Moderna asks for emergency authorization of COVID-19 vaccine for adolescents
Moderna Inc. has requested an emergency use authorization for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration.
(WJW) -- Moderna Inc. has requested an emergency use authorization for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration.
Currently, the vaccine is authorized for those 18 and older.
According to a press release, the company in May announced that in the Phase 2/3 study of the vaccine in adolescents, no cases of the virus were observed in participants who received two doses of the vaccine.
“We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic," said Stephane Bancel, CEO of Moderna, in the release.
The release states the vaccine was generally well-tolerated "with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified to date. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain."