Scientists began Phase 1 trials of the first experimental vaccine for COVID-19 in mid-March. The vaccine, called mRNA-1273, is being co-developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and the Cambridge, Mass.-based biotech company Moderna (NSDQ:MRNA). Forty-eight healthy adults ages 18 to 55 were divided into three groups, each of which received different doses of the vaccine — 25, 100, or 250 µg. Participants received two injections, 28 days apart.
The two-dose vaccine is designed to prompt the immune system to produce antibodies against a portion of the coronavirus “spike” protein, which the virus uses to bind to and enter human cells. The vaccine uses messenger RNA (mRNA), a molecule critical for the virus to produce protein, according to the National Institutes of Health (NIH).
A larger Phase 2 clinical trial began in late May, followed by the Phase 3 trial, which launched in July with a goal of enrolling 30,000 adults. Moderna is conducting the Phase 3 trial in conjunction with NIAID and the Biomedical Advanced Research and Development Authority (BARDA). The primary endpoint will be the prevention of symptomatic COVID-19, with key secondary endpoints including prevention of severe COVID-19 (defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 (the virus causing COVID-19) regardless of symptomology. Primary efficacy analysis will be based on the number of participants with symptomatic COVID-19 disease, according to NIH.
As of September 18, the Phase 3 trial had enrolled 25,976 participants and 11,879 had received their second vaccination. Moderna and competitor Pfizer took the unusual step of making their Phase 3 study protocols public before the study was completed, possibly due to the political pressure to produce a COVID-19 vaccine before the November 2020 election. Moderna’s protocol may be found here. Other companies have since followed suit.
Moderna is also collaborating with PPD for drug development, laboratory and lifecycle management services, while the company last month announced a collaboration for large-scale, commercial fill-finish manufacturing of its vaccine candidate with Catalent (NYSE:CTLT). Moderna said in July that it remains on track to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021.