Moderna (MRNA) - Get Report said Thursday it has formally asked the U.S. Food & Drug Administration for emergency approval to use allow its coronavirus vaccine to be administered to teenagers over the coming months.
Moderna, which filed a similar request with European health authorities earlier this week, said late-stage data from its TeenCOVE study "met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination' with a vaccination efficacy of 100% among the 2,500 participants. A 93% efficacy rate was also noted 14 days after the first of the vaccine's two dose regiment, Moderna said.
The drugmaker is asking the FDA to issue an Emergency Use Authorization (EUA) notice that will allow its mRNA-1273 to be given to children between the ages of 12 and 18.
“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said CEO Stéphane Bancel. “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,” he added.
Moderna shares, which hit an all-time high of $227.71 each during Monday trading, were marked 1.7% higher in trading Thursday to change hands at $221.20 each.
Data published by the Centers for Disease Control and Prevention Wednesday indicated that around 141 million Americans have been fully vaccinated against COVID-19, with nearly 305 million doses administered around the country.
Last month, Moderna posted stronger-than-expected first quarter earnings of $2.84 per share on revenues of $1.9 billion, and boosted its full-year vaccine sales forecast to around $19.2 billion for the full 2021 financial year.
Moderna's base plan for 2021 is to produce 800 million doses of its messenger-RNA vaccine, which received emergency approval from the FDA in December of last year, with the aim of r"working hard to get as close to 1 billion doses in 2021 as we can," Bancel said in early May.
"The feedback from governments around the world requesting high-efficacy mRNA vaccines and variant boosters is overwhelming. We are now actively engaged in discussions and agreements for 2022 with all of the governments we are currently supplying for 2021."