New Delhi: Pharma giant Moderna’s Covid-19 vaccine, mRNA-1273 has been found to be safe and effective in adolescents, according to a clinical trial in the US on over 3,700 participants aged 12-17.
According to the study published in the New England Journal of Medicine Wednesday, the incidence of Covid-19 among teens between 12 and 17 years of age was approximately 900 per 100,000 population from 1 April through 11 June. So far, the safety and efficacy of the mRNA-1273 vaccine in adolescents were unknown, since clinical trials had only included adults.
As many as 3,732 participants were recruited for the latest study. They were divided into two groups, where 2,489 participants got the 100 μg vaccine while 1,243 participants received the placebo.
All participants received two injections at an interval of 28 days.
The team, which included researchers from Kool Kids Pediatrics, a medical clinic in the US, and Moderna, wanted to evaluate the safety of mRNA-1273 in teens. They also wanted to check if the immune response generated in adolescents was in any way inferior to that seen in young adults (18-25) in a phase-3 trial.
The study also looked at the efficacy of mRNA-1273 in preventing Covid or asymptomatic SARS-CoV-2 infection.
The study findings
Among the 2,489 participants who received the vaccine, the most common adverse reactions included pain in the injection site, headache and fatigue.
These were the most common adverse reactions in the placebo group as well, although the percentage of participants who reported these side effects were much lower.
No serious adverse events related to mRNA-1273 or placebo were noted.
The researchers also conducted lab tests of blood samples of vaccinated individuals and measured the average antibody levels generated in samples from teens compared to those from young adults.
They found that the antibody response in blood samples from teens was very similar to that found in blood samples from young adults. They confirmed that the vaccine efficacy was not inferior in teens.
The study noted that 14 days after the vaccination, there were no cases of Covid onset reported in the mRNA-1273 group. Meanwhile, there were four teens in the placebo group who got infected with Covid over the course of the study.
“The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19,” the researchers wrote in their study.