Dr. Anthony Fauci said results from early-stage clinical testing show the vaccine candidate is safe and produces an immune response, which supports the start of a Phase III clinical trial. Fauci is the director of the National Institute of Allergy and Infectious Diseases (NIAID) and a member of the White House Coronavirus Task Force.
The Phase III trial is called the COVE (Coronavirus Efficacy) study. The investigational vaccine directs the body’s cells to express the SARS-CoV-2 spike protein to elicit a broad immune response.
“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” Fauci said in a news release.
The primary goal of the Phase III study is to prevent symptomatic COVID-19, with secondary goals including preventing severe COVID-19 (patients who need to be hospitalized) and preventing the infection of SARS-CoV-2, the virus that causes COVID-19.
In the randomized, placebo-controlled trial, volunteers will either get two intramuscular injections about 28 days apart of 100 micrograms of mRNA-1273 or two shots of a saline placebo.
The vaccine candidate will be tested at 89 U.S. clinical research sites and is expected to enroll approximately 30,000 adult volunteers who do not have the virus.
The NIH Coronavirus Prevention Network (CoVPN) will participate in conducting the trial. The network is said to bring together expertise from existing NIAID-supported clinical research networks, and 24 of the 89 clinical research sites are part of the CoVPN.
“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,” Fauci said. The vaccine was co-developed by Massachusetts-based Moderna and the NIAID, part of the National Institutes of Health. Funding for the trial comes from NIAID and the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
The vaccine efficacy trial is said to be the first implemented under Operation Warp Speed, a multiagency collaboration led by HHS that aims to speed along the development, manufacturing and distribution of medical countermeasures for COVID-19.
“Thanks to President Trump’s leadership and the hard work of American scientists, the investigational vaccine developed by NIH and Moderna has reached this Phase 3 trial at record pace,” said Alex Azar, HHS Secretary. “Operation Warp Speed is supporting a portfolio of vaccines like the NIH/Moderna candidate so that, if the results of clinical trials meet FDA’s gold standard, these products can reach Americans without a day’s delay.”
Moderna said it remains on track to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.