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MOSCOW: President Putin said on Tuesday that Russia had become the world's first country to grant regulatory approval to a COVID-19 vaccine after but two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.

The vaccine still has got 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 place it into production by the top of the year.

Russian doctors treating COVID-19 patients are going to be offered the prospect of volunteering to be vaccinated within 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'll allow the economy, which has been battered by fallout from the virus, to return to full capacity.

Kirill Dmitriev, head of Russia's sovereign wealth fund, hailed the event as a historic "Sputnik moment", like the Soviet Union's 1957 launch of Sputnik 1, the world's first satellite.

The vaccine are going to 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 ultimate stages of clinical trials to check safety and efficacy are over, has worried some scientists, who fear Moscow could also be putting national prestige before safety.

Speaking at a government meeting on state television, Putin dismissed those concerns, saying the vaccine, developed by Moscow's Gamaleya Institute, was safe which it had even been administered to at least one of his daughters.

"I know that it works quite effectively, forms strong immunity, and that i repeat, it's passed all the needed checks," said Putin .

He said he hoped production would start soon.

PHASE III TRIAL

The vaccine's approval by the health ministry comes before the beginning of a bigger trial involving thousands of participants, commonly referred to as a phase III clinical trial trial.

Such trials, which require a particular rate of participants catching the virus to watch the vaccine's 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 world's top drugmakers in Russia in the week urged the health ministry to postpone approval until that final trial had been successfully completed.

In a letter to the ministry, it said there have been high risks related to registering a drug before that happened.

"It is during this phase that the most evidence of a vaccine's efficacy is collected, also as information on adverse reactions that would appear in certain groups of patients: people with weakened immunity, people with concomitant diseases then forth," it said.

Some international experts have also questioned the speed at which Russia approved its vaccine.

"Normally you would like an outsized number of individuals to be tested before you approve a vaccine," said Peter Kremsner from the University Hospital in Tuebingen, currently testing CureVac's COVID-19 vaccine in clinical trials.

"In that respect, i feel it's reckless to try to to that (approve it) if many people haven't already been tested."

Duncan Matthews, a professor of property law at Queen Mary University of London, said news of a possible COVID-19 vaccine was to be welcomed, "but safety must be the priority".

"The U.S. Food and Drug Administration (FDA) and therefore the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use and that we got to see evidence that Russia is adopting an equally prudent approach," Matthews said in an emailed comment.

More than 100 possible vaccines are being developed round the world to undertake to prevent the coronavirus pandemic. a minimum of four are in final phase III clinical trial human trials, consistent with World Health Organization (WHO) data.

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