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.
- Vladimir Putin revealed the vaccine had already been administered to one of his daughters
- The President said he hoped Russia would soon start mass producing it
- But the World Health Organization has urged caution over the vaccine, which was developed by Moscow’s Gamaleya Institute
Russia said the development paved the way for the mass inoculation of the population, even as the final stage of clinical trials to test safety and efficacy continued.
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 it may be putting national prestige before sound science and safety.
Asked on Monday about Russia’s plans to register the Gamaleya vaccine, the World Health Organization urged caution.
“There are established practices and there are guidelines out,” WHO spokesman Christian Lindmeier said at the United Nations in Geneva.
“Any vaccine … [or medicine] for this purpose should be, of course, going through all the various trials and tests before being licensed for rollout.
“Sometimes, individual researchers claim they have found something, which is of course, as such, great news.
“But between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference.”
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 foreshadowed 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.
Regulators around the world have insisted 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.
Tony Cunningham, a key adviser to the Australian Federal Government on the COVID-19 vaccine and founding director of virus research at Sydney’s Westmead Institute, said the vaccine community knew “little” about the Russian candidate.
He said a vaccine had never been produced within that six-month timeframe, which he described as “extraordinarily fast”.
“We don’t know much about it,” Professor Cunningham said.
“And it doesn’t seem to be adequate time to properly assess the efficacy and safety of the product in large numbers of people.
“But we would be very interested to see the data [on the Russian vaccine] when it is published.”
US Health and Human Services Secretary Alex Azar says it is more important to have a safe and effective vaccine against the coronavirus than to be the first to produce a vaccine.
Mr Azar, on a visit to Taiwan, was asked what he thought of Russia’s announcement that it had become the first country to register a vaccine against the virus.
He replied: “The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective for the American people and the people of the world.”
He said it’s important to have transparent data on the vaccine to prove its safety and efficacy, and noted that the US has six vaccines in development under the Operation Warp Speed initiative.
Russian health workers treating COVID-19 patients would 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.
More to come.