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Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.
Moderna announced on April 28, 2022 that it has submitted a request for emergency use authorization (EUA) to FDA for its COVID-19 vaccine to be used in children six months to under six years of age. The company states that similar requests are underway with international regulatory authorities. The vaccine, called SPIKEVAX, is currently authorized for use for active immunization against COVID-19 in individuals aged 18 years or older.
The submission comes after positive results from a study conducted to gauge the safety and efficacy of the vaccine for use in young children. The efficacy estimates were shown to be similar to vaccine efficacy shown in adults. The results showed a robust neutralizing antibody response in children six months to six years of age.
Moderna is also studying booster doses for pediatric patients. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). The EUA submission for children ages 6 months to under 6 years will be complete next week.
"We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," said Stéphane Bancel, CEO of Moderna, in a press release. "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers."