An investigational vaccine developed by the drug maker Moderna and the National Institute of Allergy and Infectious Diseases began Phase 3 trials on Monday, becoming the first candidate to reach that step in testing.
About 30,000 adult volunteers will enroll in the trial, according to CNN, which added that the first patient was dosed at a site in Savannah, Georgia. A test group will receive two injections of 100 micrograms from the candidate while a control group receives a placebo, both approximately four weeks apart, the network noted.
“We are pleased to have started the Phase 3 COVE study,” Moderna CEO Stephane Bancel said in a statement. “We appreciate the efforts of so many inside and outside the company to take us to this important milestone. We are indebted to the participants and researchers who are now beginning the work of the COVE study. We hope that this trial will demonstrate the potential of our vaccine to prevent COVID-19, so that we can overcome this pandemic. “
Based on data published in the New England Journal of Medicine, the above tests induced immune responses in all volunteers. Mild side effects included chills, headaches, muscle pain, and fatigue, but the vaccine was generally safe.
Several drug manufacturers, including Moderna, are receiving support from the federal government through their Operation Warp Speed program, and the company announced Sunday that the Advanced Biomedical Research and Development Authority has provided an additional $ 472 million for the Phase 3 study. and further development, for a total of $ 955 million so far.
The World Health Organization lists around 25 potential vaccines in clinical trials worldwide. Phase 1 of the trials generally looks at whether a drug induces an immune response in a small number of people, while a Phase 2 trial extends the study to people with characteristics similar to those of the intended vaccine recipients. Phase 3 trials generally involve thousands of subjects and tests of safety and efficacy.
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