Moderna Plans New U.S. Trial to Evaluate COVID-19 Vaccine in Adolescents

Moderna is preparing to launch a new phase 2/3 trial in the U.S. to assess its promising coronavirus vaccine in adolescent participants aged 12 to 17, though it’s not yet clear when it will start enrolling volunteers.

The drugmaker has not yet publicly announced the phase 2/3 trial, which plans to eventually enroll approximately 3,000 participants at seven sites, according to the company’s Dec. 2 entry on clinicaltrials.gov. The study aims to assess the highly effective vaccine’s safety, efficacy and reactogenicity in adolescents.

Moderna declined to supply further details of the trial beyond what is posted on its ClinicalTrials.gov page.

The Cambridge, Mass., drugmaker’s mRNA-based vaccine, mRNA-1273, was shown to be 94.1 percent effective in adults in its late-stage trial’s primary efficacy, or final, analysis, and the company this week became the second COVID-19 vaccine developer to file for Emergency Use Authorization (EUA) with the FDA.

The agency’s vaccine advisory committee will assemble to discuss the Moderna vaccine on Dec. 17, and an EUA could be granted soon after if the panel offers a positive recommendation.

HHS Secretary Alex Azar has said he believes both Pfizer’s and Moderna’s shots could receive FDA emergency clearance before Christmas. If either one is cleared by then, vaccinations will likely begin for high-risk patients before the year is up, with distribution slated to start within 24 hours of an EUA being granted (DID, Dec. 1).

According to Moderna, the company is on track to produce half a billion to one billion doses of its vaccine for use around the world next year. — James Miessler