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Data and distrust hamper Russia’s vaccination programme

BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o321 (Published 11 February 2022) Cite this as: BMJ 2022;376:o321

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COVID-19 Pandemic, COVID-19 Vaccines and successful vaccination programmes: a further clarion call to observe research governance-related best practices and a critical look at preprints

Dear Editor

The need to uphold the strict and robust ‘Research Governance Principles’ has been repeatedly emphasized to assure ‘COVID-19 Pandemic Interventional Strategies’ are situate with ‘Best Practices’ for the desired ‘Global COVID-19 Pandemic Control’ [1-6]. The need for such strict ‘Research Governance-compliance’ is particularly apt concerning ‘Research Output’ to avoid ‘COVID-19 Research Wastes’ as previously canvassed [7-12]. Also, the imperative for the strict ‘Research Governance-compliance’ in ‘COVID-19 Vaccines Production and Approvals’ has been particularly amplified in previous ‘Communications’ to avoid ‘Programmatic Difficulties’ in the desired and envisioned ‘Vaccines-Vaccinations Translation’ [13-16]. For the ‘Global COVID-19 Pandemic Control’, ‘Determinants’ that undergird ‘Vaccine Hesitancy’, ‘Poor Population Vaccine Uptake’ and, indeed, ‘Populace-Government Intervention Distrust’ MUST be consciously and concertedly avoided at all costs. It is against this backdrop that the recent ‘Communication’ [17] excites curious interest and the need for ‘Independent Global Critical Scrutiny’ of various and varied ‘Country COVID-19 Vaccines Programmatic Proclamations’.

The ‘Russian Situational Realities and Revelations’ [17] are quite bothersome concerning the ‘Approved COVID-19 Vaccines’: Sputnik V, EpiVacCorona and CoviVac. It is reported that the ‘Approvals’ and ‘Vaccines Distribution’ for ‘Population Uptake’ were not strictly ‘Research Governance-compliant’ and ‘Data Governance-compliant’. It is reported that the Association of Clinical Research Organizations protested ‘Gross Violations of Clinical Trials Conduct, Russian Legislations and Recognized International Norms’ [18] For instance, the Sputnik V COVID-19 Vaccine was formally announced as ‘Approved’ in August 2020 without ‘Verifiably Available Accessible Published Clinical Trials Data’ while only ‘Phases I and II Clinical Trials Data’ were subsequently published in the Lancet in September 2020 [19]. All Data related to the ‘Clinical Trials Phases I, II and III’, by ‘Best Practices’ and strict ‘Research Governance-compliance’ and ‘Data Governance-compliance’, ought to have been ‘Independently Critically Scrutinized’ to guide and inform the ‘Sputnik V COVID-19 Vaccine Approval’; certainly the ‘Cart before the Horse Picture’ cannot be an acceptable disposition. It is also reported that ‘Preliminary Phase III Clinical Trials Data’ were only released 11th November 2020 ‘Just a few days after PfizerBioNTech and Moderna COVID-19 Vaccines were declared effective’ [20]. An ‘Independent Polls’ was reported to indicate that less than 40% of the Russian Public agreed to get vaccinated with the Sputnik V Vaccine [17]. By the Spring 2021, about 3% of Russians had reportedly received the ‘Russian COVID-19 Vaccines’. Not even the use of Government-introduced ‘QR Code Vaccine Passport’ issued in relation to ‘Vaccination’ with the ‘3 Russian COVID-19 Vaccines’ remarkable altered the ‘Vaccine Uptake’; some citizens, in fact, reportedly preferred to wait for ‘Foreign Vaccines’ or travel abroad to receive ‘Foreign Vaccines’ and there are reports of ‘Fake QR Code Vaccine Certificates’. For ‘Global COVID-19 Control’, ‘Populace Distrust’ MUST be avoided to assure impactful patronage of ‘Government Programmatic Interventions’.

By June 2021, several Independent Citizen Science Groups reported much lower ‘Vaccine Efficacy Data’ for the EpiVacCorona and CoviVac COVID-19 Vaccines compared with previously published Data by the Government in February 2021 [21,22]. The Developers of CoviVac issued a ‘Preprint on Phases I and II Clinical Trials’ to begin in February 2022 [23]. It is difficult to appreciate and understand this ‘Vaccine Development, Approval and Population Uptake’ in terms of ‘Processes and Procedures’ situate with ‘Best Practices’ in these ‘Matters’ as disposed in the recent ‘Communications’ [17,23].

The ‘Revealed Russian COVID-19 Vaccines Realities’ are reportedly similar to the ‘Russian Flu Vaccines’ Development, Approval and Population Uptake [17]. The ‘Russian Flu Vaccines’ were reportedly ‘Approved’ with paucity of ‘Clinical Trials Data’. Some were also reportedly ‘Approved’ despite ‘Trials Data’ showing ‘Vaccine Ineffectiveness’. Also, some ‘Russian Flu Vaccines’ were reported to contain less than the ‘WHO Recommended Antigen Amount’ required to stimulate ‘Immune Response’ [24].

The recent ‘Communication’ highlighting the ‘Russian COVID-19 Vaccines Realities’ is instructive but must not be regarded as a ‘Peculiar Russian Phenomenon’. Other Countries have also veered into the ‘Research Governance Enterprise’ and ‘Data Governance Enterprise’ re: Some acting as ‘Pseudo-Research Approval Committees’, ‘Dictating Terms and Speed of Phases of Clinical Trials’, ‘Monitoring and Steering the Approval Mechanisms’ and ‘Sieving and Filtration of Data Release’ among several others. The World is guided, with the ‘Revealed Russian COVID-19 Vaccines Realities’ , to mount more ‘Critical Scrutiny’ regarding ALL the ‘Processes, Procedures and Regulatory Mechanisms’ of ‘COVID-19 Vaccines’ from ‘Research’, ‘Development’, ‘Manufacturing’, ‘Roll-out/ Distribution’ to ‘Vaccine Uptake/ Populace Vaccinations’ ensuring unalloyed upholding of ‘Best Practices’ situate with strict ‘Research Governance Principles’ and ‘Data Governance Principles’.

The ‘Research and Scientific Community’ should rise up to protect ‘Science’ against ‘Politics’ in whatever guise it is disposed. Scientists and Researchers, as Professionals with avowal to uphold the Sanctity, Immutability and Factuality of ‘Research Governance Principles’, MUST Promote, Project and Protect ‘Science and Facts’ for the benefit of ‘Our Common Humanity’ as we strive for success in the ‘Global Fight’ against the ravaging ‘COVID-19 Pandemic’ now increasingly driven by the increasingly emerging ‘SARS-CoV-2 Variants’. The ‘Research and Scientific Community’ MUST take a ‘Critical Look’ at the role of ‘Preprints’ in the ‘Publication Enterprise and Industry’ situate with ‘Procedural Expedience’, ‘Data Governance’ and ‘Research Governance’. The possible ‘Attribution’ to ‘Preprints’ in the ‘Revealed Russian COVID-19 Vaccines Realities’ is not complimentary and excites an imperative for ‘Critical Scrutiny’ of ‘Publications Dissemination’ without the ‘Robust Dependable Reliable Peer-Review Mechanism’. Previous ‘Communications’ have addressed the ‘Preprints Issue’ [12,25-27]. We MUST avoid ‘COVID-19 Research Wastes’ from ‘Preprints’ among others. The possible contribution of ‘Preprints’ to the ‘COVID-19 Infodemic Pandemic’ was disposed previously [12].

This ‘Communication’ is a modest ‘Contribution’ to the ‘Protection’ of ‘Science’ against ‘Politics’ in our quest to succeed in the ‘Global Fight’ against the ‘COVID-19 Pandemic’ using the ‘COVID-19 Vaccines Interventional Strategy’. ‘Vaccines-Vaccination Translation’ MUST be assured by courting the ‘Populace Trust’ and ‘Patronage’ of ‘Government Interventions’ through the compliance with robust ‘Research Governance Principles’, ‘Data Governance Principles’ and a ‘Critical Look’ at ‘Preprints’ in Scientific Communications’.

REFERENCES
1. Public Health England. Green Book. Chapter 14a: Covid-19-SARS-CoV-2. Dec 2020.https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
2. Coronavirus: BMJ urges NYT to correct vaccine ‘mixing’ article. BBC News 2021 Jan 3. https://www.bbc.co.uk/news/uk-55519042
3. Wu KJ. Britain opens door to mix-and-match vaccinations, worrying experts. New York Times 2021 Jan 1. https://www.nytimes.com/2021/01/01/health/coronavirus-vaccines-britain.html.
4. Mahase E. Covid-19: UK approves Oxford vaccine as cases of new variant surge. BMJ 2020; 371:m3968
5. Eregie C.O. ‘COVID-19 Pandemic and vulnerability of science to assault: Imperatives to uphold research governance principles’. https://www.bmj.com/content/372/bmj.n12/rr-4 of 22nd January 2021
6. Eregie C.O. ‘CIVID-19 Pandemic: A persisting pervading devastating unprecedented 21st century scourge; the imperative to protect, project and promote the immutability of the factuality of science to the rescue’. https://www.bmj.com/content/374/bmj.n1896/rr-0 of 23rd August 2021
7. Clinical Trials.gov. History of changes for study. NCT04280705, 1 May 2020. https://clinicaltrials.gov/ct2/history/NCT04280705?A=10&B=15&C=Side-by-S....
8. Yan W. Coronavirus tests science’s need for speed limits. New York Times 2020 Apr 14. https://www.nytimes.com/2020/04/14/science/coronavirus-disinformation.html
9. Hoffmann T, Glasziou P. What if the vaccine or drugs don’t save us? Plan B for coronavirus means research on alternatives is urgently needed. The Conversation, 21 Apr 2020. https://theconversation.com/what-if-vaccine-or-drugs-dont-save-us-plan-b...
10. Glasziou PP, Sanders S, Hoffmann T. Waste in covid-19 research. BMJ 2020; 369:m1847
11. Eregie CO. COVID-19 Pandemic: The multifaceted picture of compromised COVID-19 research and the COVID Phenomenon’. https://www.bmj.com/content/369/bmj.m1847/rr-12 of 10th June 2020
12. Eregie C.O. ‘COVID-19 Pandemic, the quest for urgent information and solutions and the paradox: making haste slowly to avoid ‘COVID-19 Research Waste’. https://www.bmj.com/content/370/bmj.m2668/rr of 17th July 2020
13. Mahase E. Covid-19: Where are we on immunity and vaccines? BMJ 2020;370:m3096
14. Altmann D. Finding the best covid-19 vaccine should not be a race: 14th August 2020. https://blogs.bmj.com/bmj/2020/08/14/finding -the-best-covid-19-vaccine-should-not-be-a-race.
15. Torreele E. The rush to create a Covid-19 vaccine may do more harm than good. BMJ 2020; 370:m3209
16. Eregie C.O. ‘COVID-19 Pandemic and COVID-19 Vaccinations: Beyond the ‘Vaccines Marathon Finish Line’; The Unfolding ‘Works in the Work’. https://www.bmj.com/content/372/bmj.n24/rr-1 of 20th January 2021
17. Loseva P. Data and Distrust hamper Russia’s vaccination programme. BMJ 2022; 376:o321
18. Dyakonova O, Reiter S. Scientists in Russia have tested the Covid vaccine on themselves. Pharmaceutical companies considered it a violation. BBC 2020. https://www.bbc.com/russian/news-52772808
19. Logunov DY, Dolzhikova IV, Zubkova OV et al. Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia. Lancet 2020; 296:887-97
20. Gamaleya Center. The first interim data analysis of the Sputnik V vaccine against covid-19 phase III clinical trials in the Russian Federation demonstrated 92% efficacy. 2020. https://sputnikvaccine.com/newsroom/pressreleases/the-first-interim-data...
21. Logunov DY, Dolzhikova IV, Shcheblyakov DV et al. Gam-COVID-19-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomized controlled phase 3 trial in Russia. Lancet 2021; 397:671-81
22. Krinitsky AA. Study of the immunogenicity and potential protectiveness of the vaccine “EpiVacCorona”. Covid-19Preprints (Preprint) 2021. https://covid-19-preprints.microbe.ru/article/252
23. Ishmukhametov AA. Sinuigina AA. Yagovkina NV et al. Safety and immunogenicity of inactivated whole virion vaccine CoviVac against COVID-19: a multicenter, randomized, double-blind, placebo-controlled phase I/II clinicaltrial. MedRxiv (Preprint) 2022. https://www.medrxiv.org/content/10.1101/2022.02.08.22270658v1
24. Remish A. A lot does not mean good: Ultrix, Grippol, Sovigripp-what to choose? 2019. https://biomolecula.ru/articles/mnogo-ne-znachit-khorosho-ultrix-grippol...
25. Conroy G. Preprints boost article citations and mentions. Nature Index 2019 Jul 9. https://www.natureindex.com/news-blog/preprints-boost-article-citations-...
26. Fry NK, Marshall H, Mellins-Cohen T. In praise of preprints. Microb Genom 2019; 5:e000259. Doi: 10.1099/mgen.0.000259. pmid:30938670
27. Nassisi M, Audo I, Zeitz C et al. Impact of the COVID-19 lockdown on basic science research in ophthalomology: the experience of a highly specialized research facility in France. Eye (Lond) 2020; 34:1187-8

Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria.
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria.
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria,
*No Competing Interests.

Competing interests: No competing interests

23 February 2022
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology and Consultant Paediatrician and Neonatologist, University of Benin and University of Benin Teaching Hospital, Benin City, Nigeria.
Institute of Child Health, College of Medical Sciences, University of Benin, Benin City, Nigeria