The decision will now go to the Food and Drug Administration, which is expected to make a final ruling in the coming days.
Several of the breakthrough cases were considered severe, and there were two deaths.
Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, noted that it’s still unknown what levels of antibodies are needed for protection. However, the booster trial didn’t include enough participants to evaluate whether the extra dose raised the risk forMyocarditis, or inflammation of the heart muscle, has been linked to both Moderna and Pfizer’s COVID-19 vaccines. The condition is rare and mostly commonly seen in men under 30.
"The rate of it is really, really low compared to what you would have expected, if it was the same rate as after the second dose," she said."Perhaps it’s because we’re giving this dose five months or later" as opposed to giving two doses three weeks apart.
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