The investigational vaccine was developed by the Modern biotechnology company and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial will take place at nearly 100 research sites in the U.S., according to Moderna. The first patient was dosed at a site in Savannah, Georgia.
The trial is expected to enroll about 30,000 adult volunteers and assess the safety of the Modern / NIH vaccine and whether it can prevent symptomatic Covid-19 after two doses, among other results. The volunteers will receive two injections of 100 micrograms of the vaccine or a placebo 28 days apart. The researchers and participants will not know who received the vaccine.
Results from a Phase 1 trial of the vaccine published earlier this month in the New England Journal of Medicine found that it induced immune responses in all volunteers and was generally safe. She had mild side effects such as fatigue, chills, headache, muscle pain, pain at the injection site.
A Phase 1 study generally studies a small number of people and focuses on whether a vaccine is safe and elicits an immune response. In Phase 2, the clinical study is expanded and the vaccine is administered to people who have characteristics, such as age and physical health, similar to those for which the new vaccine is intended, according to the Centers for Disease Control and Prevention. of U.S. Diseases In Phase 3, the vaccine is administered to thousands of people and its efficacy and safety are tested again.
The Modern / NIH vaccine is one of 25 clinical trials worldwide, according to the World Health Organization.
Moderna is one of several companies that received support from Operation Warp Speed, the federal government’s Covid-19 vaccine program. On Sunday, Moderna announced that it had received an additional $ 472 million from the Advanced Biomedical Research and Development Authority for the Phase 3 study and development of its Covid-19 vaccine, bringing the total to $ 955 million.
According to the Johns Hopkins University case count in the United States, there are more than 4.2 million confirmed cases of coronavirus in the United States, and at least 146,935 people have died.
