“You may choose to look the other way, but you can never say again that you did not know.”
— William Wilberforce
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 […]
According to the British Medical Journal (BMJ), more than 30,000 British women experienced changes to their menstrual cycle after getting the COVID-19 vaccine. Reproductive immunologist Victoria Male, PhD wrote an opinion piece for BMJ calling for more research on the subject and stating, “a link is plausible and should be investigated.”1 Reported changes to women’s […]
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 […]
On Aug. 2, 2021, Senator Lindsey Graham of South Carolina became the first fully vaccinated (for COVID-19) U.S. Senator to disclose he had tested positive for the SARS-CoV-2 virus. Sen. Graham said he had begun to experience “flu-like symptoms” two days earlier and eventually decided go to the doctor and get tested.1 Despite becoming another […]
Public Health Ontario (PHO) in Canada recently released report, Myocarditis and Pericarditis Following Vaccination with COVID-19 mRNA Vaccines in Ontario: December 13, 2020 to August 7, 2021, which found that the majority of COVID-19 vaccine recipients who went to the hospital for heart inflammation after the novel vaccine were young people.1 Adolescents and young adults […]
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 […]
Two weeks ago, the Pfizer COVID-19 vaccine was reported as the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA) for individuals aged 16 and older.1 But, for some, questions remain regarding conflicting discrepancies of the wording surrounding the approval.2 While the FDA’s report states that full approval was […]
A new retrospective observational study conducted by researchers at Tel Aviv University and Maccabi Healthcare in Israel found that unvaccinated individuals who developed an infection with the SARS-CoV-2 virus were considerably more protected against the Delta variant of the virus than those who had received two doses of the Pfizer/BioNTech’s experimental messenger RNA (mRNA) biologic […]
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 […]