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 […]
A United States senior army surgeon Lieutenant Colonel Theresa Long, MD, MPH, who specializes in infectious diseases, filed an affidavit under the Military Whistleblower Protection Act against the Biden administration’s COVID-19 vaccine mandate for active duty military personnel.1 Her affidavit states that there is risk of myocarditis and pericarditis, which involves inflammation of the heart, […]
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 […]
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 […]
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 […]
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 […]