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Fda Authorization

All articles tagged with #fda authorization

health2 years ago

FDA authorizes Novavax's updated protein-based COVID vaccine, distinguishing it from other shots

The FDA has authorized Novavax's protein-based COVID-19 vaccine, providing Americans with an alternative to mRNA-based shots for the fall booster campaign. The vaccine, which has already received CDC approval, uses a traditional protein subunit-based design and targets the spike protein of the omicron subvariant. While head-to-head clinical data on its efficacy against circulating variants is not available, accumulated data suggests it is similarly effective to mRNA vaccines. The vaccine will be available to everyone aged 12 and up, and Novavax expects it to be available in thousands of locations nationwide.

health2 years ago

Novavax's Updated COVID Vaccine Receives FDA Authorization

The FDA has granted emergency use authorization for Novavax's updated COVID-19 vaccine for individuals aged 12 and older, making it the third vaccine option available in the United States. Novavax's protein-based vaccine targets the omicron subvariant XBB.1.5 and is expected to provide an alternative for those who prefer non-mRNA shots from Pfizer and Moderna. The vaccine still requires a recommendation from the CDC before it can be accessed at distribution sites. The authorization comes as Pfizer and Moderna's updated shots have already reached millions of Americans, helping to combat the surge in COVID-19 cases driven by newer strains.

health2 years ago

"Pfizer Aims for End-of-Month Authorization of Updated Covid Boosters"

Pfizer CEO Albert Bourla stated that the FDA could authorize updated Covid boosters by the end of August. The boosters are designed to target the XBB.1.5 subvariant, which was previously advised by the FDA. Although XBB.1.5 is no longer the predominant strain, accounting for 12.3% of new cases, Bourla expects a new Covid wave to start in the U.S. this fall. The decision on recommending boosters for everyone will be made by the CDC after FDA authorization. Currently, only 17% of the U.S. population has received an updated booster.