WHO: Meeting on Options for Increasing the Access of

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