Moderna, which is also seeking similar authority from health officials in Canada, 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.
Moderna added that it will seek to expand its Emergency Use Authorization (EUA approval from the U.S. Food & Drug Administration to include those under the age of 18.
“We are pleased to announce that we have submitted for conditional marketing approval of our COVID-19 vaccine with the European Medicines Agency for use in adolescents in the European Union,” 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 filed for authorization with Health Canada and we will file for an Emergency Use Authorization with the U.S. FDA and regulatory agencies around the world for this important younger age population."
"We remain committed to doing our part to help end the COVID-19 pandemic,” he added.
Moderna shares were marked 6% higher in early trading Monday to change hands at $218.50 each, extending its year-to-date gain to around 103%. The stock hit an all-time high of $221.25 each earlier in the session.
Last month, 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."