EXPERT REACTION: Russia approves COVID-19 vaccine
It has been reported overnight that Russia has approved a COVID-19 vaccine known as Sputnik V for widespread use, after less than two months of human testing. Russian President Vladimir Putin announced the Russian regulator had approved the vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, despite the drug yet to complete any large scale stage 3 trials. Australian experts respond.
Organisation/s: Australian Science Media Centre, Flinders University, RMIT University, University of Technology Sydney (UTS), Griffith University, Australian Catholic University
These comments have been collated by the Science Media Centre to provide a variety of expert perspectives on this issue. Feel free to use these quotes in your stories. Views expressed are the personal opinions of the experts named. They do not represent the views of the SMC or any other organisation unless specifically stated.
While the recent announcements are potentially very exciting, the information supplied to date on the vaccine, and the trial results that support its use, have been lacking.
Vaccine development is certainly progressing at a rate faster than ever seen, however it is important that we do not compromise any of the usual checks or balances that support progression, initially from pre clinical to clinical trials, and then through each of the phases of clinical trials. While this may seem to be an arduous process, it exists for a reason such that for a vaccine to be approved, we can be completely confident of both its safety and efficacy. This data may have been generated for this vaccine candidate, however until it is available for review it is impossible to be certain that this vaccine is likely to be both safe and effective.
Since the pandemic began, we have seen many preliminary and unsubstantiated reports of drug as well as vaccine efficacy, and while the need for therapies and vaccines for a pathogen has never been greater, to inform our decision to approve or utilise any of these products, we still need robust evidence to be able to make these decisions. And again for this vaccine, I have not yet seen this evidence.
I hope the data required to enable robust assessment of this vaccine candidate will follow soon, however until that happens my recommendation would be to remain somewhat sceptical.
It is positive to see multiple COVID-19 vaccines steadily advancing through human trials, although no vaccine has yet to definitely show efficacy against human disease. A key challenge is at what stage a vaccine should be authorised for more general use.
The key point is that a general marketing authorisation that would allow a vaccine to be used indiscriminately across entire populations of hundreds of millions of people should never be issued without first confirming safety and effectiveness in each specific population in which it is going to be used. This would generally require a large Phase 3 clinical trial with completely open recruitment, i.e. no exclusions, or a series of large Phase 2 trials looking at each specific population.
This is not to say that a vaccine should not be used more widely prior to completion of Phase 3 trials, just that a marketing authorisation should not be issued until after the Phase 3 trials. The other mechanisms that could be used in advance would be emergency use authorisation, which specifies the exact circumstances in which a vaccine can be legitimately used outside of a formal clinical trial, such as to target specific outbreaks or to provide access to medical staff at the front line. The benefit of emergency use authorisation is that it can be easily suspended at any time if, for example, excess adverse events were to be seen. It can also come with conditions that require follow up of those who receive the vaccine, even though they are not in an official trial, thereby allowing the effects of the vaccine to be better tracked.
It is still not clear to what extent the Russian authorisation is open-ended or contains such limitations. For example, does it allow the use of the Sputnik vaccine in children or immune-suppressed individuals in which it could be highly dangerous? We can only hope that Russian authorities have the sense to impose tight restrictions on their vaccine’s use, as otherwise, this vaccine could cause serious harm, not just to those who receive the vaccine, but to COVID-19 vaccine programs more generally. Certainly politics should have no role in the vaccine approval process in any country, as this would be playing with fire as experience with some historic vaccine programs has shown.
Professor Magdalena Plebanski is Director of the Biomedical and Health Innovation Enabling Capability Platform and Head of the Translational Immunology and Nanotechnology Program at RMIT University. She is a leading expert in vaccine development.
It is difficult to know without further information how safe or effective this new vaccination strategy is. It is based on other currently leading strategies worldwide using the adenovirus, so that is a plus. But concerns remain.
For example, 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? Rolling out a vaccine to everybody without additional tests is risky.
Moreover, it’s one thing to find antibodies present in blood, it’s another thing completely to know that they protect against the virus in the body. In-depth immunological studies on what exactly on the virus these antibodies recognize, and once they recognize the virus, how they signal the rest of the immune system to eliminate it - as this can be in very safe or less safe ways - could also provide some reassurance. It is unclear if such data exists.
Last, but not least, the way vaccines are produced and distributed also needs to conform to safety standards. It is hoped there will be good checks in place to ensure quality control.
Only time will tell if the approach taken is correct.
In the normal course of events, phase 3 studies are when a drug is given to a large number of people and the effectiveness and safety evaluated. In some ways the approach reported to be taken in Russia is to have a phase 3 trial on the whole population.
If there are safety issues then there is the potential for a lot of people to be affected, and if the vaccination does work or doesn’t work as well as other options, then you miss the opportunity to use the best vaccination in the population.
However, if the vaccination proves to be successful, I’m sure that people will ask why other countries didn’t also take this approach.
Russia has announced the approval of a COVID-19 vaccine based only on responses in a limited number of individuals and before larger phase 3 trials have been undertaken. Phase 1 clinical trials provide some indication as to whether a vaccine is tolerated and if any significant adverse effects might arise from its use. Phase 3 trials involve a larger number of participants and determine the efficacy (ability to confer protection) of a vaccine. These trials also help to highlight adverse effects which might only be seen in selected cohorts involved in these larger trials (e.g. more pronounced reaction in individuals who suffer from other medical conditions).
Russia’s move to large scale manufacture before phase 3 trials have been completed has been described as reckless and unethical and may represent a mixture of anxiety and desperation to control an increasing number of cases and deaths caused by SARS-CoV-2. Conversely, marketing the vaccine as Sputnik V does suggest a propaganda exercise at a time when results are being reported for other vaccine candidates, which are in more advanced stages of development such as the Oxford vaccine.
President Putin has indicated the Russian vaccine is safe following inoculation of one of his daughters, but this is akin to President Trump claiming hydroxychloroquine is safe because of personal use and despite warnings from the FDA. Clinical trial data for the Russian vaccine is not available for scrutiny so it is difficult to verify claims of safety or possible adverse effects and suspect more harm will come from this approach than progress to control SARS-CoV-2.
The issue is nothing is published or reported, in terms of immunity and safety, so no one can actually tell what’s going on. More importantly, without a phase 3 trial, it's impossible to know that it even gives any protection against COVID-19, let alone how long protection will last.
This is vaccine nationalism at play (the Sputnik V name says it all) 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.
It is neither simple nor fair to make comments (whether it is positive or negative) on any therapeutic candidates without knowing the precise details. However, based on the timeframe available for the vaccine candidate being produced by Russia scientists and the general requirement for therapeutic goods evaluation in Australia, one would expect that this vaccine ‘candidate’ from Gamaleya Institute is unlikely to have gone through the same level of safety, and more importantly (effectiveness) evaluations, that are needed in Australia.
Many vaccine candidates (being produced against SARS-CoV-2 at the moment) are 'subunit' vaccines (a small part of real SARS-CoV-2). With current available biotechnology capacity available globally, all of these vaccine candidates are likely to be safe to human and will not cause diseases. However, safe does not equal effective. A carefully planned and rigorous phase III clinical trial will be paramount to demonstrate the potential effectiveness of any vaccine candidate to offer protection against SARS-CoV-2 infection (or at least blocking the development of COVID-19 diseases).
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