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Covid-19: Assess the effects of extending Pfizer vaccine dosing interval, expert urges

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n162 (Published 19 January 2021) Cite this as: BMJ 2021;372:n162

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COVID-19 Pandemic, COVID-19 Vaccines and ‘2nd Dose Uncertainties’: Still unresolved evolving matters

Dear Editor

It is increasingly clearer that the ‘Vaccines-Vaccinations Programmatic Transformation’ is increasingly confounded more by ‘Logistics and Determinants’ that are beyond the ‘Vaccines Marathon Finish Line’[1-8]! The ‘Rush’ and ‘Speed’ to get ‘Approved COVID-19 Vaccines’ may not necessarily translate programmatically to ‘Rapid Successful Vaccinations’ in defined Populations across Countries in the world!! Indeed, the ‘2nd Dose’ of ‘Approved COVID-19 Vaccines’ has become increasingly riddled with ‘Unresolved Evolving Uncertainties’ which have been ventilated in recent ‘Communications’[6,9-22]!! The ‘2nd Dose Uncertainties’ in the ‘Vaccines-Vaccinations Programmatic Transformation’ have assumed the ‘Front Burner’ for ‘COVID-19 Pandemic Control Conversations’!!!

Another addition to the ‘2nd Dose Uncertainties’ is reflected in a recent ‘Communication’[24]. A Statistician requested the United Kingdom Health Secretary to investigate the effects of extending the ‘Interval’ between the 1st and 2nd Doses of the Pfizer-BioNTech Vaccine[25]! The ‘Priority’ has been on the 1st Dose of both the Pfizer-BioNTech Vaccine and the Oxford-AstraZeneca Vaccine with the ‘2nd Doses’ scheduled for the end of 12 weeks after the ‘1st Dose’[26]! The Pfizer-BioNTech Candidate Vaccine Trials reportedly did not investigate ‘Different Intervals’ between the 1st and 2nd Doses unlike the Oxford-AstraZeneca Candidate Vaccine Trials that reportedly investigated the ‘Interval Variable’! After the 1st Dose, Vaccine Efficacy was reported to be 52% but there was no evidence of Vaccine Efficacy after 21 days[26]!! Therefore, the ‘Vaccination Plan Recommendations’ rescheduling the ‘2nd Dose’ beyond 21 days must be critically reviewed!

It is reported that 59% of recipients of Oxford-AstraZeneca Vaccine had their ‘2nd Dose’ between 9 and 12 weeks and Vaccine Efficacy after the ‘2nd Dose’ was investigated. It was higher at 65.4% with greater than 6 weeks between the 1st and 2nd Doses compared with 53.4% when the ‘Interval’ between the 1st and 2nd Doses was less than 6 weeks[21]! A previous Report indicated no sustained ‘Immune Response’ 42 days after the 1st Dose of the Pfizer-BioNTech Vaccine[27]!! It is, therefore, imperative for the ‘Scientific and Research Community’, situate with ‘Best Practices’ and ‘Robust Research Governance Principles’, to reconcile the ‘Reported Data’ of ‘Higher Vaccine Efficacy’ of ‘Intervals’ greater than 6 weeks (42 days)!! These ‘Scientific Research Reports’ require urgent ‘Reconciliation’ to minimize ‘Discrepancies’ and protect against the ‘Vulnerabilities’ of ‘Science’[28]!!!

While the ‘Interval’ between the 1st and 2nd Doses of the ‘Approved COVID-19 Vaccines’ remain the ‘Fulcrum’ of extant ‘COVID-19 Vaccinations Conversations’, the emergence of ‘SARS-CoV-2 Variants’ must remain in focus as these are facilitated by undue ‘Delays’ between the 1st and 2nd Doses[20,29]!! The ‘Variants’ also have ‘Programmatic Implications’ for ‘Successful COVID-19 Vaccinations’ in the ‘Global Fight’ against ‘COVID-19 Pandemic’!! The ‘Programmatic Issues’ of ‘Booster Doses’ are increasingly being discussed and will continue to assume greater attention and ‘Conversational Proportions and Dimensions’! These ‘Unresolved Evolving 2nd Dose Uncertainties’ will also progressively stoke ‘Vaccine Hesitancy’ with implications for ‘Successful Vaccination Programmes’ as veritable ‘Interventions’ in the ‘Global Fight’ against the ‘COVID-19 Pandemic’!!

This brief ‘Communication’ is a modest ‘Contribution’ to the raging evolving ‘Unresolved 2nd Dose Uncertainties Conversations’ which need to be given the deserved attention and focus to positively energize and drive the ‘Successful COVID-19 Vaccinations’ if ‘Vaccines’ must become ‘Vaccinations’ and be ‘Solutions’ to the ‘COVID-19 Pandemic’!! The ‘Communication’24 from the Statistician to the United Kingdom Health Secretary shows clearly that the ‘2nd Dose Uncertainties’ are not disappearing from the ‘Front Burner’ in a hurry in the ‘Global Fight’ against the ‘Unprecedented Devastating 21st Century Scourge’!!

REFERENCES
1. Mahase E. Covid-19: Where are we on immunity and vaccines? BMJ 2020;370:m3096
2. Antibodies Brouwer PJM, Caniels TG, Straten K et al. Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability. https://science.sciencemag.org/content/2020/06/15/science.abc5902
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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

08 February 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.