Moderna’s COVID-19 vaccine, mRNA-1273, has proven highly effective in a phase 2/3 study in adolescents aged 12 to 17.
The study enrolled 3,732 adolescent participants and randomised them to receive either two doses of mRNA-1273 or placebo.
The trial, known as TeenCOVE, met its primary endpoint of non-inferior immunogenicity compared to adult participants in the phase 3 study comparator group.
In addition, no cases of COVID-19 were observed after two doses of mRNA-1273 in the vaccine group, compared to four cases in the placebo group – reflecting a vaccine efficacy of 100% starting 14 days after the second dose.
Moderna added that since the incidence rate of COVID-19 is lower in this age group, the study also evaluated a secondary case definition based on the CDC definition of COVID-19.
This definition requires only one COVID-19 symptom and a nasopharyngeal (NP) swab or saliva sample that tests positive for SARS-CoV-2 by RT-PCR.
Using this definition, Moderna concluded that the vaccine efficacy for mRNA-1273 is 93% after the first dose.
The company plans to submit the data from the study to global regulators in early June.
“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection,” said Stéphane Bancel, chief executive officer of Moderna.
“We will submit these results to the US FDA and regulators globally in early June and request authorisation. We remain committed to doing our part to help end the COVID-19 pandemic,” he added.
While safety data continues to accrue, Moderna will also continue to monitor participants for 12 months after their second dose to assess long-term protection and safety.
With Moderna hoping to extend the reach of its COVID-19 vaccine into younger age groups, a newly announced deal with Samsung Biologics to bolster its production network will become even more crucial.
Moderna and Samsung Biologics have signed a deal for large-scale, commercial fill-finish capabilities for mRNA-1273.
Technology transfer is set to begin immediately upon completion of the deal, with Samsung planning to leverage its facilities in Incheon, South Korea for the finishing, labelling and packaging of mRNA-1273.
“Due to the high level of urgency in supplying the vaccine to the global population, we have set immediate action plans and schedule to make mRNA-1273 available for commercial distribution in the early second half of 2021,” said John Rim, chief executive officer of Samsung Biologics.