Addressing the committee, Martha Dawson, the president of the Nationwide Black Nurses Affiliation, mentioned that some sufferers will really feel extra snug utilizing protein-based vaccines, a expertise that has been in use for many years. “I encourage the F.D.A. to provide us one other, extra conventional medical intervention on this combat,” she mentioned.

In medical trials, the Novavax vaccine was discovered to have an efficacy of 90.four % at stopping delicate, reasonable or extreme an infection with older variants of the virus. Not one of the volunteers who received the vaccine skilled reasonable or extreme an infection, translating to an efficacy of 100 %.

The trial befell earlier than the rise of the Delta and Omicron variants, which have evaded among the immunity from different vaccines.

In briefing paperwork launched on Friday, F.D.A. scientists recognized six circumstances of myocarditis and pericarditis, types of coronary heart irritation, in about 40,000 trial volunteers. The F.D.A. paperwork mentioned that the circumstances raised concern that the vaccine was the trigger and that the charges of the issues might turn into greater than with mRNA vaccines.

Moderna and Pfizer-BioNTech didn’t discover any circumstances of myocarditis or pericarditis of their preliminary medical trials. However after authorization, as soon as the vaccines got to thousands and thousands of individuals, they have been each discovered to create a small further threat of myocarditis in boys and younger males.

Of their presentation on Tuesday, Novavax officers defended their vaccine towards these considerations. Their evaluation discovered that myocarditis and pericarditis circumstances have been balanced throughout the group of volunteers that acquired the vaccine and the group that acquired a placebo. In the actual world, there have been reviews of 1 case of seemingly myocarditis and eight circumstances of seemingly pericarditis out of 744,000 doses given in wealthy international locations which have approved the vaccine, the corporate mentioned.

“We imagine that the totality of the medical proof right here is just not sufficient to ascertain an general causal relationship with the vaccine,” mentioned Dr. Denny Kim, Novavax’s chief security officer.