President Vladimir Putin says Russia has become the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.
The development paves the way for the mass inoculation of the Russian population, even as the final stage of clinical trials to test safety and efficacy continue.
The speed at which Russia is moving to roll out its vaccine highlights its determination to win the global race for an effective product but has stirred concerns that it may be putting national prestige before sound science and safety.
Speaking at a government meeting on state television, Mr Putin said the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.
“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” Mr Putin said.
He said he hoped the country would soon start mass-producing the vaccine.
Its approval by the health ministry foreshadows the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.
Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
The WHO checking Russia’s vaccine claims
The World Health Organisation and Russian health authorities are discussing the process for possible WHO pre-qualification for its newly approved COVID-19 vaccine, a WHO spokesman said.
“We are in close contact with Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine, but again pre-qualification of any vaccine includes the rigorous review and assessment of all required safety and efficacy data,” WHO spokesman Tarik Jasarevic told a UN briefing in Geneva, referring to clinical trials.
Regulators around the world have insisted that the rush to develop COVID-19 vaccines will not compromise safety.
But recent surveys show growing public distrust in governments’ efforts to rapidly produce such a vaccine.
Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated soon after the vaccine’s approval, a source told Reuters last month.
More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic.
At least four are in final Phase III human trials, according to WHO data.