Moderna Begins Late-Stage COVID-19 Vaccine Study In Adolescents: What You Need to Know

Here's what Moderna Inc MRNA investors need to know about the latest update Thursday from the biopharma on its coronavirus vaccine program.

What Happened: Cambridge, Massachusetts-based Moderna said the first adolescent participants have been dosed in a Phase 2/3 study of mRNA-1273, its investigational vaccine against SARS-CoV-2.

The company plans to enroll adolescents from ages 12 to less than 18 in the new study, which is being conduction in collaboration with the federal government's Biomedical Advanced Research and Development Authority. 

Moderna's Phase 3 COVE study — which is the basis for the company's application for emergency use authorization for mRNA-1273 — evaluated participants ages 18 and up. 

"This adolescent study will help us assess the potential safety and immunogenicity of our COVID-19 vaccine candidate in this important younger age population. We hope we will be able to provide a safe vaccine to provide protection to adolescents so they can return to school in a normal setting," CEO Stéphane Bancel said in a statement. 

Related Link: Week Ahead In Biotech: FDA To Decide On Emergency Use Of Pfizer's COVID Vaccine, Hematology Conference Presentations Pick Up Pace

Moderna's Adolescent Vaccine Study Design: The randomized, controlled Phase 2/3 study will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.

The company plans to to enroll 3,000 adolescent participants in the U.S., with each receiving a placebo or a 100 mcg dose at both vaccination points. Participants will be followed through 12 months after the second vaccination, Moderna said.

What's Next For Moderna: Moderna said it expects to generate data in the spring of 2021 that will support the use of mRNA-1273 in adolescents in advance of the 2021 school year.

Ahead of this, Moderna's vaccine candidate will be discussed at FDA's vaccine committee meeting scheduled for Dec. 17, which could pave the way for approval on an emergency basis.

The European Medicines Agency has a Jan. 12 deadline for issuing its verdict on mRNA-1273.

MRNA Price Action: At last check Thursday, Moderna shares were trading slightly negative at $156.53.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates