COVID Vaccine Update: Sputnik V: Hope, Skepticism, and Politics [] Jessica Frick-Liston

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News Category: News, COVID 19, and Health/Fitness

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  • Published January 28, 2021
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    Everyone would like to see the end of this nightmare that is the global COVID-19 pandemic. Safe and effective vaccines are key components to this goal. And to meet the production and distribution need in an expedited timeframe, it will require many different vaccines from many different companies around the world to make this happen.
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    As of today, Mexico has issued Emergency Use Authorizations (EUA) for Oxford-AstraZeneca’s and Pfizer’s vaccines and the country is looking to other companies to meet the immediate demand. In recent news, Sputnik V, the vaccine developed by the Gamaleja Research Center in Moscow has submitted its technical file for approval.
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    Like so much else in Russia history, the rollout of Sputnik V was entangled in politics and propaganda. There have been considerable reservations worldwide about this vaccine because the Russian government issued an (EUA) in August 2020, after only a phase II trial. Russia faced international criticism and experts both in Russia and worldwide warned against its use until the tests are completed. Early on they made efficacy claims based on small numbers of tested subjects. And to date, Russia hasn’t publicly released late-stage phase III data on its vaccine in any peer reviewed journals.
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    But from the perspective of “then vs now”, is it time to move past politics and propaganda and consider what we know?
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    Early skepticism from Western experts focused mostly on the questionable early approval, not the vaccine’s design.
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    > Sputnik V uses a platform based on the adenovirus, which causes the common cold, and has been studied in vaccine development for decades. In fact, research on human adenoviruses as a potential base for vaccine development began in 1953 (Zhou, 2016).
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    > These types of vaccines do not contain live human adenoviruses, but human adenovirus vectors, that is, human viruses that cannot multiply in the body. Adenovirus vectors deliver the genetic instructions for SARS-CoV-2 antigens directly into patients’ cells, provoking a robust immune response.
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    > Six vaccine candidates in clinical trials for COVID-19 employ this vector technology including the ones produced by the AstraZeneca-Oxford University partnership and Johnson & Johnson. Three candidates rely on weakened human adenoviruses to deliver the recipe for the spike protein of the pandemic coronavirus, while two use primate adenoviruses and one uses measles virus.
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    > Sputnik V has one key, clever difference from the Astra and J&J vaccines: It uses the same adenovirus as J&J for the first dose (adenovirus-26) and a different adenovirus (adenovirus-5) for the second dose. In this way, it avoids the possibility of immunity to the first dose impacting the ability of the second dose to work efficiently. One issue is that a large percentage of people have pre-existing immunity to adenovirus-5, but that’s not a huge drawback if the efficacy is very high. A potentially more promising alternative would be to try a combination of adenovirus-26 for the first shot and Astra’s adenoviral vector – made from a chimp adenovirus – for the second, which is exactly what the two groups have agreed to do in a collaboration announced on December 11, 2020 (Balfour, 2020).
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    > The Sputnik V has been tested in a phase III trial involving 22,714 subjects, with three interim analyses when the number of confirmed cases reached 20, 39 and 78, respectively. While the final number of cases is lower than that in the Moderna and Pfizer Inc.-BioNTech SE vaccine trials, those were larger and conducted in the U.S., where the infection rates were rising rapidly. Efficacy at each interim analysis in the Sputnik V trial was consistently at 90% or above, based on comments in press releases. There were also no cases of severe Covid-19 in vaccinated individuals, though definitions of disease severity are not clear. Overall, trial organizers expect to have results on over 40,000 participants by mid to late February.
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    >While public apprehension hasn’t completely subsided, and the developers have yet to release detailed data on adverse events observed during the trials, the Russian government has now vaccinated about one million of its own citizens and exported Sputnik V to Belarus, Argentina and other countries, suggesting that any harmful side effects, would by now have come to light.
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    If clinical results show to equal what press releases say, at the moment, the data released on the Sputnik V vaccine looks to be the best in the field of the adeno-vectored vaccines.
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    Mexico and Sputnik V, the saga continues……
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    Mexico has stated it is close to granting approval for Russia’s Sputnik V coronavirus vaccine, but has repeatedly stated that it would not receive COFEPRIS authorization without proven effectiveness, safety and quality.
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    Despite weeks of conversations with Russian officials, Hugo López-Gatell, Mexico’s assistant health secretary, did not have access to the results of Phase 3 trials, which are normally published in international medical journals and indicate how effective the vaccine is.
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    With no published data, López-Gatell traveled to Argentina, which has already approved and is using Sputnik V, to see what information was available. Mexican officials had access to “the entire scientific and technical file” on the Russian vaccine while in Argentina and with permission from Russia, the Argentines shared the Phase 3 trial results and data. This information was submitted to Mexican regulatory officials for review.
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    After reviewing the information, the technical part, the main part of COFEPRIS, particularly the committee on new medications, has given a favorable recommendation to authorize. But even though the technical committee has given a favorable recommendation, Mexican authorities won’t grant authorization without original data from Russia. So, at this point, the original file data is lacking for COFEPRIS, Mexican authorities are speaking with Russia daily to get the info, in order to give the final go-ahead.
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    Bottom line:
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    The world needs as many good vaccines as it can get.
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    Sputnik V is grounded in well-established adenovirus vector technology. Its clever design bases its two doses on different viral vectors, in principle producing a strong, long-term immune response. Unlike the available alternatives, it’s cheap — reportedly less than $10 per dose—and it doesn’t require expensive ultra-refrigeration.
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    To date, Russia hasn’t released late-stage phase III data on its vaccine and no peer reviewed published data is available.
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    Mexican authorities have seen the scientific and technical file, but are waiting for original data from Russia for approval.
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    So, a little less hype and a little more candor would go a long way toward establishing Sputnik V as a credible element of the global pandemic response. At some point, I hope soon, the phase III data for the Sputnik V vaccines will be published in a peer-reviewed journal so that we can move past the politics of last fall and make up our own minds about the robustness of their efficacy and safety.
    Works Cited
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    Balfour, H. (2020, December 14). AstraZeneca to test combination of AZD1222 and Sputnik V vaccines. Retrieved from European Pharmaceutical Review: https://www.europeanpharmaceuticalreview.com/…/astraze…/
    Zhou, C. Z. (2016). Adenoviral vector-based strategies against infectious disease and cancer. Human Vaccines and Immunotherapuetics, 2064–2074. .

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