Moderna is poised to become the second vaccine manufacturer to provide jabs to younger teens. Pending FDA clearance, Moderna will follow Pfizer in rolling out COVID-19 vaccines for under-18 teens in the US. 

In a statement, Moderna said it has filed for EUA (emergency use authorization) from the Food and Drug Administration to inoculate teens aged 12 to 17 with its COVID-19 vaccine. FDA first authorized Pfizer to give jabs to adolescents aged 12 to 15 years in May.

Moderna has rolled out its vaccine for US adults 18 years and older since December. Since the US deemed children’s vaccination crucial in controlling the pandemic, the firm began testing its COVID-19 vaccine among children six months old to younger than 12 years in March. The positive results led the company to apply for the EUA.

Moderna’s teen trials

Moderna’s request for FDA authorization comes after its successful clinical trials involving two-dose mRNA vaccine in 3,7000 children aged 12 to 17. The company concluded that the trial registered a 93% efficacy rate following the first dose. 

Moreover, after the second dose, results showed only up to moderate side effects: arm pain within the injection site, fatigue, headache, and muscle aches. The clinical trials also concluded that adolescents’ immune responses were as strong as adults’. Therefore, administering the COVID-19 vaccine was considered safe for this age group.

In a statement, Moderna CEO Stéphane Bancel said the clinical trials are an encouraging development since it signals the high effectiveness of the vaccine in the prevention of COVID-19 and SARS-CoV-2 infections in younger children. 

Based on data from the Centers for Disease Control and Prevention (CDC), around 4.7 million 12 to 17-year-old adolescents have been administered at least one dose of vaccine. By and large, the vaccines have been deemed safe and effective. However, the CDC notes that there are a few cases where adolescents and younger adults experience myocarditis following the jabs. 

Vaccine rollout expansion in younger age groups

Meanwhile, the CDC revealed that 101 million people in the US had been fully inoculated against COVID-19. The analysis also showed a total of 10,262 infections reported in 46 states and territories while acknowledging that this may not reflect actual infections due to the non-reporting of mild or asymptomatic infections.

Of the breakthrough cases, 63% were female and 58 years old, 27% were symptomatic, 10% needed hospitalization, and 2% of this count died. Of the 160 patients who died, the average age was 82 years old, with 18% of them asymptomatic.

Pfizer-BioNTech performed clinical trials for their two-dose mRNA COVID-19 vaccine to be administered to children ages 5 to 11 in March. The company announced early this week that it is expanding clinical trials to cover younger children from 6 months to 5 years old.

Aside from filing EUA with the US FDA, Modern has also filed EUA with the European Medicines Agency and Health Canada to use their vaccine in adolescents.