“The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older,” the company said.
Following the CHMP’s positive opinion, the European Commission will consider authorizing the vaccine for adolescents.
Moderna stock recently traded at $333.06, up 3%. The shares have surged 155% in the past six months.
“On June 10, Moderna announced data from the ongoing Phase 2/3 study, which enrolled 3,732 participants ages 12 to less than 18 years in the U.S.,” the company said.
“The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults.
“After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase 3 COVE study, compared to four cases in the placebo group, resulting in a vaccine efficacy of 100%.”
In other Moderna news, it joined the vaunted S&P 500 stock index Wednesday, replacing Alexion Pharmaceuticals (ALXN) - Get Alexion Pharmaceuticals, Inc. Report. AstraZeneca (AZN) - Get Astrazeneca PLC Sponsored ADR Report completed its $39 billion takeover of Alexion this week.
In May, Moderna posted stronger-than-expected earnings for the first quarter. Profit totaled $2.84 a share, with revenue rising to $1.9 billion. The drugmaker also boosted its full-year vaccine sales forecast to around $19.2 billion for the full 2021 financial year.