Phase 3 clinical trial of another drug begins in U.S.
Russia plans to register a coronavirus vaccine by August 10-12, clearing the way for what its backers say would be the world’s first official approval of inoculation against the epidemic.
The drug, developed by Moscow’s Gamaleya Institute and the Russian Direct Investment Fund, may be approved for civilian use within three to seven days of registration by regulators, according to a person familiar with the process, who pleaded anonymity because the information isn’t public.
The Gamaleya vaccine is expected to get conditional registration in August, meaning it will still need to conduct trials on another 1,600 people, Deputy Prime Minister Tatyana Golikova said in a televised meeting of officials with President Vladimir Putin yesterday. Production should begin in September, she said.
“The key requirements for a vaccine are its proven effectiveness and safety, so everything needs to be done very carefully and accurately,” Putin said at the end of the meeting. “Our confidence in the vaccine must be absolute.” Earlier, state news service, RIA Novosti, reported the vaccine might be approved August 15-16. The Gamaleya Institute and RDIF declined to comment.
While the vaccine has been touted by its developers as safe and potentially the first to reach the public, the data hasn’t been published and the speed with which developers are moving has raised questions. In other countries Gamaleya is scheduled to begin Phase 3 trials next week in Russia, Saudi Arabia and the United Arab Emirates.
Russia has over 800,000 confirmed cases of COVID-19, the fourth-most in the world. While the number of new daily infections is down by more than half from the peak, Putin said at the meeting that some regions moved too fast when reopening after a nationwide lockdown ended in May.
“The situation remains difficult and can, as they say, swing in any direction,” Putin said. “There is no reason for complacency, to relax, to forget about the recommendations of doctors.”
Similarly, Phase 3 clinical trial of a vaccine against COVID-19 has begun in the United States. The trial of the investigational vaccine, that was developed by the biotechnology company, Moderna, and the United States National Institute of Allergy and Infectious Diseases, a subsidiary of the National Institutes of Health (NIH), is to be conducted at nearly 100 U.S. research sites, according to Moderna. The first patient was dosed at a site in Savannah, Georgia.
About 30,000 adult volunteers are to be enrolled for the trial that will evaluate the safety of the Moderna/NIH vaccine and whether it can prevent symptomatic COVID-19 after two doses, among other outcomes. Volunteers will receive either two 100-microgram injections of the vaccine or placebo about 28 days apart. Investigators and participants will not know who has received the vaccine.
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 and pain at the injection site.
According to the US Centers for Disease Control and Prevention (CDC), a Phase 1 study typically 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 given to people who have characteristics -such as age and physical health – similar to those for whom the new vaccine is intended. In Phase 3, the vaccine is given to thousands of people and tested for efficacy and again for safety.