Enlarge /. MOSCOW, RUSSIA – AUGUST 14, 2020: Alexander Gintsburg, director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Ministry of Health, which makes a COVID-19 vaccine.
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A top Russian researcher behind the Sputnik V coronavirus vaccine defended the vaccine before the tests were completed, saying he plans to release data from clinical trials early – so early that the data is unlikely to be interpretable.
Alexander Gintsburg, head of the Gamaleya Institute that developed Sputnik V, outlined his thoughts on the vaccine and the pandemic in an interview with Reuters published on Tuesday.
"People die as if they were going to war," said Gintsburg as he sat in his wood-paneled office in Moscow holding a crystal model of a coronavirus in his hand. “But that fast pace doesn't mean, as some media outlets have suggested, corners being trimmed. Under no circumstance."
Russian President Vladimir Putin announced in August that the country had granted the world's first regulatory approval for a vaccine against the pandemic coronavirus, despite not even having started Phase III clinical trials demonstrating the safety and effectiveness of a vaccine Tens of thousands of people will be tested. The approval was quickly criticized by health experts who viewed it as a dangerous political ploy to create the impression that Russia was ahead of the pack in the race to develop a vaccine.
But Gintsburg defended the consent on ethical grounds, saying, "The choice was to allow people to protect themselves or to let them play roulette with this deadly infection."
According to Reuters, the Department of Health has since given doses of Sputnik V to around 400 members of the public who did not participate in a clinical trial. Initially, government figures suggested that millions of people could be vaccinated.
Russian researchers have now carried out the standard phase III studies. On September 9, the researchers vaccinated the first 5,000 study participants and planned to vaccinate more than 40,000 in total. Gintsburg said researchers will publish data from these participants after just six weeks (42 days) of monitoring. That would mean the first data will be in by October 21, and Gintsburg expects to be released in late October or November.
Given the small number of participants and the short follow-up, it is unlikely that such early data would be informative or even interpretable. Several vaccines are currently in Phase III trials worldwide, including some that began in June and July. None of the researchers and companies conducting these studies have yet to publish data, and most of their progress will be based on COVID-19 cases in participants (both those who were vaccinated and those who were given a placebo) than in measured at an arbitrary point in time.
Pfizer and its partner BioNTech started a phase III study with a COVID-19 vaccine in July. The companies have announced that they will conduct an initial interim analysis if 32 people in the study tested positive for the virus. Moderna, which also started a Phase III study in July, said it would conduct an interim analysis when there are 53 cases among study participants. AstraZeneca, which started a Phase III study of a vaccine at Oxford University before July, is waiting for 75 cases before an interim analysis is carried out.
If interim analyzes are extremely positive, vaccine developers could publish the data and even stop studies prematurely. To do this, they would have to find that most COVID-19 cases among study participants were more likely to be in the placebo group than the vaccinated group, suggesting that the vaccine is disease-resistant. However, it is more likely that the data will be harder to interpret early on. Publication of “promising” but inconclusive data can easily lead to over-interpretation.
Ending attempts early is even more risky. Once a study is over, it is very difficult to gauge exactly how well a vaccine is working. There are no longer any study controls or placebo groups for comparison.
Still, President Donald Trump has urged that interim analyzes be carried out as soon as possible and that a vaccine be made available to the public by November 3, election day. Experts say it is extremely unlikely that a vaccine will be ready in the US before the elections. Additionally, the Food and Drug Administration has been working to tighten requirements for vaccine approval based on early data for interim analysis (though the White House may be able to override these stricter guidelines).
However, according to Gintsburg's schedule, Russia could have data on Sputnik V in time for November 3rd.
"For me, for example, it's too short," said Gintsburg of the 42-day analysis. "But it's already too long for people interested in how things are going."