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Covid-19: Millions could be offered booster vaccinations from September

BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1686 (Published 02 July 2021) Cite this as: BMJ 2021;374:n1686

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COVID-19 Pandemic and COVID-19 Vaccine Hesitancy: An Imperative to be Cautious with COVID-19 Vaccine Boosters; Avoid ‘Programmatic Recommendation Precocity’

Dear Editor

The ‘COVID-19 Pandemic’ unearths ‘Intricate Issues’ which MUST be conclusively addressed ‘Systemically-Systematically’ for the world to win the ‘Global Fight’ against the ‘21st Century Unprecedented Scourge’. Only a few ‘Issues’ will be discussed in this ‘Communication’! The first ‘Issue’ is the ‘Rapidly Dynamically Transmuting COVID-19 Specifics’ which occasioned the ‘COVID-19 Research Outpourings’ to be at par with the ‘Ravaging Devastating Scourge’! The need for the ‘Rapid COVID-19 Research Harvests’ reportedly contributed to less stiff adherence to ‘Robust Research Governance Principles-Pillars’ with the resultant ‘COVID-19 Research Wastes’[1-4]! Scientists were, in fact, counseled to protect ‘Science’ and ‘Research’ against ‘Vulnerabilities’ thrown up by the ‘COVID-19 Pandemic Challenges’[5]!!

Several other ‘Issues’ beyond the ‘COVID-19 Marathon Finish Line’ were discussed previously and not further in this ‘Communication’[6-8]! These include, among others,’ Vaccine Transportation’, ‘Vaccine Distribution’, ‘Vaccine Delivery-Vaccine Administration Dissociation’, ‘Vaccine Hesitancy’ and ‘Vaccine Uptake’, ‘Vaccine Efficacy’ and ‘VIP Concept’, ‘Vaccine Trial Population Diversity’ and ‘SARS-CoV-2 Variants Issue’[8]!

An important ‘Issue’ is the ‘2nd Dose Uncertainties’ which is now a ‘Programmatic Cog’ in the ‘Wheel of Progress’ in the ‘Global COVID-19 Pandemic Control’[9-23]! The ‘Issues of 2nd Dose Uncertainties’ constitute a ‘Huge Pool of Difficulties’ which were also disposed previously[16,18,23]! They are not discussed further in this ‘Communication’ but include, among several others: ‘2nd Dose Required’, ‘Interval Before 2nd Dose’, ‘Extended Interval Before 2nd Dose’, ‘Dosage for 2nd Dose’, ‘Vaccine Type for 2nd Dose’, ‘1st Dose In Clinical Trials’, ‘Unknown 1st Dose’, ‘Prioritizing 2nd Dose Before 1st Dose In Others’, ‘2nd Dose After Inadvertent 1st Dose In Pregnancy’, ‘Delayed 2nd Dose and Vaccine-resistant SARS-CoV-2 Mutations’ and ‘2nd Dose and Previous Incomplete Vaccinations’!!

Other ‘Unresolved 2nd Dose Issues’ include, among others: ‘2nd Dose and Signed Informed Consent Form’, ‘2nd Dose and Indemnity’, ‘2nd Dose and Epidemic Curve Realities’, ‘2nd Dose and Health Services Strain’, ‘2nd Dose and Contraindications’, ‘2nd Dose, Interval Delay and Cost-Burden’, ‘2nd Dose Delays, Vulnerable Groups and Consequences’, ‘2nd Dose, Vaccination Coverage and Complete Vaccination’, ‘2nd Dose, Vaccine Production-Supply Chain Logistics and International Politics-Transparency’, ‘2nd Dose and Dose Reduction’, ‘2nd Dose and Inverse Equity Hypothesis’ and ‘2nd Dose and Boosters’! Indeed, the ‘Booster Doses Issue’ has complicated the ‘Vaccination Programmatic Plan’ for the ‘Global COVID-19 Pandemic Control’!!

A new ‘Booster Doses Conversation’ is increasingly emerging and possibly assuming greater attention and ‘Conversational Proportions and Dimensions’! For some ‘COVID-19 Vaccines’, this may become the ‘2nd Dose’ after the previously ‘Scientifically Recommended Single-Dose Vaccination Plan’ while for others possibly the ‘3rd Dose’ also after the previously ‘Scientifically Recommended 2-Dose Vaccination Plan’!! The recent articulation of some relevant ‘COVID-19 Vaccinations and Boosters Issues’ is instructive24! The Joint Committee on Vaccinations and Immunizations (JAVI) advised ‘COVID-19 Booster Vaccinations’ in England from September 2021[25]! The ‘Booster Vaccinations’ will be rolled-out as a ‘2-Staged Programme’ with the ‘Annual Flu Vaccinations’:

Stage 1: ‘COVID-19 Booster Dose’ to be administered with ‘Annual Flu Vaccinations’ to (i) Immunosuppressed Adults 16 years and over, (ii) Residents of Residential Care Homes for Older Adults, (iii) All Adults 70 years and over, (iv) Clinically Extremely Vulnerable Adults 16 years and over and (v) Frontline Health and Social Care Workers.

Stage 2: Soon after Stage 1, the ‘COVID-19 Booster Vaccinations’ with the ‘Annual Flu Vaccinations’ are offered to (i) All Adults 50 years and over, (ii) People 16-49 years in Groups at risk for Serious Illness from Flu and COVID-19 and (iii) Adult Household Contacts of Immunosuppressed Persons.

The JAVI reportedly stated that this ‘Advice’ (‘Advisory’-‘Recommendation’) will be ‘Updated by September 2021 after further Data Analysis’[1]. Why the ‘Rush’ to issue the ‘COVID-19 Booster Vaccinations Advice’ ahead of September 2021 when, in fact, further Data Analysis is yet to be undertaken with envisioned ‘Possible Advice Update’? This is tantamount to a ‘Programmatic Recommendation Precocity’! For STRICT compliance with ‘Research Governance Principles/ Pillars’ and ‘Data Governance Principles’, ‘Results should be predicated on Complete Data Analysis’ and ‘’Advice’/ ‘Recommendations’ are predicated on such ‘Results’’! Any ‘Process Flow’ which is ‘NON-STRICTLY COMPLIANT’ with ‘STRICT RESEARCH AND DATA GOVERNANCE PRINCIPLES’ increases the ‘Vulnerabilities’ of ‘SCIENCE’ and ‘RESEARCH’ to avoidable ‘Assault’!! In a ‘RUSH’ in a ‘Programmatic Intervention’, we MUST ‘Make Haste Slowly’ to avoid ‘Research Waste’ and, in this particular case, ‘COVID-19 Research Waste’[26-28]!!

The ‘JAVI Advice’ has, indeed, been critiqued for its ‘Necessity’ and ‘Practicalities’ in addition to ‘Justified Resource Deployment’ for ‘COVID-19 Booster Vaccinations’ in a ‘World’ where several ‘Vulnerable Disadvantaged Populations’ are yet to receive their ‘COVID-19 Vaccinations 1st Dose’[24]! At the moment, there is ‘Little Clinical and Laboratory Evidence for Booster Doses’[24]! The JAVI, in fact, reportedly also indicated that ‘Final Advice is to be based on Vaccine Safety, Efficacy, Durability and Latest Epidemiological Evidence and Information on Emerging Variants and Results of Clinical Trials’[29]!! This, again, amplifies the imperative that ‘Programmatic Recommendation Precocity’ MUST be AVOIDED!!!! The NHS England plans the Stage 1 for 6th September to 17th December 2021[30]!!!

Current ‘Global News’ monitored recently (9th July 2021) revealed that the FDA and CDC in the USA countered the proposed ‘Booster Dose’ for the ‘Pfizer-BioNTech COVID-19 Vaccine’! Also, the European Medicines Agency (EMA) reportedly stated that ‘There were not enough Data on Booster Doses’ for ‘COVID-19 Vaccines’!! The ‘Stance’ of the ‘Regulatory Authorities’ in the USA and European Union disposes another support to AVOID ‘Programmatic Recommendation Precocity’!!!

‘Vaccine Hesitancy’ is a ‘Huge Difficulty’ poking a ‘Hole’ in the ‘Global Fight’ against the ‘COVID-19 Pandemic’! Several ‘Determinants’ to this ‘Programmatic Phenomenon’-‘Vaccination Obstacle’ include, among several others: Unresolved Origin of SARS-CoV-2, Natural or Man-made ‘Bio-Terrorism-Weapon’, Vaccine Production Candidate Target Diversity, Meteoric Clinical Trials Phases, Population Diversity Issues in Clinical Trials, Vaccine Distribution and Inverse Equity Hypothesis, Vaccination Plan Recommendations and Inconsistencies, 2nd Dose Uncertainties and now: ‘COVID-19 Vaccine Booster Doses’ and the avoidable ‘Programmatic Recommendation Precocity’!! ‘Vaccines-Vaccinations Transformation’ was discussed previously and will be remarkably undermined by the likely-to-be-worsened ‘Vaccine Hesitancy’ necessitating the imperative to AVOID ‘Programmatic Recommendation Precocity’ with ‘COVID-19 Vaccine Booster Doses’[28]!!

This ‘Communication’ is a ‘Contribution’ to the evolving ‘COVID-19 Vaccination Booster Doses Conversation’ and the imperative to AVOID ‘Programmatic Recommendation Precocity’!

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

11 July 2021
CHARLES OSAYANDE EREGIE
MEDICAL DOCTOR
Professor of Child Health and Neonatology and Consultant Paediatrician and Neonatologist
Institute of Child Health, College of Medical Sciences, University of Benin, Benin City, Nigeria.