FDA Vaccine Committee Voted Favorably for Protein-Based COVID-19 Vaccine
The U.S. FDA's Vaccines and Related Biological Products Advisory Committee announced today it voted (21 yes, with one abstained) to endorse the protein-based Novavax COVID-19 vaccine (NVX-CoV2373) for active immunization in adults in the USA.
This FDA committee reviews and evaluates data regarding the safety and efficacy of vaccines and related biological products intended to prevent, treat, or diagnose human diseases.
However, the FDA staff makes the formal authorization and vaccine labeling decisions.
Novavax's vaccine has already been authorized in over 170 countries, including the World Health Organization.
Regarding heart health risks, Novavax stated on June 3, 2022, that 'the data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%).
As with all products regulated by the FDA, vaccines undergo a rigorous review of laboratory and clinical data to ensure these products' safety, efficacy, purity, and potency.
Currently, the FDA has approved/authorized three COVID-19 vaccines.
As of June 7, 2022, about 66.7% of the U.S. population had been 'fully vaccinated' with an Approve/Authorized COVID-19 vaccine.
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