Moderna Starts Dosing of Adolescents in Phase 2/3 COVID-19 Vaccine Trial

Moderna has begun dosing adolescents in a phase 2/3 trial evaluating messenger RNA-based vaccine candidate mRNA-1273 and plans to enroll 3,000 U.S. participants aged 12 to 17.

The randomized, controlled study, conducted in partnership with the Biomedical Advanced Research and Development Authority, will evaluate the vaccine’s safety, efficacy and reactogenicity in healthy adolescents via a two-dose regimen administered 28 days apart.

The Cambridge, Mass., drugmaker will follow up with participants for 12 months after they receive the second dose and said it plans to have data available in spring to support the vaccine’s use ahead of the 2021 school year.

The vaccine, mRNA-1273, was shown to be 94.1 percent effective in adults in its late-stage trial’s final analysis, and Moderna recently became the second COVID-19 vaccine developer to file for Emergency Use Authorization (EUA) with the FDA (DID, Dec. 1).

Yesterday, the agency’s vaccine advisory committee met to discuss the Pfizer/BioNTech vaccine, demonstrated to be 95 percent effective in late-stage trials, with an EUA possibly coming this weekend or early next week.

The same committee will discuss the Moderna vaccine on Dec. 17, and an EUA for it could be granted shortly after if the panel gives a positive recommendation. The federal government has said distribution of vaccines will begin within 24 hours of receiving an EUA.

Previously, Moderna said the company is on track to produce half a billion to 1 billion doses of mRNA-1273 for global use next year. ― Jason Scott