Influenza immunization of pregnant women in low and middle income countries: Lessons learned Alan R. Hinman, MD, MPH Technical Consultation on Maternal Influenza Immunization Evidence and Implementation March 26, 2015
Outline of presentation • Partnership for Influenza Vaccine Introduction (PIVI) – History – Countries involved • Pregnant women immunized 2012-2014 • Features of PIVI • Lessons learned Although PIVI is concerned with all SAGE- identified priority groups, this presentation will focus on vaccination of pregnant women
PIVI Terms of Reference • Vision - Equitable access to seasonal influenza vaccines • Mission - To reduce morbidity and mortality of influenza in low- and middle-income countries (LMICs) by working with a wide range of global stakeholders to foster creation of sustainable national annual influenza vaccination programs
Development of PIVI
Evolution of PIVI • 2012 – 375,000 doses of excess NH Novartis influenza vaccine from Walgreens donated to Lao PDR • 2013 – 100,000 doses donated SH bioCSL to Lao PDR – 35,000 doses SH to Nicaragua (through PAHO Revolving Fund) – Grant from BMGF to expand PIVI • 2014 – 763,000 doses donated SH bioCSL to Lao PDR – ~32,000 doses SH Green Cross to Nicaragua (through PAHO RF) – 60,000 doses donated SH Green Cross to Armenia – 123,000 doses donated SH Green Cross to Morocco
Pregnant women vaccinated with PIVI- provided vaccine Lao PDR Nicaragua 2012 29,213 -- 2013 14,035 27,121 2014 36,173 24,997* Total 79,421 52,118 Grand total 131,539 *Nicaragua also purchased 95,000 doses with national funds so all 128,000 pregnant women in the country could be vaccinated
PIVI Evaluations Partner countries required to conduct program evaluations to inform country sustainability (and global evidence base) Operational: -post-introduction evaluations (PIE) -vaccine coverage/wastage -effect of flu vax on other health programs -program costs/requirements -year-round vs. annual delivery Safety: -adverse event monitoring (e.g. pregnancy outcomes ) Health impact: -focus in 2013-14 on effect of vaccine on infant outcomes (e.g. birth weight, prematurity) -modeled impact and cost-effectiveness
Evaluations of vaccine effect on birth outcomes - 2014 • Conducted in Laos and Nicaragua • Pilot of data collection and feasibility in 2013 • Enrollment in 2014 – Spring-summer vaccination – Follow-up completed by Q1 2015 • Laos – Sites: 3 hospitals (Vientiane [2], Luangprabang) – Enrolled women – 5,000 • Nicaragua – Sites: 2 hospitals (Managua) – Enrolled women – 4,000 • Expected results – Q3 2015
Planned evaluations - 2015 • PIE – Morocco, Armenia, (Cote d’Ivoire) • Feasibility and impact of year-round vs annual vaccination – Laos, (Kenya) • Cost, cost-effectiveness – Laos, Morocco, (Kenya) • AEFI – (Cote d’Ivoire) • Vaccine effectiveness to prevent respiratory disease in infants (Laos – 2016) • Modelled impact of vaccination – Laos, (Kenya)
Progress towards sustainability • Laos – 2014 – program costs borne by MoH – 2015 – MoH to support program and may purchase 25K doses of vaccine • Nicaragua – 2014 – 33K doses provided by PIVI; 95K doses purchased by MoH to ensure vaccine accessibility to all pregnant women in country • Armenia – Following 2014-5 PIVI donation, have increased flu vaccine purchase for 2015-6 • Morocco – PIVI donation in 2014 to be followed by increased MoH purchase in 2015 • (Kenya) – PIVI to support 2-3 year phased introduction, followed by MoH support of program (pending MoH decision)
Features of PIVI - 1 • Large public-private partnership including: – Ministries of Health in partner countries – The Task Force for Global Health – Centers for Disease Control and Prevention – Non-governmental organizations – The Bill & Melinda Gates Foundation – Vaccine manufacturers – Vaccine distributors – Other stakeholders, eg., • WHO HQ and Regional Offices • WHO Country Offices
Features of PIVI - 2 • Focus on building capacity in low and low- middle income countries to introduce and implement influenza immunization through – Technical assistance – Training – Provision of vaccines/supplies • Aim to foster sustainable influenza immunization programs • Country partners selected based on readiness and interest
Features of PIVI - 3 • An implementation project rather than a research project • Evaluations designed to identify factors facilitating/impeding influenza vaccine implementation • To date has relied on donations of funds or vaccines, which have come late in the season • Currently exploring purchase options
Implementation lessons learned - 1 • Close collaboration between EPI and ANC programs is essential – This is not always the case at the outset – ANC staff may not be adept/practiced at immunizing pregnant women – Mere proximity of services may not be adequate • One-stop shopping enhances participation – Avoids two waits for service – With effort and good will, collaboration can be achieved
Implementation lessons learned - 2 • In both Lao PDR and Nicaragua, EPI staff supplemented MCH staff as major providers of immunization in ANC clinics as well as “campaigns” • Combination of maternal immunization with other MCH activities (e.g., vitamin A distribution, deworming, tetanus toxoid was effective)
Implementation lessons learned - 3 • Step-wise addition of sites and complexity of data gathered was effective in increasing the complexity of studies — layering new information in successive years • Country MCH and EPI staff are interested in year-round maternal influenza immunization activities
Implementation lessons learned - 4 • Obtaining vaccine commitments in advance of the season rather than relying on later donations will enable more effective planning and implementation of maternal influenza immunization activities • Purchasing vaccine at a discount will promote a more sustainable program
Implementation lessons learned - 5 • Single dose pre-filled syringes (PFS) are preferred by staff for non-campaign approaches for convenience and to prevent wastage – However, PFS markedly increase storage/cold chain capacity requirements
Health lessons learned • In Lao PDR and Nicaragua, pregnant women were very accepting of influenza vaccination • Preliminary indications are that there may be more hesitancy in pregnant women in Armenia and Morocco • No serious AEFIs were encountered • Minor AEFIs were as expected • Impact on outcome of pregnancy being analyzed – Preliminary indications suggest no increased risk to fetus/newborn
Conclusions • To date, more than 130,000 pregnant women have received influenza vaccine through PIVI – In total, >1.4 million persons have received influenza vaccine through PIVI • PIVI has shown it is feasible to introduce influenza immunization of pregnant women in developing countries • Important lessons have been learned about introduction of influenza vaccine in developing countries
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