Influenza immunization of pregnant women in low and middle income - - PowerPoint PPT Presentation

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
• f 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
• utcomes )

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

• f immunization in ANC clinics as well as

“campaigns”

• Combination of maternal immunization with
• ther 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
• f 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