ALERT CENTER: Advisers to the FDA back COVID19 vaccine from Novavax. Agency must now decide whether to authorize. MORE:
Next, the FDA must decide whether to authorize the vaccine made by latecomer Novavax, a protein vaccine that's made with a more conventional technology than today's U.S. options.
“We do have a problem with vaccine uptake that is very serious in the United States," Marks said. "Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do.” Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. One complication: Those studies were done far earlier in the pandemic, well before more contagious coronavirus variants emerged -- including the omicron mutant and its relatives.
And while the trials showed generally people experienced only mild reactions such as injection-site pain or fatigue, the FDA did highlight a possible concern: six cases of heart inflammation, known as myocarditis, found among the 40,000 people who received the vaccine in studies.
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