The modified adenovirus-strain candidate did not reach phase 3 assessment, and was criticized by the WHO for being rushed through assessment.
A Russian healthcare regulator has approved the first vaccine for coronavirus 2019 (COVID-19), according to an announcement from President Vladimir Putin on Tuesday morning.
The vaccine, from Gamaleya Institute, was not previously assessed in any phase 3 testing—raising global agency concerns that the country is skipping very necessary stages of safety and efficacy research prior to administering the vaccine to at-risk populations.
The vaccine uses a pair of genetically-modified adenovirus strains that typically cause mild colds in humans. Its immunity-seeking approach is similar to the Oxford University/AstraZeneca vaccine candidate, currently undergoing phase 3 assessment.
In a cabinet meeting Tuesday, Putin praised the vaccine’s development for the sake of the country, “and generally for the whole world,” implying a belief the Gamaleya product could have widespread benefit.
“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Putin said.
Russia Minister of Health, Mikhail Murashko, previously stated the country will begin a mass vaccination campaign in the fall, according to The New York Times, and said on Tuesday that with teachers and medical workers would be prioritized for vaccination in August.
Last week, the World Health Organization (WHO) stressed to Russia that standard means of testing vaccine safety and efficacy should not be deviated from in the pursuit of a COVID-19 candidate. The WHO currently tracks 30 vaccines out of 165-plus in development which have reached human trial assessment.
Gamaleya’s vaccine, the very first to be regulated by a national agency, is not one of them.