- FDA is delaying its decision on whether kids 12 to 17 should receive Moderna to determine if it increases the risk of a rare side effect that impacts kids’ hearts
- The biotech company said that it would need until at least January 2022 before the FDA can finish its review of the Moderna application for children 12 to 17
- The agency informed Moderna on Friday night that it would require the extra time to further examine ongoing and emerging data on the risks of myocarditis
- Myocarditis is an inflammation of the heart muscle that in rare cases occurs after vaccination
- The news comes after several countries, from Nordic nations to Japan, voiced concerns that Moderna vaccine increased risk of myocarditis in men 18 to 30
- Meanwhile, The US Food and Drug Administration (FDA) authorized Pfizer-BioNTech’s COVID-19 vaccine for children between ages five and 11 on Friday
The FDA announced it will delay its decision on whether children ages 12 to 17 should receive the Moderna COVID-19 vaccine to determine if the shot increases the risk of a rare side effect that impacts kids’ hearts, the agency said Sunday.
The announcement comes just three days after the FDA authorized Pfizer-BioNTech’s COVID-19 vaccine for children between ages five and 11.
Moderna, based in Cambridge, Massachusetts, was told the federal agency would need until at least January 2022 before the FDA can finish its review, according to the Washington Post.
The company also added that it will delay its request for FDA authorization of its COVID vaccine for children 6 to 11 years old, the paper reported.
The agency informed Moderna on Friday night that it would require the extra time to further examine ongoing and emerging data – from international sources – on the risks of myocarditis, which is an inflammation of the heart muscle that in rare cases occurs after vaccination.
The announcement comes after several countries, from Nordic nations to Japan, voiced concerns that the Moderna vaccine increased the risk of myocarditis in men ages 18 to 30.
And in Sweden and Finland, health officials there have recommended against the use of the Moderna shot for men younger than 30, the outlet reports.
In June, Moderna requested the FDA to authorize its vaccine for adolescents, with the shot having been approved previously for people 18 and older.
The proposed vaccine treatment protocol for teens would be the same as that for adults, with two 100-microgram shots received 28-days apart.
Moderna’s proposed vaccination for children 6 to 11 years old that is now on hold would have been for them to receive two half-dose shots of 50 micrograms, the Post reported.
In its statement, Moderna said ‘the safety of vaccine recipients is of paramount importance’ and that it’s working closely with the FDA.
The Moderna delays come just after the agency’s advisory committee recommended emergency use of the vaccine be expanded to young children.
About 28 million American kids will be eligible to receive the two-dose vaccine, which is one-third the dose given to people aged 12 and older, and is administered 21 days apart.
The final step will be a recommendation by the Centers for Disease Control and Prevention’s (CDC) advisory panel next week, meaning the first children may be dosed starting Wednesday.
Parents have been split 50/50 over vaccinating children because kids rarely get severely ill and make up less than 0.1 percent of all Covid deaths in the US.
Last week, the Biden administration released its plans for vaccinating children over the next few months.
Child-size vials that can be kept in refrigerators along with smaller needles necessary for injecting young kids will be sent to providers across the country.
Youngsters will be able to get the shot at their pediatrician’s offices or local pharmacies, and potentially even their schools rather than mass immunization sites.
And children’s hospitals will set up clinics on nights and weekends so mothers and fathers can vaccinate their kids after they get off of work.
As of Friday, the federal government has purchased 110 million doses of the Pfizer pediatric shot and 15 million doses are ready to be shipped as soon as the vaccine is authorized, reported the New York Times.
