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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 3 rd 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., Competing Interests: None

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., Competing Interests: Disclosure of interest: The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and declare the following activities and relationships: AKZ is now employed by the Bill and Melinda Gates Foundation, Seattle USA. She also maintains an adjunct teaching appointment at the Aga Khan University. She approved the final manuscript but did not influence these analyses., (Copyright © 2022 by the Journal of Global Health. All rights reserved.)

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., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2022 Kodish et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: WHO recommends hospital-based treatment for young infants aged 0-59 days with clinical signs of possible serious bacterial infection, but most families in resource-poor settings cannot accept referral. We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for 7 days for situations in which hospital referral was not possible., Methods: In a multisite open-label equivalence trial in DR Congo, Kenya, and Nigeria, community health workers visited all newborn babies at home, identifying and referring unwell young infants to a study nurse. We stratified young infants with clinical signs of severe infection whose parents did not accept referral to hospital by age (0-6 days and 7-59 days), and randomly assigned each individual within these strata to receive one of the four treatment regimens. Randomisation was stratified by age group of infants. An age-stratified randomisation scheme with block size of eight was computer-generated off-site at WHO. The outcome assessor was masked. We randomly allocated infants to receive injectable procaine benzylpenicillin-gentamicin for 7 days (group A, reference group); injectable gentamicin and oral amoxicillin for 7 days (group B); injectable procaine benzylpenicillin-gentamicin for 2 days, then oral amoxicillin for 5 days (group C); or injectable gentamicin for 2 days and oral amoxicillin for 7 days (group D). Trained health professionals gave daily injections and the first dose of oral amoxicillin. Our primary outcome was treatment failure by day 8 after enrolment, defined as clinical deterioration, development of a serious adverse event (including death), no improvement by day 4, or not cured by day 8. Independent outcome assessors, who did not know the infant's treatment regimen, assessed study outcomes on days 4, 8, 11, and 15. Primary analysis was per protocol. We used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000286044., Findings: In Kenya and Nigeria, we started enrolment on April 4, 2011, and we enrolled the necessary number of young infants aged 7 days or older from Oct 17, 2011, to April 30, 2012. At these sites, we continued to enrol infants younger than 7 days until March 29, 2013. In DR Congo, we started enrolment on Sept 17, 2012, and continued until June 28, 2013. We randomly assigned 3564 young infants to either group A (n=894), group B (n=884), group C (n=896), or group D (n=890). We excluded 200 randomly assigned infants, who did not fulfil the predefined criteria of adherence to treatment and adequate follow-up. In the per-protocol analysis, 828 infants were included in group A, 826 in group B, 862 in group C, and 848 in group D. 67 (8%) infants failed treatment in group A compared with 51 (6%) infants in group B (risk difference -1·9%, 95% CI -4·4 to 0·1), 65 (8%) in group C (-0·6%, -3·1 to 2·0), and 46 (5%) in group D (-2·7%, -5·1 to 0·3). Treatment failure in groups B, C, and D was within the similarity margin compared with group A. During the 15 days after random allocation, 12 (1%) infants died in group A, compared with ten (1%) infants in group B, 20 (2%) infants in group C, and 11 (1%) infants in group D. An infant in group A had a serious adverse event other than death (injection abscess)., Interpretation: The three simplified regimens were as effective as injectable procaine benzylpenicillin-gentamicin for 7 days on an outpatient basis in young infants with clinical signs of severe infection, without signs of critical illness, and whose caregivers did not accept referral for hospital admission., Funding: Bill & Melinda Gates Foundation grant to WHO., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Background: WHO recommends referral to hospital for possible serious bacterial infection in young infants aged 0-59 days. We aimed to assess whether oral amoxicillin treatment for fast breathing, in the absence of other signs, is as efficacious as the combination of injectable procaine benzylpenicillin-gentamicin., Methods: In a randomised, open-label, equivalence trial at five sites in DR Congo, Kenya, and Nigeria, community health workers followed up all births in the community, identified unwell young infants, and referred them to study nurses. We randomly assigned infants with fast breathing as a single sign of illness or possible serious bacterial infection, whose parents did not accept referral to hospital, to receive either injectable procaine benzylpenicillin-gentamicin once per day or oral amoxicillin treatment twice per day for 7 days. A person who was off-site generated randomisation lists using computer software. Trained health professionals gave injections, but outcome assessors were masked to group allocations. The primary outcome was treatment failure by day 8 after enrolment, defined as clinical deterioration, development of a serious adverse event including death, persistence of fast breathing on day 4, or recurrence up to day 8. The primary analysis was per protocol and we used a prespecified similarity margin of 5% to assess equivalence between regimens. This study is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12610000286044., Findings: From April 4, 2011, to March 29, 2013, we enrolled 2333 infants aged 0-59 days with fast breathing as the only sign of possible serious bacterial infection at the five study sites. We assigned 1170 infants to receive injectable procaine benzylpenicillin-gentamicin and 1163 infants to receive oral amoxicillin. In the per-protocol analysis, from which 137 infants were excluded, we included 1061 (91%) infants who fulfilled predefined criteria of adherence to treatment and adequate follow-up in the injectable procaine benzylpenicillin-gentamicin group and 1145 (98%) infants in the oral amoxicillin group. In the procaine benzylpenicillin-gentamicin group, 234 infants (22%) failed treatment, compared with 221 (19%) infants in the oral amoxicillin group (risk difference -2·6%, 95% CI -6·0 to 0·8). Four infants died within 15 days of follow-up in each group. We detected no drug-related serious adverse events., Interpretation: Young infants with fast breathing alone can be effectively treated with oral amoxicillin on an outpatient basis when referral to a hospital is not possible., Funding: Bill & Melinda Gates Foundation grant to WHO., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.)

The use of molecular diagnostic tools in epidemiological investigations of Cryptosporidium, Giardia, and Enterocytozoon has provided new insights into their diversity and transmission pathways. In this study, 157 stool specimens from 2-month to 70-year-old patients were collected, a polymerase chain reaction (PCR)-restriction fragment length polymorphism (RFLP) analysis of the small subunit (SSU) rRNA gene was used to detect and differentiate Cryptosporidium species, and DNA sequence analysis of the 60 kDa glycoprotein (gp60) gene was used to subtype Cryptosporidium hominis and Cryptosporidium parvum. Giardia duodenalis, and Enterocytozoon bieneusi in the specimens were detected using PCR and sequence analysis of the triosephosphate isomerase (tpi) gene and internal transcribed spacer (ITS), respectively. C. hominis and C. parvum were found in two (1.3%) and one (0.6%) specimen respectively, comprising of Ia and IIe (with 8 nucleotide substitutions) subtype families. The G. duodenalis A2 subtype was detected in five (3.2%) specimens, while four genotypes of E. bieneusi, namely A, type IV, D and WL7 were found in 10 (6.4%) specimens. Children aged two years or younger had the highest occurrence of Cryptosporidium (4.4%) and Enterocytozoon (13.0%) while children of 6 to 17 years had the highest Giardia infection rate (40.0%). No Cryptosporidium, Giardia, and Enterocytozoon were detected in patients older than 60 years. Enterocytozoon had high infection rates in both HIV-positive (3.3%) and HIV-negative (8.3%) patients. Results of the study suggest that anthroponotic transmission may be important in the transmission of Cryptosporidium spp. and G. duodenalis while zoonotic transmissions may also play a role in the transmission of E. bieneusi in humans in Kaduna State, Nigeria., (Published by Elsevier Inc.)

Background: The health care sector depends to a large extent on human labor. Poor worker motivation can greatly affect health outcomes and patient safety. There is little information on the health workers' perceptions of working conditions in resource-poor settings., Method: Three state-owned facilities in each state were selected by simple random sampling technique. The selected facilities were visited on weekdays between 9 and 10 a.m. A self-administered structured questionnaire was given to all health care workers on duty in the facility at the time of visit., Results: A total of 299 questionnaires were returned. The response rate was 85.43%. Two hundred four (68.2%) workers experienced general satisfaction with their current jobs. The relationships between general job satisfaction and presence of conflict at work (P = 0.001), freedom of expression (P > 0.001), managerial support for staff welfare (P > 0.001), managerial support for staff career development (P > 0.001), availability of tools and consumables in the workplace (P > 0.001) and progress towards personal professional goals (P = 0.001) were statistically significant., Conclusion: The level of general job satisfaction was high. Though salaries were important, presence of conflict at work, freedom of expression, managerial support for staff welfare, managerial support for staff career development, availability of tools and consumables in the workplace and progress towards personal professional goals appear to play a role in worker motivation.

Objective: To determine the level of maternal care in Northern Nigeria., Design: A cross-sectional descriptive study design was used., Setting: The Study was Community based and carried out in the ten states that constitute UNICEF D zone in northeast Nigeria., Population: Women who delivered in the 11 months preceding the survey and resident in the study area., Methods: The WHO cluster sampling methodology was used to draw a sample of 210 eligible women in each of the 10 local government areas (LGAs)., Main Outcome Measures: Utilization of antenatal care (ANC) services, tetanous toxoid immunization, skilled attendant at delivery and postnatal care., Results: Majority of the respondents, 73.2%, were between the ages 20 and 34 years. Overall, 50% of the women attended antenatal clinics during their last pregnancy, with a range of ANC coverage by LGA of 14.0-81.0%. The proportion of women who booked in the first, second and third trimesters was 22.8, 63.0 and 14.2%, respectively. The antenatal services offered ranged from 95.7% for abdominal examination to 41.2% for urine examination. Sixty percent of the women received no tetanus toxoid in their last pregnancy, 11% had one dose and 29% had at least two doses. Home delivery was still the norm throughout the zone with 1791 (85.3%) delivering at home. Up to 80.5% of the deliveries were supervised by personnel with no verifiable training in sanitary birthing techniques. Only 11.4% (233) of those who received ANC had postnatal check-up., Conclusions: Maternal health care as evidenced above is far from the ideal. Likewise, the commitment of the 5th Millennium Development Goal is extremely far-reaching: to reduce the maternal mortality ratio by 75% by the year 2015 with this level of maternal care.

The strategy of integrated management of childhood illness (IMCI) aims at improving the skills of first level health workers and consequently, improving the survival chances of children. The guidelines have been shown to be cost-effective. We aimed to determine the potential impact of using IMCI guidelines on drug treatment cost. The cost of drugs prescribed for 129 sick children, by first level health workers, who were managed at three primary health facilities in Sabon Gari Local Government Area of Kaduna State, was calculated. The corresponding cost using the IMCI guidelines was also calculated. There were 74 males and 55 females (M:F=1.3:1). An average of 4.5 drugs per patient were prescribed by the health workers compared to 2.3 drugs per patient when using the IMCI guidelines. The total cost of drugs prescribed by the health workers was N15,279.39 with an average of N118.44 per child. The corresponding costs had the IMCI guidelines been used were N3,062.53 and N23.73, respectively. Treatment cost using the traditional method was 4.98 times more expensive than using methods advocated by the IMCI guidelines. The projected cost savings related to drugs when using IMCI guidelines were based on the assumption that inappropriate drugs would not be prescribed by health workers once they are introduced to and started using the IMCI guidelines.