VZCZCXYZ0000
RR RUEHWEB

DE RUEHGV #1060/01 1200813
ZNR UUUUU ZZH
R 300813Z APR 07
FM USMISSION GENEVA
TO RUEHC/SECSTATE WASHDC 3719
INFO RUEHBK/AMEMBASSY BANGKOK 1921
RUEHBJ/AMEMBASSY BEIJING 5658
RUEHSW/AMEMBASSY BERN 7941
RUEHBY/AMEMBASSY CANBERRA 6281
RUEHJA/AMEMBASSY JAKARTA 2126
RUEHLO/AMEMBASSY LONDON 2709
RUEHOT/AMEMBASSY OTTAWA 5576
RUEHFR/AMEMBASSY PARIS 3191
RUEHKO/AMEMBASSY TOKYO 6624
RUEHPH/CDC ATLANTA GA
RUEAUSA/DEPT OF HHS WASHINGTON DC
RHEFHLC/DEPT OF HOMELAND SECURITY WASHINGTON DC
RUCNDT/USMISSION USUN NEW YORK 2206
RHEHAAA/WHITE HOUSE WASHDC

UNCLAS GENEVA 001060 
 
SIPDIS 
 
SIPDIS 
 
DEPT FOR G, AIAG, OES, IO/T 
HSC FOR RAJEEV YENKAYYA 
 
E.O. 12958: N/A 
TAGS: TBIO AORC
SUBJECT:  WHO: Meeting on Options for Increasing the Access of 
Developing Countries to H5N1 and other Potential Pandemic Vaccines 
 
 
¶1. Summary.  The World Health Organization (WHO) convened subject 
meeting April 25 to discuss strategies to expand access to influenza 
vaccines, including stockpiling options and increased vaccine 
production.  Participants included representatives from donor 
countries, countries affected by the H5N1 virus, and vaccine 
manufacturers.  Agreeing that scientific evidence and political 
commitments indicate stockpiles are feasible, the participants asked 
the WHO Secretariat to undertake further work on the details about 
how to create, maintain, fund and use an H5N1 vaccine stockpile 
resource, and to continue to consult with Member States and other 
partners on the development of a mechanism for broader access to 
pandemic vaccines.  Ambassador John Lange, Special Representative on 
Avian and Pandemic Influenza (AIAG) led the U.S. delegation.  End 
Summary. 
 
¶2. Responding to calls from developing countries, particularly 
Indonesia, for greater access to adequate stocks of H5N1 and other 
pre-pandemic and pandemic influenza vaccines, the WHO 
Director-General, Dr. Margaret Chan, convened a meeting on April 25 
in Geneva to address these concerns.  In opening the meeting, the 
Director-General characterized the issue of a potential influenza 
pandemic as one of the biggest dilemmas in public health today. 
Noting the finite resources available for public health, Dr. Chan 
emphasized the universal threat a pandemic poses to health security, 
and re-emphasized the collective obligations WHO Member States have 
under the revised International Health Regulations (IHRs), which 
come info force on June 15, 2007. 
 
¶3. Dr. David Heymann, WHO Assistant Director-General for 
Communicable Diseases, noted flu viruses had been freely shared for 
over fifty years for the production of seasonal flu vaccines, and 
stressed the importance of the Global Influenza Surveillance Network 
(GISN), with its 115 National Influenza Centers, and the WHO?s 
Global Pandemic-Influenza Action Plan to Increase Vaccine Supply as 
mechanisms in place to increase the availability of seasonal and 
pandemic influenza vaccine.  Heymann reviewed a series of meetings 
that were leading up to the May 2007 World Health Assembly (WHA), 
which would consider resolutions on sample-sharing and access to 
vaccines.  He noted particularly the January 2007 WHO Executive 
Board, which had adopted a draft resolution on virus sharing; the 
meeting on responsible practices for virus sharing and resulting 
benefits, held in Jakarta in March 2007; the April 17-18, 2007, 
meeting of the Strategic Advisory Group of Experts (SAGE), which had 
recommended that the WHO Secretariat should create an H5N1 vaccine 
stockpile for countries without capacity to produce influenza 
vaccines or the ability to purchase such vaccines; and the April 
19-20, 2007, meeting of experts that reaffirmed the importance of 
GISN as a public-health resource, supported the draft WHO document 
on Best practice for sharing influenza viruses and sequence data, 
and called for the WHA to consider a draft resolution on access to 
vaccines. 
 
¶4. Dr. Viroj Tangcharoensathien of the Ministry of Public Health of 
Thailand presented developing-country perspectives on increasing 
access to influenza vaccines.  Noting U.S. and Japanese support for 
capacity-building in a number of countries, Thailand placed top 
priority on expanding vaccine production.  Describing GISN as the 
backbone of the response to a potential pandemic, Thailand called on 
all countries to participate fully in GISN, share influenza viruses 
freely and without restriction, and adhere to the IHRs.  Thailand 
asked development partners to provide increased resources, urged 
industry to carry out research and development (R&D) on better 
vaccines, and called on the WHO Secretariat to continue its work on 
standard operating procedures for virus transfer.  (Comment:  Dr. 
Viroj?s presentation was more balanced and fair than his colleagues? 
statements at the WHO Executive Board in January of this year.  He 
admitted afterwards to have deliberately steered clear of 
intellectual-property issues.  The more moderate discourse from the 
Thai delegation could reflect an attempt to put distance between the 
Thais and the Indonesians as Jakarta continues to renege on promises 
made to cooperate with the international community at large.  End 
comment.) 
 
¶5. The Developing Country Vaccine Manufacturers Network (DCVMN) and 
 
the International Federation of Pharmaceutical Manufacturers and 
Associations (IFPMA) provided industry perspectives.  Both committed 
to work with countries and the WHO leadership to address pandemic 
preparedness, and to develop approaches for funding, allocating and 
distributing potential vaccines.  IFPMA said industry is investing 
in increased vaccine supply, and expects current production capacity 
to double in the next two to three years.  IFPMA also noted vaccine 
manufacture is highly complex, is highly regulated, and must be 
compliant with good manufacturing practices - a validation process 
that can take many years.  IFPMA said industry is prepared to 
contribute to global stockpiles once their scope and magnitude has 
been defined.  DCVMN noted it is already providing the bulk of 
vaccines purchased by United Nations agencies, and, with support 
from the international community, could establish the capacity to 
produce H5N1 vaccines. 
 
¶6. Switzerland provided an industrialized-country perspective on 
increasing access to vaccines.  Noting it has already purchased 
enough H5N1 pre-pandemic vaccines for the entire Swiss population 
(although not mentioned, this purchase was from GlaxoSmithKline and 
Novartis), Switzerland said it had also entered into an advance 
purchase contract for one dose of pandemic vaccine for each Swiss 
citizen.  Noting that a country?s first obligation is to its own 
people, Switzerland argued that having met that obligation first 
allowed it to then secure government funds to support global 
stockpiles, either through donations or financial contributions.  To 
do this, Switzerland said it was exploring issues related to legal 
liability, differential pricing, and advance purchase commitments, 
and would continue to work with the WHO Secretariat on these 
issues. 
 
¶7.  Reacting to Switzerland?s presentation, Thailand said it had 
quickly calculated that it must have cost Switzerland USD20 per 
person to provide this vaccine coverage, a cost no developing 
country could afford.  And, Thailand asked, if all the rich 
countries did the same, how many vaccine doses would be left for the 
rest of the world? 
 
¶8. In the afternoon session, the Chair, Dr. Jean-Claude Manuguerra, 
head of the French influenza collaborating center at the Institut 
Pasteur, asked Member States for their views, although not all 
contributed to the discussion.  The separate French delegation said 
international solidarity was essential, and that strict 
implementation of the IHRs would benefit all countries.  Japan 
agreed stockpiles were one option to consider, but influenza-vaccine 
stockpiles were more complicated than other kinds.  Much more 
information about the operation of such stockpiles was necessary to 
make a decision on their feasibility, and the WHO Secretariat should 
present that information to the WHA.  Thailand said it could not 
support pre-pandemic stockpiles unless the WHO Secretariat provided 
a cost-benefit analysis of the proposal, and, because of the 
possibility of stockpiling the wrong vaccine, only if the vaccines 
provided cross-protection.  The United Kingdom (UK) expressed 
support for the SAGE recommendations (SAGE is chaired by the UK) and 
GISN.  Australia expressed support for the WHO?s ongoing work in 
this area, and suggested an expert group should address the 
technical issues that had been raised.  China, whose expert was 
unable to attend because Switzerland had not issued the required 
visa, expressed support for the views of developing countries, and 
welcomed the forward-leaning positions taken by developed countries. 
 China also supported the draft document on Best practice for 
sharing influenza viruses and sequence data.  Indonesia, represented 
by Dr. Widjaja Lukito, an Adviser on public policy to the Minister 
of Health, was reserved, and seldom intervened, other than to 
promote the outcomes of the Jakarta meetings and to express 
appreciation for the support it had received from the WHO. 
 
¶9. US Del expressed strong support for the WHO Secretariat?s work in 
this area, and called for accelerating the implementation of the 
Global Action Plan to Increase Vaccine Supply as the foundation to 
increase the availability of seasonal and pandemic-influenza vaccine 
globally.   Noting the critical gap in access to vaccines, US Del 
recalled the U.S. Government?s contribution of USD10 million to the 
WHO Headquarters to expand the development and manufacturing 
 
infrastructure for influenza vaccine in developing countries. 
Echoing Thailand?s reference to GISN as the backbone of the global 
response, US Del stressed its support for the current framework for 
sample sharing, without any encumbrances.  US Del expressed 
willingness to consider contributions to a WHO-managed pre-pandemic 
vaccine stockpile in the short term, either by committing a portion 
of the current USG domestic pre-pandemic stockpile or by providing 
financial support to a WHO-established stockpile, although the U.S. 
Government is unable to provide specific commitments at this time. 
In the long term, US Del said the United States is willing to 
consider contributions to a global virtual pandemic vaccine 
stockpile ? again without providing specific commitments now. 
Recalling Director-General Chan?s reference to the need to consider 
measures other than vaccines, US Del referred to the U.S. Community 
Mitigation Guidance and Pandemic Severity Index, both of which are 
described on the U.S. website www.pandemicflu.gov.  US Del closed by 
reiterating the responsibility that all nations have to share data 
and virus samples, and stressed responding to a pandemic will demand 
the cooperation of the world community. 
 
¶10. The meeting concluded with the adoption of Summary Points (see 
para 12) that reaffirmed that the work on virus-sharing, H5N1 
vaccine stockpiles, access to pandemic vaccines and other means of 
strengthening pandemic preparedness must all be based on the IHRs, 
the overarching framework to ensure global health security.  Despite 
attempts by Indonesia to include a reference to the Jakarta 
Declaration as guidance for improved access to vaccines, US Del was 
successful in limiting a reference to the Jakarta meeting to a 
footnote that listed other meetings (not included in para 12). 
 
¶11. The WHO Secretariat will now set up expert groups to focus on 
the details of how to create, maintain, fund and use an H5N1 vaccine 
stockpile.  The WHO leadership will continue to consult with 
appropriate partners and Member States on the development of 
mechanisms for broader access to pandemic vaccines. 
 
¶12. Text of Summary Points: 
 
The International Health Regulations (2005) are the overarching 
framework to ensure global public health security and provide the 
basis for this work. The WHO Best Practices for Sharing Influenza 
Virus and Sequence Data document provides guidance, and conclusions 
from recent discussions and meetings1 can assist in attaining a goal 
that is internationally agreed upon: to improve access to H5N1 and 
pandemic vaccines as a means, among others, to strengthen pandemic 
preparedness. 
 
The current meeting focused on feasibility of vaccine stockpiles to 
complement production capacity building efforts.  Scientific 
evidence and political will indicate that vaccine stockpiles may be 
feasible: 
 
H5N1 vaccines have been shown to be safe and immunogenic 
 
New data suggest lower antigen doses and cross protection are 
realistic expectations 
 
Based on scientific evidence reviewed, SAGE has recommended that WHO 
proceed to assess the feasibility of H5N1 vaccine stockpiles 
 
Realizing its potential, the Developing Country Vaccine 
Manufacturers Network has indicated its commitment to work on its 
mission with WHO and its Member States 
 
The International Federation of Pharmaceutical Manufacturers 
Association has indicated the same commitment and forecasts 
increasing manufacturing capacity in the next 3 to 5 years to meet 
potential growing demand 
 
Some Member States expressed commitment to work with WHO 
 
Next Steps 
Agree on the need to now focus on the details about how to create, 
maintain, fund and use such an H5N1 vaccine stockpile resource. 
 
 
WHO will continue to consult with appropriate partners and Member 
States on the development of mechanisms for broader access to 
pandemic vaccines. 
 
TICHENOR