The Moderna vaccine was 93% effective against COVID-19 in children aged 12 to 17 after the first dose and 100% two weeks after the second dose, with no cases of COVID-19 reported among vaccinated participants.
In addition, no serious safety concerns were identified, data from the company’s Phase 2/3 clinical trial released Tuesday showed.
According to the company, the trial involved more than 3,700 adolescents, two-thirds of whom received the vaccine and one-third of whom received a placebo.
There were no cases of COVID-19 among the vaccinated group after two shots, compared with four cases in the placebo group, an efficacy rate of 100%, according to the company’s study.
In addition, the vaccine was found to be 93% effective starting 14 days after the first dose for milder disease, as defined by the Centers for Disease Control and Prevention.
The most common adverse event was pain at the site of the injection, according to the study. The most common after the second dose were headache, fatigue, muscle pain and chills.
All participants in the TeenCOVE will be monitored for 12 months after their second shot to assess the long-term protection and safety of the Moderna vaccine, the company said.
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Moderna hopes to be able to amend the emergency use authorization for its vaccine from the Food and Drug Administration to allow children as young as 12 to receive it.
“We will submit these results to the U.S. FDA and regulators globally in early June and request authorization,” said Stéphane Bancel, chief executive officer of Moderna.
Currently, Moderna’s vaccine is only available for people 18 and above because it was initially only tested in adults. It took time to enroll enough teens in the appropriate age group.
The Pfizer-BioNTech vaccine was authorized for use in adults and teens 16 and older in December; the allowed age was dropped to 12 in May.
Depending on when the FDA application is made and how quickly it is processed, it could offer families more choices for vaccinating children over the summer vacation and before the 2021-22 school year begins.
It could also boost overall vaccination numbers in the United States, which is home to 17 million adolescents.
Although teens tend not to get very serious cases of COVID-19, they can get sick and can pass the virus to others.
More than 3.94 million children have tested positive for COVID-19 as of May 24, according to the American Academy of Pediatrics. Children represent 14.1% of all COVID-19 cases.
While COVID-19 is generally mild in children, in rare cases, it can cause serious disease and even death. At least 316 American children had died of COVID-19 as of May 20, compared with 166 who died of the flu during the 2019-20 flu season, according to the American Academy of Pediatrics.