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 […]
Pfizer, BioNTech Seek COVID Biologic Emergency Use Authorization for Infants as Young as Six Months Old
Pfizer and BioNTech have requested emergency use authorization (EUA) for doctors to administer two doses of their mRNA COVID-19 biologic to infants as young as six months old. A statement from Pfizer states that the “rolling submission” application was submitted on Feb. 1, 2022 at the request of the U.S. Food and Drug Administration (FDA) […]
White House Reveals Plans to Give COVID Shots to All 5 to 11 Year Old Children
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 […]
Two FDA Officials Resign Over White House Booster Shot Decision
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 […]
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 […]
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 […]