Moderna Begins Phase 3 COVID-19 Vaccine Trial

Moderna has begun a much-anticipated phase 3 trial of its COVID-19 vaccine candidate mRNA-1273 — the first phase 3 trial of a coronavirus vaccine in the U.S.

The study will enroll 30,000 participants at nearly 100 sites who will either receive two 100 mcg injections of the vaccine or a placebo. Data from the trial are expected by the fall.

HHS’ Biomedical Advanced Research and Development Authority (BARDA) has expanded its existing contract with Moderna by $472 million to support the study, bringing the total value of the contract to $955 million.

The partners entered the contract in April for late-stage clinical development of the vaccine and the production of millions of vaccine doses (DID, April 20).

The company said it is on track to deliver 500 million doses per year, and up to 1 billion doses per year beginning in 2021.

In a phase 1 study, mRNA-1273 produced high levels of neutralizing antibodies in all participants given two doses (DID, July 15). Moderna is currently conducting a phase 2 trial of the vaccine in 600 participants, which completed enrollment this month. — Jordan Williams