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Interim Recommendations on the Use of COVID-19 Vaccines in Nigeria

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Interim Recommendations on the Use of COVID-19 Vaccines in Nigeria Nigeria Immunization Technical Advisory Group (NGI-TAG) Interim Recommendations on the Use of COVID-19 Vaccines in Nigeria Should the COVID-19 vaccines be introduced for use among targeted Nigerian populace? If so, which COVID vaccines should the country introduce? What groups should be prioritized to receive the vaccines first? 1 Contents Acronyms ................................................................................................................................... 4 Executive Summary .................................................................................................................. 6 Introduction ..................................................................................................................... 9 2.1 Context of the question ........................................................................................... 10 2.2 General Information on the subject ......................................................................... 11 Methodology ................................................................................................................. 16 3.1 Establishment and functioning of a Working Group .............................................. 16 3.2 Recommendation framework ................................................................................. 16 3.3 Evidence Search and Assessment ........................................................................... 16 Presentation of the evidence ....................................................................................... 18 4.1 Vaccine and immunization characteristics .............................................................. 18 4.1.1 Safety ................................................................................................................. 18 4.1.2 Efficacy and effectiveness ................................................................................ 42 4.1.3 Vaccine indirect effects .................................................................................... 75 4.1.4 Vaccine characteristics ..................................................................................... 78 4.2 Disease ...................................................................................................................... 91 4.2.1 Burden of disease ............................................................................................. 91 4.2.2 Clinical characteristics of disease ................................................................... 105 4.3 Use and costs of health care ................................................................................. 134 4.4 Alternative measures ...................................................................................... 143 4.5 Regional and international considerations ........................................................... 146 4.6 Economic and operational considerations .................................................... 149 4.7 Vaccine related costs and resource use ................................................................ 149 4.8 Vaccine availability ........................................................................................... 151 4.9 Vaccine affordability ....................................................................................... 153 4.9.1 Socio-economic and social impact of disease ............................................... 156 4.10 Economic impact on immunization programme .......................................... 159 4.11 Health policy and programmatic issues......................................................... 174 4.11.1 Feasibility ..........................................................................................................174 4.12 Vaccine registration and regulation ............................................................... 175 4.13 Impact on Resources ...................................................................................... 177 4.13.1 Ability to evaluate ............................................................................................ 177 2 4.13.2 Acceptability .................................................................................................... 179 4.13.3 Equity ............................................................................................................... 185 4.13.4 Social Consideration ....................................................................................... 197 Discussions ................................................................................................................... 199 Proposed Recommendation (s)/Options ................................................................... 207 Annexes ....................................................................................................................... 210 References ............................................................................................................................. 211 3 Acronyms ACRONYMS DEFINITIONS ACE Angiotensin Converting Enzyme ADE Antibody Dependent Enhancement AEFI/AESI Adverse Events Following Immunization AFENET African Field Epidemiological Network ARDS Acute Respiratory Distress Syndrome BMGF Bill and Melinda Gates Foundation CEPI Coalition for Epidemic Preparedness Innovations CHAI Clinton Health Access Initiative DCL/IVAC Direct Consulting and Logistics/International Vaccines Access Centre DHS Demographic and Health Survey DM Diabetes Miletus ECG Electrocardiogram EOC Emergency Operations Centre EPI Expanded Program on Immunization ESRD End-Stage Renal Disease EUA Emergency Use Assessment EUL Emergency Use Listing FMoH Federal Ministry of Health GAVI Global Alliance on Vaccines and Initiative HCWs Health Care Workers HICs High Income Countries HIV Human Immunodeficiency Virus HRF Hypoxemic Respiratory Failure ICU Intensive Care Unit LMICs Low-Middle Income Countries MERS Middle East Respiratory Syndrome MICS/NICS Multiple Indicator Cluster Survey/National Immunization Coverage Survey MIS-C Multisystem Inflammatory Syndrome in Children MoF Ministry of Finance mRNA Messenger RNA NAAT Nucleic Acid Amplification Test NAFDAC National Agency for Food and Drug Administration NBS National Bureau of Statistics NCDC National Center for Disease Control NGI-TAG National Immunization Technical Advisory Group NLPS National Longitudinal Phone Survey NPHCDA National Primary Health Care Development Agency NPIs Non-Pharmaceutical Interventions PEG Polyethylene Glycol PICO Population, Intervention, Comparator, and Outcomes Format PPE Personal Protective Equipment PTF Presidential Task Force RBD Receptor Binding Domain 4 RDT Rapid Diagnostic Test RNA Ribonucleic Acid RSA Republic of South Africa SAGE WHO Strategic Advisory Group of Experts on Immunization SARS Severe Acute Respiratory Syndrome SARS CoV2 Severe Acute Respiratory Syndrome Coronavirus 2 SOP Standard Operating Procedure SORMAS Surveillance Outbreak Response Management & Analysis System UCC Ultra-Cold Chain UK United Kingdom UNICEF United Nations International Children Emergency Funds USA United States of America WB World Bank WG Working Group WHO World Health Organization 5 Executive Summary Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), the causative virus of COVID-19 disease, has caused a pandemic of a proportion only seen over a century ago when the Spanish flu ravaged the world in 1918. This virus causes an acute respiratory syndrome with varying involvement of other organ systems. The case fatality rates vary across nations and do clearly correlate with the health systems capacities in the different regions. Similarly, the transmissibility has been significantly different, with the USA, UK, Brazil, and Europe having the highest proportion of transmission and fatalities. No one is immune from being infected by this virus. However, it is noteworthy that adults, mainly those aged 50 years and above, have been the most vulnerable to this viral infection and children are mostly asymptomatic or display mild symptoms of the disease. The first case of COVID-19, in Nigeria, imported from Italy, was confirmed on 27th February 2020. Subsequently, there was an increasing number of COVID-19 cases with the peak of the first wave at 790 cases on 1 July 2020 and the current surge as high as 2,314 on January 22, 2021, with total confirmed cases of 143,516 and total deaths of 1,710, as of February 12, 2021. These figures are a significant underestimation due to sub-optimal testing of the population for COVID-19. Lagos State remains the epicenter with almost a third of the country's total number of cases, but there has been progressive spread to all the other states of the country. The rapid rate of spread during the present resurgence (second wave) in many countries, including Nigeria, has been alarming. There has been a significant fatality among the frontline health workers, including Nigeria. The case fatality rate (CFR) of COVID-19 in Nigeria is 1.2%. COVID-19 is a disease that is still being studied with several unanswered questions. While it is now known that the immunological and inflammatory responses in the pathophysiology of the disease are the core drivers of the severity of the illness, controlling these have been more problematic in individuals with pre-existing morbidities. The various pharmaceutical measures to prevent and/or cure the disease have not produced total and prompt elimination of SARS CoV2. Still, the prompt institution of dexamethasone and anti-coagulants beneficially modulate the severity
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