Shelved vaccine project upsets future manufacturing ambition


TAIPEI, Taiwan — A build-own-operate (BOO) project to manufacture influenza vaccine has been called off after years of delays, delivering a setback to the country’s ambitious plan to be the first developing country to build an independent and self-sufficient vaccine manufacturing capacity, government and pharmaceutical industry sources said last week.

The project, which was launched in 2004, will be put on hold, as an operation plan submitted by Dutch pharmaceutical company Akzo Nobel was rejected by the Department of Health (DOH) earlier this month for failing to meet criteria stipulated in the Act for Promotion of Private Participation in Infrastructure Projects, a senior DOH official said on condition of anonymity.

Although Akzo Nobel is making a final pitch by appealing the decision, a source close to the project said that “it is fair to say the project is terminated, at least for now.” Despite the frustrating experience and outcome, the government and private sectors are still enthusiastic about the vaccine BOO deals, an official of the Centers for Disease Control under the DOH said, the government has not given up hope and strongly believes that “in its second try, the project will go smoothly.”

Chi Steve Chan, chairman and CEO of ADImmune Corporation (ADI) and a prominent figure in medical and political circles, also expressed great interest in participating in the project in the future, should the government decide to re-launch it. The dual-purpose project, set up amid concerns over an influenza pandemic triggered by a flu virus like H5N1, was aimed at building the country’s capacity to develop and manufacture influenza vaccine by using the advanced cell-based method with the cooperation of the pharmaceutical company.

The vaccine plant under the BOO would provide seasonal influenza vaccines, for which Taiwan at present relies totally on imports, but should a pandemic occur, the facility would expand to manufacture specific vaccine to tackle the pandemic.

Under the original design, the construction of the plant should have been completed in 2007 and should have become operational in 2008, making Taiwan the first developing country capable of manufacturing influenza vaccine.

The facility would have produced 2.5 million doses of seasonal influenza vaccine annually, with the DOH allocating NT$4 billion for guaranteed purchases.

But the project has been mired in difficulties arising from competition between foreign and local companies, international business mergers and complex legal issues.

The project was at least two to three years behind schedule. Public health officials, however, have managed to find consolation in “the good news” that an influenza pandemic has not occurred.

They have also indicated that in the past few years, local pharmaceutical companies have acquired advanced biotechnology and manufacturing abilities, pointing to cooperation between ADI and Dutch biomedical company Crucell.

The private venture is expected to manufacture about 30 million doses of flu vaccine per year for both the domestic and international markets, according to the ADI.