May 30, 2007 (CIDRAP News) – Indonesia's health minister said yesterday that Baxter Healthcare Corp would launch a clinical trial of an H5N1 avian influenza vaccine in Indonesia in July, according to news reports, but a Baxter official said the company has not announced any clinical trials.
Siti Fadilah Supari, Indonesia's health minister, said the clinical trial would involve "hundreds of participants" and conclude in October, according to an Associated Press (AP) report published today. She also said Indonesia would initially stockpile 2 million doses of the vaccine.
In February, Indonesia revealed it had stopped sharing H5N1 virus samples with the World Health Organization (WHO) in a protest against drug companies' use of the samples to make vaccines seen as too costly for developing countries. Soon afterward Indonesia signed a memorandum of understanding with US-based Baxter International, owner of Baxter Healthcare, which laid the groundwork for future collaboration or supply agreements on H5N1 vaccines.
Chris Bona, a Baxter spokesman in Deerfield, Ill., told CIDRAP News today that the company has not announced any plans for a clinical trial of its vaccine in Indonesia and has not signed any new agreements with Indonesia beyond the initial memorandum of understanding in February.
Bona said there were no firm plans to produce the company's vaccine in Indonesia and no agreements about stockpiling. In addition, any Indonesian H5N1 samples Baxter would use to develop a vaccine would likely come directly from the WHO, Bona said.
On May 15 Indonesia announced it had resumed sharing its H5N1 samples with the WHO. A week later, during the annual meeting of WHO member countries, the WHO negotiated a preliminary agreement designed to maintain the international sharing of flu virus samples while ensuring that developing countries can obtain pandemic flu vaccines
Baxter has a cell culture–based H5N1 vaccine under development. Last October the company said the preliminary results of a phase I/II clinical trial showed a good immune response against drifted H5N1 strains. The vaccine was based on a 2004 strain of H5N1 from Vietnam.
Oct 17 CIDRAP News article "Baxter says cell-based H5N1 vaccine shows potential in trial"