Setback for GSK's malaria vaccine
Release Date: 2009-03-31
UK pharmaceutical group freezes anti-malarial vaccine trials in Gabon after the national ministry of health requests further informationGlaxoSmithKline faced a setback for its experimental malaria vaccine on Monday when the authorities in the first country due to host final-stage clinical trials called a temporary halt just before testing was to begin.
The UK pharmaceutical group was scheduled to begin the first vaccinations in small children for a large-scale phase-three trial for its product RTS,S, also branded Mosquirix, in Gabon at the start of this week but froze the trial when the national ministry of health requested further information.
Individuals working on the trial said they were trying to clarify what extra data were required, and hoped it would proceed rapidly.
The unexpected hold-up highlights the challenges of conducting ambitious clinical trials even in African countries that could most benefit from a successful malaria vaccine.
The clarification may relate to the appointment of a new minister of health in Gabon only at the start of this year who wants to be present at the vaccination but is currently travelling, as well as recent lack of communication because government offices were closed for a week after the death of the country’s first lady.
Mosquirix has shown strong results in earlier-stage trials and a positive result from the latest test should lead to a filing for regulatory approval – although that will still require the need to find substantial international donor funding to cover the costs of manufacture and distribution.
Meanwhile, GSK filed additional data with US regulators on Monday as it sought approval for Cervarix, its cervical cancer vaccine long approved in Europe and other markets.
The US Food and Drug Administration is believed to have requested more information linked to the vaccine’s proprietary adjuvant, a chemical mix that boosts the body’s immune response. A similar adjuvant is used in Mosquirix and other vaccines the company is developing.
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