Pfizer, Moderna Apply for EUA for COVID Shots for Infants, FDA to Decide Quickly
On June 1, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) to distribute their messenger RNA (mRNA) BNT162b2 (also known as “Comirnaty”) COVID-19 biologic for children as young as six months to five years old. The application is for a three-dose regimen, […]
FDA Approves Fourth COVID Shot. Fifth Shot Considered.
On Mar. 29, 2022, the U.S. Food and Drug Administration (FDA) approved a second booster dose (a fourth shot) of the Pfizer/BioNTech messenger RNA (mRNA) biologic BNT162b2 (“Comirnaty”) and Moderna/NIAID mRNA-1273 (“Spikevax”) for people 50 years of age and older, as well as younger individuals who are immunocompromised. The second booster would be given no […]
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 […]
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 […]
Johnson & Johnson’s COVID-19 Vaccine Suspended After Blood Disorder Reports
A manufacturing plant in Baltimore, Maryland where two experimental COVID-19 vaccines are manufactured has caused the U.S. Food and Drug Administration (FDA) to delay authorization of the plant’s production lines due to the contamination of 15 million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine.1 Ingredients Used in Two COVID-19 Vaccines “Mixed Up” During Production […]
FDA Opposes COVID-19 Vaccination Dose and Schedule Changes to Vaccinate More People
Only two weeks after the first experimental biologic for SARS-CoV-2 became available, the U.S. was more than 16 millions doses behind Operation Warp Speed’s goal of giving COVID-19 vaccines to 20 million people by the end of 2020.1 Responding to the slow rollout, Operation Warp Speed chief adviser Moncef Slaoui, MD proposed giving half-doses to […]
Patient in Georgia, Health Worker in New York Suffer Anaphylaxis After Getting Pfizer/BioNTech COVID-19 Vaccine
On Dec. 22, 2020, a patient at Decatur Morgan Hospital in Decatur, Alabama suffered a severe allergic reaction called anaphylaxis just minutes after receiving Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 vaccine for COVID-19.1 2 3 In a press release, the Alabama Department of Public Health (ADPH) stated the patient, who reportedly had a history of […]
Novartis Manipulated Data in FDA Biologics License Application
On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]
