Russia cuts size of coronavirus vaccine study, stops further enrolment

Topics Coronavirus | Russia

Representative image

Russia's Health Ministry agreed Wednesday to cut the size of a study of a domestically developed coronavirus vaccine and to stop the enrolment of volunteers.

The decision comes a week after developers said enrolment of study volunteers has slowed since Russia began giving out the Sputnik V vaccine while the late-stage study was still continuing. They also cited ethical concerns about giving a dummy shot to some of the volunteers. The study size was cut to about 31,000 from 40,000 participants.

Alexander Gintsburg, head of the Gamaleya Center, the state-run medical research institute that developed Sputnik V, said that many of those who received dummy shots had figured it out and gotten vaccinated. If large numbers of volunteers in the placebo group drop out, it could affect the results,

Svetlana Zavidova, executive director of Russia's Association of Clinical Trials Organizations, said.

They simply won't be able to gather (the necessary) statistics," she said. Russia has been widely criticized for giving Sputnik V regulatory approval in August after the vaccine only had been tested on a few dozen people. Two weeks later, the 40,000-volunteer study was announced.

Despite warnings to wait for the study's results, Russian authorities started offering it to people in risk groups such as medical workers and teachers within weeks of approval.

President Vladimir Putin, who has publicly hailed Sputnik V, ordered the Russian government this month to start a large-scale immunization campaign. By mid-December, over 150,000 people had been vaccinated, according to Gintsburg.

In a statement, the Health Ministry said that interim study data on the vaccine's safety and effectiveness was considered as part of the decision to reduce the study size.

The ministry said the study would continue and participants will be monitored for at least six more months.

Gintsburg had suggested giving the vaccine to all volunteers who received the placebo shot, but the ministry said there would be no unblinding of the study at this point. In other words, volunteers will not be told whether they received real or dummy vaccines.

Kirill Dmitriev, head of the Russian Direct Investment Fund that bankrolled Sputnik V, noted that U.S. drugmaker Johnson & Johnson recently reduced the size of its vaccine trial.

Sputnik V's developers have said data suggests the vaccine was 91% effective, a conclusion based on 78 coronavirus infections among nearly 23,000 participants. That's far fewer cases than Western drugmakers have accumulated during final testing before analyzing how well their candidate worked. Important demographic and other details from the study also have not been released.

Western vaccine developers have released much more information, while a lot about the Russian vaccine remains unknown at this point, said Ilya Yasny, head of scientific research at the Russian investment fund Inbio Ventures.

We don't have any data about the vaccine's proven effectiveness aside from what Gintsburg and the Russian Direct Investment Fund says, Yasny said.



Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel