The first results of the small-scale human trial of the vaccine
developed by the Gamaleya Institute in Moscow have shown it to be safe to use, according to a report released Sunday by RIA.
MOSCOW Russia (Agencies) – A Russian institute developing one of the country’s potential coronavirus vaccines is waiting for the final stage of testing on a small group of the general public in mid-August, the RIA news agency said Monday, citing the institute’s director.
Globally, only two of the 19 experimental COVID-19 vaccines for human testing are in Phase III trials – one by Sinopharm of China and one by AstraZeneca and Oxford University. Sinovac Biotech in China will become the third later this month.
The first results from the small-scale human trial of the vaccine developed by the Gamaleya Institute in Moscow have shown it to be safe for use, according to a report released Sunday by RIA.
“I hope that, around August 14-15, the small amount of vaccine we can produce will enter public circulation,” said Alexander Ginsburg, director of the institute.
That will be equivalent to a Phase III trial because the people who receive the vaccine will remain under supervision, RIA reported, citing Ginsburg.
Phase I and Phase II trials typically review the safety of a drug before it enters Phase III trials that test its effectiveness in a larger group of volunteers.
The Gamaleya Institute’s human trials of the vaccine began June 18, when nine volunteers received one dose, and nine others tested the possibility of a booster dose.
The group experienced no significant side effects and should be discharged from the hospital by Wednesday, RIA reported Sunday, citing the director of Sechenov University in Moscow, where the trial was conducted.
“The data currently available … show that volunteers have developed an immune response to the coronavirus vaccine,” said the Defense Ministry, which is involved in the trials, RIA said Monday. Another 20 volunteers received the vaccine at a military hospital on June 23.
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