Russia may start phase III trial of Covid-19 vaccine in mid-August
A Russian institute developing one of the country’s potential coronavirus vaccines hopes to start its final stage testing in a small section of the general public in mid-August, the RIA news agency cited the institute’s director as saying on Monday.
Globally, of 19 experimental COVID-19 vaccines in human trials, only two are in final Phase III trials — one by China’s Sinopharm and another by AstraZeneca and the University of Oxford.
China’s Sinovac Biotech is set to become the third later this month. Early results from the first small-scale human trial of the vaccine developed by the Gamaleya Institute in Moscow has shown it to be safe for use, according to a separate RIA report on Sunday. “Around 14-15 August, I hope, the small amount of vaccine that we should be able to produce will enter public circulation,” Alexander Ginsburg, the institute’s director, was quoted as saying.
This will be equivalent to a Phase III trial, since people getting the vaccine will remain under supervision, RIA reported, citing Ginsburg. Phase I and Phase II trials typically test the safety of a drug before it enters Phase III trials that test its efficacy on a bigger group of volunteers.
Human trials of the Gamaleya Institute’s vaccine began on June 18, with nine volunteers receiving one dose, and another nine testing the prospective booster dose. The group did not experience any significant side effects and is due to be released from hospital on Wednesday, RIA reported on Sunday, citing a director at the Sechenov University in Moscow where the trial took place.
“Data currently available... shows the volunteers to have developed an immune response to the coronavirus vaccine,” the defence ministry, involved in the trials, was cited by RIA as saying on Monday.
Another 20 volunteers were administered the vaccine at a military hospital on June 23.