FDA’s Expert Panel Recommends COVID-19 Booster Dose for Seniors and Others, Rejects Booster Dose for Children
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 […]
Vaccinated Americans Count Their Blessings Despite Getting COVID
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 […]
Top FDA Vaccine Officials Resign Over Fast-Tracked Booster Shot Approval by CDC and White House
Two of the FDA’s senior vaccine officials are stepping down. The news comes as boosters and children’s shots are being weighed by the department. In a letter sent to staff and obtained by BioPharma Dive, the agency’s Center for Biologics Evaluation and Research announced the departure of Marion Gruber and Phil Krause, two of the […]
Robert Malone, MD on the Availability of Comirnaty
[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 […]
Guillain-Barré Syndrome Warning Added to AstraZeneca’s Vaxzevria COVID Vaccine in Europe
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 […]
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 […]