PREVALENCE, PATTERN AND OUTCOME OF ACUTE EVENT FOLLOWING IMMUNIZATION AMONG CHILDREN LESS THAN 24 MONTHS ATTENDING IMMUNIZATION CLINIC AT KACHAKO PRIMARY HEALTH CENTER

CHAPTER ONE

1.1 BACKGROUND OF THE STUDY

Immunization entails making an individual resistant to disease. The process by which an individual is made immune or resistant to an infectious disease, typically by the administration of a vaccine (UNICEF). Immunization remains of the most important public health interventions and a cost-effective strategy to reduce both the morbidity and mortality associated vaccine-preventable diseases (Tagbo Omotowo,Nwokoye,2012). VPDs are a major source of mortality and morbidity among children throughout the developing world, causing deaths in millions every year (UNICEF).

To prevent these diseases, vaccines are delivered through routine health services and through supplemental immunization activities to the children targeted (Mallika,2014).Immunization is essential in achieving targets 3.3 and 3.8 of the Sustainable Development Goals (SDG) which hope to end epidemics of communicable diseases and achieve universal health coverage by 2030, respectively (WHO 2017). Globally, it is estimated that immunization averts an estimated two to three million deaths from diphtheria, tetanus, pertussis (whooping cough) and measles every year in all age groups (Araki and Bruno, 2006.). Despite the numerous benefits of immunization, uptake of vaccines is still very low especially in developing countries Nigeria inclusive, making VPDs the most common cause of childhood mortality with an estimated 2-3million deaths each year (GAVI 2016).In the United States of America (USA), the Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination against 14 diseases during the first 24 months of life (Wodi,Ault,Hunter,McNally,Szilagyi,2021).

In the USA, report showed that coverage among children born during 2016–2017 compared with coverage among children born during 2018–2019 increased for a majority of recommended vaccines (Holly,Michael,Laurie,Elam-Evans,Yankey,2019).Coverage was >90% for ≥ 3 doses of poliovirus vaccine (93.4%), ≥ 3 doses of hepatitis B vaccine (HepB) (92.7%), ≥1 dose of measles, mumps, and rubella vaccine (MMR) (91.6%), and ≥1 dose of varicella vaccine (VAR) (91.1%); coverage was lowest for =2 doses of hepatitis A vaccine (HepA) (47.3%) (Holly et al,2019).

Adverse event following immunization (AEFI) has been defined as any untoward medical occurrence which follows immunization, and which does not necessarily have a causal relationship with the usage of the vaccine (WHO). Vaccine-associated adverse events may affect healthy individuals and should be promptly identified to allow additional research and appropriate action to take place. If not rapidly and effectively dealt with, these events undermines people’s confidence in a vaccine and can ultimately lead to dramatic consequences for immunization coverage and disease incidence (WHO). These adverse events are global phenomena (Tagbo et al.,2012, Jolly et al,2019). For example, in the USA, it was reported that for every 10,000 cases of vaccinations, 1.14 cases of AEFIs were reported with 1.4% deaths (Puliyel, 2013).In Australia, 14.1 cases of AEFIs were reported per 100,000 doses in 2009 (Hu,Li,Lin,Chen,Chen,2013) and in 2012, 129.5 per 100,000 vaccine doses in Sri Lanka (MOH Sri Lanka,2013). A descriptive study done in Brazil reported that BCG vaccine was responsible for 41.3% of all cases of cold subcutaneous abscess, lymphadenitis and ulcers bigger than 1cm (Bisseto 2017). A study conducted in China revealed that majority of the AEFI occurred more than 24 hours after vaccination (Hiu 2012). A study done in Iran revealed that most AEFI were more frequently observed after the first dose than the second dose of vaccination with the pentavalent vaccine (Karimi et al ,2017) Which might be because the immune system is already sensitized after the first dose leading to better tolerance upon administration of the second dose (Adam,Onowugbeda,Osuji,Omohwovo,2020.).

Similarly, a study in India revealed that the overall incidence of any AEFI reported (including any major, minor or coincidental events) with the first dose vaccination, was 136/1000 vaccination events, with most people experiencing any AEFI after 30 min but within 24 h following immunization (Chaudhary et al,2022.). The spectrum of symptoms reported within 30 min of vaccination ranged from local events (redness and itching) to systemic or generalized symptoms such as Ghabrahat or tachycardia were most common. A total of 75 AEFIs were reported within 24 h with the most common complaint being onset of fever within 24 hrs among any AEFI reported. The occurrence of AEFI within 7 days of vaccination was reported to be 15, where the most frequent symptom was fever of all AEFI reported (Chaudhary et al, 2022.).

Another similar study in Hamadan, Iran revealed that the cumulative incidence rate of pentavalent-related adverse events during 48 hours following immunization was estimated to be 15.8% for swelling, 10.9% for redness, 44.2% for pain, 12.6% for mild fever, 0.1% for high fever, 20.0% for drowsiness, 15.0% for loss of appetite, 32.9% for irritability, 4.6% for vomiting and 5.5% for persistent crying, however, there was no evidence for the occurrence of convulsion and encephalopathy among children who receive pentavalent vaccines (Karamin et al, 2017).

In Africa context, for example, in Malawi and other countries in East Africa and southern Africa, MDR H58 S. Typhi (Typhoid Conjugate Vaccine) which emerged in 2010 after its introduction from Asia (Feasey et al,2015,Wong et al,2015) specifically became the predominant bloodstream infection among adults and children in Malawi, with a 21% incidence of complications among children (including a 3.6% incidence of small-bowel perforation) and a 2.1% case fatality rate (Musicha 2017; Olgemoeller 2020). Another study in Malawi revealed a primary outcome following Typhoid conjugate vaccine was blood culture confirmed typhoid fever which occurred any time after vaccination.¹³ Secondary outcomes were the safety profiles of Vi-TCV and the MenA vaccine (assessed according to the number of adverse events detected in the first 30 minutes after vaccination), the number of serious adverse events within 28 days after vaccination, and the number of adverse events within 6 months after vaccination. For the primary evaluation of vaccine efficacy, all children were under enhanced passive surveillance for at least 18 months from February 21, 2018, to April 3, 2020 (Patel et al, 2021).

Despite a 2008 WHO recommendation for programmatic use of existing vaccines in countries in which typhoid is endemic (WHO 2008), no African country integrated these vaccines into routine schedules, largely because of the unsuitability of their use in the youngest children and the need for repeated doses (Patel et al, 2021).

A study conducted in Enugu among 331 mothers revealed that 190 (57.4%) of children less than 24 months with AEFI were managed by giving paracetamol, 43 (19.5%) took their children to the hospital, while 2 (0.9%) used herbal mixtures (Osa-eloka, Ekwueme, 2009). Another study at the University of Benin Teaching Hospital (UBTH), Benin State reported that fever was the commonest AEFI reported by majority, 142 (84.0%) of the caregivers, followed by swelling and pain at the injection site (Adam et al,2020). Majority of the caregivers claimed that the AEFI occurred 24 hours or more after the vaccine was administered 106 (62.7%) and especially after the first dose of vaccine was given 107 (63.3%).

Three-quarters of the caregivers, 126 (74.6%) reported a previous AEFI episode following BCG vaccination, while 68 (40.2%), 48 (28.4%) and 40 (23.7%) stated that the AEFI occurred following pentavalent, measles and yellow fever vaccine respectively. A study done in Ilorin, North-central, Nigeria revealed about 49.1% of the reported AEFI cases occurred after administering Diphtheria, Pertussis and Tetanus (DPT) has the most commonly reported cause of AEFI (Aderibigbe,et al.,2010).

A study done on AEFI in Kaduna State, revealed Zaria local government area (LGA) had the highest reporting rates of AEFI in the Kaduna State while Sanga LGA has the lowest reporting rate per 10,000 doses of vaccines administered (Ishaku, et al., 2021). Although, Kaduna state have an overall of AEFI reporting rate of 9.09 per 10,000 administered doses. This Kaduna study further revealed that Pentavalent vaccine is the suspect antigen responsible for the highest number of AEFI cases and accounted for 90.91% of reported cases and a vaccine reaction rate of 44.77 per 10000 doses while the suspect antigen for the lowest number of attributable AEFI cases is Td with only 17 cases being reported for the period representing 0.22% and a vaccine reaction rate of 0.18 per 10000 doses (Ishaku,et al.,2017).

The distribution of the cases by gender showed that 49.9% (3904) were males, while 50.1% (3920) were females (Ishaku,et al.,2017). Twenty-one (21) of the 28 reaction types in the line- list with fever(<38℃) the main reaction types reported while no single case of anaphylaxis, anaphylactic shock, facial paralysis, neck stiffness, encephalopathy, sepsis, or unconsciousness were reported (Ishaku,et al.,2017).

In a study conducted in selected PHCs within Kano metropoly on AEFI among children less than 24 months the prevalence of AEFI was (43.5%, n=164), and most cases (72.4%, n=273) were mild. Fever was the most common type of AEFI reported (66.5%, n=109) and was higher among infants less than three months (44.5%, n=73). Age of the index child was the only significant predictor of AEFI (OR:0.18, 95% CI: 0.10-0.35). The study shows that AEFI was common among children less than 24 months old in Kano (Maizare, et al., 2021).

1.2 PROBLEMS STATEMENT

AEFIs underreporting is one of the barriers to achieving the objectives of pharmaco-vigilance of vaccines worldwide (WHO 2016; Tsafaka, 2015). Nigeria mainly practices a mix of passive and active AEFI surveillance, which involves spontaneous reporting by health workers (HWs) and the general public report any condition that they believe could be associated or related to a vaccine/vaccination (FMOH Nigeria,2020). Some reports in Nigeria revealed a high prevalence (34.9%) of AEFI and 22.1% for pentavalent vaccine in the country (Kaduna State PHCDB, 2018; Lawan, et al., 2016).In Africa, poliomyelitis vaccine was suspended in Nigeria for one year following quality and safety issues alleged by religious leaders (Muhammad, et al., 2018) This led to massive rebound of polio cases (Clement,et al.,2006). Similarly, a review of Nigerian AEFI national report for 2018 showed Kaduna State as one of the States with sub-optimal reporting of AEFI cases in the country (Ishaku, et al., 2021; Sadon,et al.,2018). The WHO in 1999, developed generic guidelines for AEFI surveillance that can be adapted to local resources and systems (Pan American Health Organization,2002); In tackling the problems in the past, Nigeria have instituted AEFI surveillance into its Expanded Programme on Immunization (EPI), in line with WHO AEFI guidelines, and its AEFI guidelines produced in 2011 were revised in 2018 to meet current challenges (FMOH, 2020). Modules on AEFI have previously been part of the Basic Guide for Routine Immunization training conducted for health workers across the country in 2017  Kaduna State, in North-western Nigeria, has, in this regard, trained 2405 personnel from 1184 public and private health facilities in all its 23 Local Government areas (Kaduna State PHCDB, 2018).

In Nigeria, studies have shown that immunization coverage was on the decline. Reasons include failure to assess immunization status of children during visit to health facilities, failure to administer all the needed vaccines simultaneously (Tagbo,2005) and probably fears of adverse events, as is seen in developed countries today (Sadoh, et al.,2007). Poor AEFI surveillance impacts negatively on immunization (Bardenheir,2004).To reduce the occurrence of vaccine adverse events and maintain public confidence in vaccines, further research is important to improve understanding of vaccine safety and thereby foster the development and use of safer vaccines (Muhammad et al.,2018).

1.3 JUSTIFICATION OF THE STUDY

The importance of AEFI in Nigeria cannot be underscored in helping to link the causality association between the vaccine administered and the reported event for action (FMOH, 2020). According to the International Vaccine Access Center (IVAC) projections, achieving immunization coverage of 90% in Nigeria in the next decade will increase the country’s economy by $17 billion. Several reports and local community surveys have indicated that AEFI is one of the primary reasons for inadequate immunization coverage in Kaduna State (KSPHCDB 2016; National Bureau of Statistics,2016/2017)  coupled with the fact that in recent times, Nigeria had introduced new vaccines into the immunization schedules. More are expected in the coming years, thereby making it essential to strengthen AEFI surveillance in the country through timely detection, analysis, and adequate responses to AEFI cases (FMOH,2020).

The rationale for carrying out this present study among caregivers of children less than 24 months is because research has shown that most caregivers are ignorant about AEFI and sometimes failed to report these adverse events following immunization (Rania et al.,2017). Again, a study revealed that AEFI affects immunization uptake among children less than 24 months in ABUTH, Zaria (Ishaku et al,2021). To my best knowledge although a study was conducted on prevalence and outcome of AEFI among children less than 24 months attending selected PHCs within Kano metropoly, no similar research was conducted on similar topic in a PHC outside Kano metropoly . To add to the existing body of knowledge of this topic, it is important to find out the prevailing pattern of occurrence of AEFI among children under 24 months attending immunization clinic of Kachako PHC. In order to influence evidence-based policy decision-making and planning for immunization services in Kachako Ward, Takai LG and Kano state at large. Also, this present study would help to fill the knowledge gaps of the caregivers about AEFI and make them more aware of AEFI.

1.4 AIM AND OBJECTIVES

1.4.1 GENERAL OBJECTIVES     

To determine the prevalence, pattern and outcomes of adverse event following immunization among children less than 24months attending immunization clinic in Kachako PHC, Kachako, Takai LG, Kano State.

1.4.2 SPECIFIC OBJECTIVES

1.      To determine the prevalence of adverse event following immunization among children less than 24months attending immunization clinic in Kachako PHC.

2.      To determine the patterns and trends of adverse event following immunization among children less than 24months attending immunization clinic in Kachako PHC

3.      To determine the outcomes of adverse event following immunization among of children less than 24months attending immunization clinic in Kachako PHC.

4.      To assess the factors influencing adverse event following immunization among children less than 24 months in Kachako PHC.

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