Moderna says vaccine safe and effective in teens, will submit to FDA
Moderna’s novel coronavirus (COVID-19) vaccine is highly effective in adolescents, according to an announcement earlier today. Company representatives said they plan to submit its data to the U.S. Food and Drug Administration (FDA) to request emergency authorization in early June.
The study, known as the TeenCOVE study, enrolled 3,732 adolescent participants ages 12 to less than 18 years old, 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 four cases in the placebo group, resulting in a vaccine efficacy of 100 percent starting 14 days after the second dose.
Since the incidence rate of COVID-19 is lower in adolescents, a secondary case definition based on the U.S. Centers for Disease Control and Prevention (CDC) definition of COVID-19 was also evaluated to include cases presenting with milder symptoms. Using the CDC definition, which requires only one COVID-19 symptom and a nasopharyngeal (NP) swab or saliva sample positive for SARS-CoV-2 by RT-PCR, a vaccine efficacy of 93 percent after the first dose was observed, the company said.
The vaccine was generally well tolerated with a safety and tolerability profile generally consistent with the Phase 3 COVE study in adults. No significant safety concerns have been identified to date. Most adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia, and chills.
Safety data continues to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. Consequently, these data are subject to change based on ongoing data collection. The company said it plans to submit data from the TeenCOVE study to a peer-reviewed publication.