The Russian vaccine known as “Sputnik V,” developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health in Russia back on Aug 11. This was viewed as a controversial move by the global biopharmaceutical industry, and for good reason, as the sponsors essentially approved the vaccine for commercial use before even completing any Phase 3 clinical trial. TrialSite has called out that in fact it was a marketing move to position this investigational product for global distribution deals once Phase 3 studies were completed in targeted markets. It would appear this point of view may be correct as that’s exactly what’s unfolding. Just recently, Russia’s Direct Investment Fund (RDIF) announced both the Government of the State of Parana (Brazil) and Uniao Quimica Farmaceutica Nacional (UQFN) announced the submission of preliminary documents to Brazil’s National Health Surveillance Agency (ANVISA) in a bid to register Sputnik V in conformity with the Brazilian regulatory procedures. These documents were filled with ANVISA on October 29, 2020.
TrialSite breaks down this most recent activity for the viewers. So what is the real story underneath this news? First, some context.
What is the context in a nutshell?
RFID is serving as a business development agency to promote this Russian vaccine. Regardless of quality and how well it may work or not, the sponsors took extremely unorthodox measures to get this investigational vaccine product to market, including A) human challenge studies accomplished in some cases even prior to Phase 1; B) a condensed Phase 1 and 2; C) with no domestic Phase 3 until first; and D) the successful registration of the product in Russia with that nation’s health authority. It’s not considered within GxP and FDA standards, et al compliance guidelines to commercialize a product prior to completion of Phase 3 studies. They have submitted the paper work to initiate the registration process with ANVISA for the southern state of Parana.
What’s the status on RDIF’s latest deal making?
Led by their chief, Harvard- and Stanford-educated Kirill Dmitriev—who TrialSite has noted appears to be a relentless deal maker—appears to be informing the market that they will enter a technology transfer agreement with UQFN to product and supply the state of Parana. Apparently, that local company would produce and distribute the vaccine in that state assuming the vaccine is deemed safe and effective post Phase 3 clinical trials.
Is there any evidence of efficacy early on?
Yes, there are some data pints. By Sept. 4, The Lancet published peer reviewed data as to the results of Phase 1 and Phase 2 clinical trials of the Sputnik V vaccine.
Is Russia conducting a Phase 3?
Although the RDIF positions the study involving 40,000 participants as a “Post-registration” clinical trial, in reality this is their Phase 3 trial executed post registration.
Who is Uniao Quimica Farmaceutica Nacional (UQFN)?
Based near Sao Paulo and founded in 1966, UQFN is a manufacturer of pharmaceutical products in Brazil. With 5,640 employees, the company touts its 6 manufacturing facilities across the country and a manufacturing unit in the United States.
Is the proposed distribution deal between RDIF and UQFN nationwide or just one state?
It would appear from the press release that the deal would be (its not complete yet apparently) for one state (Parana) in the south of Brazil.
Why wouldn’t RDIF just do a nationwide deal?
TrialSite can’t be certain but more than likely its due to fierce competition in the large nation of Brazil. For example, AstraZeneca announced on Aug 31 that Brazil would be hosting a Phase 3 clinical trial as would be Russia for this vaccine candidate, considered to be one of the leading investigational candidates.
Moreover, Sputnik V faces fierce competition from the East (China). Just on Oct. 19, Reuters reported that thus far Sao Paulo’s Butantan Institute, one of Brazil’s top research centers, which also was the lead trial site organization for the Phase 3 study of “CoronaVac (developed by Sinovac), had reported that in a clinical trial with up to 9,000 volunteers, the vaccine’s safety data was positive.
It should be noted in that same article, Reuters shared that the state of Sao Paulo inked a deal with Sinovac to procure up to 60 million doses by the end of February 2021 of the CoronaVac vaccine candidate.
And Reuters reported back in July that Brazil was interested not only in the AZD1222 vaccine (Oxford vaccine from AstraZeneca) but also the mRNA-based vaccine candidate form America’s Moderna.
Has RDIF & Gamaleya Institute disclosed more about the Sputnik V vaccine?
Yes. They have a website where they share more details about the human adenoviral vectors and other information associated with Sputnik V.
What is RDIF? Are they a pharmaceutical company?
No, but this sovereign wealth with as much as $40 billion under management has been actively working with the government to respond to the COVID-19 pandemic. See the link.
They are a sovereign wealth fund formed in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF’s management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.9 tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia’s GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 billion.
What’s the rest of the world think?
As TrialSite has reported, much of the global biopharmaceutical industry and associated academic medical centers view Sputnik V with considerable suspicion. For example, The Lancet Infectious Disease published a paper by Vijay Shankar Balakrishnan that questions the underlying level of quality associated with the investigational vaccine.
It could be that this vaccine works and that would be good news—the more countries and companies that can develop successful vaccines and therapies the better. And the RDIF appears to be entering into clinical trials and associated distribution deals with at least a handful of low to middle-income countries.
However, as mentioned above, what could be deemed by industry thought leaders as unacceptable short cuts were taken in the Sputnik V journey.
Only time and the actual data will ultimately shine more light on the true situation.
What are the top Ranked vaccine candidates?
Pfizer/BioNTech, Moderna and AstraZeneca (Oxford’s vaccine known as AZD1222). Johnson & Johnson has commenced the Phase 3 ENSEMBLE trial for its experimental vaccine product called Ad26.COV2.S. Other Western vaccines include Novavax and Inovio Pharmaceuticals, as well as a collaboration with GSK and Sanofi. Germany’s Curevac looks promising (another mRNA-based approach) and dozens of others of what TrialSite refers to as Vaccine 2.0 candidates are in the earlier stages.