Russia has become the first country in the world to approve a coronavirus vaccine after less than two months of human testing.
President Vladimir Putin has announced the jab was officially registered with the Russian Health Ministry after it brought about “stable” immunity “quite effectively”.
Putin added one of his two daughters received the vaccine and is doing well.
Russia’s deputy prime minister Tatyana Golikova has said vaccination will begin among medical staff in August, before being rolled out to the public as part of a mass campaign in early 2021.
Some experts, however, are wary about the lack of data demonstrating the jab’s efficacy.
One warned the “collateral damage” of introducing a “less than safe and effective” vaccine could exacerbate the world’s “current problems insurmountably”.
“This morning, for the first time in the world, a vaccine against the new coronavirus was registered”, Putin announced during a televised video conference call with government ministers on 11 August.
“I know it works quite effectively, forms strong immunity and, I repeat, it has passed all the needed checks.”
The president – who called the approval a “a very important step for the world” – added one of his daughters “did the inoculation herself” and developed just a mild fever.
Russia’s health minister Mikhail Murashko has stressed the jab’s registration is conditional and clinical trials into its effectiveness will continue while mass production is underway.
Regulatory approval of the vaccine, manufactured by Moscow’s Gamaleya Institute, comes several months before the clinical trials into its safety and efficacy were due to complete.
Russia is ‘essentially conducting a population level experiment’
The development of a vaccine typically takes years, with different study phases having to be completed.
Dr Adair David Richards from the University of Warwick previously argued “methods that can significantly shorten these phases can be considered desirable or even necessary if it is ethical to do so”.
Speaking of Russia’s coronavirus vaccine candidates, Professor Danny Altmann from Imperial College London said “there seems to be rather little detail”.
“The bar is necessarily set very high for criteria that must be satisfied for approval after phase 3 clinical trials,” he said.
“The collateral damage from [the] release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably.
“I hope these criteria have been followed. We are all in this together.”
Other experts have also expressed concern about a lack of information about the jab.
“It is unclear precisely what is actually happening with the Russian vaccine,” said Dr Michael Head from the University of Southampton.
“It is vital any vaccine roll-out has the confidence of the general public, and that there is good communication of the level of effectiveness and any likely side effects.
“At this point in time, there is no data on the Russian-led vaccine for the global health community to scrutinise.”
Professor Keith Neal from the University of Nottingham agreed, adding: “It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis and then there may be problems on data quality.”
One expert was slightly more optimistic, providing Russia delivers on its promise of safety,
“News of a potential [coronavirus] vaccine is to be welcomed but safety must be the priority,” said Professor Duncan Matthews from Queen Mary University of London.
“The US Food and Drug Administration and the European Medicines Agency have fast-track approval procedures for emergency humanitarian use, and we need to see evidence Russia is adopting an equally prudent approach.”
Dr Ayfer Ali, a specialist in drug research at Warwick Business School, worries accelerated vaccine approvals may miss side effects that are “rare but serious”.
“Another issue is missing potential antibody-dependent enhancement, which is a phenomenon where a vaccine is not protective enough to prevent the disease but instead allows the virus to enter the body more easily and worsen the disease the vaccine is supposed to protect against,” he said.
“When this happens at the population level, it can have devastating effects. That is one reason proper testing is paramount.
“Russia is essentially conducting a large population level experiment.”
Professor Eleanor Riley from the University of Edinburgh agreed, arguing the rapid approval of a coronavirus vaccine is not justified given the “effective public health measures to sustain this [pandemic] in the short to medium term”.
Vaccine ‘not a magic bullet’
A coronavirus vaccine has often been hailed a route back to normality after people all over the world have endured months of lockdown.
Some have stressed, however, a jab should not be rushed, warning “crises are not an excuse to lower standards”.
Kirill Dmitriev, head of Russia’s sovereign wealth fund, likened the search for a vaccine to the Soviet launch of the world’s first satellite in 1957.
Russia’s jab is known to be based on adapted strains of the adenovirus, which usually causes the common cold.
Vaccine hopes were previously raised after scientists from the University of Oxford produced a candidate that stimulated an immune response in an early-stage clinical trial.
At the time, experts praised the “exciting” results, but stressed “it is not the end of the road, far from it”.
“I’ll be amazed if we have a vaccine distributed in the next six months,” Dr Head told Yahoo UK in July.
“At Easter I said [maybe a jab will be ready in] 12 months. I still think that’s the earliest realistic estimate to have a vaccine available, manufactured and distributed.”
Professor James Naismith from the Rosalind Franklin Institute said at the time that a jab will not be available in the near future.
“Optimistically a vaccine campaign could be underway by the end of this year,” he told Yahoo UK. “More realistically sometime next year.”
Even if a vaccine is developed, it is unclear how long immunity may last.
“We can’t think of a vaccine as our magic bullet out of this,” Professor Michael Tildesley from the University of Warwick told Yahoo UK.