‘Yet to see any robust data’: Russia’s vaccine claims in doubt

Despite having yet to pass large-scale phase 3 clinical trials, Russia’s Ministry of Health issued a registration certificate for the approval of Gam-COVID-Vac – dubbed Sputnik V – on Tuesday 11 August.
 
The vaccine candidate, developed by Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, completed Phase 1 and 2 trials on 1 August, according to the official Sputnik V website. It has reportedly been tested on 76 volunteers.
 
‘All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine induced strong antibody and cellular immune response,’ the website states.
 
Russian President Vladimir Putin backed the claims during a cabinet meeting broadcast on state television, saying the vaccine had even been administered to one of his daughters.
 
‘She’s feeling well and has a high number of antibodies,’ he said.
 
‘I know that it works quite effectively, forms strong immunity and, I repeat, it has passed all the needed checks.’
 
But with the vaccine yet to be tested on thousands of volunteers, experts have raised concerns about its safety and efficacy.
 
Paul Griffin, Director of Infectious Diseases at Mater Health Services and Associate Professor of Medicine at the University of Queensland, said while it has potential to be ‘really positive news’, he is concerned over the lack of transparency.
 
‘To have an approval in this sort of time frame does make me a bit sceptical,’ he told newsGP.
 
‘We’re yet to see any robust data to support not only its widespread use, but even its progression from pre-clinical to clinical trials.
 
‘With all the other lead candidates, we’ve seen that data come out, it’s been really informative and obviously supportive of progression. With this vaccine, we’re yet to see that.’
 
Neither has the World Health Organization (WHO).
 
Jarbas Barbosa, Assistant Director of the WHO’s regional branch, the Pan American Health Organization, said they had yet to receive enough information on Russia’s COVID-19 vaccine to evaluate it.
 
As with the COVID-19 vaccine developed by the University of Oxford and AstraZeneca, currently undergoing phase 3 trials, Sputnik V has been developed using an adenovirus.
 
A fragment of SARS-CoV-2 genetic material is inserted into an adenovirus vector, which then delivers the surface protein of the coronavirus into the body and triggers an immune response.
 
‘In order to ensure lasting immunity Russian scientists came up with a breakthrough idea to use two different types of adenovirus vectors (rAd26 and rAd5) for the first and second vaccination, boosting the effect of the vaccine,’ the Sputnik V website states.
 
The vaccine is administered in two doses, 21 days apart, and is said to provide up to two years’ immunity against the coronavirus.
 
Russia’s Minister of Health Mikhail Murashko said on Tuesday that a mass vaccination campaign would soon be rolled out, starting with healthcare workers and teachers this month, with plans to extend its use more broadly in January 2021.
 
In the meantime, phase 3 clinical trials involving more than 2000 people in Russia, the United Arab Emirates, Saudi Arabia, Brazil and Mexico will commence on 12 August.
 
The lack of extensive trials means widely rolling out the vaccine is ‘risky’, according to Professor Magdalena Plebanski, a leading expert in vaccine development and Head of the Translational Immunology and Nanotechnology Program at RMIT University.
 
‘If the initial small trials were only done in healthy adults, how would this vaccine protect and affect older adults, who have a different immune system from younger adults? Or how could it affect potentially vulnerable groups with already overactive immune systems, such as people with a predisposition to asthma or other respiratory inflammatory diseases?,’ she said.
 
‘Moreover, it’s one thing to find antibodies present in blood, it’s another thing to know that they protect against the virus in the body.
 
‘In-depth immunological studies on what exactly on the virus these antibodies recognise, and once they recognise the virus, how they signal the rest of the immune system to eliminate it … could also provide some reassurance. It is unclear if such data exists.’ 


With the Russian vaccine yet to be tested on thousands of volunteers, experts have raised concerns about its safety and efficacy.

Russia has been hard hit by the pandemic, with close to 900,000 positive cases and 15,131 deaths.
 
Mass production of Sputnik V is slated for September.
 
While it is not usual practice for vaccines to move to this stage prior to phase 3 trials given the large investment, Associate Professor Griffin, who is running a number of COVID-19 vaccine studies – including Novavax – says this has become much more common in the COVID era.
 
‘One of the biggest ways we’re saving time with this whole process is a large number, if not the majority, of the lead candidates are actually scaling up manufacturing,’ he said. ‘In fact, even before we’ve got phase 1 data, let alone waiting for the phase 3 data,’ he said.
 
‘So once the data supports it, there’ll be millions of doses available for wider spread use.
 
‘In fact, if they’re commencing that now when … a number of the other lead candidates commenced that at the beginning of the year, then, in fact, even though they’re making the claims that we’re hearing today, [Russia] may not actually be all that far ahead of a number of the other candidates that we’ve heard a lot about.’
 
But while countries are scrambling to find a vaccine, experts have stressed the need to follow clinical protocols.
 
‘The thing about the phase 3 trials is that’s where we really want to see that the vaccine provides protection in a real world situation,’ Associate Griffin said.
 
‘The more people that have received a vaccine compared to those who received the placebo are protected from the infection, and to do that properly involves large numbers, which inherently means there’s a significant amount of time and logistics involved in those trials.
 
‘It is an arduous process for a good reason.
 
‘It’s by design that there are a number of very robust hurdles that need to be jumped through to make sure that at every step we’re very confident with both safety and efficacy before we progress to the next stage. That’s why we have phases of clinical trials and don’t just give products to people randomly.’
 
Professor Nigel McMillan, Director in Infectious Diseases and Immunology at Menzies Health Institute Queensland at Griffith University, believes Russia’s fast-tracked approval system is rather ‘vaccine nationalism at play’.
 
‘The Sputnik V name says it all,’ he said. 
 
‘And the danger here is that if there are issues going forward with this vaccine, in terms of efficacy or safety, it will put the entire vaccine effort in a very difficult position, as people will lose trust or hope that any vaccine will work.’  
 
Associate Professor Griffin agrees. If Russia’s claims turn out to be unsubstantiated, he says it could fuel anti-vaccination rhetoric and negatively impact uptake.  
 
‘Even if we had a vaccine that was fantastic, if the uptake is poor the vaccine still isn’t going to be our ticket back to normality,’ he said.
 
‘So if there are claims made – and this is a general statement about all these vaccines – that then aren’t substantiated, whether it be that it doesn’t work quite so well or, worse still, that the safety profile doesn’t support it, then I think that can set us back significantly.
 
‘So we need to start considering uptake and rollout already, and getting everyone to get the right message out there that there’ll be no vaccine that’ll be recommended unless safe and effective.
 
‘And when that time comes, the uptake will be the biggest determinant of how quickly we get back to our normal lives.’
 
But what if the vaccine is successful? Associate Professor says it is unlikely Australia would get access any time soon.
 
‘If they’re only starting to look at the scaling of manufacturing now, I can only presume that this is going to be something that’s prioritised within their own country,’ he said.
 
‘So I don’t think this is going to be the candidate that the world looks to necessarily to solve its problems.
 
‘We need to keep a healthy level of scepticism about this until we see the data to support it and, obviously, continue all the other programs that are progressing very well.’
 
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