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Viewing cable 09BANGKOK1359, MGSF01: WHO and GPO Thailand developing vaccines

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Reference ID Created Released Classification Origin
09BANGKOK1359 2009-06-04 10:07 2011-08-25 00:00 UNCLASSIFIED//FOR OFFICIAL USE ONLY Embassy Bangkok
VZCZCXRO0294
OO RUEHAST RUEHCHI RUEHDH RUEHDT RUEHHM RUEHLN RUEHMA RUEHNH RUEHPB
RUEHPOD RUEHTM RUEHTRO
DE RUEHBK #1359/01 1551007
ZNR UUUUU ZZH
O 041007Z JUN 09
FM AMEMBASSY BANGKOK
TO RUEHC/SECSTATE WASHDC IMMEDIATE 7207
RUEHCHI/AMCONSUL CHIANG MAI 6630
RUEHZN/ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE
RUCNASE/ASEAN MEMBER COLLECTIVE
RUEHKT/AMEMBASSY KATHMANDU 7498
RUEHSV/AMEMBASSY SUVA 0467
RUEAUSA/DEPT OF HHS WASHINGTON DC
RUEHPH/CDC ATLANTA GA
RUEHRC/USDA FAS WASHDC
UNCLAS SECTION 01 OF 03 BANGKOK 001359 
 
SIPDIS 
SENSITIVE 
DEPARTMENT FOR OES/IHB:JJONES,CPATTERSON; EAP FOR DHANNEMAN 
DEPT FOR USAID/GBH 
USDA FOR FAS AND APHIS 
HHS FOR CDC 
USCINCPACLO FOR AFRIMS 
 
E.O. 12958: N/A 
TAGS: KFLU AEMR ASEC CASC TBIO KSAF KPAO PREL PINR AMGT
MG, ECON, EAID, WHO, TH 
SUBJECT:  MGSF01: WHO and GPO Thailand developing vaccines 
 
REF:  Bangkok 611 
 
BANGKOK 00001359  001.2 OF 003 
 
 
SENSITIVE BUT UNCLASSIFIED 
1. SUMMARY. Thailand's Government Pharmaceutical Organization (GPO) 
has been working with World Health Organization to develop its 
vaccine production capabilities for both seasonal and pandemic 
influenzas.  The technology utilized will be through a sub-license 
from the American pharmaceutical company Schering-Plough via an 
award from the WHO.  Currently Thailand is producing clinical lots 
of seasonal influenza treatments and with the recent WHO agreement 
will use new technology to produce vaccine models.  In September 
2009 Thailand will start construction on an industrial scale vaccine 
production plant. Reflecting Thailand's growing science and 
technology capabilities, it would become one of the few nations in 
Asia that could manufacture flu vaccines, though the goal of 
beginning large-scale production by 2012 may be optimistic.  On May 
30, 31 and June 2 Thailand reported and confirmed three new cases of 
A/H1N1 since the first two cases on May 3. END SUMMARY. 
WHO AGREEMENT WITH GPO 
---------------------- 
2. (U) Bangkok media reported in May that The World Health 
Organization (WHO) signed an agreement with the Royal Thai 
Government's (RTG) Government Pharmaceutical Organization (GPO) 
allowing GPO to use seed viruses developed by the Institute for 
Experimental Medicine in St Petersburg, Russia, to produce live 
attenuated influenza vaccines for domestic use in the event of a 
pandemic.  The signing ceremony took place at the 62nd World Health 
Assembly and was witnessed by WHO Director General Margaret Chan and 
RTG Public Health Minister Witthaya Kaewparadai.  A Health Ministry 
spokesman said locally that the GPO will be able to access the 
technology through a license granted to WHO for the benefit of 
developing countries by Nobilon (a division of U.S. firm 
Schering-Plough) in January 2009. 
3. (SBU) The WHO representative in Thailand explained to ESTHoff 
that there have been three agreements to date with GPO. The first 
was a capacity building grant in May 2007 for $2 million. The second 
was a renewal of the first agreement in April 2009 also for $2 
million.  The third agreement in May 2009 was for the one year 
sublicense for use of Live Attenuated Influenza Vaccine (LAIV) 
technology to produce vaccines and continuing activities for 
producing clinical lots of seasonal influenza.  GPO will receive 
LAIV samples to study and then report back to WHO on viral growth 
results before producing live attenuated vaccines for clinical use. 
GPO plans to begin clinic trials in September /October with 
LAIV(H1N1).  GPO will also use inactivated influenza technology to 
create a vaccine model for seasonal flu. 
THAILAND CAPACITY TO PRODUCE INFLUENZA VACCINE 
--------------------------------------------- - 
4. (U) In local media reports, Public Health Minister Wittaya 
announced that Thailand is transforming one of the existing GPO labs 
(used for producing vaccines for other diseases) into another pilot 
flu vaccine plant.  (Note: CDC contacts observed that retrofitting 
an existing vaccine factory for flu vaccine is problematic because 
the processes are so different and conversion is costly. End Note.) 
 
 
5. (U) The GPO has also been working on setting up a 1.41-billion 
baht ($40 million USD) industrial scale, avian flu H5N1 vaccine 
production factory, which could be adapted for H1N1 vaccine 
production.  The Bangkok Post quoted GPO managing director Witit 
Atthavejkul's remarks that construction of the plant would begin in 
September 2009, with production starting in 2012.  The factory, to 
be built in Saraburi province, could produce 60-120 million doses of 
live attenuated flu vaccine or up to 2-4 million doses of 
inactivated vaccine per season.  "In case there is influenza 
pandemic, the two GPO pilot plants can produce up to 3 million doses 
of live attenuated flu vaccine per month," Minister Wittaya said. 
"This amount, although not adequate for the whole Thai population of 
65 million, will be enough for high-risk groups and those 
responsible for patient care and national security." (Note: Embassy 
CDC staff find the timeline and numbers highly optimistic. End 
Note.) 
 
6. (SBU) Thailand's National Strategic Plan on Influenza Pandemic 
Preparedness (2005-2007) has been modified to plan for influenza 
vaccine production activity in a five-year plan (2007-2011) by a 
consortium of Thai organizations coordinated by GPO.  WHO contacts 
report that through a competitive process, WHO awarded GPO a grant 
 
BANGKOK 00001359  002.2 OF 003 
 
 
for $2 million to develop the pilot plant that would produce 
inactivated or live attenuated seasonal and/or H5N1 avian influenza 
vaccine.  According to WHO and Thailand's Influenza Vaccine 
Production Project press release, Thailand will use egg-based 
inactivated split technology to produce 2 million seasonal flu 
vaccine doses per year; using LAIV techniques, the tentative surge 
capacity would be 60 million doses per year. 
 
BACKGROUND ON WHO/GPO AGREEMENT AS IT RELATES TO THAILAND 
--------------------- 
7. (U) WHO and Nobilon (the vaccine division of Schering-Plough) 
signed an agreement at WHO's headquarters in January 2009 in which 
WHO was granted a non-exclusive license to develop, register, 
manufacture, use and sell seasonal and pandemic live, attenuated (or 
weakened) influenza vaccines (LAIV) produced in chicken eggs.  WHO 
is able to grant sublicenses to vaccine manufacturers in developing 
countries who are working within the framework of the WHO Global 
Pandemic Influenza Action Plan to Increase Vaccine Supply. 
 
8. (U) In November 2006 WHO's Initiative for Vaccine Research (IVR) 
launched the "Global Pandemic Influenza Action Plan to Increase 
Vaccine Supply" (GAP) in order to identify promising approaches for 
increasing availability of influenza vaccines. Three strategic 
approaches were identified: 1) increase in seasonal vaccine use, 
leading to increased commercial demand for influenza vaccine with 
consequently increased production capacity 2) increased capacity by 
building new production plants in both developing and industrialized 
countries, and 3) research and development of novel broad spectrum 
influenza vaccines. Through the GAP, Thailand is one of six 
developing countries that originally received grants to develop 
domestic vaccine production capacity.  The others are Indonesia, 
Mexico, Brazil, Vietnam, and India.  Egypt, Korea, Romania, Serbia, 
and Iran have recently been designated for new WHO grants to develop 
domestic vaccine production capacity.  The total value of all grants 
is about $12 million. Significant funding for this program comes 
from the Department of Health and Human Services, the government of 
Japan, and the Asian Development Bank. Currently the only countries 
in the region that are able to produce the A/H1N1 vaccine (whenever 
such a vaccine is developed) are Japan, China, South Korea, and 
Singapore. 
 
9. (U) Live Attenuated Influenza Vaccines (LAIV) have at least three 
major advantages compared to the currently available inactivated 
vaccines.  First the number of doses of LAIV which can be produced 
per egg are much higher; second LAIVs are administered nasally 
through a simple device, much easier for large-scale use by 
non-medically trained staff; third since a LAIV mimics natural 
infection more than injectable vaccines, LAIV is thought to induce a 
more rapid and broader immune response. 
 
THAILAND VACCINE PRODUCTION BACKGROUND 
-------------------------------------- 
10. (U) During Thailand's 2007 WHO Influenza Vaccine Production 
Grant, early phases for vaccine, capacity of the Government's 
National Strategic Plan were successfully developed.  The process 
for preparing vaccines from 2 Influenza A and 1 Influenza B strain 
at laboratory scales was developed and complies with WHO testing 
requirements.  The number of doses of trivalent seasonal inactivated 
vaccine was 2 doses per egg, a yield that is highly competitive. 
Using LAIV, preliminary results show the possibility of preparing 
100 doses of vaccine per egg. 
 
UPDATE OF THAILAND A/H1N1 STATUS 
-------------------------------- 
 
11. (SBU) On Saturday May 30 the Ministry of Public Health (MoPH) in 
Thailand confirmed its third case of A/H1N1.  The female patient 
recently returned from the United States.  The patient was treated 
at home with oseltamivir.  Her symptoms are reported to be mild. She 
was traveling with one other person who tested negative for A/H1N1. 
On Sunday May 31 Thailand confirmed its fourth case of A/H1N1.  The 
male patient recently returned from the United States. This patient 
was also treated from home with oseltamivir.  His wife and four 
family members were given antiviral drugs and are pending lab test 
results for A/H1N1.  On June 2 a fifth case was reported.  This 
female patient recently returned from the United States.  She was 
admitted to the hospital and her condition is reported to be well. 
Four of her family members are being monitored and are taking 
 
BANGKOK 00001359  003.2 OF 003 
 
 
prophylaxis. 
12. (SBU) MoPH's principal H1N1 official told ESTHoff that he hoped 
a second interagency meeting chaired by a Deputy Prime Minister 
would happen soon as promised.  He said that Thailand has no current 
plans to hold a simulation exercise to test preparedness. 
U.S. GOVERNMENT ASSISTANCE 
-------------------------- 
 
13. (U) Mission health agencies the Armed Forces Research Institute 
for Medical Sciences (AFRIMS), CDC, and USAID, with current 
investigations and diagnostics, are contributing strongly to the 
regional response.  AFRIMS regional office in Bangkok can currently 
confirm H1N1 infection and is running diagnostics for Embassy 
Medical Units in Bangladesh, Vietnam, China, Cambodia and India. 
USAID continues to work with implementing partners to refine 
pandemic influenza preparedness. 
 
14. POC is ESTH officer Hal Howard, howardhh@state.gov. 
 
ENTWISTLE