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A leading Russian researcher behind the Sputnik V coronavirus vaccine defended the use of the vaccine before testing was completed and said that he plans to publish the data from clinical trials sooner, in fact the data is unlikely to be interpretable. .
Alexander Gintsburg, director of the Gamaleya Institute that developed Sputnik V, laid out his thoughts on the vaccine and the pandemic in an interview with Reuters published on Tuesday.
“People are dying like during a war,” Gintsburg said as he sat in his wood-paneled office in Moscow, holding a glass model of a coronavirus. “But this fast pace is not synonymous, as some media have suggested, with cutting corners. No way.”
Russian President Vladimir Putin announced in August that the country had granted the world’s first regulatory approval for a pandemic coronavirus vaccine, even though it had not even started phase III clinical trials, which generally test safety and efficacy of a vaccine in tens of thousands of people. The approval drew swift criticism from health experts, who saw it as a dangerous political stunt to give the appearance that Russia was leading the race to develop a vaccine.
russian roulette
But Gintsburg defended the approval on ethical grounds, saying: “The choice was between giving people the opportunity to protect themselves or letting them play roulette with this deadly infection.”
Since then, the Health Ministry has administered doses of Sputnik V to about 400 members of the general public who are not enrolled in a clinical trial, according to Reuters. Initially, government figures had suggested that millions of people could be vaccinated.
Meanwhile, Russian researchers have gone ahead with standard phase III trials. On September 9, researchers vaccinated the first 5,000 trial participants and have planned to vaccinate more than 40,000 in all. Gintsburg said the researchers will release the data for those participants after just six weeks (42 days) of monitoring. That would mean the first data would be ready by October 21, and Gintsburg expects it to be released in late October or November.
These early data are unlikely to be informative or even interpretable, given the small group of participants and the short follow-up. Globally, there are several vaccines that are currently in Phase III trials, including some that began in June and July. None of the researchers and companies conducting those trials have yet released data, and most of their progress is measured by COVID-19 cases in participants (both those vaccinated and those who received a placebo) rather than an arbitrary moment.
Too short
For example, Pfizer and its partner BioNTech began a phase III trial of a COVID-19 vaccine in July. The companies have said they will conduct a first interim test when 32 people in the test test positive for the virus. Moderna, which also started a phase III trial in July, said it will conduct an interim analysis when there are 53 cases in the trial participants. AstraZeneca, which started a phase III trial of a vaccine with the University of Oxford even before July, is waiting for 75 cases before conducting an interim analysis.
If the interim tests are extremely positive, the vaccine developers might publish the data and even stop the trials early. To do that, they would need to see that the majority of COVID-19 cases in study participants were those in the placebo group rather than the vaccinated group, suggesting that the vaccine protects against the disease. But the data is more likely to be more difficult to interpret up front. And publishing “promising” but inconclusive data could easily lead to overinterpretation.
Stopping trials early is even more risky. Once a trial is over, it is very difficult to assess exactly how well a vaccine works. There are no longer any trial controls or placebo groups to compare.
Still, President Donald Trump has pushed for interim tests as soon as possible and for a vaccine to be released to the public by Election Day Nov. 3. Experts say that a vaccine is highly unlikely to be ready in the United States before the election. In addition, the Food and Drug Administration has worked to tighten the requirements for any vaccine to be licensed based on the first data for interim analysis (although the White House may override those stricter guidelines).
But according to the Gintsburg chronology, Russia could have data on Sputnik V in time for November 3.
“For me, for example, it’s too short,” Gintsburg said of the 42-day analysis. “But for people who are interested in how things are going, it is already too long.”
