FDA advisers voted unanimously to endorse Moderna's Covid-19 vaccines for babies and toddlers. The FDA is expected to quickly authorize the vaccine for emergency use. A vote on Pfizer's vaccine is coming soon.
The FDA’s independent vaccine advisers voted unanimously Wednesday to recommend the agency authorize two Covid-19 vaccines for babies, toddlers and preschool-age children, putting the country’s youngest age group one step closer to immunizations nearly two-and-a-half years into the pandemic.
The CDC’s panel of expert advisers will consider whether to recommend the shots’ administration during meetings on Friday and Saturday. Once CDC Director Rochelle Walensky signs off on a recommendation, children are expected to begin receiving shots by Tuesday. Children under 6 who receive the Moderna vaccine will get two 25-microgram doses, four weeks apart. The Pfizer vaccine is two 3-microgram doses three weeks apart, followed by a third dose eight weeks later.
Still, the Biden administration is girding for a slog in convincing parents to quickly vaccinate their young children. Summer vacations — and young children receiving various levels of schooling before age 5 — along with misinformation about vaccines could depress early turnout. Many young children also contracted Covid during the Omicron surge, which could convince parents to hold off on immunizing them until they’re further removed from their natural infections.
Real-world efficacy against the Omicron variant in the 6-month-to-5-year-old age group for Moderna’s vaccine ranged from 36 percent to 51 percent, but efficacy estimates were “generally consistent” with rates seen in observational studies of adults during the same variant waves, the FDA said. “My level of confidence in that number ... I do not have any idea what that number will end up being,” she said of the 80 percent figure for Pfizer’s vaccine, adding that she does think it is effective.
The manufacturers did not report any events in their trials that met the CDC definition for probable or confirmed myocarditis or pericarditis — two types of heart inflammation that have been detected as potential side effects of the messenger RNA vaccines, particularly for males ages 12 to 39.
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