Russian President Vladimir Putin says that a coronavirus vaccine developed in the country has been registered for use and one of his daughters has already been inoculated.
Speaking at a government meeting on Tuesday, Putin said that the vaccine has proven efficient during tests and offers a lasting immunity from the coronavirus.
The announcement comes a month after the National Cyber Security Centre warned hackers linked to the Russian intelligence agencies are targeting British scientists seeking to develop a coronavirus vaccine.
The vaccine, developed at the Gamaleya Research Institute, has been registered before undergoing Phase 3 trials - when thousands are involved in tests that normally last for months.
Experts have urged caution over Russia’s coronavirus vaccine claim, saying they have seen no evidence that suggests it is safe and effective.
Scientists in the UK warn that the release of a vaccine that is not safe could cause extreme damage and worsen the current situation.
Danny Altmann, professor of immunology at Imperial College London, said there are many vaccines in development around the world and there is an interest in it all being truly open. He added: “While information on the vast majority of the vaccines and trial protocols in the world have been made available, there seems to be rather little detail thus far on the Russian candidates, except for a protocol on Clintrials.gov, which seemed to suggest an adenovirus vector. “The bar is necessarily set very high for criteria that must be satisfied for approval after Phase 3 clinical trials. “The collateral damage from 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.”
How are vaccines developed?
Phase 1 - Different doses are given to a small number of healthy volunteers to get some idea of the appropriate dose and to ensure that the material is safe. The main purpose here is to identify the right dose for the next step in the testing process as well as rule out any major safety problems.
Phase 2 - The vaccine is administered to a larger number of people, often between 100 or 200 but sometimes in the thousands. At this stage, researchers evaluate whether the vaccine can produce a consistent immune response and monitor for potential side effects.
Phase 3 - The vaccine can be tested to measure how well it protects against natural infection. These studies often include tens of thousands of healthy volunteers to prove that the vaccine prevents the disease and identify rare problems or side effects that only show up in larger population or sample sizes. The speed of the Phase 3 trials is also dependent on the rate of infection and the R value - if infection rates are very low then the trial could drag on for months on end.
But Putin emphasised that the vaccine underwent the necessary tests.
He added that one of his two daughters has received a shot of the vaccine and is feeling well.
Russian authorities have said that medical workers, teachers and other risk groups will be the first to be inoculated.
Russia is the first country to register a coronavirus vaccine, although the World Health Organisation still lists the Gamaleya Research Institute in Phase 1.
The World Health Organisation has said all vaccine candidates should go through full stages of testing before being rolled out.
Dr Michael Head, senior research fellow in global health, University of Southampton, said: “It is unclear precisely what is actually happening with the Russian vaccine. “At this point in time, there is no data on the Russian-led vaccine for the global health community to scrutinise. “There have been lessons learned from previous vaccine roll-outs, that were usurped by anti-vaccination activists and population health has greatly suffered.”
Dr Ayfer Ali, a specialist in drug research at Warwick Business School, said the problem with fast approvals is that potential adverse effects which are rare but serious are likely to be missed.