Hadassah Moscow Bombshell: Gamaleya Vaccine Research Ongoing Despite Approvals

Aug 12, 2020 | Coronavirus, COVID-19, Gamaleya Institute, Gamaleya Vaccine, News, Popular Posts, Vaccine

Hadassah Moscow Bombshell: Gamaleya Vaccine Research Ongoing Despite Approvals

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.

Expanded Use

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.”

Conclusion

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.

3 Comments

  1. Walt

    Don’t all phases of testing, 1 through 4 continually check for ongoing safety using more and more subjects? I think Trial Sites suspicions of human challenge are still correct. The Russians know a large portion of the world will not accept the vaccine based on human challenge trial results so they continue with typical studies to gain worldwide acceptance while they inoculate their own population to save countless lives.Western scientists and researchers still treat this whole pandemic as some scholarly research paper, and denigrate any data that is not blessed with the holy randomized control study, or some new genetic vaccine base that will make them and their political friends wealthy. They keep frittering away time waiting for holy bible research journals to review and publish findings, wasting months and months of precious time. Look no further than to the successful use of Ivermectin in Broward county, They cannot get their paper published as the data would undermine Remdesivir and other modern unproven treatments and all the billions this rather useless drug is making.

    • TrialSite

      Walt this makes sense. In our comment article we do also question the source. The timing, the nature of the comment, etc. But we wanted to get that information out there to elicit wisdom like this.
      Thanks for visiting and contributing. We are grateful.
      Publisher

  2. TrialSite

    Peter we are sorry you feel this way. We believe in supporting a diversity of perspectives and points of view and we are not anti-Russia at all. In fact we are one of the few research focused media that track the Gamaleya vaccine. We try to maintain an objective stance but we are not always objective—we are human after all. As mentioned, we have been following Gamaleya as closely as we can and we have observed some challenges in apparently skipping Phase 3 trials. We have questioned some of their tactics as well involving preclincial human testing.

    Rarely are Phase 3 studies skipped—hence why none of the major vaccine makers in China, Germany nor the UK or the United States for that matter are skipping this critical and pivotal phase. It isn’t just a mindless slavery to “safety” at all. It follows tried and true methods and best practices associated with clinical research.

    Today, probably much to your disgust, we published another piece, this time on an Israeli medical center professor declaring that they have been working on the Gamaleya vaccine and that the studies are not over. In fact this Israeli source declared that they are still monitoring the safety data from the vaccine. We believe that there is some nationalism going on now which we don’t think is necessarily healthy in time of a pandemic and we have been on the record about this: that is if national pride supersedes that precious risk threshold so embraced by some people, for example. However true to TrialSite form, we do question the source and wonder if there is an alternative agenda–that is an anti-Russian agenda.

    We are an independent media source—no pharma money; no government money; no Russia money, just our own money and our own effort to try to get closer to the truth. We are not perfect and we certainly have made mistakes—and will continue to do so. We have a lot of experience with clinical trials–ins and outs codified in software, every rule and audit trail we have lived in software development powering thousands of clinical trials around the world. In the process our feedback is 90% positive because a great majority of visitors appreciate what we do undertake—on our own time and dime—and never have they espoused the anger and outrage toward us that you have done so in these remarks.

    Your assumption: How dare you question Russia AND Russia = Bad.

    We don’t agree. We will absolutely question Russia as we will our own government and any other government. We do question when a major government-sponsored trial skips a pivotal Phase 3 stage; the Chinese haven’t; the Americans haven’t; the Germans haven’t and Brits haven’t. That doesn’t mean Russia’s Gamaleya vaccine doesn’t work. In fact we are on the record that we hope that it does—we happen to have dear friends in Russia and consider it an incredible place.

    So we choose not to agree with your critique that we are a bunch of dumb miscreants peddling in poop just because we challenge some underlying assumptions of a major government and their decision to skip the so critical Phase 3 stage. We aren’t alone. A lot of top scientists do as well.

    However–and this is important for you to know Peter: we created this site for you.

    This is a trusted site, for people to express what they think and feel about research and investigational drugs. We continue to invest to develop an inclusive major media that is very different; that is free of commercial crap and open to a divergence of opinion. So we are grateful for your critique.

    We respect that you disagree and despite your anger we absolutely love your visits and the fact that you provide feedback in the first place. We certainly hope that you keep it coming.

    Publisher

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