A Gates Foundation study that identifies an increase in production capacity for development-stage HIV vaccines has a "fatal flaw," says a vaccine expert. The study findings are being cited among the chief reasons for killing a proposed HIV-vaccine R&D pilot facility, a planned joint effort of the Canadian government and the Bill and Melinda Gates Foundation.
The study says the capacity in North America and Europe to produce HIV vaccines for clinical trials has improved over the last few years, thanks to additional suppliers. Yet the lack of GMP facilities for clinical production is what prompted planning for the facility in the first place, says Don Gerson, president of PnuVax, who was involved in the proposal-review process. He says the additional-capacity conclusion fails to prioritize the quality aspects of clinical materials manufacturing.
Government officials say Gerson's critique is too little, too late, in terms of reviving the project. But that's done little to satisfy both the bidders and the government watchers seeking answers to why the shoo-in bid from the Ottawa International Centre for Infectious Diseases was rejected--along with three other bids--by the government in February for not meeting project criteria.
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