MGSF01: WHO and GPO Thailand developing vaccines

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