Novavax COVID-19 vaccine recommended for approval by FDA advisory committee
Novavax's COVID shot is a more traditional protein vaccine
A fourth COVID-19 vaccine will likely be available to Americans soon after an FDA advisory panel recommended Novavax's shot for emergency use authorization on Tuesday.
The Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention during a 7-hour meeting to review the company's application.
Some health officials are hopeful that the new vaccine may appeal to the 27 million American who still are not vaccinated against COVID-19, as Novavax's shot is a more traditional protein vaccine that has been used for decades to prevent hepatitis B, shingles, and other diseases.
The most widely used vaccines in the U.S., which are made by Pfizer and Moderna, user messenger RNA, or mRNA, to deliver genetic instructions for immune system to produce its own copies of the spike protein that is found on the surface of the virus that causes COVID-19.
Vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled. (Serum Institute of India for Novavax via AP / AP Newsroom)
Research into mRNA vaccines was ongoing for years but the FDA granted emergency use approval to Pfizer and Moderna's vaccines during the pandemic for the first time.
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Another option, made by Johnson & Johnson, is a viral vector vaccine that uses a cold virus to deliver instructions to your body to build up defenses. The FDA advisory panel recommended Modern and Pfizer's vaccines over Johnson & Johnson's in December due to a rare blood clotting disorder.
A study of Novavax's vaccine found that two doses were 90% effective at preventing symptomatic COVID-19 infection, though the study took place before the omicron variant was widespread.
This file photo shows a vial of the Phase 3 Novavax coronavirus vaccine ready for use in a trial at St. George's University hospital in London. (AP Photo/Alastair Grant, File / AP Newsroom)
The FDA advisory committee did highlight six cases of myocarditis, or heart inflammation, that arose in men shortly after taking the Novavax vaccine. Four of the six cases occurred in males between the ages of 16 and 31, while the other two cases were in men aged 60 and 67.
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Novavax said Friday that "the rate of myocarditis was balanced between the vaccine and placebo" groups in their study.
Myocarditis has also been a problem among individuals who received mRNA vaccines, particularly in young men about a week after the second dose.
Novovax COVID-19 vaccines incubate in flasks at the company research laboratory in Gaithersburg, Md. (AP Photo/Angie Wang / AP Newsroom)
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A CDC study in April found that COVID-19 infection is more likely to cause myocarditis than the vaccine in both men and women.
The FDA will now decide whether to accept the advisory committee's recommendation and give final approval to Novavax's vaccine.