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Tipsheet

Moderna Will Ask FDA for Authorization for its Vaccine for Children Under 6

AP Photo/Rogelio V. Solis

Biotechnology company Moderna is working towards getting U.S. Food and Drug Administration (FDA) approval to administer a pediatric, low-dose version of its COVID-19 vaccine for children ages six months up to 6 years old.

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In an announcement published Wednesday, it stated that the company will submit a request to the FDA and the European Medicines Agency (EMA) “in the coming weeks” for a 25 microgram two-dose primary vaccine series for COVID-19.

"Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane Bancel said in a press release. Additionally, after consultation with the U.S. FDA we have initiated a submission for emergency use authorization of our COVID-19 vaccine in children ages 6 to 11 years old and are updating our submission to the FDA for emergency use authorization of mRNA-1273 in adolescents ages 12 to 17 years with additional follow-up data. We remain committed to helping to end the COVID-19 pandemic with a vaccine for children of all ages."

The vaccine in this younger age group showed “robust neutralizing antibody response” and “a favorable safety profile.” Moderna’s announcement also stated that the company is preparing to evaluate the potential of a booster shot for “all pediatric populations.”

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This year, as Townhall covered, the FDA gave Moderna its full and final approval for its COVID-19 vaccine for adults. Though in several other countries, such as FinlandSweden and Denmark, the Moderna vaccine has been limited for arising cases of myocarditis in young men. The countries recommended the Pfizer-BioNTech vaccine for this demographic group.

Last month, Townhall covered how the U.S. Centers for Disease Control and Prevention announced that the time between the two doses of the Pfizer-BioNTech and Moderna coronavirus vaccines can be up to eight weeks for certain individuals to lower the risk of myocarditis.

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