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 
 
 
¶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