The best Russian researcher behind the Sputnik V coronavirus vaccine, protected by the pre-test vaccine, said he planned to publish data from clinical trials earlier – so early, in fact, the data are unlikely to be interpreted.
Alexander Ginzburg, head of the Gamalea Institute, which developed Sputnik V, outlined his thoughts on the vaccine and the pandemic in an interview with Reuters on Tuesday.
“People die just like in war,” Ginzburg said as he sat in his wood-paneled office in Moscow, holding a crystalline model of a coronavirus. “But this fast-paced pace is not synonymous – as some media suggest – with cut corners. No way.”
Russian President Vladimir Putin announced in August that the country had issued the world’s first regulatory approval for a pandemic coronavirus vaccine, although it had not even begun phase III clinical trials, which typically test the safety and efficacy of the vaccine in tens of thousands of people. The approval drew quick criticism from health experts, who saw it as a dangerous political ploy to make Russia appear to be ahead in the race to develop a vaccine.
But Ginzburg defended the approval of ethical considerations, saying: “The choice was between giving people the opportunity to defend themselves or allowing them to play roulette with this deadly infection.”
Since then, the health ministry has given doses of Sputnik V to about 400 members of the general public who did not participate in a clinical trial, according to Reuters. Initially, government figures suggested that millions of people could be vaccinated.
Meanwhile, Russian researchers are continuing with standard phase III trials. On September 9, the researchers vaccinated the first 5,000 participants in the study and planned to vaccinate more than 40,000 in total. Ginzburg said the researchers would provide data from these participants only after six weeks (42 days) of observation. This would mean that the first data will be available by October 21, and Gintsburg expects it to be published in late October or November.
Such early data are unlikely to be informative or even interpretable, given the small number of participants and the short follow-up. There are several vaccines worldwide that are currently in phase III, including some that began in June and July. None of the researchers and companies conducting these trials have yet published data, and most of their progress is measured by cases of COVID-19 in participants (both vaccinated and placebo), and not at any time.
For example, Pfizer and its partner BioNTech began a phase III trial of a COVID-19 vaccine in July. The companies said they would perform a first interim analysis when 32 people tested positive for the virus. Moderna, which also launched a phase III trial in July, said it would conduct an interim analysis when the participants were 53. AstraZeneca, which started a phase III vaccine trial with the University of Oxford before July, is waiting for 75 cases before to make an intermediate analysis.
If the intermediate tests are extremely positive, vaccine developers could release the data and even stop the tests earlier. To do this, they will need to see that most of the cases of COVID-19 in the study participants are those of the placebo group, not the vaccinated group, which suggests that the vaccine is protected against disease. But the data is more likely to be more difficult to interpret at first. And releasing “promising” but not convincing data can easily lead to over-interpretation.
Stopping the tests earlier is even more risky. Once a trial is over, it is very difficult to assess how well a vaccine works. There are no longer control samples or placebo groups for comparison.
However, President Donald Trump insists that interim analyzes be carried out as soon as possible and that the vaccine be distributed to the public by November 3, election day. Experts say the vaccine is highly unlikely to be ready in the United States before the election. In addition, the Food and Drug Administration is working to tighten the requirements for authorizing each vaccine based on early data for interim analyzes (although the White House may repeal these stricter guidelines).
But according to Ginzburg’s schedule, Russia may have data for Sputnik V in time for November 3.
“For me, for example, it’s too short,” Ginzburg said of the 42-day analysis. “But for people who are interested in how things are going, it’s been too long.”