Moderna's COVID-19 vaccine aces trial in teens, teeing up back-to-school FDA approval

Moderna manufacturing site
Moderna's vaccine aced a study in children, setting the company up for regulatory filings next month. (Moderna)

Teens across the U.S. started getting COVID-19 vaccines this month after Pfizer’s shot. With new data released Tuesday, Moderna’s shot could soon be available to kids, too.

In a phase 3 trial in kids ages 12 to 18, Moderna’s vaccine posted 100% efficacy after two doses. Investigators enrolled 3,700 participants and randomly assigned two-thirds to receive two doses of the Moderna vaccine. The remaining third received two doses of placebo.

Investigators recorded zero COVID-19 cases in the vaccinated group 14 days after the second dose, and four in the placebo group. They didn't identify any new safety concerns.

The results set Moderna up for an FDA filing in the age group next month. Under that timeline, the vaccine could score an authorization in teens sometime this summer and play a role in a back-to-school vaccination push.

But Moderna won’t be the first COVID-19 vaccine maker to score an authorization in children. After Pfizer’s vaccine aced its own trial in participants ages 12 to 15, an emergency authorization followed—and, now, Pfizer's vaccine is authorized for people 12 and up.

Even younger children could be on their way to eligibility, too; Pfizer and Moderna are both running studies testing their vaccines in children as young as six months.

RELATED: Moderna blueprints plant upgrades to rev up vaccine supply to 3B doses a year 

Still, having another option for teens will only help the U.S. with its ongoing vaccination push. So far, more than 286 million vaccine doses have been administered in the U.S., and more than 61% of adults have received at least one shot. President Joe Biden has set a goal for 70% of adults to receive at least one dose by early July. 

Aside from seeking a U.S. filing, Moderna also plans to submit its new data in teens to other regulators worldwide.  

RELATED: Pfizer's COVID-19 vaccine scores FDA nod in adolescents, enabling a wider rollout 

Like other COVID-19 vaccine players, Moderna has been busy with its production efforts. The company is on track to produce up to 1 billion doses of its shot this year, and, thanks to expanded collaborations, it’s targeting 3 billion doses for 2022. 

Since the COVID-19 vaccine rollouts started late last year, the shots have brought in billions for the leading companies. Pfizer reported $3.5 billion in first-quarter COVID-19 vaccine sales, while Moderna tallied $1.7 billion. The companies are eying tens of billions from their vaccines in the coming years.