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Confusion reigns over whether Indonesia will share bird flu viruses

Snowy Owl

Retired in 2010, In Memoriam
Confusion reigns over whether Indonesia will share bird flu viruses

HELEN BRANSWELL

<TR><TD width="100%" valign="top" height="500" text-align="top">(CP) - Confusion reigned Thursday over whether Indonesia will soon resume sharing H5N1 avian flu viruses with the rest of the world through the World Health Organization - something it hasn't done since the beginning of the year.

The country has been withholding viral samples in a bid to extract guarantees that it will be given affordable access to H5N1 vaccines. While the WHO hopes to help Indonesia achieve its goal of affordable H5N1 vaccine, the agency is not in a position to guarantee that the country will be able to buy pandemic vaccine, at low cost or any cost.

Thursday's confusion stemmed from an announcement from Indonesia's health minister, Dr. Siti Fadillah Supari, who said the country would resume sharing viruses shortly.

Supari said she had received verbal assurances from WHO director general Dr. Margaret Chan that the viruses would be used only to study the evolution of H5N1 and not for production of vaccine. Once those assurances have been put in writing, she said, Indonesia will again ship H5N1 viruses with international laboratories.

A spokesperson for the agency, Dick Thompson, told the Associated Press that Supari's suggestion she'd been given a guarantee that the viruses would not be shared for vaccine development was incorrect.

Thompson later said that a letter to Indonesia from the WHO was still being drafted and he had been wrong to imply anything about its contents.

The WHO's influenza czar, Dr. David Heymann, refused to disclose what Chan had told Supari.

"The communications between WHO and ministers are confidential. We can't give any information out about them," Heymann said from Geneva.

It seems unlikely, however, that the international health body could agree to permanently place a limit on how viruses from Indonesia could be used.

Doing so would violate a resolution approved by the agency's executive board in January.

The 34-country executive board passed a resolution reaffirming the long-standing practice that countries freely share influenza viruses with the WHO for the purposes of tracking the evolution of the viruses and for the development of vaccines. As part of that system, WHO then shares, at no cost, the viruses with vaccine manufacturers.

Indonesia is not a member of the executive board and therefore did not vote in January. But it will have a chance to vote on the resolution in May, when the WHO's 193 member states gather for the annual meeting of its governing council, the World Health Assembly.

Two weeks ago Heymann and the head of the WHO's influenza program, Dr. Keiji Fukuda, travelled to Indonesia to meet with Supari about her refusal to share H5N1 viruses.

At that meeting, Supari and the WHO officials agreed that on an interim basis sample Indonesian viruses would only be used to study how the virus is changing. And Indonesia agreed to host a meeting of developing countries concerned about access to pandemic vaccines. The meeting is to be held later this month.

The WHO has been working on a strategy to encourage vaccine manufacturing in developing countries and will shortly announce that it has approved three proposals to this end. But building and licensing vaccine facilities is not an overnight operation.

The agency will also propose intermediate steps, Heymann said, including perhaps "a virtual stockpile of vaccines should we be able to mobilize resources for something such as that."

"Those are the short-and long-term solutions that we're looking for in the meeting in Indonesia," he said. "After that meeting we hope that we will have built enough confidence with countries that . . . that free sharing of viruses for all purposes can be sustained."

But the meeting will also lay out the hard realities of the limited global flu vaccine production capacity.

Research into new types of flu vaccines - grown in cell culture rather than hens' eggs, for instance - offers hope that in the future capacity could be rapidly scaled up. But at present the world's licensed flu vaccine makers can make only enough vaccine for a fraction of the global population. And they have no significant surge capacity.

It is believed that most of that existing capacity for pandemic vaccine is already spoken for in contracts between manufacturers and developed countries such as Canada, Britain and Switzerland.

As the standoff over the country's position on virus sharing draws on, the status of four possible human cases in Indonesia remains in limbo.

The country announced four positive cases in February but none of those have been confirmed by the WHO, which requires that a country's positive tests be affirmed by an international laboratory.

Meanwhile Indonesia is sharing viruses with the UN's Food and Agriculture Organization, though delays remain, said Dr. Peter Roeder, an animal health officer with the agency.

"Although it's getting better, the process is still very slow. And it needs to be speeded up greatly if a real time analysis of genetic variation in viruses is to be realistically appraised," Roeder said from Rome.

? The Canadian Press , 2007
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Re: Confusion reigns over whether Indonesia will share bird flu viruses

"Those are the short-and long-term solutions that we're looking for in the meeting in Indonesia," he said. "After that meeting we hope that we will have built enough confidence with countries that . . . that free sharing of viruses for all purposes can be sustained.

But the meeting will also lay out the hard realities of the limited global flu vaccine production capacity."


Indonesia knows how the system works. They want a seat at the table for distribution of vaccine. If they do not insist on a rigid procedure, they will be "left in the dust" for vaccine delivery.

They are working with Baxter International to develop a vaccine:


"..Indonesia last week appointed Swiss-based Baxter Healthcare SA, a subsidiary of U.S. drug maker Baxter International Inc., to develop human vaccines with the Indonesian strain..."

http://www.flutrackers.com/forum/showpost.php?p=65205&postcount=17


Baxter has already been involved in H5N1 vaccine development using cellular technology:


<TABLE cellSpacing=0 cellPadding=0 width="100%" border=0><TBODY><TR><TD vAlign=top align=left height=1><TABLE cellSpacing=0 cellPadding=0 width="100%" border=0><TBODY><TR><TD>Baxter Announces Safety and Immunogenicity Results from Phase I/II Clinical Trial of Cell-Based Candidate H5N1 Pandemic Vaccine



</TD></TR></TBODY></TABLE></TD><TD></TD></TR><TR><TD vAlign=top align=left width="100%" colSpan=2 height=400><TABLE cellSpacing=0 cellPadding=0 width="100%" border=0><TBODY><TR><TD width=10>
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</TD><TD vAlign=top><TABLE cellSpacing=0 cellPadding=0 width="100%" border=0><TBODY><TR><TD vAlign=top colSpan=4>Deerfield, Ill., October 4, 2006 – Baxter International Inc. (NYSE: BAX) today announced results from a preliminary evaluation of its Phase I/II clinical trial of whole-virus H5N1 influenza candidate vaccine. The results represent the first clinical evaluation of a vero cell-based candidate H5N1 pandemic vaccine.

The candidate H5N1 pandemic vaccine was produced using the company’s proprietary vero cell-based technology platform and inactivated wild-type H5N1 strain A/Vietnam/1203/2004. The clinical trial was conducted in 270 healthy adults in Austria and Singapore using four different antigen concentrations ranging from 3.75µg to 30µg in formulations. The 7.5µg and 15µg antigen concentrations were tested with and without adjuvant, a substance added to vaccines to improve immune response.

“We are extremely pleased with the clinical results from this study,” said Noel Barrett, Ph.D., vice president of Global R&D for Baxter’s vaccines business. “We have achieved an important step toward our goal of producing a safe and efficacious pandemic vaccine using the company’s proprietary vero cell-based technology.”

Hartmut Ehrlich, M.D., vice president of Global R&D for Baxter BioScience added: “This is the first clinical demonstration that a candidate H5N1 vaccine can induce antibodies that neutralize widely divergent strains of H5N1. These preliminary data, which must be confirmed in a larger study, suggest that the vaccine may provide wider protection for a larger number of people before and during a pandemic.”

Preliminary results from this trial suggest that the vaccine is well tolerated in humans: the occurrence and severity of side effects at all dose levels are similar to what has been reported for licensed interpandemic (or seasonal) influenza vaccines. Most common side effects are injection site reactions, headaches and fatigue.

In addition, the preliminary results suggest that the vaccine is highly immunogenic and elicits functional antibodies to H5N1 even at the lowest dose level of 3.75µg. Importantly, preliminary analysis of serum samples obtained from the study subjects suggests both the neutralization of the pandemic virus contained in the vaccine and cross-neutralization against widely diverse strains of H5N1, including both Hongkong/156/97 and Indonesia/05/05.

“These preliminary results are encouraging,” said Professor Frank von Sonnenburg, M.D., who heads the Section of International Medicine and Public Health within the Department of Infectious Diseases and Tropical Medicine at the University of Munich, and chairs the Data Safety and Monitoring Board for the clinical study. “If confirmed in Phase III results, the suggested safety and immunogenicity of this cell-culture derived whole virus vaccine indicate its potential to make a major contribution to public health in preparing for and combating an influenza pandemic situation.”

Baxter plans to present the initial results of the Phase I/II clinical trial October 11 at the World Vaccine Congress in Lyon, France, and October 20 during the Second International Conference on “Influenza Vaccines for the World” in Vienna, Austria, with final results available by the end of 2006.

The company also plans to begin a Phase III clinical trial of the candidate pandemic vaccine early next year and present final results by the end of 2007.

In addition to this Baxter funded Phase I/II clinical trial, the company is separately involved with the U.S. Government in other vero cell-based influenza vaccine development programs. Baxter is working with the U.S. National Institute of Allergy and Infectious Diseases, in partnership with Fisher BioServices Inc., and with the U.S. Department of Health and Human Services, in partnership with DVC LLC, a Computer Sciences Corporation Company, to further develop vero cell-based pandemic and seasonal influenza candidate vaccines. Both collaborations are the result of U.S. Government contract awards. Baxter and its partners will provide the vero cell-based candidate vaccines to the agencies for further clinical testing in the United States, which is expected to begin by the end of this year.

Baxter also is in discussions with a number of other governments regarding its proprietary vero cell-based candidate pandemic vaccine. Earlier this year, Baxter received a contract award to supply two million doses of cell-culture based candidate H5N1 vaccine to the U.K. Government.

Cell-based systems for production of vaccines offer a number of potential benefits over more traditional egg-based systems. Baxter's vero cell technology is capable of producing high yields of influenza virus without the addition of any animal-derived serum. Through the company's research and development work, Baxter has been successful in growing “wild-type” virus at pilot and commercial scales using its unique vero cell technology. This means the company is capable of manufacturing pandemic vaccine without the need to wait for high-growth or attenuated virus reassortants normally used when vaccine is produced in eggs.

Baxter is developing both seasonal (or inter-pandemic) and pandemic influenza vaccines based on the company's vero cell technology. Baxter has one of the largest existing cell-culture facilities in the world, capable of manufacturing large quantities of vaccine. Because the facility is engineered for BioSafety Level III production, the facility can utilize “wild type” pandemic strains to help accelerate production and reduce the total time required to produce vaccine by several weeks. Baxter’s technology platform also allows it to implement rapid changes in strains that may be needed for new vaccine formulations.



</TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE></TD></TR></TBODY></TABLE>http://www.baxter.com/about_baxter/news_room/news_releases/2006/10-04-06-h5n1_trial.html
 
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