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Moderna seeks expanded COVID-19 vaccine EUA
Moderna will seek to expand their EUA cover administering the vaccine to children under 18 years old.
Moderna will seek to expand the emergency use authorization (EUA) for their COVID-19 vaccine to children after it showed high efficacy in a study.
According to a news release, the phase 2/3 study of the vaccine in adolescents met its primary immunogenicity endpoint. It proved to have 93 percent efficacy 14 days after the first dose. The company plans to submit the data to global regulator in early June.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” Stéphane Bancel, CEO of Moderna, says in the release. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”
The vaccine showed 100 percent efficacy starting 14 days after the second dose was administered, the release says.
Earlier this month, the Food and Drug Administration expanded the EUA for the Pfizer vaccine to allow shots to be given to patients between 12 and 15 years of age becoming the first to receive authorization for administration to children.
