Moderna, NIH Begin Phase 3 Trial for Their COVID-19 Vaccine

The National Institutes of Health (NIH) and Moderna announced this morning they have started a Phase 3 clinical trial, called the COVE (Coronavirus Efficacy) study, for their investigational vaccine for coronavirus 2019 (COVID-19).

The vaccine, known as mRNA-1273, was co-developed by NIH and Moderna. The trial will be conducted at US sites, and is expected to enroll approximately 30000 adults who do not have the virus.

“Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial," National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, MD said. "This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”

In a wide-ranging interview he gave last Friday, Fauci spoke about a number of COVID-19 issues including vaccines.

Moderna is a biotechnology company based in Cambridge, Massachusetts and is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial.

The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.

Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.

Yesterday, Moderna announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support its vaccine initiative. Both BARDA of the US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response and NIAID are providing funding for the trial.

The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a multi-agency collaboration led by HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19.

NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P). SARS-CoV-2 is the virus that causes COVID-19; the spike protein on its surface facilitates entry into a cell. Moderna’s mRNA-1273 uses the mRNA (messenger RNA) delivery platform to encode for an S-2P immunogen. The investigational vaccine directs the body’s cells to express the spike protein to elicit a broad immune response.

A Phase 1 clinical trial found the candidate vaccine to be safe, generally well-tolerated, and able to induce antibodies with high levels of virus-neutralizing activity. Moderna initiated Phase 2 testing of the vaccine in May 2020.