"We do definitely hear the feedback. I think this has kind of arisen with the speed with which these have come forward," Moderna's Rituparna Das told the advisers.Moderna's request to vaccinate adolescents and teens had been stalled for months before the FDA, despite swifter approvals from regulators overseas.
Federal health officials had said they were concerned Moderna's 100 microgram dose might pose a higher risk than from Pfizer's vaccine of rare heart inflammation side effects, known as myocarditis and pericarditis. However, FDA officials saidthat U.S. safety surveillance data has not turned up "a significantly higher" risk from Moderna's doses at the full 100 micrograms, compared to Pfizer's vaccine in young adults.
Moderna uses the same ingredients for all of their authorized shots, an FDA spokesperson said, but it'sThere are 25 micrograms of mRNA in each of Moderna's primary series doses for children up to 5 years old; 50 micrograms up to 11 years old; and 100 micrograms for everyone else 12 years and older.
"We would expect to be addressing this gap in booster dose recommendations over the summer and into early fall," the FDA's Doran Fink told the panel.
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