Identifier
Created
Classification
Origin
09HANOI558
2009-06-17 08:42:00
UNCLASSIFIED//FOR OFFICIAL USE ONLY
Embassy Hanoi
Cable title:  

REVIEW OF RESEARCH AND DEVELOPMENT OF HUMAN VACCINES

Tags:  TBIO AMED EAGR PINR KFLU VM 
pdf how-to read a cable
VZCZCXRO1002
RR RUEHAST RUEHCHI RUEHCN RUEHDH RUEHDT RUEHHM RUEHLN RUEHMA RUEHPB
RUEHPOD RUEHTM RUEHTRO
DE RUEHHI #0558/01 1680842
ZNR UUUUU ZZH
R 170842Z JUN 09
FM AMEMBASSY HANOI
TO RUEHC/SECSTATE WASHDC 9767
INFO RUEHHM/AMCONSUL HO CHI MINH 5933
RUEHZS/ASEAN REGIONAL FORUM COLLECTIVE
RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUEHUL/AMEMBASSY SEOUL 3567
RUEHKO/AMEMBASSY TOKYO 6131
RUEHHK/AMCONSUL HONG KONG 1806
RUEHGZ/AMCONSUL GUANGZHOU 0048
RUEHCN/AMCONSUL CHENGDU 0395
RUEHIN/AIT TAIPEI 1661
RUEAIIA/CIA WASHINGTON DC
RUEHPH/CDC ATLANTA GA
RUEHRC/DEPT OF AGRICULTURE WASHINGTON DC
RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEKJCS/SECDEF WASHINGTON DC//USDP/ISA/AP//
RHMFISS/CJCS WASHINGTON DC//J2/J3/J5//
RHEFDIA/DIA WASHINGTON DC//DHO-3//
RHMFIUU/CDR USPACOM HONOLULU HI//J00/J2/J3/J5//
RHEFAFM/DIRAFMIC FT DETRICK MD//MA-1A//
RUEHSUN/USUN ROME IT
UNCLAS SECTION 01 OF 03 HANOI 000558 

SENSITIVE
SIPDIS

STATE FOR EAP/MLS, EAP/EP, INR, OES/STC, OES/IHA, MED
STATE FOR AIAG (RLOFITS/CPATTERSON/CSHAPIRO)
STATE PASS TO USAID FOR ASIA (MELLIS, DSHARMA, CJENNINGS) AND
GH (GSTEELE, DCARROLL)
DEPARTMENT OF DEFENSE FOR OSD/ISA/AP (STERN)
HHS/OSSI/DSI PASS TO FIC/NIH (RGLASS),OGHA (JKULIKOWSKI/
/MABDOO/SCUMMINGS/DMILLER),ASPR (MPERDUE/RROBINSON)
CDC FOR COGH (SBLOUNT),CCID (SREDD) AND DIV-FLU(NCOX/AMOEN)
USDA PASS TO APHIS, FAS (OSTA AND OCRA),FSIS
BANGKOK FOR RMO, CDC (MMALISON),USAID (MACARTHUR/CBOWES),APHIS,
REO (HHOWARD/RTANAKA)
BEIJING FOR HHS HEALTH ATTACHE (EYUAN) AND CDC (JMCFARLAND)
PHNOM PENH FOR CDC INFLUENZA COORDINATOR(BBRADY)
ROME FOR FAO
VIENTIANE FOR CDC INFLUENZA COORDINATOR (ACORWIN)

E.O. 12958: N/A
TAGS: TBIO AMED EAGR PINR KFLU VM
SUBJECT: REVIEW OF RESEARCH AND DEVELOPMENT OF HUMAN VACCINES
AGAINST INFLUENZA IN VIETNAM

REF: A. 2007 Hanoi 890; B. 2008 Hanoi 599

HANOI 00000558 001.2 OF 003


UNCLAS SECTION 01 OF 03 HANOI 000558

SENSITIVE
SIPDIS

STATE FOR EAP/MLS, EAP/EP, INR, OES/STC, OES/IHA, MED
STATE FOR AIAG (RLOFITS/CPATTERSON/CSHAPIRO)
STATE PASS TO USAID FOR ASIA (MELLIS, DSHARMA, CJENNINGS) AND
GH (GSTEELE, DCARROLL)
DEPARTMENT OF DEFENSE FOR OSD/ISA/AP (STERN)
HHS/OSSI/DSI PASS TO FIC/NIH (RGLASS),OGHA (JKULIKOWSKI/
/MABDOO/SCUMMINGS/DMILLER),ASPR (MPERDUE/RROBINSON)
CDC FOR COGH (SBLOUNT),CCID (SREDD) AND DIV-FLU(NCOX/AMOEN)
USDA PASS TO APHIS, FAS (OSTA AND OCRA),FSIS
BANGKOK FOR RMO, CDC (MMALISON),USAID (MACARTHUR/CBOWES),APHIS,
REO (HHOWARD/RTANAKA)
BEIJING FOR HHS HEALTH ATTACHE (EYUAN) AND CDC (JMCFARLAND)
PHNOM PENH FOR CDC INFLUENZA COORDINATOR(BBRADY)
ROME FOR FAO
VIENTIANE FOR CDC INFLUENZA COORDINATOR (ACORWIN)

E.O. 12958: N/A
TAGS: TBIO AMED EAGR PINR KFLU VM
SUBJECT: REVIEW OF RESEARCH AND DEVELOPMENT OF HUMAN VACCINES
AGAINST INFLUENZA IN VIETNAM

REF: A. 2007 Hanoi 890; B. 2008 Hanoi 599

HANOI 00000558 001.2 OF 003



1. (SBU) Summary. On Monday, June 8, the Ministry of Health (MOH)
hosted experts from around the world at a conference reviewing
research and development of human vaccines against influenza.
Chaired by MOH Vice Minister Nguyen Thi Kim Tien, the meeting
contributed needed momentum to identify and tackle critical
technical, clinical research, partnership, and policy issues
associated with influenza vaccine development. There was strong
agreement that planning efforts that previously targeted the highly
pathogenic strain H5N1 should be broadened to include seasonal
influenza and the novel H1N1. The consensus message from meeting
participants was that an open, cooperative approach, which includes
the sharing of samples and related information, supported by broad
technical assistance, can yield results. End Summary.


Vietnam Held Up as a Successful Model
--------------


2. (SBU) Since 2006, primarily through a World Health Organization
(WHO) grant, the U.S. Government (USG) has invested about USD 4.0
million and Japan, 1.3 million, in the nuts and bolts of Vietnamese
capacity to manufacture a vaccine against the H5N1 strain of highly
pathogenic avian influenza (HPAI). Vietnam has reported substantial
progress and international experts link Vietnam's decision to
continue to share human and animal samples of H5N1 virus. From one
of these samples, the WHO collaborating center network returned

virus as seed lots for the development of Vietnam's vaccine
production capacity, which meets international good manufacturing
practice (GMP) standards (Ref A).

But, Vietnamese Vaccine Program Has Issues
--------------


3. (SBU) MOH has three active projects to develop a human vaccine
against H5N1 influenza. In Hanoi, VabioTech, a private spin off of
the MOH, which had received USD 400,000 in Government of Vietnam
(GVN) funding has moved forward most quickly and has conducted two
phase I human trials (i.e., designed to test safety and not
efficacy) and has reported promising preliminary results.
Unfortunately, VabioTech utilizes a generally outmoded approach,
which relies on the growth of the virus in primary monkey kidney
cells. The use of this method no longer meets international
standards due to the possible risk of transmission of an as-of-yet
undiscovered pathogen from primates to humans. [Note: This is a
concern, for example, in the wake of the understanding of the
evolution of the retrovirus Simian immunodeficiency virus in
primates as the postulated cause of HIV in humans. End Note.] Such
a vaccine product could not be easily sold on the international
market, and may not be acceptable for use in Vietnam, as similarly
made vaccines in Vietnam to prevent other disease (e.g., rabies)
have been pulled out of production. In 2006, U.S. Department of
Health and Human Services invested USD 1 million to help VabioTech
convert to a commercially available permanent cell line called

HANOI 00000558 002.2 OF 003


"Vero" cells (from Baxter),but project progress has been slow.
Other internationally respected laboratories using this approach
have been hampered by poor yields of vaccine.


4. (SBU) In pursuit of a second approach, the USG and Japanese
governments have funded IVAC (Nha Trang) which uses a traditional
egg-based approach and is quickly building the needed capacity to
produce vaccine lots according to international GMP standards. It
will soon have material of sufficient grade and quality for clinical
trials (Ref B). A GVN investment of USD 187,000 has been
complemented with a WHO grant, of USD 2.7 million, funded equally by
USG and the Japanese government. The Ho Chi Minh City Pasteur
Institute with USD 160,000 in funding from the GVN is using Vero
cells in its vaccine initiative. According to international
experts, given the state of this technology, this effort is
considered research and will not be ready for industrial scale up in
the next five years. In addition, according to a senior scientist
from international vaccine giant Sanofi, the use of H5N1 clade 1 in
vaccine production (when clade 2.3.4 has now displaced clade 1 in
northern Vietnam) and reliance on aluminum adjuvant (current
industry standard) may not be optimally effective in preventing H5N1
infection.

Structural Issues
--------------


5. (SBU) All participants recognized the fundamental importance of
vaccines in the prevention of influenza and international experts
stressed the need for a solid national plan of action for influenza
development. Peter Carrasco, WHO Policy Advisor on Vaccine
Security, stated that while Vietnam had a solid national plan to
respond to avian and pandemic influenza, it lacks a coherent policy
for vaccine introduction and usage. To create such a policy,
Vietnam should consider establishing an independent regulatory body
to advise the MOH on influenza vaccination selection and usage
policy. This infrastructure then could be used to make and
stockpile vaccine against HPAI or other strains that might arise,
such as the recent waves of novel H1N1 influenza. Planning should
address not only the H5N1 strain, but seasonal influenza and
situations such as the emergence of novel strain of H1N1. Per
Sanofi, the GVN will need to pay attention to soon-to-be announced
WHO recommendations on how countries should make production planning
for human vaccines against seasonal, H5N1 HPAI, and novel H1N1
influenza.


6. (SBU) Vice Minister Tien acknowledged the point and pledged to
improve myriad bureaucratic regulatory procedures. Finally, all
participants agreed that efforts to build public health capacity for
influenza surveillance, supported by CDC and WHO, have been
successful in developing virological and basic epidemiological
information necessary to understand the circulation of seasonal
influenza viruses. The next step must be to add components to the
current system to assess the burden of illness (e.g., how much
pneumonia and death is due to influenza). Related impact studies
would provide critical information for Vietnamese experts to develop

HANOI 00000558 003.2 OF 003


a sound vaccine policy. Continued funding remains a challenge,
especially in light of Japanese withdrawal from the WHO grant
project.

PALMER