A screenshot taken from modernatx.com on July 14, 2020 shows the graphics and title of U.S. biotech company Moderna’s latest release “Moderna’s Work on a Potential Vaccine Against COVIOD-19.” (Xinhua)
Special: Battle Against Novel Coronavirus
U.S. biotech company Moderna plans to begin its final phase of testing for its COVID-19 vaccine on July 27, according to details posted Tuesday on government database clinicaltrials.gov.
The Cambridge, Massachusetts-based biotech company is the first to announce a start date for phase 3 study in the United States.
The study aims to valuate the efficacy, safety, and immunogenicity of the mRNA-1273 SARS-CoV-2 vaccine in adults aged 18 years and older, according to information on the website, which is maintained by the U.S. National Library of Medicine of the National Institutes of Health.
Researchers plan to enroll 30,000 adult participants, including people whose locations or circumstances put them at high-risk of infection. Participants will either receive the vaccine or a placebo.
The experimental group will be injected with 100 micrograms of the vaccine on day one and again on day 29. The placebo group will be injected with two doses of matching placebo on the same dates.
Researchers will evaluate whether the participants develop COVID-19 14 days after they get their second dose.
The participants will be followed for two years after receiving their second dose.
The study will be conducted at 87 locations across the United States.
Moderna Chief Medical Officer Tal Zaks said earlier that the company is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate its vaccine’s ability to significantly reduce the risk of COVID-19 disease.
Moderna was the first company in the United States to launch phase 1 study of COVID-19 vaccine in March in Seattle.
In May, the company announced positive interim clinical data of the vaccine, saying it was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies.
According to Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, the U.S. government will fund and conduct key studies on three experimental coronavirus vaccines.
The phase 3 trials will begin with one by Moderna in July, then an Oxford/AstraZeneca vaccine in August and one by Johnson & Johnson in September, according to Fauci.