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Covid-19: Vaccine brands can be mixed in “extremely rare occasions,” says Public Health England

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n12 (Published 04 January 2021) Cite this as: BMJ 2021;372:n12

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COVID-19 Pandemic and vulnerability of science to assault: Imperatives to uphold research governance principles

The recent ‘Communication’ in the BMJ disposes concerns exciting close scrutiny of SCIENCE, its APPLICATION within the confines of permissible dispositions situate with 'Best Practices’/ ‘Robust Research Governance Principles[1]! The ‘COVID-19 Pandemic’ remains an enlarging ‘Hydra-headed Enigma’! It is a ‘Rapidly Dynamically Transmuting Scourge’ with ‘Disease Specifics’ as ‘Work in Progress’ concerning its Aetiology, Epidemiology, Manifestations, Interventions (Pharmaceuticals/ Non-Pharmaceuticals), Prognosis/ Outlook and evolving ‘Collateral Contemporary Issues’!! With the ‘COVID-19 Pandemic’ have evolved such ‘Collateral Contemporary Issues’ assuming ‘Pandemic Proportions’ as: ‘COVID-19 Pandemic Specifics in a Rapid Flux’ with increasingly much more being unearthed daily and, indeed, increasingly much less known with certainty[2-15]! The ‘COVID-19 Infodemic’ with the plethora of ‘Distortions’ in ‘Pandemic-related Information’[16,17] and ‘COVID-19 Pandemic-aggravated Social Disparities-Structural Racism’ with the amplification/ worsening of Inequalities and Inequities in the ‘Pandemic-related Afflictions and Interventions’ are truly bothersome[16, 18-20]!! Also, ‘COVID-19 Research Wastes’ with some ‘Research Outpourings’ not STRICTLY compliant with ‘Robust Research Governance Principles’[21-25] and ‘COVID-19 Vaccines Post-Approval Unfolding Difficulties’ now ‘Throwing Spanners in the Works’[26,27], among others, are matters exciting ‘Contemporary Programmatic Discourse’; Matters ventilated and communicated previously!!

The peculiarities of ‘COVID-19 Pandemic’ require that Science is insulated from Politics, as previously recommended by WHO, to minimize or eclipse the POTENTIALITY towards increasing the deleterious ‘COVID-19 Research Wastes’[21-25]! The support for MODERATING ‘Research Governance Principles’ antedating the ‘Heat of the Vaccines Marathon Finish Line’[28-31] has not been productively beneficial for the ‘Global Fight’ against the ‘COVID-19 Pandemic’!! They have, indeed, possibly contributed to the ‘Post-Vaccines Approval Difficulties’ which, if not ‘Strategically Managed’, could be heading for a ‘Difficult Pandemic’[26,27]! The World was ‘Forewarned’ and ‘Forearmed’ to forestall the evolving unenviable ‘Post-Vaccines Approval Difficulties’[32]!!

Antedating the ‘COVID-19 Vaccines Marathon Finish Line’ were ‘Communications’ 33-40 ventilating ‘Issues’ that required Strict Adherence to ‘Robust Research Governance Principles’ expected to undergird every facet of the ‘Candidate Vaccines’ in the ‘Phase III Clinical Trials’! The World is now challenged to resolve ‘Avoidable Post-Vaccines Approval Difficulties’[26,27]!!

The Public Health England to The BMJ reportedly disposed: ‘Every effort should be made to give patients the same vaccine but when this is not possible, it is better to give a second dose of another vaccine than not at all’ if the concerned individual was at high-risk for COVID-19 or was unlikely to attend again[1,41]! This was reported as ‘Recommending Mixing Vaccine Brands’ which The BMJ sought to be urgently corrected[42]! ‘Mixed Vaccine Brands’ is not situate with ‘Best Practices’ and ‘Robust Research Governance Principles’!! ‘Approved Vaccines’, even if based on the ‘SARS-CoV-2 Spike Protein’, will most likely dispose ‘Manufacturer-related Peculiarities and Specifics’ compounding the ‘Vaccine Production Precursor Diversity’! Otherwise, how do we explain the very different ‘Manufacturer Specifications’ for the Pfizer-BioNTech Vaccine’ and the ‘Moderna Vaccine’ viz: Storage Temperatures of -20OC and 2nd Dose after 4 weeks for Moderna Vaccine and Storage Temperatures of -70OC and 2nd Dose after 3 weeks for Pfizer-BioNTech Vaccine? Additionally, there are reports of ‘Adverse Reactions’ after the ‘First Doses’ of the ‘Approved Vaccines’ and how do the ‘Vaccine Brands’ compare from the ‘Candidate Vaccines Phase III Clinical Trials’ for envisioning the ‘Potential Possibilities’ in a ‘Mixed Brand Vaccination Regimen’? Permitting ‘Mixed Brands’ of ‘Vaccines’ for ‘Vaccinations’ must be critically reviewed for overall ‘Vaccine Efficacy’ and ‘Vaccine Safety’! The ‘Different Vaccine Brands’ may also have differential stimulation of ‘Humoral Immunity’ and ‘Cellular Immunity’[13-16] with implications for ‘Vaccination Success’ using ‘Mixed Vaccine Brands’!! ‘Reduced Vaccine Dosage’ has also been touted for ‘2nd Doses’!!!

It was reportedly suggested that ‘Mixing Vaccine Brands’ was going to be ‘Commonplace’[42]! This is not an inspiring ‘Programmatic Performance Milestone’ for a ‘Systemically Systematically Coordinated Intervention’ Strictly guided by the Science of the ‘Candidate Vaccines Clinical Trials’!! The ‘Vaccine Brands Mixing’ envisioned as ‘Commonplace’ speaks volumes concerning how well the ‘COVID-19 Vaccinations Plan’ was informed by ‘Data Governance’-‘Research Governance’ of the ‘Candidate Vaccines Phases I-III Clinical Trials’!!

Unlike the permitted ‘Vaccine Brands Mixing’, albeit in rare circumstances, in the United Kingdom, it is reported that the United States of America ‘Will not allow the receipt of two different Vaccine Brands for lack of Data’[1,43]! The ‘American Vaccine Brands Mixing Policy’ is rational! The ‘United Kingdom Permitted Vaccine Brands Mixing’ may undermine the determinant ‘Science of Vaccinology’ and, indeed, ‘Research Governance Principles’. This, indeed, exposes the Vulnerability of Science! Conventionally, Science is about Concepts, Facts and Figures and there is the urgent imperative to uphold Strict ‘Research Governance Principles’ to protect against the Vulnerabilities of Science!!! ‘Programmatic Dispositions’ that are not backed by verifiably available ‘Transparent Scientific and Clinical Trials Data’ are not justified!!!

The posture of the United Kingdom to ‘Prioritize on getting as many at-risk people vaccinated with the first dose over ensuring people get their second dose within 3-4 weeks suggested by the Manufacturers’ should be critically appraised[1,44]! The ‘Manufactures’ Recommendations’ are predicated on, and informed by, the verifiably available ‘Candidate Vaccines Clinical Trials Data’!! ‘Vaccination Policy Positions’ to the contrary amplify, and take advantage of, the ‘Vulnerability’ of the Science of Vaccinology and ‘Best Practices’ situate with ‘Research Governance Principles’!

As a ‘Knowledge and Practice Sphere’, Science Must be clearly Defined with Strict Rules to be Rigorously Upheld! There Must be Ethos and Principles undergirding Science: Basic and Applied! The ‘Robust Research Governance Principles’ Must be Strictly Upheld at All times and in All circumstances if ‘Scientific Predictions and Expectations’ are to be realized as envisioned! The Sanctity of the ‘Principles’ and ‘Practice’ of Science Must be Upheld to eclipse its Vulnerability!! This should similarly be extended to the ‘Robust Research Governance Principles’!!! ‘Programmatic Dispositions’ Must, at All times, be guided by verifiably available transparent ‘Scientific Data’, ‘Research Data’ and ‘Clinical Trials Data’!!! Anything to the contrary disposes avoidable ‘Unjustifiable Programmatic Confusion’!!!!

This ‘Communication’ is a ‘Modest Contribution’ to the ‘Clarion Call’ to protect Science against its Vulnerabilities by Upholding its Ethos and Principles: The ‘Robust Research Governance Principles’ Must be Upheld at All times and in All circumstances! If there are no ‘Transparent Clinical Trials Data’ for ‘Mixed Vaccine Brands Vaccination’, it is not justifiable!

REFERENCES
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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

22 January 2021
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology, University of Benin and Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria. Also, UNICEF-Trained BFHI Master Trainer and ICDC-Trained in Code Implementaion. Also a Technical Expert/ Consultant on FMOH-UNICEF-NAFDAC Project on Code Implementation in Nigeria
Institute of Child Health, College of Medical Sciences, University of Benin, Benin City, Nigeria