The Business of Global Health No. 23

Candidate No. 4  A fourth Ebola vaccine candidate has advanced to human trials. Last week, Novavax announced that it was recruiting 230 subjects in Australia for a Phase I study of its Ebola GP Vaccine (FierceVaccines press release). The candidate, comprising a Ebola glycoprotein and a proprietary adjuvant called Matrix-M™, is the first vaccine to employ an Ebola subunit rather than the entire virus and was designed, animal tested, and manufactured at scale in an amazingly short six months. As reported by a FierceVaccines story, although the Novavax candidate is starting behind three others (by GlaxoSmithKline, Merck, and Johnson & Johnson), due to its subunit design, it is closely matched to the epidemic strain and may be more effective. The candidate is also unique in that it is made using Novavax’s pioneering insect-cell-based and single-use (disposable) manufacturing that can generate large quantities of protein at lower costs than traditional approaches.

Fast Track  As for getting an Ebola vaccine tested and approved, the track has been a bit murky because each country in which a vaccine is tested for efficacy or approved for use needs to have a strong regulatory authority and/or trust a national (like the USFDA), regional (none), or international (like WHO’s Prequalification Program) review agency. An expert panel convened by UK’s Wellcome Trust and the University of Minnesota’s Center for Infectious Disease Research and Policy examined this question and others and recently published guidelines for accelerating vaccines against Ebola and other emerging infectious diseases (Wellcome press release). The Recommendations all make sense (e.g., streamlining manufacturing, working with afflicted countries’ public health officials, and stockpiling vaccine for the future) but, to me, are too non-specific to be helpful. For example, at the country level I’d like to know who is responsible in the afflicted countries for approving trials, who will be responsible for post-marketing monitoring, and who will provide liability coverage. Also disappointing was the lack of interest in defining the role of the private sector. Instead the panel noted a (incorrect) “fundamental conflict between public health and profit as a driver for developing new vaccines” and the assumption that “price transparency” is needed to assure vaccine supply. I found it surprising that the panel did not even acknowledge that many companies are making substantial and risky financial commitments and the least it can do is make realistic, specific recommendations to reduce that risk to increase the likelihood that an effective vaccine is developed soon.

More Water in the Pool  The UN-backed organization, Medicines Patent Pool (MPP) announced completion of a license agreement with Merck & Co. for use of its antiretroviral drug, raltegravir, a key medicine approved for children living with HIV, in pediatric formulations (MPP press release). Under the terms of the license, the MPP may offer sublicenses to generic drug makers at no or low royalty cost for formulations to be sold in 92 low- and middle-income countries, the intent being stimulation of wider access and the invention of regionally-tailored versions (MPP did a similar deal with AbbVie for two antivirals last December). Since its founding in 2010, MPP has closed agreements with five companies and the NIH for 11 antiretrovirals and one medicine and has sublicensed 10 manufacturers who are “actively distributing low-cost medicines in developing countries or pursuing development plans for future introduction.” While I think this is a valid and potentially fruitful approach to providing needed global meds, if done aggressively and widely (for a bit more see my post, “Checking the Pool’s Temperature”), I favor business-to-business deals with technology transfer as Gilead Sciences has done for its antivirals and more recently for anti-hepatitis C drugs. In this B2B approach, the originator company engages the strongest and most committed partners and has a stake in their success.

 

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