Covid-19: Ukraine conflict calls Russia’s vaccine diplomacy into questionBMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o626 (Published 09 March 2022) Cite this as: BMJ 2022;376:o626
Although Russian covid vaccines are licensed in over 70 countries, their success on the international market could be impeded by the conflict in Ukraine and the onset of global sanctions against Russia and its entities.
Sputnik V, a vaccine created by scientists at the Gamaleya National Center of Epidemiology and Microbiology, was developed, promoted, and financed by the Russian Direct Investment Fund (RDIF). On 28 February the US Department of the Treasury included the RDIF in its list of sanctioned Russian entities,1 and the Council of Europe and several national executives worldwide promptly followed.
The Russian fund responded with a public statement highlighting that the restrictions would complicate its efforts to promote the covid vaccines internationally. The RDIF accused unspecified “large Western pharmaceutical companies” of piggybacking the crisis to achieve a market advantage over a competitor, underlining that the fund “was never involved in any political activities, does not interact in any way with Ukraine and follows the world’s best investment practices.”2
Sputnik V, also known as Gam-COVID-Vac, is based on two common cold virus (adenovirus) vectors delivered separately in a first and a second dose, combined with the SARS-CoV-2 spike protein. It was later followed by Sputnik Light, essentially only the second component, and more recently by Sputnik M for adolescents, which is currently licensed only in Kazakhstan.3
Arguments “beyond science”
The Sputnik vaccine first made news in August 2020 when Russia’s president, Vladimir Putin, announced that the country had authorised a “safe and effective” covid-19 biologic. This was before phase 1 or 2 data had been published and before a phase 3 trial had begun.4 The Gamaleya covid vaccines continue to face criticism for a lack of transparency in clinical trial documents.
The Lancet’s publication in September 2021 of the results of two open, non-randomised phase 1/2 studies5 was met with scepticism, particularly by a group of international researchers who contested the results as reproduced in the journal.6 The authors defended the solidity of their work and suggested that individual participant data would have been made available on request,7 which until now has not happened.
Vasiliy Vlassov, vice president at the Russian Society for Evidence Based Medicine, has told The BMJ that not much has changed since then. Vlassov has been vocal in expressing his reservations on the Sputnik vaccine’s methodological issues and on the need for a more transparent approach.8 He said that although the phase 3 trial had meanwhile been completed, “a formal final report wasn’t published,” adding that no field data on Sputnik’s safety were apparently collected in Russia.
Vlassov said that “the role of arguments beyond science was very significant in all aspects of the pandemic,” with politics and geopolitics also influencing public health affairs.
“At least in part it is a result of insufficient volume of knowledge, a permanent delay in knowledge acquisition in the course of the epidemic, and highly subjective decision making,” he said.
Future on hold?
In February 2022 Argentina’s Ministry of Health granted conditional approval to the Sputnik vaccine manufactured by a local producer, Richmond. This technology transfer is also taking place in other countries. Commercial details are not disclosed in any of the nations involved, but the Argentinian initiative could effectively open the door to further export of the Sputnik biologics in other South American countries.9
The Argentina Ministry of Health told The BMJ that no distribution issues were expected despite the international crisis, as Argentina had stockpiled enough Sputnik biologics and it was rolling out multiple covid vaccines. Over 79% of the country’s population has now been fully vaccinated.
Reuters reported that most of the Indian subcontractors that are soon expected to start producing Sputnik’s biologics had declined to comment on how the crisis would affect the Russian vaccine.10
The European Medicines Agency began a rolling review of Sputnik V a year ago, and the World Health Organization had planned to carry out onsite inspections in Russia this month.11 WHO has not yet granted the Sputnik biologic its emergency use listing, which would allow for the vaccine to be included in the Covid-19 Vaccines Global Access (Covax) initiative that distributes doses in lower income countries. It seems likely that any inspections would be on hold pending developments in Ukraine.
A European Medicines Agency spokesperson said, “The Sputnik V vaccine remains evaluated under rolling review, although there is currently no active review cycle. We are not commenting any further on ongoing assessments.”
In a quickly changing situation it is hard to assess the potential impact of the international crisis on the availability and rollout of the Russian vaccines. Politico has reported that the RDIF has explicitly called for peace in Ukraine12—a statement that The BMJ was not able to independently confirm.
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