Vladimir Putin was savaged by scientists today for his ‘reckless and foolish’ claim that Russia has developed the world’s first effective coronavirus vaccine.
Putin says the vaccine offers ‘sustainable immunity’ against Covid-19 and says his daughter has already been given the jab, with Russia eyeing up mass injections as soon as October – causing widespread alarm because it has not yet passed clinical trials.
One scientist blasted Putin’s move as ‘unethical’ because an ‘improperly tested vaccine’ could have ‘disastrous’ effects on public health, while others warned that there is ‘no data’ to tell whether the Russian vaccine is effective.
Another expert warned that ‘the damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably’.
While small trials can show whether a vaccine is likely to be safe, the usually months-long Phase III tests which measure its effectiveness have not yet taken place, while the WHO has not yet granted approval for the jab.
Nonetheless, Russia claims that 20 countries have already ordered a billion doses of the vaccine, which has been named Sputnik V after the former Soviet space satellites.
The Kremlin and its state-controlled media have touted Russian scientists as global pioneers and turned the vaccine race into a matter of national prestige – leading to fears that safety could be compromised for the sake of Russia’s image.
Britain, the US and Canada claimed last month that Russia had tried to hack into Western vaccine research in its quest to win the race.
Vladimir Putin claims Russia has a coronavirus vaccine and says one of his daughters has already been injected – prompting widespread scepticism
Russia claims the jab sped through early trials on monkeys and humans, known as Phase I and II trials, and was safe and effective at producing antibodies against Covid-19.
But the scientists behind the vaccine have released no scientific data from the trials, meaning the results likely haven’t been scrutinised by independent experts.
The Russian jab has also not been put through rigorous Phase 3 trials, which are considered the only way to ensure vaccines are safe and actually work.
During these tests, sometimes known as efficacy trials, scientists give the vaccine to tens of thousands of people and wait to see how many become infected.
They then compare their results with volunteers who caught the infection after receiving a placebo.
Scientists say this final phase is the only way to statistically prove a vaccine prevents infection.
And because it’s a much larger testing group, the trials can also pick up subtle side effects that may only affect a small percentage of people.
These rare side effects can become dangerous when vaccines are scaled up for entire populations of tens of millions of people.
Professor Peter Openshaw, an experimental medicine expert at Imperial College London, said today: ‘It’s important to emphasise that this vaccine has not been approved or even fully tested. The Russian health authorities are discussing the process for possible WHO pre-qualification as an approved vaccine.
‘There are currently 19 vaccines that have been tested for the ability to generate antibody (Phase I), another 11 that have passed this stage and gone on to expended testing (Phase II), eight at Phase III and one vaccine approved for limited use.
‘So far, it is reported that the Russian vaccine has undergone less than two months of human testing in a total of 38 people. It appears to be at Phase I or II. According to news sources, there is a Phase III trial of 1,600 people planned. That’s not actually very large for a vaccine trial and would assume a high rate of infection in the volunteers.’
Professor Openshaw suggested that the type of vaccine the Russians have produced would be likely to cause mild side effects such as fever, headache and tiredness.
Speaking at a government meeting today, Putin claimed that the vaccine has undergone proper testing and been proven safe to use.
‘I would like to repeat that it has passed all the necessary tests,’ he said. ‘The most important thing is to ensure full safety of using the vaccine and its efficiency.’
The Russian leader added that one of his two adult daughters has received two shots of the vaccine and is feeling well. ‘She has taken part in the experiment,’ Putin said.
Putin said his daughter had a temperature of 100F (38C) on the day of the first vaccine injection, which then dropped to 99F (37C) on the following day.
After the second shot she again had a slight increase in temperature, but then it was all over, Putin said.
He did not reveal whether it was his daughter Maria or Katerina who received the vaccine. However, reports in Russia said it was the younger Katerina who was inoculated.
Further reports last month claimed that some of Russia’s business and political elite had been given access to experimental vaccines as long ago as April.
The Russian president said he hoped the country would soon start mass producing the vaccine.
-Dailymail