Moderna seeks EUA for COVID-19 vaccine for use in adolescents
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Moderna announced that it has requested an emergency use authorization from the FDA for its COVID-19 vaccine for use in adolescents aged 12 to 17 years.
If authorized, it would become the second COVID-19 vaccine available for children in the United States after the Pfizer-BioNTech shot, which received an emergency use authorization (EUA) for children as young as age 12 years last month.
Moderna’s submission is based on the results of a phase 2/3 study that showed the vaccine was as effective in adolescents as it is in adults.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We remain committed to helping to end the COVID-19 pandemic,” Moderna CEO Stéphane Bancel said in a statement.
It took 31 days for the FDA to authorize the Pfizer-BioNTech vaccine for adolescents after the companies formally requested the expanded EUA.
The Biden administration is trying to reach a goal of getting 70% of eligible Americans at least partially vaccinated by July 4. A major part of the plan is to vaccinate children.
According to the AAP, as of June 3, there have been 3,994,151 pediatric cases of COVID-19 reported in the U.S., accounting for 14.1% of all COVID-19 cases in the country.
References:
AAP. Children and COVID-19: State-level data report. https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/. Accessed June 10, 2021.
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Moderna. Moderna files for emergency use authorization for its COVID-19 vaccine in adolescents in the United States. https://investors.modernatx.com/news-releases/news-release-details/moderna-files-emergency-use-authorization-its-covid-19-vaccine. Accessed June 10, 2021.
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