Moderna said Tuesday that its COVID-19 vaccine is safe and appears to be effective in adolescents aged 12 to 17, based on the results of its trial.
The company said the blood samples of the 3,732 children involved in the clinical trial showed that the vaccine generated an immune response that was equivalent to earlier findings in adults.
Moderna said none of the children who got the vaccine contracted COVID-19 beginning 14 days after their second dose. Four of the children in the placebo group tested positive for COVID-19. Moderna said that finding is "consistent with a vaccine efficacy of 100%."
"We will submit these results to the U.S. [Food and Drug Administration] and regulators globally in early June and request authorization" for use in kids from age 12 to 17,” Moderna CEO Stéphane Bancel said in a statement.
Potential side effects were mild
The trial results come approximately two weeks after the FDA said adolescents are now eligible to receive Pfizer’s COVID-19 vaccine.
Moderna said the side effects of its vaccine are similar to that of Pfizer’s and tend to be on the mild or moderate side. The company said the vaccine was “generally well tolerated,” and side effects included headache, fatigue, muscle pain, and chills following the second dose.
In addition to submitting the findings to the FDA for emergency use authorization for adolescents, Moderna said it will submit the data to a peer-reviewed publication.
The FDA and other federal health officials were quick to approve the use of Pfizer’s vaccine in adolescents, in part because vaccine experts have seen that it has been used safely in adults. The timeline will likely be similar for Moderna.
Moderna and Pfizer are also testing their vaccines in younger children (those aged 6 months to 11 years). However, that testing and approval process will likely take longer since elementary age children may require different doses.