New Delhi (NVI): The first Phase 3 clinical trial of a coronavirus vaccine in the United States has begun. The vaccine, known as mRNA-1273, is developed by the biotechnology company Moderna and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH).
The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19, according to media reports.
Volunteers will receive either two 100 microgram injections of the vaccine or a placebo about 28 days apart. Investigators and participants will not know who has received the vaccine.
Moderna is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial.
Results from a Phase 1 trial of the vaccine published earlier this month in the New England Journal of Medicine found it induced immune responses in all of the volunteers and was generally safe. It had mild side effects, including fatigue, chills, headache, muscle pain, pain at the injection site. Moderna’s phase 2 testing is still ongoing.
A phase 3 trial is usually a drug or vaccine’s final test be it can be sold to the public. Phases 1 and 2, which typically involve giving the drug to smaller groups of volunteers, aim to show that a vaccine candidate generates an antibody response and is generally safe.
Phase 3 trials test a vaccine’s safety and efficacy on a larger number of people across multiple locations.
The Moderna/NIH vaccine is one of 25 in clinical trials around the world, according to the World Health Organization.
According to Johns Hopkins University’s tally of cases in the United States, there are nearly 4.3 million confirmed cases of coronavirus in the country and more than 1,48,935 people have died.
-CHK
