![]() “That clearly needs to be watched closely going forward as we expand the use of the vaccine,” said Dr. But experts say the studies may have had too few participants for a rare side effect like that to appear. In their review, FDA scientists said there were no confirmed cases of the heart inflammation in Moderna’s kid studies. Moderna got extra scrutiny because its shots are a far higher dose. That’s mostly a risk for teen boys and young men, and also can occur with the Pfizer vaccine. ![]() ![]() The FDA held up Moderna’s teen vaccine for months while it investigated a rare side effect, heart inflammation. “I believe that this will provide families an important option” and may be particularly important for families who live in areas where coronavirus spread is increasing, said another panel member, Dr. “The data do support that the benefits outweigh the risks for both of these doses, in both of these age groups,” said the CDC’s Dr. Tuesday’s vote was only for two doses - full-strength for 12-17 and half-sized doses for those 6-11. The Massachusetts company is seeking clearance for two doses, and plans to later offer a booster. If the FDA authorizes Moderna’s vaccine for teens and younger children, the Centers for Disease Control and Prevention will next decide whether to formally recommend the shots. and elsewhere and more than three dozen countries offer it to older children, too. Moderna’s COVID-19 vaccine has long been available for adults in the U.S.
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