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Human Vaccines 7:5, 291-291; May 2011; © 2011 Landes Bioscience

Human Vaccines: Policy Response to Commentaries Donald W. Light. Email: [email protected]

Human Vaccines has assembled a set of highquality, important commentaries on my policy analysis and concerns about the future of GAVI and its Advanced Market Commitment (AMC). Several affirm the value of GAVI in raising funds and playing a key role in immunizing millions more children than before, and I fully agree. The real worries concern their current and upcoming use of donations. Several authors, especially Elias, emphasize the importance of advance purchase commitments to guarantee price, ensure capacity, stabilize supply, and facilitate an immunization program. I agree. As outlined at the end of my history of the AMC,1 an “AMC” can be designed a number of ways. It should fit the technical and fiscal circumstances of each case and the needs of the stakeholders. Elias highlights the example of the new, 40-cent, conjugate meningitis A vaccine, where no large financial commitment is needed. He points out that while low-cost alternatives are being developed, an AMC can play an important interim role in making expensive new vaccines available to low-income countries. Elias provides a valuable 3-stage framework for product development partnerships. Several authors emphasize the value of the AMC in raising funds, and as Mahoney emphasizes, getting more funds for vaccinating poor children is the greatest need. But must it be done with exaggerated claims and promises? Most basic is the claim by several that “vaccines are among the most effective, affordable, and beneficial tools for saving lives.” But is this not an empirical question? If evidence of effectiveness is partial, indirect or questionable, and if the price is relatively high, then a vaccine is not a good value. Some vaccines are effective and affordable, and some are not. Using GAVI’s costs for the PCVs at the AMC’s much-reduced prices, I calculated that each child saved would cost $4722, and it looks as if evidence of these new vaccines reducing total mortality is patchy. No commentator took up this key questioning my essay of how

efficacious and cost-effective these new vaccines are. Representing GAVI, Schwalbe claims that “GAVI can avert about 700,000 deaths by 2015 and up to seven million deaths by 2030.” But she does not clarify the basis, assumptions, or calculations for how the Pneumococcal Conjugate Vaccine (PCV) AMC could possibly save so many lives. Why have these estimates not been adjusted to reflect the number of countries that will lose eligibility for GAVI subsidies?2 Dobbin and Avebury set out to show how the UK Parliamentary Group rejected my arguments and claims, for example, that lives saved will be a fraction of GAVI’s estimate; but they fail to mention that their entire investigation was initiated and funded by the Pneumo ADIP in what I feel was a self-promoting “evaluation.” It is one of a several evaluations and endorsements of the AMC that my history of the AMC shows have been pursued for years. Dobbin and Avebury provide no substantive challenge to my analysis. Meantime, the AMC solution to the pneumococcal scourge that was promoted from 2006-23010 as costing $1.5 billion is now estimated by GAVI to cost $15.8 billion through 2030, a sinkhole for donors and GAVI.2-4 The most important comment is probably that by Berman and Malpani, because they represent the two most distinguished and influential NGOs advocating for the world’s poor. Both MSF and Oxfam have already published in-depth analyses of the AMC and of how best to develop and deliver vaccines for neglected diseases. Calling the AMC costeffective is “disingenuous”, they write, and donations go primarily to “top up” profits at the world’s 2nd and 4th largest pharmaceutical companies, as I pointed out in The Lancet in 2007. Lower prices are critical, they believe, not “fine-tuning” as another commentator put it. GAVI needs to “speed up the development of new products by low-cost producers, which the AMC has failed to do.” Berman and Malpani believe that this will not happen until

representatives of manufacturers resign from the Board as a precondition for future donations. Transparent prices, they point out, are critical to help developing countries negotiate better prices, especially those no longer eligible for GAVI subsidies. Birn and Lexchin independently come to similar conclusions: three-quarters of the GAVI Board are aligned with for-profits, and GAVI is neither transparent nor accountable, claims to the contrary not withstanding. They conclude, in line with MSF and Oxfam, that AMCs are designed to protect patents through deep discounts, which are still much higher than competitive prices or what low-income countries can afford. They urge that GAVI’s new leadership critically appraise its business model, values, and operations over recent years. A GAVI dedicated to empowering poor countries would develop public, parastatal companies to produce vaccines cheaply and locally, as India, Brazil and Cuba are doing. But new GAVI leaders are reiterating the grand, unrealistic claims and apparently catering to their industry allies, who apparently stand ready to bail them out of their own self-induced funding crisis, claiming it is “the best public health investment we could make.”3 It would be a shame if GAVI champions did not call for a soul-searching review of GAVI’s values, strategies, and conflicts of interest.

©201 1L andesBi os c i enc e. Donotdi s t r i but e.

www.landesbioscience.com

References 1. Light DW. Advanced Market Commitments: Current Realities and Alternate Approaches. Amsterdam: HAI Europe/Medico International Publication; 2009. 2. GAVI. Next steps on the Pneumococcal AMC. Geneva: GAVI Alliance board meeting; 2010 (16 June). 3. USAID administrator Rejiv Shah highlights vaccines as “the best public health investment we can make”. GAVI, 2011. Accessed Mar 20, 2011, at http://www. gavialliance.org/media_centre/statements/usaid_rajiv_ shah_speech.php )

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