The United Kingdom’s health regulator extended its approval for the Moderna COVID-19 vaccine to be given to 12- to 17-year-olds, giving another option to the younger age group as schools are slated to return.
Moderna’s vaccine was granted authorization for adolescents after health experts said the safety data was “comparable” to what was seen among young adults, with most adverse events ranging from mild to moderate, the Medicines and Healthcare Products Regulatory Agency (MHRA) said in a release.
“The vaccine is safe and effective in this age group,” June Raine, the MHRA chief executive, said in a statement. “We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines and this surveillance will include the 12- to 17-year age group.”
The approval followed the safety data from a study in the U.S. involving more than 3,700 participants in the age range who received at least one dose of the Moderna vaccine or a placebo.
The research documented no new side effects among the adolescents, with the most common being injection site pain, headache and fatigue.
Currently, 12- to 15-year-olds are able to get the Pfizer-BioNTech shot in the U.K. if they are considered clinically vulnerable or live with someone at risk. But those aged 12 to 17 years in Northern Ireland have already been allowed to get the Moderna shot since late July.
The U.K. this month declared that 16- and 17-year-olds in England could schedule their first vaccine by Aug. 23, so students can build up immunity ahead of the school year.
So far in the U.S., the Food and Drug Administration (FDA) has only granted an emergency use authorization for the Pfizer-BioNTech vaccine to be given to 12- to 17-year-olds. The Moderna and Johnson & Johnson shots are currently only available to adults.
But Moderna said in May that its vaccine was found to be 100 percent effective in those adolescents, and the company filed for emergency use authorization for the age group in June.
The U.K.’s approval also comes as pediatric hospitals across the country are filling up as many children remain ineligible to get vaccinated and back to school season approaches.