FDA to evaluate Novavax’s COVID-19 vaccine Tuesday


A volunteer receives a dose of Maryland-based biotech Novavax’s protein-based COVID-19 vaccine during a trial. The U.S. Food and Drug Administration’s advisory committee is set to debate Tuesday whether or not to issue emergency use authorization for the shot. Photo courtesy Novavax

June 6 (UPI) — The U.S. Food and Drug Administration will meet Tuesday to debate issuing an emergency approval for a traditional style vaccine for COVID-19, produced by Novavax.

“The (FDA advisory) committee will meet in open session to discuss an Emergency Use Authorization (EUA) request by Novavax for a vaccine to prevent COVID-19 in individuals 18 years of age and older,” according to the FDA website.

The Maryland-based biotech company originally applied to the FDA in February for the emergency authorization.

“An EUA allowing for rapid and widespread deployment of the vaccine to millions of individuals, including healthy people, would need to be supported by clear and compelling evidence of effectiveness and adequate safety follow-up to make a determination of favorable benefit/risk,” the FDA said in a statement ahead of Tuesday’s meeting of its Vaccines and Related Biological Products Advisory Committee.

The Novavax vaccine is a more traditional protein-based type of vaccine, employing a whole, deactivated virus, unlike the newer mRNA-based vaccines developed by Moderna and Pfizer already approved by the FDA.

“America, have you been waiting for more #COVID19vaccine choices,” the company wrote on Twitter Wednesday.

The single-dose Johnson & Johnson COVID-19 vaccine is the only non-mRNA shot approved for use in the United States by the FDA, which limited its use in May, restricting it to adults who can’t receive other versions of the vaccine.

The agency made the move because of the risk of thrombosis with thrombocytopenia syndrome, which can cause rare but potentially life-threatening blood clots and low levels of blood platelets about one to two weeks after the administration of the shot.

Britain’s Medicines and Healthcare products Regulatory Agency granted Novavax conditional marketing authorization for the vaccine in February, for use in adults 18 and older. In April, the company applied to expand that for use in adolescents between 12 and 17.



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