The pharmaceutical and biotechnology company Moderna, Inc. (MRNA) has submitted an application to Swissmedic for the authorized use of its COVID-19 vaccine in adolescents in Switzerland.
Last week, the company requested emergency use authorization (EUA) with the FDA to administer the vaccine to adolescents in the United States.
In May, the company announced that the Phase 2/3 TeenCOVE study of its COVID-19 vaccine (mRNA-1273) met its primary immunogenicity endpoint in adolescents. The study showed no cases of COVID-19 infection in individuals administered with two doses of the Moderna COVID-19 vaccine using the primary definition. Furthermore, the vaccine represented an efficacy of 93% in seronegative participants, 14 days after receiving the first dose, using the secondary CDC case definition of COVID-19, which tested for milder disease.
Moderna CEO Stephane Bancel said, “We are pleased to announce that we have submitted an authorization application for our COVID-19 vaccine with Swissmedic for use in adolescents in Switzerland.”
Bancel further added, “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 already filed for authorization with the U.S. FDA, Health Canada and the European Medicines Agency and we will continue to file with regulatory agencies around the world for this important younger age population. We remain focused on helping to end the COVID-19 pandemic.” (See Moderna stock analysis on TipRanks)
On June 10, Merrill Lynch analyst Geoff Meacham reiterated a Sell rating on the stock and a price target of $100 (51.8% downside potential).
Meacham said, “While we do see clear positive read-through from success in COVID-19 to the company’s prophylactic vaccines, many of Moderna’s pipeline assets are several years from the market with multiple derisking steps left to go.”
The rest of the Street is cautiously optimistic about the stock with a Moderate Buy consensus rating based on 6 Buys, 3 Holds, and 3 Sells. The MRNA average analyst price target of $194 implies 6.5% downside potential to current levels. Shares have increased 40.9% over the past six months.