The Business of Global Health No. 10

Two Ebola Vaccines Move into Humans  As noted last week in FierceVaccines, companies and government agencies of multiple countries have moved two Ebola vaccines candidates into human trials with lightening speed. Slightly in the lead, GlaxoSmithKline started to test its “cAd3-ZEBOV” vaccine with Ministry of Health of Mali in health care workers and a similar test will begin in Gambia. Both directed are by a University of Maryland School of Medicine clinician (UMD press release). Also last week, the Public Health Agency of Canada announced that it had started a Phase I trial at Walter Reed Army Institute of Research (Canadian government press release). The rights to the candidate vaccine, named “VSV-EBOV,” are licensed to NewLink Genetics Corp., a publicly-traded company based in Ames, IA, that is participating in, but apparently not funding, the trial.

Rotavirus Vaccine Price War?   Also reported in FierceVaccines last week, Sanofi has initiated Phase III trials of a candidate vaccine against a major cause of child mortality and illness, the water-borne rotavirus. Since 2009, the WHO has recommended global rotavirus vaccination and the GAVI Alliance has subsidized the purchase and distribution of two vaccines developed by GlaxoSmithKline (Rotarix) and Merck (RotaTeq) (see GAVI Support). Sanofi’s unnamed candidate is being developed by its Indian subsidiary, Shantha Biotech. Another product, Rotavac by Bharat Biotech, is expected to be approved in India this year, and the company has said it will price its vaccine at $1 per dose (Bharat Vaccines), considerably lower than the current GAVI prices of $2.50-3.50 per dose. And in the wings is a Chinese company. As noted in Pharmabiz, BravoVax Co. Ltd. received a license for all markets except the US, Europe, and Japan from Rochester, MN-based International Medica Foundation for its rotavirus vaccine candidate, RotaShield. RotaShield, one may recall, was originally developed and sold by Wyeth (now part of Pfizer) but pulled from the market when its use was associated with a fatal intestinal blockage in some infants and subsequently shown to be safe when administered within an age range (Intl Medica RotaShield). The Foundation recently completed its own Phase II trial in Ghana.

PATH and Pfenex Partner on Vaccine Manufacture  Pfenex Inc., a San Diego-based biologics development and manufacturing company that recently went public, announced a contract with the Gates-Foundation-backed product development program, PATH, to test its platform in making a vaccine adjuvant and a vaccine candidate (Pfenex press release). The vaccine candidate, Pfs25, has the unique approach of blocking transmission of the malaria parasite by vaccinating mosquitoes (see my post,“Vector Vax”), and one version has been tested unsuccessfully in a Phase I study (PATH Malaria Vaccines). Pfenex uses a bacterial expression system that was originally developed by one of the first agri-biotech companies, Mycogen Corp. that was founded in 1982 and later acquired by Dow Chemical.

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