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
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
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 […]