Israel will Meet with Gamaleya Once Sputnik V Goes Through the Rigor of Phase 3 Clinical Trials

Israel will Meet with Gamaleya Once Sputnik V Goes Through the Rigor of Phase 3 Clinical Trials TrialsiteN

The state-owned Russian media TASS claims that at least 20 nations have sought to purchase at least 1 billion doses of the Gamaleya (Sputnik V) COVID-19 vaccine. Yuli Edelstein, Israeli Health Minister, is on the record that his nation would consider the vaccine if it worked. Acknowledging that the vaccine is not done—even though it’s been “registered” with the regulatory authorities—Edelstein commented that there’s little use in hoping that, “the vaccine will be available tomorrow.” Why? the health official proclaimed, “there is yet to be a vaccine that passed all the necessary [trial] stages and received all the needed certifications.”

Accelerated Clinical Trials + Human Challenge Studies

As TrialSite has discussed, the registration of Sputnik V was more marketing than meaningful. Developed by the Gamaleya Research Institute of Epidemiology and Microbiology, the actual clinical trials took place through June and July, while what appears to be intensive human challenge trials started during the “preclinical” animal stage and continuing throughout the summer. Many demographics appeared to partake in human challenge studies, including the very rich and powerful,  President Putin’s daughter, and perhaps the most powerful financial broker in the country at this point, Kirll Dmitriyev, CEO of the Russian Direct investment Fund (RDIF). Undoubtedly the authorities in Russia maintained a different kind of research initiative, one that wouldn’t be acceptable in the West. It certainly would be of interest if meticulous records were to materialize that revealed not only how many people were involved in the human challenge studies, but also data around immunogenicity and safety.

The Registration

TrialSite reported that there was talk of “mass distribution” and then “registration,” which did in fact occur recently. The world’s first formally-approved COVID-19 vaccine developed in record time. National pride was undoubtedly served by this strategy, as Sputnik V is now a considerable news topic. In addition to lofty ambitions to be “number one,” more than likely this registration was done for marketing purposes as it: 1) establishes Russia as the first to approve a vaccine for SARS-CoV-2; 2) generates attention and differentiation against what could most likely be deemed superior product candidates from the U.S., UK, Germany and China; 3) triggers more “pre-sales” discussions than would be the case if they had to follow the normal regulatory pathway; and 4) no doubt deeper, more nuanced points than the TrialSite can even speculate about.

No ‘Silver Bullet’

Critiques of Sputnik V come from many different sources, with varying credibility. The World Health Organization suggested Russia slow down conveying that there was no “silver bullet.” The Association of Clinical Trial Organizations in Moscow pleaded to the Russian government that phase 3 data must be collected, in an open letter to the Ministry of Health. One prominent drug-development opinion leader, Onyema Ogbuagu with Yale School of Medicine, is involved with the Pfizer/BioNTech Phase 3 clinical trial and was purported to call Russia “reckless.” And prominent health figures in places such as Germany and the United States have raised concerns about the hasty approach. 

The Market

In following this line of thought and fitting to the TASS narrative, now at least 20 nations are in discussions with Russia to procure this “certified” health product targeting COVID-19 pandemic conditions. Although in reality, Sputnik V remains an “investigational” product—meaning it’s not approved by any health authority in the West or Japan (these are by far the largest markets for health care products, with China coming up). Either way, Russian negotiators now are at the table to many more procurements than if they had gone down the path that all the other major vaccine candidates must go down—e.g. rigorous clinical trials including a mission-critical, pivotal Phase 3. Even TASS news serves as a public relations bureau to further this multifaceted strategic end. And the Stanford educated Mr. Dmitriyev, whose finance agency has backed a lot of the vaccine development (and who also participated in the human challenge studies), is on the record that Russia has “finalized” contracts with unnamed nations in Latin America, the Middle East, and Asia.

Not Complete but…

According to Israel’s health minister, the product is not done. That’s the declaration made by Mr. Edelstein who was quoted by TASS: “there is yet to be a vaccine that passed all the necessary [trial] stages and received all the needed certifications.” 

Yet, “so what?” The Israel minister is still, seemingly at the procurement table, interested in holding talks to purchase the product despite the unorthodox, to say the least, methods employed. A good amount of what happens today is reactionary; meaning crises commence and unfold—such as the emergence of the novel coronavirus–and players (national actors, NGOs, multinational corporations, etc.) react, alliances shift, while paradigms and ideologies along with material needs interplay, contributing to an unfolding human story. 

A Bigger Picture Emerges

Pre-COVID-19 era agendas still remain the drivers for much of what continues to unfold. That the life sciences as an industry can be considered one of national security imperative has been established in China, and undoubtedly Russia takes concurs. The advanced life sciences’ market forces in the West operate at a high level. But in what were the “BRICs,” the vitally important sector needed nurturing, incubation and ongoing care. 

By 2013, “a biotechnology revolution” was “gathering steam in Russia”, as reported by media centered on attracting investment into the Russia. Over a decade ago, smart consultants of PWC called out, “Escalating demand for medicines” in BRIC nations. Over the last decade PWC reported sales in the BRIC countries (Brazil, China, India and Russia) grew 22%.

Russia has been active developing industrial policy and strategy instruments conceived to accelerate the growth of domestic sectors, as well as positioning them for exports to the rapidly-growing middle classes in various nations worldwide. The country has faced a number of systemic challenges impeding economic growth, including in the high tech and life sciences sectors. 

Hence, a foundational undertaking there continues to be the nurturing of a modernized, “high-tech” industrial complex (including life sciences) that contributes to economic sustainability. An underlying, unstated driver inherent in the reaction to the COVID-19 crisis continues to be the impetus for industrial policy-driven initiative involving the need for economic diversification, financial sustainability and sectoral growth with further penetration of new markets. To a great extent this becomes essential as Russia’s demographics changes and its healthcare sector morphs from a primarily state-dependent sector to one that’s more diversified with greater privatization.  

Diversification, privatization—with heavy state backing of considerable activity thrown in—combined with unfolding and changing markets and profound demographic shifts necessitates a dynamic industrial policy in this part of the world. As reported by Deloitte in 2017, Russia still imported far more pharmaceutical product than it exported; and among these exports 86 percent goes to post-Soviet countries.

Back to Israel: Prove It

In the meantime, Israel acknowledged its  “interest” in exploring a discussion around the Sputnik V vaccine with its maker—the Gamaleya Research Institute of Epidemiology and Microbiology. But according to the report by TASS, conditionally: assuming the product actually works. In the meantime, health minister Edelstein says there’s little use in hoping, “that the vaccine will be available tomorrow,” because it hasn’t gone through Phase 3 testing.