Alexander Gintsburg, director of the Gamaleya Institute that produced the Sputnik V vaccine, told Reuters that the pace of its development was necessary in the “wartime” conditions of a pandemic, but that no corners were being cut.
Russia has moved forward with its potential COVID-19 vaccine at full speed with mass public vaccinations alongside the main human trial, raising concern among some observers that it was prioritizing national prestige over sound science and safety.
“People are dying like during a war,” Gintsburg said, holding a glass model of a coronavirus in his hand. “But this fast pace is not synonymous, as some media have suggested, with cutting corners. No way.”
Sitting in his wood-paneled office at the institute in Moscow, Gintsburg said his team had a tight deadline to produce a vaccine, but all guidelines had been followed to test the safety and efficacy of Sputnik V.
The plan to publish interim results based on the first 42 days of volunteer monitoring means that Russia has a high probability of becoming the first country in the world to announce any data from an end-stage trial, which is known as Phase III. .
The first of the 5,000 volunteers was vaccinated on September 9, which means that interim results could be published sometime after October 21. Russia’s sovereign wealth fund, which has invested in the launch of the vaccine, has said it expects the interim results to be released. in October or November.
PUBLIC INTEREST
A number of Western developers are conducting final stage tests that have been running for over 42 days now, but have not released any interim results.
Drug makers have said they would wait until they had enough infections to get a reliable reading of the data before publication, rather than assigning a specific date.
Gintsburg said there was a public interest argument to share the interim results after 42 days, as they would show the general trend in the data.
“For me, for example, it’s too short. But for people who are interested in how things are going, it’s already too long.”
Gintsburg said the volunteers would be monitored for 180 days after the last of 40,000 participants were vaccinated. Six months later, his team planned to tally the final results and then publish them in an international journal.
The results of their early-stage trials were peer-reviewed and published in The Lancet.
In parallel with the trial, Russia began vaccinating members of the general public deemed high-risk on Sept. 8, another unconventional move by Moscow in the race for a vaccine.
So far about 400 people have been vaccinated, according to the Health Ministry. They undergo a less rigorous medical examination than the trial volunteers, although they can submit data on their health after inoculation via an online platform.
A government source told Reuters that the interim results of the Phase III trial would likely inform a decision on whether to expand this mass inoculation campaign, starting with people over 60.
RUSSIAN ROULETTE
Gintsburg said that so far no serious side effects had been reported during the phase III trial, while minor side effects were expected to occur in just 14% to 15% of volunteers. A quarter of the participants receive a placebo.
He also defended early registration of the vaccine for public use, saying it was the most ethical approach.
“The choice was between giving people the opportunity to protect themselves or letting them play roulette with this deadly infection.”
He also said Russia was aiming for the vaccine to be roughly 75% more effective than a placebo, which is above the 50% threshold for COVID-19 vaccines set by the US Food and Drug Administration.
Gintsburg said having 40,000 test participants meant the test would be effective even with low levels of COVID-19 transmission in the Russian capital.
“It guarantees that even with a low infection rate, we would still have statistically significant data.”
Moscow registered 642 new COVID-19 cases on the day the trial began. The infection rate has risen since then, with 2,217 new cases on Monday, although it is still well below the peak of around 6,000 daily infections in the capital in early May.
Other vaccine manufacturers have launched massive trials in countries such as Brazil, South Africa and the United States, looking for places where the disease is still widespread after the epidemic subsided from its peak in Europe.
Russia also plans to conduct tests in several countries, including Belarus, Brazil and India.
IMPOSSIBLE AND ANTIETIC
Drug makers are also committed to ensuring that their larger clinical trials include diverse groups of volunteers in terms of race, ethnicity, gender, age, and other factors.
Russia is setting Phase III age quotas to ensure a sufficient number of elderly participants, Gintsburg said, but no other special groups are being formed. More than a fifth of those vaccinated in the trial so far have been over 50, he said.
The rate of transmission among trial participants affects when many vaccine manufacturers plan to release interim results, as they need to record a certain number of COVID-19 infections before the first data can be shared.
British drugmaker AstraZeneca launched a phase III trial for its vaccine in May and has yet to reveal any trends.
US pharmaceutical giant Pfizer, which is developing a vaccine with German partner BioNTech, and US vaccine maker Moderna began testing in late July. Neither have made preliminary disclosures yet.
BioNTech has said that it may have data for a regulatory filing in late October or early November.
In a bid to speed up the search process for a vaccine, Britain plans to conduct trials in which volunteers deliberately become infected with COVID-19.
Gintsburg said that this type of trial was impossible in Russia and considered it unethical: “We were surprised by the news.”
This story was published from a news agency feed with no changes to the text. Only the title has been changed.
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