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«04.16.14 THE UNCERTAIN FUTURE OF VACCINE DEVELOPMENT AND DEPLOYMENT FOR INFLUENZA PANDEMICS On December 13, 2013, a joint communique O ’NE IL L ...»

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BRIEFIN G PAP ER N O. 8

PAG E 1 O F 9

SAM F. HA LABI

04.16.14

THE UNCERTAIN FUTURE OF

VACCINE DEVELOPMENT AND

DEPLOYMENT FOR INFLUENZA

PANDEMICS

On December 13, 2013, a joint communique

O ’NE IL L INST IT U T E

The O’Neill Institute for National

issued by seven European and North

and Global Health Law at Georgetown University was American governments, Japan, and the established to respond to the need for innovative solutions to the most European Commission noted three influenza pressing national and international health concerns. Housed at the viruses now circulating globally that with Georgetown University Law Center in Washington D.C., the O’Neill unpredictable ease may become large- Institute reflects the importance of public and private law in health scale pandemics. They affirmed their policy analysis. The essential commitment to “support open sharing [of vision for the O’Neill Institute rests upon the proposition that the law influenza samples], as endorsed through has been, and will remain, a fundamental tool for solving the World Health Organization (WHO) critical health problems in our global, national, and local commu- Pandemic Influenza Preparedness (PIP) nities. By contributing to a more powerful and deeper understand- Framework and the International Health ing of the multiple ways in which law can be used to improve health, Regulations (2005) (IHR)” and recognized the O’Neill Institute hopes to encourage key decision-makers in “the importance of pathogen sample the public, private, and civil society sectors to employ the law as a sharing in strengthening our capabilities to positive tool to enable individu- als and populations in the United respond to emerging public health threats States and throughout the world to lead healthier lives. For of international concern.”1 The communique additional information, please visit did not specifically mention the ultimate www.oneillinstitute.org.

aim of sharing samples – the development of pandemic vaccines – nor how the medical

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The Uncertain Future of Vaccine Development and Deployment for Influenza Pandemics vaccines. Indeed, they could not; no such system exists. In the wake of the world’s 2009 experience with H1N1 pandemic influenza A (so-called “swine flu”,) high-, middle-, and lowincome countries, the World Health Organization, and the major vaccine manufacturers (which are overwhelmingly located in the countries issuing the communique) have made only halting progress in ensuring that pandemic vaccines are developed, approved, and distributed consistently with approaches that maximize their public health impact. This briefing paper assesses the obstacles to vaccination donation and distribution faced by the major global pharmaceutical companies, the World Health Organization, donor and recipient governments during the 2009 H1N1 pandemic and outlines some features of an effective system to deal with vaccine access when the next pandemic strikes.

BACKGROUND

When researchers in Mexico and the United States concluded that influenza-related hospitalizations in separate, non-contiguous areas of Mexico, southern California, and New York City uniquely affected children and young adults, they were alerted to the possibility that a new pandemic viral subtype of influenza had emerged.2 After the U.S. Centers for Disease Control and Prevention (CDC) received samples from two early H1N1 patients in mid-April, 2009, researchers exposed banked blood samples taken before and after vaccinations from 2005 to the new virus. Samples from children produced no antibodies, while samples from adults vaccinated against seasonal flu showed a slight increase in antibodies against the pH1N1 virus. Because it did not appear that the seasonal vaccine would adequately protect adults against infection, the CDC recommended development of a vaccine specific to the new strain. This recommendation was echoed in WHO’s June 11, 2009 declaration of a Phase 6 pandemic. Under the WHO classificatory scheme operating in 2009 (it has been revised in light of the H1N1 experience), in Phases 1-3 of a pandemic, influenza circulates predominantly in animals and there are few human infections. In Phase 4, there is sustained human-to-human transmission and in Phases 5 and 6, sustained human transmission spreads to at least two WHO regions.3 Vaccines are the first line of defense against influenza to prevent infection and control spread of the disease because they are more effective and burden society less than non-pharmaceutical measures like masks, closing of public gathering places, and isolation of patients. The CDC’s recommendation and WHO’s declaration triggered a race by a small number of vaccine manufacturers to develop and then put into production a pandemic-specific vaccine both because a market had instantaneously developed and because some manufacturers already had in place agreements with governments that required them to shift to pandemic vaccine production. Aside from the governments that had already put procurement policies and contracts in place, the vast majority of the world’s governments and the populations they represented lacked access to vaccines and looked to WHO to work with firms and potential donor governments to facilitate access. The gene sequence of wild-type pandemic pH1N1 was Jose A. Cordova Villalobos et. al., The Influenza A(H1N1) Epidemic in Mexico:: Lessons Learned Health Research 2

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The Uncertain Future of Vaccine Development and Deployment for Influenza Pandemics made publicly available on 27 April 2009. By 8 May 2009 samples of wild-type virus had been sent from reference laboratories to vaccine manufacturers, all of which were in Europe and the USA because they had the necessary high-level biological containment facilities.

After researchers concluded that the seasonal flu vaccine did not protect against pH1N1, pharmaceutical firms, five of which control approximately 80% of the influenza vaccine market, found themselves negotiating with WHO over conditions for donation, shipment, and distribution of vaccines. Governments with preexisting contracts sought to preserve as much of their firms’ capacity – that is, firms located within the territorial borders of the procuring governments – as would be necessary to inoculate their populations first before giving or selling to others; and a much larger than usual number of procurement officials, regulators, and other health care providers and vaccine distributors.

From the manufacturers’ perspective, these negotiations occurred in the shadow of potentially large liabilities related to their existing contractual arrangements with governments, detailed processes for vaccine approval, distribution and marketing, as well as more general exposure should quickly-developed vaccines generate unexpected adverse reactions or safety problems.

Regulatory approval for marketing and use is dependent on laboratory-generated evidence and clinical trial outcomes. Even safe and effective vaccines generate adverse events among those inoculated, ranging from (common) soreness at the injection site to fever, discomfort and muscle pain to (rare) anaphylaxis and oculo-respiratory syndrome (WHO 2012). One of the vaccines produced specifically for pH1N1 by GlaxoSmithKline has been associated with an increased risk of narcolepsy (CDC 2013). In many jurisdictions, manufacturers bear legal responsibility for these adverse events, although many states change these liabilities in cases of public health emergencies. Nevertheless, manufacturers faced a range of legal barriers to production, donation and discounted sale of pandemic vaccines like the process by which vaccines may be approved and registered with national regulatory authorities, protection from and indemnification for liability, preexisting advanced market commitment agreements which affect the ability to enter into additional contracts once a pandemic has been declared.

THE LEGAL FRAMEWORK FOR PH1N1 PANDEMIC INFLUENZA VACCINEDISTRIBUTION

Development, approval, and distribution of the 2009 pH1N1 vaccine was shaped by preexisting frameworks that had been established to address the outbreak of H5N1 avian flu in Southeast Asia.4 That subtype spread quickly around the globe but did not (and has not to date) evolved to become easily transmissible to humans. The concern that H5N1 may become easily transmissible to and then between humans resulted in both divergent (if accelerated) regulatory approval processes as well as a set of agreements entered into between two manufacturers – GlaxoSmithKline (GSK) and Sanofi Pasteur (Sanofi) – and the World Health Organization for donations of prepandemic H5N1 vaccine doses. After the pN1H1 influenza strain was identified, WHO immediately began negotiations with “all known” influenza vaccine McConnell J. (2010). Pandemic influenza: learning from the present. Public Health; 124(1):3-4.

4 O’N EILL INST I T U T E • BR I EF I N G PA P E R N O. 8 • 0 4.1 6.1 4 PAG E 4 O F 9 The Uncertain Future of Vaccine Development and Deployment for Influenza Pandemics manufacturers. Those discussions were shaped by planning for H5N1.

When the World Health Organization declared a Phase 6 pandemic, GSK and Sanofi had pledged 50 million and 60 million doses of H5N1 vaccine respectively, although no legal agreements for donations were in place. GSK and Sanofi agreed to convert those commitments to pandemic influenza A pH1N1 vaccine and to increase the number of doses to 150 million.

GSK and WHO signed an agreement for the donations on 10 November 2009 which resulted in just over 24 million doses actually donated. Sanofi announced a “flexible” donation of up to 100 million doses on 17 June 2009 but the donation agreement was not signed until December

2009. Novartis specifically eschewed donations, favoring pricing mechanisms to establish a “sustainable way” to deliver vaccines to developing countries.

Despite the small number of players, negotiations over all aspects of procurement were difficult and protracted, revealing a near total lack of planning to move vaccines from their private sector developers and manufacturers to the populations that needed them. Negotiations involved at least 4 manufacturers and 12 governments on the donor side and nearly 100 governments on the beneficiary side.5 WHO’s negotiation with GSK served as a template for agreements with CSL Australia, MedImmune, and Sanofi, which concluded in December

2009. Novartis signed an agreement in January 2010, although a 2011 WHO assessment of its response to the pandemic strongly suggests that the Novartis agreement differed from the other four. Legal agreements with governments followed those with firms: the USA (16 December), Australia (22 December), France (15 January 2010), Belgium (29 January 2010), Switzerland (16 March 2010), Norway (19 March 2010), Italy (16 April 2010), the UK (28 May

2010) and Singapore (21 June 2010). Some states perceived that WHO “shopped” different agreements with different legal terms to different governments, a practice that generated suspicion among the donor governments and further delay in finalizing terms.

The delay in placing agreements between firms, governments, and WHO was attributable to at least two causes. First, both firms and governments had entered into advance purchase agreements that constrained the ability of firms to donate or otherwise provide vaccines to WHO or governments directly. Second, vaccine manufacturers insisted on strong protections from liability should the pandemic influenza vaccine result in adverse health events in populations as well as coverage for interests affected by specific title-transfer arrangements.

ADVANCE PURCHASE AGREEMENTS AND TERRITORIAL RESTRAINTS

Long before WHO declared a pandemic, many countries including Belgium, Canada, Finland, France, Germany, Italy, Switzerland, The Netherlands, the United States, and the United Kingdom had already placed large orders of pH1N1 vaccine or had advanced agreements in place.6 In advance purchase agreements, a vaccine manufacturer agrees to supply its pandemic World Health Organization. Implementation of the International Health Regulations (2005). Report of the Review 5 Committee on the Functioning of the International Health Regulations (2005) in Relation to Pandemic (H1N1) 2009 (2011). Geneva: World Health Organization.

Doshi P, Jefferson T. (2010). Another question for GSK, BMJ: 340(June):c3455.

6 O’N EILL INST I T U T E • BR I EF I N G PA P E R N O. 8 • 0 4.1 6.1 4 PAG E 5 O F 9 The Uncertain Future of Vaccine Development and Deployment for Influenza Pandemics influenza vaccine as soon as possible after a pandemic has been declared and agrees to reserve a specified number of doses for the country or to more openly meet that country’s orders first.

When it commenced negotiations with manufacturers, WHO did not know about key aspects of the agreements. When asked whether they would be willing to reserve (not donate) 10% of real-time production for purchase by UN agencies, many vaccine manufacturers cited advance purchase agreements with high-income countries as a barrier. Contracting states noted the relatively inflexible terms of those agreements, which required orders for pandemic vaccine not tailored to severity or ultimate need.



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