REVIEW OF RESEARCH AND DEVELOPMENT OF HUMAN VACCINES

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 �0A;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