Russia announced it’s sending a coronavirus vaccine into mass production just two months after it first entered human trials. It’s raised the eyebrows of the world’s health authorities and Australia’s own body will need to take a long, hard look at this proposed solution to the world’s woes.
Russian President Vladimir Putin has said a new COVID-19 vaccine, called Sputnik V after the country’s satellite program, will enter mass production in September. It’s then expected to be delivered to the Russian population by October.
Sputnik V first entered human trials on June 17 using 76 patients and has since finished the second phase too. To this date, the researchers undertaking the study in Moscow’s Gamaleya Institute have not released any of the safety or immunity data from these studies.
“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” Putin said, adding his own daughter had received the supposed vaccine.
While it completed the first two phases of trials, it has not yet completed the crucial third phase, prompting concerns from health experts around the globe.
In early August, the World Health Organisation (WHO) cautioned any news of vaccines, which had yet to complete the full set of trials to determine efficacy and safety.
“Sometimes individual researchers claim they have found something, which is of course, as such, great news,” WHO spokesman Christian Lindmeier said, admitting WHO had not been notified of Russia’s intentions to deploy the vaccine immediately.
“But between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference.”
Many of the world’s regulatory health authorities require that a new vaccine has undertaken all the phases of trials in order to determine the potential short and long-term effects of the vaccine. With phrase three trials not yet completed and no scientific papers presented, its future in Australia looks shaky at best.
Sputnik V will have a hard time being introduced to Australia
Professor Damian Purcell, a University of Melbourne virologist and laboratory head at the Doherty Institute, said third phase human trials really inform countries whether a vaccine candidate is safe to use in the long run.
“Phase three data is really what is then presented to the regulatory agencies. The regulatory agencies then assess that and will determine whether further studies are needed, or whether it is at that point safe to move forward into larger scale deployment, as a licensed vaccine,” Professor Purcell told Gizmodo Australia in a phone call.
In Australia, that regulatory body is the Therapeutic Goods Administration (TGA). While the first phase looks for adverse effects in a small group of participants — think rashes, headaches or passing out — phase two works to determine the best dose of the vaccine candidate. It’s in phase three, where up to 3,000 participants can be involved, that determines the risk-benefit balance it could provide.
“I think it’s going to be interesting to watch things like this because you know it’s a bold move and one that wouldn’t happen in the US, Australia or Europe.”
Without that data, Russia’s proposed solution will be a hard sell locally.
“Not every vaccine is 100 per cent safe, for example in some instances, people who are immunocompromised or, you know, extremely young or extremely old,” Professor Purcell said.
“Perhaps what Russia is saying is that the benefit will outweigh what would be a very great risk of deploying this vaccine.
“Even in the U.S. and other jurisdictions, there are methods about our emergency use authorisations that can also shortcut wider deployment of vaccines so it’s all about the risk versus benefit.”
Usually when a vaccine is presented to Australia, it comes with safety assessments and has already been approved by the two major international regulatory bodies — the U.S. Food & Drug Administration and the European Medicines Agency.
These bodies, Professor Purcell said, would absolutely require phase three data in order to make a determination.
“This particular vaccine would find it extremely difficult to find an approved deployment in Australia,” Professor Purcell said.
“We have standards that require long term safety, that only comes through phase three testing.”
It’s something the federal Department of Health has confirmed is an important step in order to understand the veracity of claims made about it. The department said it was unaware of the results or status of the first and second phases of Sputnik V’s trials.
“We note the World Health Organisation’s concerns that this candidate has not gone through all the necessary trials and tests before being licensed for rollout,” a health department spokesperson told Gizmodo Australia.
“The Department of Health requires robust, published scientific data and analysis before delivering any endorsement of a vaccine candidate. This is a critical part of the scientific process. We continue to follow our rigorous regulatory procedures in Australia to ensure that vaccine candidates are effective and safe for use.”
It suggests that even if Russia was interested in sharing its vaccine hopes with the world, a lot more of the data would need to be released in order for it to ever see the light of day in Australia.
Australia has other options in the race for a vaccine
The good news is that Sputnik V is not our only hope right now.
In an address to the National Press Club on Wednesday, CSIRO boss Dr Larry Marshall admitted he was optimistic about the science agency’s chances of creating a vaccine.
“There’s two ways to deal with this — you can keep your powder dry and get it done and tweet about it once you’ve done it and people are getting vaccines or you can blow your trumpet now and hope you can deliver later,” Dr Marshall said.
“I think the Australia way is to shut up and do it and you can shout about it from the rooftops once you’ve succeeded.”
— Brett Mason (@BrettMasonNews) August 12, 2020
The CSIRO first entered pre-clinical trials in early April on two possible vaccine candidates — one from U.S. pharmaceutical company Inovio and a promising Oxford University option.
The team is in the final stages of testing and is expected to present their findings in the coming months.
Still, the Russian vaccine, if it proves to be as capable as Putin promises it is, has steered out far ahead of its competitors in the vaccine race.
“I think it’s going to be interesting to watch things like this because you know it’s a bold move and one that wouldn’t happen in the US, Australia or Europe,” Professor Purcell said.
“Failed vaccines inform greatly about about where you need to make changes for safety.
“I’m hoping that it is safe but if it’s not safe, that’s a very bad outcome for those individuals who receive that vaccine but it will be potentially beneficial to other manufacturers and developers if that information is shared fully with the world so that we can adapt our vaccination designs and manufacturing platforms to overcome those failures.”