and safety of the Pfizer-BioNTech COVID-19 vaccine (licensed under the name COMIRNATY), the U.S. Food and Drug Administration (FDA) convened the advisory committee on Friday, Sept. 17, 2021 to vote on booster doses of the vaccine.1 The […]
[Comirnaty] is absolutely not available. So the little trick that they have done here, is [the U.S. Food and Drug Administration] issued two separate letters for two separate vaccines. The Pfizer vaccine, which is what currently available is still under Emergency Use Authorization… The product that’s licensed [by the FDA] is the BioNTech product, which […]
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 […]
by Carolyn Hendler, JD, Theresa Wrangham and Marco Cáceres on
On Aug. 23, 2021, the U.S. Food and Drug Administration (FDA) gave full approval to a Biologics License Application (BLA) submitted by BioNTech Manufacturing GmbH of Mainz, Germany on May 18, 2021 for a biologic drug called COVID Vaccine, mRNA. The FDA gave permission to BioNTech to label the product “Comirnaty” and market it in […]
Health Canada, the Canadian government’s department responsible for national health policy, earlier this month updated the product information label for Pfizer/BioNTech’s experimental messenger RNA (mRNA) biologic (also known as BNT162b2 or “Comirnaty” vaccine) to reflect reported cases of Bell’s palsy—an immune mediated neurological disorder characterized by temporary muscle weakness or paralysis on one side of […]
Opinion | It is interesting to observe the mainstream media’s reporting of the recent news that Governor Greg Abbott of Texas has tested positive for the SARS-CoV-2 virus. For example, the headline of an article by CNBC reads, “Texas Gov. Abbott, who banned mask and vaccine mandates, tests positive for Covid.” Another headline by Yahoo! News reads, “Texas […]
Singapore’s Ministry of Health (MOH) announced on Aug. 16, 2021 that it had awarded S$225,000 (just over $165,000) to the family of a 16-year-old boy in Singapore who suffered a heart attack six days after receiving the first dose of Pfizer/BioNTech’s experimental messenger RNA (mRNA) COVID-19 biologic (also known as BNT162b2 or “Comirnaty” vaccine) on […]
A 22-year-old man in France died on July 26, 2021 nine hours after receiving the first dose of Pfizer/BioNTech’s experimental COVID-19 biologic (also known as BNT162b2 or “Comirnaty” vaccine). Maxime Beltra was vaccinated at about 2 pm in the southern French city of Sète and then went to a local restaurant with friends. At 10 […]