Competition for Cholera Vax Hilleman Laboratories Pvt. Ltd. of New Delhi, India, is an joint-venture between Merck & Co. and UK’s Wellcome Trust, with a mission to develop affordable vaccines and last month announced a step toward initiating human trials on its candidate vaccine for cholera. As described in a Lab press release, the Hillman formed a partnership with public health research organization, ICDDR,B and pharma company, Incepta Vaccine Ltd., both based in Bangladesh, to provide clinical trial and manufacturing expertise, respectively. The candidate vaccine was licensed from Gotovax AB of Sweden in June of this year and is made as a dry powder and reconstituted before administration so does not require costly and often unavailable refrigeration (FierceVaccines story, FierceVaccines story). The Hilleman product will compete against current vaccines by Sanofi and Crucell (Johnson & Johnson) that require refrigeration and an oral vaccine by PanVax that recently completed Phase III trials (see BGH No. 16).
A Deeper Pool The Global Alliance for Vaccines and Immunisation (GAVI) and its financier, the International Finance Facility for Immunisation Co. (IFFIm), recently announced the issuance of a $500 million sukuk, a form of bonds acceptable under Islamic practices (such practices prohibit the accepting or charging of interest) (Reuters story). The IFFIm issuances are underwritten by pledges from nine countries (but not the US), offer competitive rates, and generate cash that GAVI uses to subsidize vaccine purchases by developing countries. Under the sukuk, investors are buying a share of an asset, in this case the approximately $8 billion in vaccines that GAVI purchases each year. GAVI has been a model for global health funding since its founding in 2000.
Ebola Dx Deal Qiagen, a major diagnostics company based in the Netherlands, and altona Diagnostics GmbH of Germany announced a distribution agreement for the latter company’s RealStar® Ebolavirus RT-PCR Kit 1.0 (FierceDiagnostics story). The test recently received an emergency use authorization from the FDA that limits its use to detection of Ebola virus RNA in “CLIA High Complexity Laboratories” in the US and similarly qualified non-U.S. laboratories. More helpful would be a rapid, field-use diagnostic.
Ebola Vax Candidate Hiccup As noted by a FierceBiotech story, the Phase I trial of the candidate Ebola vaccine, rVSV-EBOV, licensed recently by Merck from Newlink Genetics, was ended a week early due to the report of joint pain in four of 59 subjects. The Phase I will resume in January. The candidate has been “fast-tracked” by the NIH with the intent to start a Phase III trial in early 2015.
Creating a Market Although there is a need for Ebola vaccines, there has been no market to date. GAVI, the international vaccine program (see above), changed that recently by announcing the commitment of up to $300 million to purchase an Ebola vaccine, if and when approved (GAVI press release). Specifically, GAVI said it will:
- Spend up to $300 million to buy up to 12 million doses (about $25 per dose);
- Spend up to $45 million to help countries deploy the vaccine;
- Spend another $45 million on the rebuilding of health systems in the affected countries; and
- Buy quantities of first- and second-generation Ebola vaccines for stockpiles for future outbreaks.
Previously, the financing of vaccine development and deployment had been discussed in an October meeting sponsored by the WHO, and, according to a Science Magazine story, the UK representatives offered to purchase vaccine needed for Sierra Leone and asked that the US and France to make a similar commitment for Liberia and Guinea, respectively.
Who is Liable As Ebola vaccine candidates advance to efficacy trials in Africa, and if/when approved and used, the developers and manufacturers will need liability protection because no drug or vaccine is 100% effective and individuals, “advocacy” groups, and governments have sued pharma companies for damages alleged to be caused by their products. In the US, the problem was addressed by the Health and Human Services Department issuing a declaration of immunity under the Public Readiness and Emergency Preparedness (PREP) Act (FierceVaccines story and HHS press release). The declaration protects the developers of three vaccines (Merck, GlaxoSmithKline, and Johnson & Johnson) against legal claims related to their manufacturing, testing, distribution, and use, but only in the US. According to a November Bloomberg News story, the WHO has discussed a role for the World Bank, which is providing $1 billion in financing for the affected countries, in providing indemnification but no commitment was announced. The liability issue was discussed in an October meeting sponsored by WHO, according to a Science Magazine story, where it was pointed out by UK representatives that the governments of the affected counties had the primary responsibility for approving the development and use of vaccines.