Cohort event monitoring for safety signal detection in adult individuals 18 years and above after immunisation with coronavirus disease 2019 vaccines in Nigeria.

Introduction: In Nigeria, immunisation with coronavirus disease 2019 (COVID-19) vaccines commenced in March 2021. COVISHIELD from AstraZeneca (AZ), a viral vector vaccine, was the brand administered in the first phase of vaccinations for pre-determined eligible adults 18 years and above. As more brands of COVID-19 vaccines have been introduced in Nigeria, identifying effective and safe vaccine brands is essential to pharmacovigilance and public health. The current study assessed the safety of the AZ-AZD1222 (ChAdOx1) COVID-19 vaccine in adults during the first phase of the vaccination exercise in Nigeria. Methodology: We conducted a descriptive analysis of safety data from selected vaccination sites across six states in Nigeria between June 2021 and September 2021. Respondents were monitored over 3 months for local and systemic reactions, as well as hospitalisation and mortality. Measures obtained from respondents include age, sex, pre-existing comorbidity, local and systemic reactions to vaccines, timing onset of reactions, hospitalisation and mortality. Bivariate and multivariable regression models were used to assess factors associated with vaccine reactogenicity. Results: A total of 1284 individuals were enrolled in the cohort study from the six selected states (Anambra, Borno, Edo, Katsina, Lagos and Plateau) representing the geopolitical zones of Nigeria. A total of 675 individuals or 52.6% of enrolees reported non-serious adverse effects, and only one individual or 0.08% reported a serious adverse event following immunisation in the first 7 days after vaccination. None of the enrolled participants reported adverse events requiring hospitalisation. The most common self-reported symptoms amongst vaccine recipients were tenderness at the injection site 20.9% and fever 20.3%. A majority of symptoms (55.5%) occurred on or before the 3rd day after vaccination. Multivariable logistic regression model showed that age 60 years or above (vs. 18-24 years) was significantly associated with a lower likelihood of a vaccine-related symptomatic reaction (adjusted odds ratio: 0.35; 95% confidence interval: 0.20-0.61). There was no reported mortality amongst all the enrolled and followed-up vaccine recipients. Conclusion: Our findings suggest that the safety profile of the AZ vaccine is acceptable, and the observed symptoms were mild and mostly within the first 3 days following vaccination. Vaccine recipients will benefit from counselling about potential transient reactions, and improving public awareness can potentially encourage the uptake of vaccines and reduce the spread of the COVID-19 pandemic.

Acceptance and compliance with micronutrient powder (MNP) among children aged 6-23 months in northern Nigeria.

This study sought to understand the utilization patterns and influencing factors of micronutrient powder (MNP) use among children aged 6-23 months in northern Nigeria as part of formative research to inform the design of an infant and young child feeding (IYCF) intervention. It had an iterative, multi-phase design whereby mixed methods data were collected from 144 households participating in an 8-week home-feeding trial. During the first four weeks, 12-hour direct observations were conducted with 24 households using MNP. Over the next four weeks, 18 of the same households were observed. In-depth interviews were also conducted among 27 caregivers to understand factors related to utilization. Unannounced spot checks (n = 86) were also conducted to gauge MNP compliance. Most households (76.7%) (66/86) adhered to instructions for using MNP (Adamawa (34/44 = 77.3%) and Kebbi (32/42 = 76.2%)). Facilitating factors to MNP adherence were identified, most notably the high ease of utilization, with 90.0% of caregivers indicating the MNP was 'easy' or 'very easy' to use. Several barriers to MNP compliance were identified and organized into three domains: product-related (e.g. difficulty opening sachet), child-related (e.g. not finishing fortified staple), and caregiver-related (e.g. difficulty making food daily). In Kebbi and Adamawa, MNP was accepted and utilized according to guidelines among most study participants. Findings may be used for scaling up MNP within a more comprehensive IYCF intervention in northern Nigeria.

Oral amoxicillin plus gentamicin regimens may be superior to the procaine-penicillin plus gentamicin regimens for treatment of young infants with possible serious bacterial infection when referral is not feasible: Pooled analysis from three trials in Africa and Asia.

Background: Hospital referral and admission in many- low and middle-income countries are not feasible for many young infants with sepsis/possible serious bacterial infection (PSBI). The effectiveness of simplified antibiotic regimens when referral to a hospital was not feasible has been shown before. We analysed the pooled data from the previous trials to compare the risk of poor clinical outcome for young infants with PSBI with the two regimens containing injectable procaine penicillin and gentamicin with the oral amoxicillin plus gentamicin regimen currently recommended by the World Health Organization (WHO) when referral is not feasible. Methods: Infant records from three individually randomised trials conducted in Africa and Asia were collated in a standard format. All trials enrolled young infants aged 0-59 days with any sign of PSBI (fever, hypothermia, stopped feeding well, movement only when stimulated, or severe chest indrawing). Eligible young infants whose caretakers refused hospital admission and consented were enrolled and randomised to a trial reference arm (arm A: procaine benzylpenicillin and gentamicin) or two experimental arms (arm B: oral amoxicillin and gentamicin or arm C: procaine benzylpenicillin and gentamicin initially, followed by oral amoxicillin). We compared the rate of poor clinical outcomes by day 15 (deaths till day 15, treatment failure by day 8, and relapse between day 9 and 15) in reference arm A with experimental arms and present risk differences with 95% confidence interval (CI), adjusted for trial. Results: A total of 7617 young infants, randomised to arm A, arm B, or arm C in the three trials, were included in this analysis. Most were 7-59 days old (71%) and predominately males (56%). Slightly over one-fifth of young infants had more than one sign of PSBI at the time of enrolment. Severe chest indrawing (45%), fever (43%), and feeding problems (25%) were the most common signs. Overall, those who received arm B had a lower risk of poor clinical outcome compared to arm A for both per-protocol (risk difference = -2.1%, 95% CI = -3.8%, -0.4%; P = 0.016) and intention-to-treat (risk difference = -1.8%, 95% CI = -3.5%, -0.2%; P = 0.031) analyses. Those who received arm C did not have an increased risk of poor clinical outcome compared to arm A for both per-protocol (risk difference = -1.1%, 95% CI = -2.8%, 0.6%) and intention-to-treat (risk difference = -0.8%, 95% CI = -2.5%, 0.9%) analyses. Overall, those who received arm B had a lower risk of poor clinical outcome compared to the combined arms A and C for both per-protocol (risk difference = -1.6%, 95% CI = -3.5%, -0.1%; P = 0.035) and intention-to-treat (risk difference = -1.4%, 95% CI = -2.8%, -0.1%; P = 0.049) analyses. Conclusions: Analysis of pooled individual patient-level data from three large trials in Africa and Asia showed that the WHO-recommended simplified antibiotic regimen B (oral amoxicillin and injection gentamicin) was superior to regimen A (injection procaine penicillin and injection gentamicin) and combined arms A and C (injection procaine penicillin and injection gentamicin, followed by oral amoxicillin) in terms of poor clinical outcome for the outpatient treatment of young infants with PSBI when inpatient treatment was not feasible. Registration: AFRINEST study [9] is registered with the Australian New Zealand Clinical Trials Registry: ACTRN12610000286044. SATT Bangladesh study [10] is registered with ClinicalTrials.gov: NCT00844337. SATT Pakistan study [11] is registered at ClinicalTrials.gov: NCT01027429.

Comparative assessment of infection prevention and control practice among maternity unit health workers in public and private secondary health facilities in Kaduna state, Nigeria

OBJECTIVES: Infection prevention and control (IPC) practice in health facility (HF) is abysmally low in developing countries, resulting in significant preventable morbidity and mortality. This study assessed and compared health workers' (HWs) practice of IPC strategies in public and private secondary HFs in Kaduna State. MATERIAL AND METHODS: A cross-sectional comparative study was employed. Using multistage sampling, 227 participants each were selected comprising of doctors, midwives, and nurses from public and private HF. Data were collected using interviewer-administered questionnaire and observation checklist and analyzed using bivariate and multivariate analysis. Statistical significance determined at P < 0.05. RESULTS: The practice of infection prevention was poor. Overall, 42.3% of the HWs did not change their gowns in-between patients, with the significantly higher rates in 73.1% of private compared to 42.3% of public HF workers (P < 0.001). In addition, 30.5% and 10.1% of HWs do not use face mask and eye goggle, respectively, when conducting procedures likely to generate splash of body fluids, however, there was no significant difference in these poor practices in public compared to private HFs. The mean IPC practice was 51.6 ± 12.5%, this was significantly lower among public (48.8 ± 12.5%) compared to private (54.5 ± 11.9%) HF workers (P < 0.0001). Private HF workers were 3 times more likely to implement IPC interventions compared to public HF workers. CONCLUSION: IPC practice especially among public HF workers was poor.

Comparative assessment of infection prevention and control practice among maternity unit health workers in public and private secondary health facilities in Kaduna state, Nigeria

Objectives: Infection prevention and control (IPC) practice in health facility (HF) is abysmally low in developing countries, resulting in significant preventable morbidity and mortality. This study assessed and compared health workers' (HWs) practice of IPC strategies in public and private secondary HFs in Kaduna State. Material and Methods: A cross-sectional comparative study was employed. Using multistage sampling, 227 participants each were selected comprising of doctors, midwives, and nurses from public and private HF. Data were collected using interviewer-administered questionnaire and observation checklist and analyzed using bivariate and multivariate analysis. Statistical significance determined at P < 0.05. Results: The practice of infection prevention was poor. Overall, 42.3% of the HWs did not change their gowns in-between patients, with the significantly higher rates in 73.1% of private compared to 42.3% of public HF workers (P < 0.001). In addition, 30.5% and 10.1% of HWs do not use face mask and eye goggle, respectively, when conducting procedures likely to generate splash of body fluids, however, there was no significant difference in these poor practices in public compared to private HFs. The mean IPC practice was 51.6 ± 12.5%, this was significantly lower among public (48.8 ± 12.5%) compared to private (54.5 ± 11.9%) HF workers (P < 0.0001). Private HF workers were 3 times more likely to implement IPC interventions compared to public HF workers. Conclusion: IPC practice especially among public HF workers was poor. Keywords: Hospital-acquired infection, Infection prevention and control, Maternity unit, Practice

New global guidance supports community and lay health workers in postpartum hemorrhage prevention.

New global guidance has emerged to support countries as they consider introducing or scaling-up misoprostol for postpartum hemorrhage (PPH). The World Health Organization (WHO) and the International Federation of Gynecology and Obstetrics (FIGO) recognize the critical role that community and lay health workers play in preventing PPH and increasing access to misoprostol where skilled birth attendants are not available. As case examples from Nigeria and Nepal illustrate, community engagement and empowerment are critical strategies in successful misoprostol for PPH programs, and must increasingly be viewed as part of efforts to improve maternal health and achieve Millennium Development Goal 5.