FDA panel recommends authorizing Novavax COVID-19 vaccine for adults
Jun 8, 2022
A Food and Drug Administration advisory committee yesterday recommended the agency authorize emergency use of the Novavax COVID-19 vaccine for adults. Based on the scientific evidence available, the Vaccines and Related Biological Products Advisory Committee voted 21-0 that the vaccine’s benefits outweigh its risks when administered as a two-dose series in individuals aged 18 and older. In a large clinical trial early last year before the current COVID-19 variants, the vaccine showed 94.6% efficacy against the virus with a reassuring safety profile, the company said.
If authorized by the FDA, the protein-based vaccine could be stored at 2-8 degrees Celsius (about 36-46 degrees Fahrenheit), enabling the use of existing vaccine supply and cold chain channels. According to news reports, FDA must still finish reviewing data related to the vaccine’s manufacturing process. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices also must recommend the vaccine for this population before it can become available for use.