Two FDA Officials Resign Over White House Booster Shot Decision

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

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.

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 […]

Moderna, Pfizer Test mRNA Experimental Biologics on Children

Moderna, Pfizer Test mRNA Experimental Biologics on Children

On Dec. 10, 2020, American biotechnology company Moderna, Inc., which is pioneering the development of experimental messenger RNA (mRNA) therapeutics and vaccines, gave a 12-year old a dose of the company’s mRNA-1273 vaccine in a Phase 2/3 study of the new vaccine. Moderna CEO Stephane Bancel said, “Our goal is to generate data in the […]

Lyme Disease Vaccines: Past and Future

Lyme Disease Vaccines: Past and Future

Story Highlights A new Lyme disease vaccine candidate approved by the FDA using the fast track process is currently in its second phase of clinical trials. In 1998, the FDA granted licensure for a Lyme disease vaccine called LYMErix. Following reports of severe adverse reactions to LYMErix, GlaxoSmithKline (formerly SmithKline Beecham) withdrew the vaccine from […]