Reports out of Israel now suggest that an Israel medical center has a branch in Moscow that is working on going on Gamaleya vaccine research. Although Vladimir Putin recently declared that the Gamaleya vaccine is complete, done, and authorized by health authorities, Phase 3 clinical trials, in addition to so-called “Expanded Use” studies, continue to assess the safety and efficacy of the drug. Israel’s Hadassah Medical Center’s Professor Zeev Rotstein reports via an interview on 103FM Radio that Hadassah’s clinic in Skolkovo, Moscow is engaged with the clinical trials in Russia. This information seems to potentially contradict the Russian declarations yesterday. What’s going on here?
The Facts out of Russian Media
TrialSite reported yesterday that Russia’s President Putin declared the Gamaleya vaccine was completed, deemed safe and effective, and now approved for mass inoculations by the Russian Health Ministry. Russian officials, reports the Times of Israel, suggested that large-scale production of the Gamaleya vaccine would commence in September with ensuring mass vaccination by October. Russia’s health organizations would start with at-risk members of society, such as healthcare workers, teachers, first responders, etc. TrialSite has been tracking the Gamaleya vaccine to the best of its ability and found it difficult to comprehend a major COVID-19 vaccine deemed completely safe and effective within a few months. But perhaps, TrialSite speculated, the Russians employed human challenge trials while bypassing Phase 3 trials? And now are treating what should be a Phase 3 trial as a Post-marketing surveillance study.
‘I’ll Tell You a Secret’
In a not so secretive moment, Professor Zeev Rotstein said, “I’ll tell you a secret,” noting that Hadassah hospital is involved in the clinical research on the new Russian vaccine. “It is being done in Moscow, in Skolkovo, at the Hadassah hospital there. We are first of all checking the safety level, it will take time.” This very statement, locked and loaded, triggered several scenarios and situations to consider.
Phase 3 Clinical Trials Underway
Now in a serious twist to the recent news which represents a forceful and clear declaration that the vaccine was done, complete and approved, Professor Rotstein emphasizes that actually, the studies are an ongoing action: that Phase 3 trials are continuing “as is customary in the Western world” suggesting in a simultaneous manner with the finalization of the vaccine, reports the Times of Israel.
In addition to customary Phase 3 Western-style clinical trials, the Gamaleya vaccine is now part of an “Expanded Use” program which is often used in the West to offer investigational drug access in scenarios and situations where it could make a difference to the patient—such as in serious or life-threatening situations.
Israeli Investigational Site in Moscow
Now a not so stealthy site, known as Hadassah Moscow, operated as a Russian medical center and research operation and in the ongoing support of the studies, according to Professor Rotstein. Rotstein claimed, reported the Times of Israel, the Russians are doing a good job there, although “They work differently from us, and we are adapting ourselves to them.” TrialSite found that Hadassah did enter into an agreement back in 2012 with the “European Medical Center (EMC) of Moscow, facilitating the exchange of knowledge and experience between clinical specialists in the two medical institutions.” Although several years old, this certainly evidences collaboration between Hadassah and Russian medical providers. And of course, there is the named site, Hadassah Moscow, the actual site Professor Rotstein refers to in the radio interview. It’s touted as the first medical center in Russia under the supervision of a foreign hospital—Israel’s Hadassah.
World Health Organization
The Times of Israel reported that the World Health Organization (WHO) was in contact with Russia about the vaccine. The Times of Israel article conveyed, “To secure a WHO stamp of approval on a COVID-19 vaccine candidate would require a rigorous safety data review.” Tarik Jasarevic from Geneva told the Israeli media, “We are in close contact with the Russian health authorities and discussions are ongoing with respect to possible WHO prequalification of the vaccine.”
Israel Position: Open-Minded
Yuli Edelstein, Health Minister for Israel, reported that Israel was interested in engaging with Russia about the claims and benefits of the Gamaleya authorized and approved vaccine, noting, “If we are convinced it’s a genuine product then we will try to enter into negotiations.”
If Professor Rotstein’s account is accurate, then it would appear that the Russians approved the vaccine while simultaneously continuing ongoing clinical trials and expanded use options for those in dire condition to access investigational products. This doesn’t necessarily mean that the vaccine isn’t formally approved. It would imply that the Russians accelerated the approval, despite the fact that Phase 3 and Expanded Use research ensues. However, what certainly raises a red flag is Professor Rotstein’s comment that “we are first of all checking the safety level, it will take time.” This statement implies that key researchers, embedded in an Israeli research organization in Moscow, aren’t certain as to the safety of the product. If that’s the case, how could the Russian authorities be so confident about the assurance of safety and efficacy? On the other hand, perhaps Professor Rotstein misspoke, miscommunicated, or had another agenda? We can’t say.