A group of leading scientists have questioned the ‘highly improbable’ results of Russia’s Covid-19 vaccine tests.
The 19 scientists, who work at prominent universities across Europe and the US, have cosigned an open letter highlighting their concerns over a series of duplications in antibody response results from early-stage Sputnik V vaccine trials.
Enrico Bucci, a biology professor at Temple University in the US, told the Moscow Times that the repeated appearance of data in the results published in The Lancet on Friday is ‘highly improbable’.
‘It’s like if you throw a dice and you get exactly the same sequence of numbers several times,’ he said.
Andrea Cossarizza, professor of pathology and immunology at the University of Modena, said the values look like they’d been ‘photoshopped’.
A group of leading scientists have cosigned an open letter highlighting their concerns over a series of inconsistencies they see in Russia’s Covid-19 vaccine results, which were published by leading medical journal The Lancet last Friday
Bucci said he saw ‘strange patterns’ in the data, which shows the number of antibodies produced by patients in different groups.
Russia tested six different formulations of Sputnik V on 76 patients. The 76 were split into four groups of nine and two groups of 20. Each group was given a different vaccine.
Bucci said that it was ‘highly improbable’ to see so many duplicate values across the four groups of nine patients in particular.
He said that in other vaccine trials, like those published by Oxford University, China and the US, there were no unexplained duplications.
The letter calls on the authors of the study to publish the raw data, which was not included with the original article.
Bucci said the omission of the data is ‘not tolerable for such important research in such an important journal’.
‘There might be an error, there might an explanation, there might be fraud. We just don’t know’, he added. ‘This is a request for clarification. It’s not an allegation of anything.’
Cossarizza also called the data ‘very strange’, adding that it looked like it had been ‘photoshopped’.
Russian President Vladimir Putin attends a meeting with winners of the Leaders of Russia contest for managers via video conference at his residence outside Moscow today
‘It’s too similar and too unlikely from a statistical point of view’, Cossarizza said while discussing a series of charts that were published alongside the results in the Lancet.
Cossarizza said it was surprising that the mistake was not noticed before the results were published.
Denis Logunov, who is the lead author of the article and in charge of developing Sputnik V, refuted the allegations and said there were no errors in the information published by The Lancet.
Logunov told Russian publication Meduza he wouldn’t reply directly to the authors of the open letter but that he would engage with The Lancet’s editorial board if required.
The Lancet told MailOnline in a written statement: ‘We encourage scientific debate on papers we have published, and are aware of the open letter on the Russia vaccine trial by Logunov et al.
‘We have shared the letter directly with the authors and encouraged them to engage in the scientific discussion.’
Sputnik V became the first vaccine in the world to be approved for mass use last month, with Vladimir Putin suggesting nationwide injections could be available from as early as October.
The move sparked uproar in the scientific community because there was no evidence to prove the vaccine worked or was safe.
And it later emerged that British spies had detected a Russian cyber attack on Oxford University scientists who are developing an almost identical vaccine, raising fears that Moscow had tried to steal research from the UK.
But results from two early clinical trials done in Moscow and published Friday in the prestigious Lancet, initially indicated the vaccine was safe and effective.
The Russian scientists behind the studies said the jab stimulated an immune response in all inoculated participants and did not cause any serious health issues.
Production of antibodies seen in the patients suggests the vaccine was able to prepare the body to be able to fend off Covid-19.
Independent Western scientists said the results were ‘somewhat reassuring’ but warned the trials were too small and narrow to justify injecting millions of Russians.
Just 76 people were involved in the study, only half of whom were actually jabbed, and volunteers were all healthy and mostly in their 20s and 30s.
WHAT DO WE KNOW ABOUT RUSSIA’S VACCINE?
The Russian jab is a type called a viral vector vaccine, meaning it uses another virus to carry the immune agent – damaged parts of the real coronavirus, which can trigger a reaction but not cause an infection – into human cells.
Putin’s vaccine uses an adenovirus, a type of virus best known for causing the common cold, which has been weakened so it cannot trigger illness.
Oxford University’s vaccine candidate uses the same method.
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.