Russia has been advancing its potential COVID-19 vaccine to maximum speed, with mass public vaccinations alongside the main human trial, raising concerns among some observers that it was prioritizing national prestige over solid science and security.
“People are dying like in a war,” Gintsburg said, holding a crystal model of a coronavirus in his hand. “But this accelerated pace is not synonymous, as some media have suggested, with corner cuts. No way. ”
Sitting in his paneled office at the Moscow institute, Gintsburg said his team had been given a tight deadline to produce a vaccine, but all guidelines for testing the safety and efficacy of Sputnik V had been followed.
The plan to publish interim results based on the first 42 days of volunteer follow-up means that Russia has a strong chance of becoming the first in the world to report data from a final phase, or phase three, trial.
The first of 5,000 volunteers was vaccinated on September 9, which means provisional results could be released sometime after October 21. Russia’s sovereign wealth fund, which has invested in the vaccine deployment, said it expects interim results to be released in October. or November.
Several Western developers are running endgame trials that have already lasted for more than 42 days but have not released any interim results.
The drugmakers said they would wait until they have 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 interim results after 42 days, as they would show the general trend of the data.
“For me, for example, it’s too short. But for people who care about how things are going, it’s already too long. ”
Gintsburg said the volunteers would be followed for 180 days after the last of 40,000 participants were vaccinated. Six months later, his team plans to count the final results and publish them in an international journal.
The results of their preliminary trials have been peer reviewed and published in The Lancet.
In parallel with the trial, Russia on September 8 began inoculating members of the general public who were considered high risk, another unconventional Moscow initiative in the vaccine race.
About 400 people have been vaccinated so far, according to the health ministry. They undergo a less rigorous medical examination than test volunteers, although they can submit data about their health after inoculation through an online platform.
A government source told Reuters that the results of the interim phase three trial would likely inform a decision to expand this mass inoculation campaign, starting with people over 60.
Gintsburg said no serious side effects had been reported so far during the phase three trial, while minor and anticipated side effects had occurred in only 14 to 15% of the volunteers. A quarter of participants are given a placebo.
He also advocated early registration of the vaccine for public use, saying it was the most ethical approach.
“The choice was between giving people the option to protect themselves or letting them play roulette with this deadly infection.”
He also said Russia is aiming for the vaccine to be around 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 participants in the trial meant the trial would be effective even with low levels of COVID-19 transmission in the Russian capital.
“This ensures that even with a low infection rate, we would still have statistically significant data.”
Moscow registered 642 new cases of COVID-19 on the day the trial began. The infection rate has since increased, 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 makers have launched mass trials in countries like Brazil, South Africa and the United States, looking for places where the disease is still rampant after the outbreak has recovered. heyday in Europe.
Russia also plans to test in several countries, including Belarus, Brazil and India.
The drugmakers 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 in the process of setting phase three quotas by age to ensure a sufficient number of elderly participants, Gintsburg said, but no further special groups have been formed. More than a fifth of those vaccinated in the trial to date were 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 register a number of COVID-19 infections before early data can be shared.
British drug maker AstraZeneca launched a phase three trial for its vaccine in May and has yet to reveal any trends.
US pharmaceutical giant Pfizer, which is developing a vaccine with its German partner BioNTech, and US vaccine maker Moderna both began trials at the end of July. Neither has made any preliminary disclosures yet.
BioNTech said it may have data for a regulatory filing by late October or early November.
In a bid to speed up the process of finding a vaccine, Britain is considering hosting trials where volunteers are deliberately infected with COVID-19.
Gintsburg said this type of trial was impossible in Russia and considered unethical: “We were surprised by the news. “