Moderna on Tuesday said its coronavirus vaccine was effective and it strongly protects kids as young as 12, a potential step that could put the shot on track to become the second option for school-aged children in America.
In adolescents aged 12-17, Moderna’s Covid-19 vaccine showed no new or major safety problems in a clinical trial, the developer has said.
With global vaccine supplies still tight, much of the world is struggling to vaccinate adults in the quest to end the Covid-19 pandemic. But earlier this month, the US and Canada authorised another vaccine — the shot made by Pfizer and BioNTech — to be used starting at age 12.
US regulators took about a month to review a similar study from Pfizer/BioNtech, which was authorised for ages 12-15 on 10 May. If Moderna gets the same treatment, its authorisation would come in early July.
Moderna, whose vaccine is authorised for adults 18 and older, aims to be next in line, saying it will submit its teen data to the US Food and Drug Administration and other global regulators for emergency use authorisation in early June.
Modena studied over 3,700 12- to 17-year-olds
The company studied more than 3,700 12- to 17-year-olds. Preliminary findings showed the vaccine triggered the same signs of immune protection in kids as it does in adults, and the same kind of temporary side effects such as sore arms, headache and fatigue.
There were no Covid-19 diagnoses in those given two doses of the Moderna vaccine compared with four cases among kids given dummy shots. In a press release, the company also said the vaccine appeared 93% effective two weeks after the first dose.
Most children with Covid-19 develop only mild symptoms or no symptoms. Yet children remain at risk of becoming seriously ill, and they can spread the virus. Widely vaccinating 12- to 18-year olds could allow US schools and summer camps to relax masking and social distancing measures suggested by the CDC.
“We are encouraged that mRNA-1273 was highly effective at preventing Covid-19 in adolescents,” Stéphane Bancel, Moderna’s chief executive, said in a statement.
‘No new safety issues’
The researchers found no new safety issues. The most common side effects after the second dose were headache, fatigue, body aches and chills.
The firm said it is still accumulating safety data. All study participants will be monitored for 12 months after their second dose to determine long-term protection and safety.
Moderna said it plans to submit the data to a peer-reviewed publication. The company is currently testing its vaccine in children as young as six months of age.
While children are far less likely than adults to get seriously ill from Covid-19, they represent about 14% of the nation’s coronavirus cases. At least 316 have died in the US alone, as per a tally by the American Academy of Pediatrics.
With plenty of vaccine supply in the US, younger teens flocked to get Pfizer’s shot in the days after FDA opened it to them, part of a push to get as many kids vaccinated as possible before the next school year.
Both Pfizer and Moderna have begun testing in even younger children, from age 11 down to 6-month-old babies. This testing is more complex: Teens receive the same dose as adults, but researchers are testing smaller doses in younger children. Experts hope to see some results in the fall.
In addition to the United States, Pfizer’s vaccine is also authorised for use in younger teens aged 12 to 15 in Canada and Algeria.