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Moderna Announces TeenCOVE Study of its COVID-19 Vaccine in Adolescents Meets Primary Endpoint and Plans to Submit Data to Regulators in Early June
Primary endpoint of non-inferior immunogenicity versus the Phase 3 study adult comparator group was met No cases of COVID-19 observed after two doses of
About this update from Moderna, Inc.
[{"type":"text","content":"\nPrimary endpoint of non-inferior immunogenicity versus the Phase 3 study adult comparator group was met\n\nNo cases of COVID-19 observed after two doses of vaccine using the primary case definition, consistent with a vaccine efficacy of 100%\n\nSafety and tolerability generally consistent with Phase 3 COVE study in adults; no significant safety concerns identified\n\nCompany plans to submit data to regulators globally in early June\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nModerna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Phase 2/3 study of its COVID-19 vaccine (mRNA-1273) in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition. In addition, a vaccine efficacy of 93% in seronegative participants was observed starting 14 days after the first dose using the secondary CDC case definition of COVID-19, which tested for milder disease. This study, known as the TeenCOVE study, enrolled more than 3,700 participants ages 12 to less than 18 years in the U.S. The Company plans to submit these data to regulators globally in early June.\n\n“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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “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.”\n\nIn this Phase 2/3 study, 3,732 adolescent participants ages 12 to less than 18 years were enrolled and randomized 2:1 to two 100 µg doses of mRNA-1273 or placebo. The primary endpoint of non-inferior immunogenicity versus the Phase 3 adult study comparator group was met. After two doses, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase 3 COVE study, compared to 4 cases in the placebo group, resulting in a vaccine efficacy of 100% starting 14 days after the second dose. Because the incidence rate of COVID-19 is lo...