Moderna announced on Tuesday that its coronavirus vaccine is “highly effective” in preventing COVID-19 in kids aged 12 to 17 years old.
Currently approved as a two-dose regimen for adults 18 years and older, Moderna said it plans to apply for authorization in June from the Food and Drug Administration for use in teens.
Phase two/three results of Moderna’s TeenCOVE study reveal that the company’s COVID-19 vaccine is highly effective in preventing the virus in teens. The clinical trial enrolled 3,732 participants aged 12 to 17 years old.
Two-thirds of the volunteers received the two-dose regimen, and no symptomatic cases of the virus were detected in the fully vaccinated teens, translating to a 100% efficacy in preventing symptomatic COVID-19.
Additionally, Moderna reported that just a single dose of its vaccine provided 93% efficacy against symptomatic infection.
The side effects were similar to those experienced in adults and include pain at the injection site, headache, fatigue and chills.
Moderna said that safety data will continue to be collected and analyzed by an independent safety monitoring committee and all participants will be monitored for 12 months after their second injection to assess long-term protection and safety.
If approved by the FDA, it would become the second vaccine for use in kids as young as 12 years old. Pfizer and BioNTech’s vaccine was granted authorization earlier this month for use in kids aged 12 to 15 years old. That vaccine was already approved for people 16 and older.
The results are welcomed news as states across the country navigate reopening schools for the upcoming school year. New York City and some states, including Illinois, Massachusetts, Connecticut and New Jersey recently announced that schools will either restrict or completely remove remote learning and reopen for in-person instruction.