Ensuring Access to Affordable, Timely Vaccines in Emergencies

Perspectives

Ensuring access to affordable, timely vaccines in emergencies Elder Kate,a Saitta Barbara,a Ducomble Tanja,b Alia Miriam,c Close Ryan,d Scheele Suzanne,a Erickson Elise,e Scourse Rosalind,e Kahn Patriciaf & Elder Grege

Vaccination is an effective interven- in children and can lead to bacteraemia, cost ultimately led MSF to reduce the tion to reduce disease, disability, death meningitis, and other serious condi- planned PCV target population from and health inequities worldwide. Over tions, collectively known as invasive 6 weeks to 5 years (as recommended the last two decades, vaccines have pneumococcal disease.2 Children caught by WHO for high-risk populations)3 to become more accessible in low-income in humanitarian emergencies are par- 6 weeks to 2 years. Similarly, during a countries; however, significant gaps ticularly vulnerable to pneumococcal PCV vaccination campaign in May 2016 remain, particularly in humanitarian infections when exposed to overcrowd- in refugee camps in Greece, MSF found emergencies, where populations face ing, poor access to health services and no alternative to buying Pfizer’s PCV13 increased risks of many diseases. In malnutrition. PCV, which protects from local pharmacies, paying up to ap- 2013, the World Health Organization against pneumonia caused by Strepto- proximately US$ 68.10 per dose, that is, (WHO) published Vaccination in acute coccus pneumoniae, is recommended 20 times its lowest global price.5 humanitarian emergencies: a framework by WHO for inclusion in immunization These examples illustrate how the for decision-making, to provide guidance programmes for infants up to 23 months lack of agreed prices and mechanisms on which vaccines to prioritize during of age and children aged 2–5 years who for procuring vaccines in emergencies emergencies.1 However, substantial are at high risk of infection.3 leads to unpredictable pricing, also obstacles, especially high prices for new Before the implementation of the causing avoidable delays in launching vaccines, hinder implementation of this mechanism, neither humanitarian or- life-saving vaccination activities, since framework and of critical vaccination ganizations nor countries ineligible for price negotiations with manufacturers activities in emergency settings. support from Gavi, the Vaccine Alliance, can take months. In response to these challenges, could access the lowest global prices Amid ongoing problems and unsuc- global health stakeholders held a series for new vaccines such as PCV. In 2008, cessful price negotiations, in 2014, MSF of consultations in 2016 and proposed MSF stepped up attempts to procure made a rare exception to its donation a WHO-based mechanism, the Hu- PCV for children in crises; these efforts policy6 and accepted PCV donations. manitarian Mechanism, for the rapid later included working within the rec- This exception was made in view of com- procurement of affordable vaccines dur- ommendations of WHO’s framework. mitments from PCV manufacturers to ing emergencies, to be used by nongov- However, difficulties in sourcing PCV develop long-term solutions for afford- ernmental organizations (NGOs), civil at an affordable price from Pfizer and able PCV access. However, no solution society organizations, United Nations GlaxoSmithKline, the only two manu- was subsequently proposed, and after (UN) agencies and governments. facturers of PCVs, undermined our ef- the donation period concluded, MSF Here we present the background of forts, exemplifying the broader problem publicly rejected a further PCV13 dona- the creation of the mechanism from the of unaffordable vaccines in emergencies, tion in October 2016.7 perspective of Médecins Sans Frontières as described in the Global Vaccine Ac- (MSF), including a description of our tion Plan.4 In 2013, MSF added 10-valent The Humanitarian past challenges in accessing affordable PCV (PCV10) and pentavalent vaccines Mechanism pneumococcal conjugate vaccine (PCV; to a mass vaccination campaign package Box 1), a critical vaccine during many for children in a refugee camp in Yida, In May 2017, the Humanitarian Mecha- emergencies. We then describe how the South Sudan, two vaccines not in the nism was jointly launched by WHO, mechanism has so far facilitated access country’s national immunization sched- the United Nations Children’s Fund to more affordable PCV and outline ule at the time. The vaccine products (UNICEF), Save the Children and MSF.8 steps that could increase its potential represented 43% (81 040/188 449 United The mechanism aims to address the high for saving lives. States dollars, US$) of the intervention’s prices of new vaccines and to facilitate costs, mostly for GlaxoSmithKline’s rapid access to vaccines for children in Barriers to affordable PCV PCV10 vaccine: its price of approxi- emergencies who missed doses or who mately US$ 7.00 per dose was nearly live in countries where a given vaccine Streptococcus pneumoniae is the most four times that of pentavalent vaccine at is not yet in the national immunization common cause of bacterial pneumonia approximately US$ 1.85 per dose. This calendar, but where there is a high risk of

a Access Campaign, Médecins Sans Frontières, New York, United States of America (USA). b Médecins Sans Frontières, Geneva, Switzerland. c Médecins Sans Frontières, Barcelona, Spain. d Perelman School of Medicine, University of Pennsylvania, Philadelphia, USA. e Access Campaign, Médecins Sans Frontières, Rue de Lausanne 78, Case Postale 1016, 1211 Geneva 1, Switzerland. f Médecins Sans Frontières, New York, USA. Correspondence to Rosalind Scourse (email: roz.scourse@london.msf.org). (Submitted: 13 December 2018 – Revised version received: 20 May 2019 – Accepted: 3 July 2019 – Published online: 28 October 2019 )

Bull World Health Organ 2019;97:851–853 | doi: http://dx.doi.org/10.2471/BLT.18.228585 851 Perspectives Ensuring access to vaccines in emergencies Kate Elder et al.

Box 1. Timeline of key events leading to the establishment of the Humanitarian mechanism; once contracts between the Mechanism for affordable, timely access to vaccines in emergencies, 2009–2018 implementing organization and manu- facturer are in place, the administrative June 2009 aspects, and the verification process Gavi The Vaccine Alliance, launches Advance Market Commitment, with new lowest global PCV require minimal overhead cost. price of US$ 3.50 per dose (plus US$ 3.50/dose top-up subsidy) for eligible countries. June 2011 Implementation of the WHO Strategic Advisory Group of Experts constitutes Working Group on Vaccination in Humanitarian Emergencies. mechanism April 2013 In September and November 2016, the MSF’s Dear GAVI campaign calls on Gavi, The Vaccine Alliance, to extend its discounted vaccine two manufacturers announced that prices to NGOs and humanitarian actors. they would make their PCV products July 2013 available through the mechanism at MSF pays approximately US$ 7.00 per dose for 10-valent PCV to vaccinate refugee children in the lowest global price (then US$ 3.05 Yida, South Sudan. per dose).9,10 As of April 2019, the October 2013 mechanism has facilitated access to WHO Strategic Advisory Group of Experts publishes the first edition of Vaccination in acute 764 665 PCV doses for children caught humanitarian emergencies: a framework for decision-making. in humanitarian emergencies, 474 402 of December 2014 which were for 19 MSF vaccination in- MSF accepts PCV donations, an exception to its donation policy. terventions in Central African Republic, April 2015 Greece, Niger, Nigeria, South Sudan and MSF launches A Fair Shot campaign calling on manufacturers to lower PCV prices to US$ 5 per Syrian Arab Republic. The remaining child (for all three doses) for low-income countries and humanitarian organizations. PVC doses were used by UNICEF, UN May 2016 Relief and Works Agency, the Interna- MSF pays approximately US$ 68.10 per dose for 13-valent PCV from local pharmacies for a tional Organization for Migration and vaccination campaign for refugee children in Greece. the Red Crescent. In April 2019, MSF June and October 2016 procured 4800 PCV doses for US$ 3.05 MSF, WHO and other stakeholdersa meet to discuss solutions to difficulties in procuring timely each to vaccinate refugee children in supply of affordable vaccines in emergencies. Greece, the first use of the mechanism for an emergency in a high-income September 2016 country.11 GlaxoSmithKline commits to providing its two-dose vial (PCV10) at the lowest global price at the time (US$ 3.05 per dose) to civil society organizations that vaccinate refugees and internally More broadly, the strategies of MSF displaced people in emergency settings. in emergencies include vaccinating chil- dren up to 59 months old for any vaccine November 2016 identified by WHO’s framework as a Pfizer commits to providing its multi-dose (4-dose) vial (PCV13) at the lowest global price at the time (US$ 3.05 per dose) to civil society organizations that vaccinate in emergency settings. priority in a given context. These strate- gies include children who did not receive May 2017 all scheduled doses during their first Humanitarian Mechanism jointly launched by WHO, MSF, UNICEF and Save the Children. year of life because the vaccine had not May 2018 yet been introduced into the national First monitoring meeting for the Humanitarian Mechanism with representatives from WHO, immunization calendar or because of UNICEF, Save the Children, MSF, Gavi, GlaxoSmithKline and Pfizer. other reasons. Such instances highlight MSF: Médecins Sans Frontières; NGO: nongovernmental organization; PCV: pneumococcal conjugate how the framework can be used to ex- vaccine; WHO: World Health Organization; UNICEF: United Nations Children’s Fund; US$: United States pand vaccination age groups in settings dollars. where disease burden and outbreak risk a Other stakeholders included: United Nations High Commissioner for Refugees, UNICEF, International are high, and where the mechanism is in Federation of Red Cross and Red Crescent Societies, Save the Children, Médecins du Monde/Doctors place to procure vaccines that are oth- of the World, Centre for Vaccine Ethics and Policy, Gavi, the Vaccine Alliance, International Rescue Committee, International Federation of Pharmaceutical Manufacturers and Associations, Developing erwise difficult or impossible to access Countries Vaccine Manufacturers Network. rapidly and affordably.

Next steps exposure. Under the mechanism’s terms gency need for a vaccine is identified, of reference, manufacturers commit to the implementing organization makes Building on these initial successes, we supplying a particular vaccine (currently a request to WHO, specifying the con- see three critical elements of the mecha- only PCV10 and PCV13) at a set price. text, number of doses needed and other nism, which if fully implemented, could UNICEF, through its supply division, relevant details; within two days WHO greatly enhance its impact. First, the and other organizations with their own verifies the emergency context and mechanism needs to be better known supply chain capacity, negotiate con- appropriateness of the request. Upon among global health actors, including tracts bilaterally with manufacturers, verification, the order can be placed UN agencies and NGOs, who should specifying ordering and delivery terms and the vaccine supplied.8 WHO man- be encouraged to use it under appro- as well as protocols. When an emer- ages the administrative aspects of the priate circumstances. Second, while

852 Bull World Health Organ 2019;97:851–853| doi: http://dx.doi.org/10.2471/BLT.18.228585 Perspectives Kate Elder et al. Ensuring access to vaccines in emergencies the mechanism’s terms of reference in- how and where this flexibility can be ap- strengthened by multiple organizations cludes use by governments responding plied, and it can only cover Gavi-eligible recognizing the gap between existing to emergencies,8 conditions attached to countries.12 technical guidelines and constraints on the PCV pledges discussed here (the Finally, the types of vaccines their implementation, that is, the lack only pledges to the mechanism so far) pledged to the mechanism by manu- of rapidly available, affordable vaccines. exclude governmental use. Manufactur- facturers should be expanded: the only While the mechanism does not address ers should allow governments to access commitments to date are for pneumo- the broader systemic failures of the vac- the mechanism during emergencies coccal conjugate vaccines. Current and cine market, it was created to specifically to procure critical vaccines needed to future manufacturers should commit address the failure of the global vaccine protect their populations. Many middle- other vaccines with affordability and ac- market to meet relatively small, urgent income countries already grapple with cessibility challenges to the mechanism, vaccine procurement needs efficiently high vaccine prices for routine immu- so they can be procured rapidly at the and affordably. Further steps are needed nization programmes and may find the lowest global price. for the mechanism to reach its full cost of extending vaccination to influxes potential; however, it already provides of displaced people during emergencies Conclusion a critical platform during humanitar- prohibitive. While Gavi adopted a fra- ian crises for expanding the number gility, emergencies and refugees policy The mechanism is a significant step for- of people who can receive life-saving in June 2017 to allow more flexible use ward in delivering life-saving vaccines to vaccines. ■ of Gavi-supported vaccine doses in populations caught in emergencies and specific contexts, strict criteria exist for conflict. The mechanism’s mandate is Competing interests: None declared.

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