President Vladimir Putin said on Tuesday that Russia had 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 vaccine still has to complete final trials, raising concerns among some experts at the speed of its approval, but the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of the year.
The World Health Organization (WHO) said on Tuesday that any stamp of approval on a Covid-19 vaccine candidate would require a rigorous safety data review.
"We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO pre-qualification of the vaccine," the United Nations health agency's spokesman Tarik Jasarevic told reporters in Geneva at an online press briefing.
"Pre-qualification of any vaccine includes the rigorous review and assessment of all the required safety and efficacy data."
Russian President Vladimir Putin claims Russia has successfully created the first vaccine against COVID-19
"We are encouraged by the speed by which several candidate vaccines have been developing and as we have been always saying, we hope some of these vaccines will prove to be safe and efficient," said Jasarevic.
"Accelerating progress does not mean compromising on safety," he said.
Volunteers wanted for vaccine
Russian health workers treating Covid-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks, a source told Reuters last month.
Regulatory approval paves the way for the mass inoculation of the Russian population and authorities hope it will allow the economy, which has been battered by fallout from the virus, to return to full capacity.
Kirill Dmitriev, head of Russias sovereign wealth fund, hailed the development as a historic “Sputnik moment”, comparable to the Soviet Unions 1957 launch of Sputnik 1, the worlds first satellite.
The vaccine will be marketed under the name Sputnik V on foreign markets, he said. State media have trumpeted the news.
But the speed at which Russia has moved, approving a vaccine before the final stages of clinical trials to test safety and efficacy are over, has worried some scientists, who fear Moscow may be putting national prestige before safety.
Putin has declared victory in the race to develop a coronavirus vaccine. Russia will make it available to the public on Jan 1, 2021.
He says one of his daughters already took it and was fine: "a temperature of 38 on the first day, 37 on the second and that was it." pic.twitter.com/RPw7DPgw2R
— max seddon (@maxseddon) August 11, 2020
Speaking at a government meeting on state television, Putin dismissed those concerns, saying the vaccine, developed by Moscows 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,” said Putin.
He said he hoped mass production would start soon.
'Reckless and foolish'
The vaccines approval by the health ministry comes before 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 vaccines effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the worlds top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.
In a letter to tRead More – Source