Russia announced that it is ready with a Covid-19 or what it termed the Sputnik V, and planning to to undertake mass production in the next two months before giving it to its citizens. But the decision has sent shock waves among virologists who could not lay their hands on any data related to the vaccine trials.
Sputnik V claimed to be created by Russia had entered into the human trials on June 17 that included 76 patients and then went into the second phase. But as of now, Gamaleya Institute in Moscow has not released any of the safety or immunity data from these trial studies.
But Russian President Vladimir Putin said, "I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks."
Scott Gottlieb, who is a former Food and Drug Administration Commissioner (FDA) warned people about trusting Kremlin's claims that it had created a viable vaccine, saying that "I wouldn't take it, certainly not outside of a clinical trial right now."
Concerns Raised in Australia
An Australian Professor Damian Purcell, a University of Melbourne virologist and laboratory head at the Doherty Institute also expressed his concerns and noted that the third phase trials of Sputnik V on humans really inform countries whether a vaccine candidate is safe or not in the long run.
He told Gizmodo Australia that the data from phase three trial is what was presented to the regulatory agencies, which then accessed the data to determine whether further studies are required or "whether it is at that point safe to move forward into large-scale deployment, as a licensed vaccine."
Australia's regulatory body is the Therapeutic Goods Administration (TGA). The first phase of a vaccine trial is conducted to look for the side effects of the treatment, while the phase two trial actually determines the best dose of the vaccine candidate. Without proper data from the Russian authorities about the trials, the vaccine will be hard to sell elsewhere.
Prof Purcell said that not every vaccine is "100 percent safe," for example in some cases, "People who are immunocompromised or, you know, extremely young or extremely old. Perhaps what Russia is saying is that the benefit will outweigh what would be a very great risk of deploying this vaccine."
When a vaccine is presented in Australia, it happens after safety checks and pre-approval by two major international bodies, which are FDA and Europe's European Medicines Agency. As per Prof Purcell, these international agencies definitely require data from the phase three trial before coming to a conclusion.
He also clarified that in Australia, Sputnik V would find it "extremely difficult" to receive an approved deployment. "We have standards that require long term safety, that only comes through phase three testing, " he added.
No Data, No Vaccine
After the announcement about the vaccine production by Russia and Putin's claim that his own daughter had received the supposed vaccine, Daniel Salmon, the director of the Institute for Vaccine Safety at Johns Hopkins University, told The New York Times, "I think it's really scary. It's really risky."
Along with Dr. Salmon, other experts also expressed their worries and said that Russia has taken a dangerous step by jumping ahead of the so-called phase three human trials. Natalie Dean, a biostatistician and infectious disease expert at the University of Florida has earlier warned against rushing the vaccine-approval process. Now, she said the timing of Russia's announcement makes it "very unlikely that they have sufficient data about the efficacy of the product."
A New York City-based virologist John Moore at Weill Cornell Medical College told The New York Times that Russia doesn't have a Coronavirus vaccine, Putin is "just making a political statement."
The Russian institute has put on its website on Tuesday, August 11 that a phase three trial would begin on Wednesday, August 12 that will include over 2,000 people in Russia as well as the United Arab Emirates, Saudi Arabia, Mexico, and Brazil.
Apart from the Russian vaccine, there are other COVID-19 vaccines that are currently in the phase three trial, including Moderna. Unlike Russia, these trials are much larger as they include 30,000 volunteers apiece.
While talking about the Russian vaccine, former FDA Commissioner Gottlieb said, "It appears that it's only been tested in several hundred patients at most. In some reports, it's been in as few as a hundred patients." He added that at this time it is not clear, "How efficacious the Russian vaccine is going to be."