World: Anti-Viral Drugs For Possible Flu Pandemic In Short Supply, Vaccines Not Yet Ready
By Eugen Tomiuc
International officials are warning that the world is not yet fully prepared to deal with a possible pandemic if the bird-flu virus mutates into a human strain. EU foreign ministers are urging global cooperation to tackle the threat, while many countries are seeking to boost their stockpiles of Tamiflu, an anti-viral drug seen as a first line of defense. Roche, the Swiss company that manufactures the drug, says it might allow other countries to produce Tamiflu under license, while a Dutch company has announced it is developing a vaccine against the virulent H5N1 bird-flu strain.
Prague, 19 October 2005 (RFE/RL) -- Governments and health authorities around the world are scrambling to boost their anti-viral drug supplies amid fears that the current bird flu outbreak in several countries could lead to a pandemic.
The European Union, meanwhile, has called for greater international coordination to combat what it calls the "global threat" of bird flu, after cases of the potentially deadly H5N1 strain of bird flu were confirmed in Romania and Turkey. H5N1 has killed some 60 people in Asia since 2003.
EU member Greece also said it has detected the bird-flu virus on its territory and is expecting test results to see if the H5N1 strain is the culprit.
The latest scare has prompted many countries to start stockpiling anti-viral drugs such as Tamiflu, considered the most effective defense against H5N1.
"The anti-virals are the first line of defense," said EU Health Commissioner Markos Kyprianou. "Vaccines -- we will work to have them produced and distributed as soon as possible after the detection of a pandemic [flu] virus."
The World Health Organization (WHO) says Tamiflu might improve prospects of survival -- if administered early -- for cases of human infection with H5N1. But clinical data are limited.
Swiss company Roche has given the WHO 3 million doses of Tamiflu as an emergency supply to be used in case a flu pandemic breaks out.
The WHO recommends countries stock enough anti-viral drugs and flu vaccines to inoculate at least 25 percent of their populations.
But the WHO is cautioning the public against the use of Tamiflu without medical advice.
Dr. Bernardus Ganter, the WHO's regional adviser for communicable disease surveillance, told RFE/RL why: "We are also telling most people not to use Tamiflu currently, [but] to really use it when the doctor advises to use it, because there is always the potential, as with any drug, with any anti-microbial drug, that it easily makes the anti-microbes resistant to the drug. And, especially, if it's not used in the correct way, this could occur quite quickly. And we already have a note from the press that this actually happened already in a girl in Vietnam."
Some 40 governments around the world are rushing to boost their Tamiflu stocks. The production capacity of Roche has been tested to the limit, but Roche initially declined to let others manufacture the drug under license.
This led to international pressure to ignore Roche's patent rights and produce inexpensive generic versions. Companies in India, Taiwan, Thailand, and Argentina want to produce such generic versions.
In the United States, Roche announced it is ready to build a new facility to produce Tamiflu but did not specifically say it would share its patent rights. That prompted U.S. Senator Chuck Schumer (Democrat, New York) yesterday to give Roche one month to give up its rights to Tamiflu or face congressional action.
However, a spokeswoman for Roche, Martina Rupp, told RFE/RL today that the company is now ready to sublicense the manufacturing of Tamiflu under certain conditions.
"In support of the global effort to fight a potential pandemic, we are prepared to discuss all options, including sublicensing, provided that a company or group can realistically produce substantial amounts of Tamiflu for emergency pandemic use in accordance with appropriate quality specifications and also in accordance with safety and regulatory guidelines and standards," Rupp said.
Other countries are looking into developing a vaccine for the potentially deadly H5N1 strain of bird flu. Dutch pharmaceutical company Akzo Nobel has announced that it is working on a human vaccine.
Bram Van Dijk, a director at Akzo Nobel, said the vaccine could be ready for testing soon.
"From a manufacturing point of view, we think we can be ready in about six months from now," Van Dijk said. "But once you have completed your lab skill phase, you have to do clinical research in humans. Following the current guidelines -- especially the European guidelines I'm now referring to -- it will take you about three to four years to complete. [But the EU regulatory authorities] are, indeed, discussing a so-called fast-track approval of this kind of vaccine."
Hungary, which is also testing a vaccine against H5N1, has said that if tests prove effective, the government will inoculate all its citizens for free. Australia, too, announced it is ready to offer free-for-all shots once a vaccine is developed.
But the WHO is warning that there might be another problem. If a pandemic breaks out, it could be caused by a mutated bird-flu strain, different from H5N1. In that case, it would take quite some time until the new strain was identified and a vaccine developed.
Copyright (c) 2005. RFE/RL, Inc. Reprinted with the permission of Radio Free Europe/Radio Liberty, 1201 Connecticut Ave., N.W. Washington DC 20036. www.rferl.org
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