The FDA Has a History of Rushed Drug Approvals
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 […]
FDA Approves BioNTech’s Comirnaty. Pfizer COVID Shot Remains Experimental.
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 […]
Canada Adds Bell’s Palsy Warning to Pfizer COVID Shot
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 […]
Women Experiencing Enlarged Breast Lymph Nodes After COVID-19 Vaccination
Soon after the United States began rolling out experimental COVID-19 vaccines distributed under an Emergency Use Authorization (EUA), doctors began seeing an influx of female patients making mammogram appointments after the women experienced enlarged lymph nodes, known as axillary lymphadenopathy, in the armpit area after receiving a dose of mRNA COVID-19 vaccine.1 Laura Esserman, MD, […]
NFL Tackles Polarizing New COVID-19 Vaccine Rules Restrictions
The National Football League (NFL) has announced they will enforce strict new COVID vaccination, masking and testing rules this football season due to the availability of experimental COVID-19 vaccines, which are currently being distributed under an Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration. The NFL lost an estimated three to […]
COVID Vaccines Not Proven to Prevent SARS-CoV-2 Infection or Transmission
After analyzing data from a July 2021 Provincetown, Massachusetts COVID-19 outbreak where 74 percent of those infected and diagnosed were fully vaccinated, the U.S. Centers for Disease Control and Prevention (CDC) announced last month that vaccinated individuals can become infected with the SARS-CoV-2 virus and transmit it to others. Expressing “alarm” at this new information, the government agency in charge of protecting the public health doubled down on imperatives for a return to masking, including for the vaccinated, and more vaccination.