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Indonesia Upsets Flu Vaccine System, Demands Glaxo, Sanofi Pay
By John Lauerman and Karima Anjani
April 6 (Bloomberg) -- Indonesia is disrupting the 50-year- old system that supplies the world with flu vaccines by demanding compensation from drugmakers GlaxoSmithKline Plc and Novartis AG.
Siti Fadilah Supari, Indonesia's Health Minister, stopped sending the World Health Organization live viruses taken from birds and humans that scientists use for vaccines in December. Supari said shipments will resume only after the WHO helps Indonesia negotiate free supplies of pandemic-flu shots and money to build vaccine plants, the first-ever such requirement.
Without the latest versions of the avian-influenza virus, doctors can't produce the most up-to-date vaccines. The WHO said last week it will press companies to meet some of Indonesia's needs. Glaxo Chief Executive officer Jean-Pierre Garnier will meet with WHO director-general Margaret Chan today to discuss the dispute, said Nancy Pekarek, a company spokeswoman for the London-based drugmaker.
``I cannot tolerate this misuse of our viruses,'' said Triono Soendoro, who runs the flu research for Indonesia's health ministry. His Jakarta lab stores the samples Indonesia says it will withhold until an agreement is brokered.
Indonesians spend an average of $30 annually on health care, compared with $5,700 in the U.S., according to the World Health Report. Glaxo's flu vaccine costs $6 to $11 a shot in markets around the world, and receiving a flu shot from a doctor can cost as much as $59 in Jakarta.
Vaccine System
Every year, the WHO receives seasonal influenza viruses taken from humans infected in Southeast Asia. The Geneva-based health agency's regional labs then provide copies of the infectious material free to vaccine makers to produce flu shots for 300 million people worldwide that generate about $2 billion in annual revenue.
``If you don't have those viruses, you've got nothing,'' said David Fedson, former medical affairs director in Europe for Paris-based Sanofi-Aventis SA, the U.S.'s leading flu-shot supplier.
The WHO is working on an agreement that would cover access to seasonal and avian flu, including the H5N1 virus WHO says has killed at least 170 people since late 2003, mostly in Asia.
Following a two-day meeting last week with Indonesia, Thailand and other nations hit by avian flu, WHO officials pledged to develop new guidelines regulating how the agency distributes viruses now provided free by poor nations.
The new rules may require the WHO to disclose for the first time which companies use the viruses to make vaccines, said David Heymann, the agency's assistant director general for communicable diseases, who met with the countries' health officials in Jakarta. WHO also will ask the drugmakers to provide free vaccine for use by poorer countries, Heymann said.
Baxter Deal
The WHO plans to meet April 25 with Novartis, Sanofi- Aventis and other drugmakers to press for cooperation with the new rules.
Some drugmakers are already working with developing nations. Baxter International Inc., based in Deerfield, Illinois, is negotiating a deal that may enable the company to make vaccine with the country's viruses in exchange for free vaccine or shot-making capacity, said Deborah Spak, a spokeswoman.
Indonesia is discussing similar deals with at least seven companies, including EgyVac, a unit of Egypt's Vacsera Holding Co., according to Soendero. Egypt has recorded 13 human deaths from avian flu since the beginning of 2006.
Individual deals between companies and countries, as opposed to standardized rules, might make it difficult to assure the quality of a vaccine, said Fedson, the former Sanofi executive. It would be a ``chaotic situation,'' he said.
Simmering Dispute
``Sanofi still wants the WHO to keep a central role in collecting and sharing flu virus samples,'' said Pascal Barollier, a spokesman for the drugmaker. Sanofi made about half the seasonal flu vaccine shots sold worldwide last year.
The dispute has been simmering since late last year, when Australian drugmaker CSL Ltd. said it was developing a bird flu vaccine using Indonesian viruses. Indonesian officials said they hadn't given CSL permission.
Soon afterward, Supari said he ordered Indonesia's labs to stop shipping flu viruses to WHO-affiliated laboratories that conduct tests confirming the presence of the H5N1 bird flu.
As a result, none of the nine human cases of bird flu in Indonesia since late January have been recorded by the WHO.
Delays in reporting flu cases are ``incredibly dangerous,'' said Ira Longini, a researcher University of Washington in Seattle who advises the U.S. government on flu. It can impede researchers' ability to track the spread of the virus, critical to understanding if the flu has mutated into a form that can be transmitted among people, Longini said.
Extract Concessions
``In the past, originating countries sent the virus and we never knew what happened,'' Supari, Indonesia's health minister, said in a March 27 press briefing, defending her decision to withhold the samples. She said she is trying to get other affected countries to extract concessions, too.
``If we can convince them that the world is willing to buy them stockpiles of vaccine and help them out, I think they'll share their viruses,'' WHO's Heymann said in an interview. ``We can't overlook the developing countries' needs.''
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net ; Karima Anjani in Jakarta at kanjani@bloomberg.net .
By John Lauerman and Karima Anjani
April 6 (Bloomberg) -- Indonesia is disrupting the 50-year- old system that supplies the world with flu vaccines by demanding compensation from drugmakers GlaxoSmithKline Plc and Novartis AG.
Siti Fadilah Supari, Indonesia's Health Minister, stopped sending the World Health Organization live viruses taken from birds and humans that scientists use for vaccines in December. Supari said shipments will resume only after the WHO helps Indonesia negotiate free supplies of pandemic-flu shots and money to build vaccine plants, the first-ever such requirement.
Without the latest versions of the avian-influenza virus, doctors can't produce the most up-to-date vaccines. The WHO said last week it will press companies to meet some of Indonesia's needs. Glaxo Chief Executive officer Jean-Pierre Garnier will meet with WHO director-general Margaret Chan today to discuss the dispute, said Nancy Pekarek, a company spokeswoman for the London-based drugmaker.
``I cannot tolerate this misuse of our viruses,'' said Triono Soendoro, who runs the flu research for Indonesia's health ministry. His Jakarta lab stores the samples Indonesia says it will withhold until an agreement is brokered.
Indonesians spend an average of $30 annually on health care, compared with $5,700 in the U.S., according to the World Health Report. Glaxo's flu vaccine costs $6 to $11 a shot in markets around the world, and receiving a flu shot from a doctor can cost as much as $59 in Jakarta.
Vaccine System
Every year, the WHO receives seasonal influenza viruses taken from humans infected in Southeast Asia. The Geneva-based health agency's regional labs then provide copies of the infectious material free to vaccine makers to produce flu shots for 300 million people worldwide that generate about $2 billion in annual revenue.
``If you don't have those viruses, you've got nothing,'' said David Fedson, former medical affairs director in Europe for Paris-based Sanofi-Aventis SA, the U.S.'s leading flu-shot supplier.
The WHO is working on an agreement that would cover access to seasonal and avian flu, including the H5N1 virus WHO says has killed at least 170 people since late 2003, mostly in Asia.
Following a two-day meeting last week with Indonesia, Thailand and other nations hit by avian flu, WHO officials pledged to develop new guidelines regulating how the agency distributes viruses now provided free by poor nations.
The new rules may require the WHO to disclose for the first time which companies use the viruses to make vaccines, said David Heymann, the agency's assistant director general for communicable diseases, who met with the countries' health officials in Jakarta. WHO also will ask the drugmakers to provide free vaccine for use by poorer countries, Heymann said.
Baxter Deal
The WHO plans to meet April 25 with Novartis, Sanofi- Aventis and other drugmakers to press for cooperation with the new rules.
Some drugmakers are already working with developing nations. Baxter International Inc., based in Deerfield, Illinois, is negotiating a deal that may enable the company to make vaccine with the country's viruses in exchange for free vaccine or shot-making capacity, said Deborah Spak, a spokeswoman.
Indonesia is discussing similar deals with at least seven companies, including EgyVac, a unit of Egypt's Vacsera Holding Co., according to Soendero. Egypt has recorded 13 human deaths from avian flu since the beginning of 2006.
Individual deals between companies and countries, as opposed to standardized rules, might make it difficult to assure the quality of a vaccine, said Fedson, the former Sanofi executive. It would be a ``chaotic situation,'' he said.
Simmering Dispute
``Sanofi still wants the WHO to keep a central role in collecting and sharing flu virus samples,'' said Pascal Barollier, a spokesman for the drugmaker. Sanofi made about half the seasonal flu vaccine shots sold worldwide last year.
The dispute has been simmering since late last year, when Australian drugmaker CSL Ltd. said it was developing a bird flu vaccine using Indonesian viruses. Indonesian officials said they hadn't given CSL permission.
Soon afterward, Supari said he ordered Indonesia's labs to stop shipping flu viruses to WHO-affiliated laboratories that conduct tests confirming the presence of the H5N1 bird flu.
As a result, none of the nine human cases of bird flu in Indonesia since late January have been recorded by the WHO.
Delays in reporting flu cases are ``incredibly dangerous,'' said Ira Longini, a researcher University of Washington in Seattle who advises the U.S. government on flu. It can impede researchers' ability to track the spread of the virus, critical to understanding if the flu has mutated into a form that can be transmitted among people, Longini said.
Extract Concessions
``In the past, originating countries sent the virus and we never knew what happened,'' Supari, Indonesia's health minister, said in a March 27 press briefing, defending her decision to withhold the samples. She said she is trying to get other affected countries to extract concessions, too.
``If we can convince them that the world is willing to buy them stockpiles of vaccine and help them out, I think they'll share their viruses,'' WHO's Heymann said in an interview. ``We can't overlook the developing countries' needs.''
To contact the reporter on this story: John Lauerman in Boston at jlauerman@bloomberg.net ; Karima Anjani in Jakarta at kanjani@bloomberg.net .
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