Moderna says COVID-19 vaccine effective in adolescents, readies FDA submission
Moderna said Tuesday that its COVID-19 vaccine was safe and “highly effective” in a phase 2/3 study among adolescents aged 12 to 17 years, offering a level of protection in the younger age group akin to that seen in adults.
In the trial, which involved more than 3,700 children, no cases of COVID-19 were observed among participants who received two doses of the vaccine, mRNA-1273. The calculated vaccine efficiency was 93% among seronegative patients 14 days after receiving the first dose, Moderna said.
Moderna CEO Stéphane Bancel, MSc, said the company will submit the data to the FDA and international regulators in “early June,” seeking authorization in the younger age group.
Currently, the vaccine is available only for adults. If authorized for adolescents, it would become only the second COVID-19 vaccine available for a pediatric population after Pfizer-BioNTech’s vaccine, which the FDA authorized earlier this month for use in children aged 12 to 17 years.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents,” Bancel said in a statement. “It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection.”
The phase 2/3 study was conducted among 3,732 adolescents aged 12 to 17 years. Participants were randomly assigned in a 2:1 ratio to receive either two 100 µg doses of the mRNA-1273 vaccine or a placebo.
No cases of COVID-19 occurred in the vaccine group compared with four cases observed in the placebo group and there were no identified safety concerns, Moderna said.
The most common adverse events were mild or moderate in severity, with the most common being pain at injection site, according to the company. The most common solicited systemic adverse events after the second dose were headache, fatigue, myalgia and chills.
As of May 20, more than 3.94 million children have tested positive for COVID-19, according to the AAP. About 40,000 new pediatric cases of COVID-19 were reported in the week ending May 20, which marks the lowest number of weekly cases reported among children since early October.