Thursday, December 4, 2008

Vaccine makers urge speedy accord on pandemic planThu

Dec 4, 2008 10:49am EST GENEVA, Dec 4 (Reuters) - Governments need to overcome their "pandemic fatigue" and act quickly to finalise a response plan to potential flu threats, leading drugmakers said on Thursday.
The pharmaceutical industry is "very close to ready" to respond to a potential outbreak by shifting seasonal flu vaccine production to more targeted pandemic ones, said Stephen Gardner of GSK Biologics.
But Gardner told a news briefing that countries needed to stop stalling and craft an accord on sharing samples of virus strains with pandemic potential for tests that accelerate efforts to formulate effective vaccines.
"We don't have time to negotiate a new agreement when a pandemic arises. We need to get on with manufacturing quickly," he said. "Time is of the essence to ensure good vaccine supply."
The World Health Organisation (WHO) will host an inter-governmental meeting next week where the United Nations agency's member states will discuss sensitive questions about virus sample sharing and access to vaccines in case of a flu pandemic.
Indonesia, the country most affected by H5N1 bird flu, has resisted providing viral samples to the international community because it argues that material is then used by big drugmakers to create vaccines that poorer countries cannot afford or use.

TRANSFER AGREEMENT
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) wants to be included in WHO-hosted negotiations about a "material transfer agreement" covering the strains of viruses companies need to develop pandemic vaccines.
"We would like to be involved in the detail of the discussion," Gardner told the briefing in Geneva, where the talks will occur Dec. 8-13.

According to the IFPMA, the pharmaceutical industry has invested more than $4 billion in tools to prevent and stop pandemic flu, which generally strikes every 20 to 30 years. The last known outbreak was in 1968.
Tony Colegate of Novartis Vaccines said that unless manufacturers have advance notice of dangerous strains, it would take 4 to 6 months to make an effective vaccine from the moment a pandemic is announced.
"If the WHO don't get the samples from the national centres, they don't know what is going on and they can't tell us which strains to use," he told the briefing.
While H5N1 bird flu is now grabbing fewer headlines than a few years ago, when fears were high that it would morph into an easily-spreadable strain, Gardner said it continued to present a risk given its very high fatality rate of 40 to 60 percent.
"There is definitely a decrease in the interest in pandemics ... (but) the threat is still there," he said. "If the virus does adapt and start spreading like a normal flu, we are in trouble."

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