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Moderna, Inc. (NASDAQ:MRNA) shares are continuing their record run, thanks to the momentum imparted by the positive tidings related to the company's coronavirus vaccine.
Moderna Files For Authorization In Adolescents In EU and Canada: Moderna had a trio of news releases on Monday, all related to mRNA-1273, its mRNA vaccine against the novel coronavirus.
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The company said it has made regulatory submissions with the European Medicines Agency and Health Canada for emergency authorization of its vaccine in adolescents.
The submission was based on the Phase 2/3 TeenCOVE study of its COVID-19 vaccine in adolescents that met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. The study enrolled 3,732 participants ages 12 to less than 18 years in the U.S.
Moderna said it plans to submit an emergency use authorization application to the FDA to expand the authorized use of its vaccine to adolescents.
The company's vaccine has been approved for emergency use in adults in a host of countries, including the U.S., Canada, Israel, the EU, the U.K., Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and Botswana. The vaccine also has an emergency use listing from the WHO.
Related Link: The Week Ahead In Biotech: Biogen, Alexion And Vertex FDA Decisions, Multiple Conference Presentations On The Deck
Moderna Announces New Distribution Agreement: Moderna also announced a new agreement with Medison Pharma to commercialize its COVID-19 vaccine across Central Eastern Europe and Israel. The partnership will cater to 20 markets, covering over 175 million lives.
Medison is a global pharma company focusing on commercializing highly innovative therapies for patients in international markets. It provides a complete spectrum of integrated services for companies interested in establishing a presence in international markets.
"Working together with our partners, we remain steadfast in our commitment to fighting the pandemic by delivering our vaccine to populations globally," said Corinne Le Goff, Chief Commercial Officer of Moderna.
Moderna shares were up 6.5% to $219.83 at publication time.
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