Moderna on Tuesday said its COVID-19 vaccine was shown to be 100 percent effective in children between the ages of 12 and 17.
No cases of COVID-19 were observed in clinical trial participants who received two doses of Moderna’s shot, the Massachusetts-based biotechnology company said in a press release.
Moderna announced the results because it met its primary endpoint, which was a match to the vaccine’s ability to provoke an immune response seen in its trial among adults.
The phase two/three trial of children also showed an efficacy of 93 percent in seronegative participants 14 days or more after the first dose using the Centers for Disease Control and Prevention’s (CDC) secondary definition, which requires one COVID-19 symptom and a nasal swab or saliva sample testing positive for the virus that causes the disease.
The trial, dubbed TeenCOVE, enrolled more than 3,700 participants between the ages of 12 and 17 in the United States. Moderna plans to submit the data to a peer-reviewed publication at some point and to regulators around the world next month, including the Food and Drug Administration (FDA), which regulates vaccines and drugs in America.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” Stéphane Bancel, Moderna’s CEO, said in a statement. “We will submit these results to the U.S. FDA and regulators globally in early June and request authorization. We remain committed to doing our part to help end the COVID-19 pandemic.”
Moderna said its vaccine, known as mRNA-1273, was generally well tolerated in trial participants. The majority of adverse events were mild or moderate in terms of severity, with the most common being injection site pain, headache, fatigue, myalgia, and chills. Full data, including a breakdown of adverse events, was not provided.
Moderna did not respond when asked whether any participants developed myocarditis, or heart inflammation. The CDC is investigating cases of post-vaccination myocarditis, primarily among youth.
All trial participants will be monitored for one year after their second shot to assess longer-term protection and safety. Participants are located across 18 states, according to the trial record. Approximately two-thirds of participants received Moderna’s shot; the rest got a placebo. They self-reported symptoms or lack of symptoms over the phone and logged entries in an e-Diary about any symptoms.
Walid Gellad, professor of medicine at the University of Pittsburgh’s School of Medicine, said the trial results were good news.
“But important to see these data, not just press release. Also important to note there were only four cases in the placebo group,” he wrote in a tweet.
Pfizer, which makes one of the other COVID-19 vaccines authorized for emergency use in the United States, said in late March that a trial showed its vaccine was safe and strongly protective in kids as young as 12. The FDA on May 10 expanded the emergency use authorization for Pfizer’s shot to children between the ages of 12 and 15.
About 88,000 kids in that age group have since received two Pfizer jabs. Another 2.1 million have gotten one dose of the shot.