Implementation of a human papillomavirus vaccination demonstration project in Malawi: successes and challenges.

BACKGROUND: Cervical cancer is a major public health problem in Malawi. The age-standardized incidence and mortality rates are estimated to be 75.9 and 49.8 per 100,000 population, respectively. The availability of the human papillomavirus (HPV) vaccine presents an opportunity to reduce the morbidity and mortality associated with cervical cancer. In 2013, the country introduced a school-class-based HPV vaccination pilot project in two districts. The aim of this study was to evaluate HPV vaccine coverage, lessons learnt and challenges identified during the first three years of implementation. METHODS: This was an evaluation of the HPV vaccination project targeting adolescent girls aged 9-13 years conducted in Malawi from 2013 to 2016. We analysed programme data, supportive supervision reports and minutes of National HPV Task Force meetings to determine HPV vaccine coverage, reasons for partial or no vaccination and challenges. Administrative coverage was validated using a community-based coverage survey. RESULTS: A total of 26,766 in-school adolescent girls were fully vaccinated in the two pilot districts during the first three years of the programme. Of these; 2051 (7.7%) were under the age of 9 years, 884 (3.3%) were over the age of 13 years, and 23,831 (89.0%) were aged 9-13 years (the recommended age group). Of the 765 out-of-school adolescent girls aged 9-13 who were identified during the period, only 403 (52.7%) were fully vaccinated. In Zomba district, the coverage rates of fully vaccinated were 84.7%, 87.6% and 83.3% in year 1, year 2 and year 3 of the project, respectively. The overall coverage for the first three years was 82.7%, and the dropout rate was 7.7%. In Rumphi district, the rates of fully vaccinated coverage were 90.2% and 96.2% in year 1 and year 2, respectively, while the overall coverage was 91.3%, and the dropout rate was 4.9%. Administrative (facility-based) coverage for the first year was validated using a community-based cluster coverage survey. The majority of the coverage results were statistically similar, except for in Rumphi district, where community-based 3-dose coverage was higher than the corresponding administrative-coverage (94.2% vs 90.2%, p < 0.05), and overall (in both districts), facility-based 1-dose coverage was higher than the corresponding community-based (94.6% vs 92.6%, p < 0.05). Transferring out of the district, dropping out of school and refusal were some of the reasons for partial or no uptake of the vaccine. CONCLUSION: In Malawi, the implementation of a school-class-based HPV vaccination strategy was feasible and produced high (>80%) coverage. However, this strategy may be associated with the vaccination of under- and over-aged adolescent girls who are outside of the vaccine manufacturer's stipulated age group (9-13 years). The health facility-based coverage for out-of-school adolescent girls produced low coverage, with only half of the target population being fully vaccinated. These findings highlight the need to assess the immunogenicity associated with the administration of a two-dose schedule to adolescent girls younger or older than 9-13 years and effectiveness of health facility-based strategy before rolling out the programme.

The composition of demand for newly launched vaccines: results from the pneumococcal and rotavirus vaccine introductions in Ethiopia and Malawi.

Understanding post-launch demand for new vaccines can help countries maximize the benefits of immunization programmes. In particular, low- and middle-income countries (LMICs) should ensure adequate resource planning with regards to stock consumption and service delivery for new vaccines, whereas global suppliers must produce enough vaccines to meet demand. If a country underestimates the number of children seeking vaccination, a stock-out of commodities will create missed opportunities for saving lives. We describe the post-launch demand for the first dose of pneumococcal conjugate vaccine (PCV1) in Ethiopia and Malawi and the first dose of rotavirus vaccine (Rota1) in Malawi, with focus on the new birth cohort and the 'backlog cohort', comprised of older children who are still eligible for vaccination at the time of launch. PCV1 and Rota1 uptake were compared with the demand for the first dose of pentavalent vaccine (Penta1), a routine immunization that targets the same age group and immunization schedule. In the first year, the total demand for PCV1 was 37% greater than that of Penta1 in Ethiopia and 59% greater in Malawi. In the first 6 months, the demand of Rota1 was only 5.9% greater than Penta1 demand in Malawi. Over the first three post-introduction months, 70.7% of PCV1 demand in Ethiopia and 71.5% of demand in Malawi came from children in the backlog cohort, whereas only 28.0% of Rota1 demand in Malawi was from the backlog cohort. The composition of demand was impacted by time elapsed since vaccine introduction and age restrictions. Evidence suggests that countries' plans should account for the impact of backlog demand, especially in the first 3 months post-introduction. LMICs should request for higher stock volumes when compared with routine needs, plan social mobilization activities to reach the backlog cohort and allocate human resources and cold chain capacity to accommodate high demand following vaccine introduction.