What happened
Shares of Moderna (MRNA -0.58%) jumped 6.2% on Wednesday after the drugmaker announced that it had requested permission to administer its COVID-19 vaccine candidate to adolescents in Canada and the European Union.
So what
Moderna said in May that a phase 2/3 clinical trial of its vaccine in adolescents demonstrated 93% efficacy against mild COVID-19 and 100% against a more severe classification of the disease among the study's nearly 2,500 participants who received its drug. The vaccine was also generally well tolerated, with no significant safety concerns identified during the trial.
Moderna is seeking the ability to distribute its coronavirus vaccine for adolescents. Image source: Getty Images.
Moderna believes these promising results could allow it to obtain authorization of its vaccine in adolescents from Health Canada and a conditional marketing approval (CMA) from the European Medicines Agency (EMA). The biotech also said it intends to file for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) and other international regulatory agencies.
Now what
In anticipation of these potential regulatory authorizations, Moderna struck a deal with Medison Pharma to distribute its COVID-19 vaccine in Israel and 20 European countries. The agreement could help to bring Moderna's lifesaving drug to as many as 175 million people in these markets.
"Working together with our partners, we remain steadfast in our commitment to fighting the pandemic by delivering our vaccine to populations globally," Moderna Chief Commercial Officer Corinne Le Goff said in a press release.
