DCVMN AND VACCINE SECURITY IN ASEAN REGION. ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, 2014.

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1 DCVMN AND VACCINE SECURITY IN ASEAN REGION ASEAN Countries on Opportunities for Regional Vaccine Security 1-3 October, Phuket - Thailand

2 Developing Countries Vaccine Manufacturers Network (DCVMN) DCVMN consists of 39 members from 15 countries and territories Mission and Vision: To protect people against known and emerging infectious diseases globally by increasing the availability and enhancing the quality of vaccines produced in developing countries. To strengthen vaccine manufacturers through the provision of information programs and professional training on technical improvements, research in vaccine production, encouraging technology transfer initiatives, and educating the public about the availability of safe and effective vaccines, from developing world manufacturers and related programs. Objective: To provide a consistent and sustainable supply of quality vaccines at an affordable price to developing countries

3 DCVMN members in ASEAN region Indonesia: BIOFARMA, a state-owned vaccine and antisera manufacturer in Indonesia which plays a vital role in supporting the National Immunization Program. Thailand: GPO (The Government Pharmaceutical Organization ), a state enterprise under Ministry of Public Health of Thailand BioNet-Asia Co., Ltd Queen Saovabha Memorial Institute, The Thai Red Cross Society Vietnam: VABIOTECH (The Company for Vaccine and biological production No.1, Hanoi) POLYVAC (The Scientific Center for Vaccine and Med-Products, Hanoi) IVAC (The Vaccine Institute, Nha Trang)

4 The licensed locally produced vaccines BIOFARMA Tetanus Toxoid Vaccine (TT) Tetanus Toxoid Vaccine (Bio-TT) Diphtheria and Tetanus Vaccine (DT) Tetanus and Diphtheria Vaccine (for adult) Diphtheria, Tetanus and whole -cell Pertussis Vaccine (DTP) Tetravalent Combination Vaccine (DTP-HB) Hepatitis B Vaccine (HB) Monovalent, bivalent Polio Vaccine (mopv, bopv) Trivalent Oral Polio Vaccine (topv) Measles Vaccine (Measles) Tuberculosis Vaccine (BCG) Seasonal flu Vaccine (Flubio) Diphtheria, Tetanus, Whole-cell Pertussis, Hep-B and Haemophilus Influenzae type b: DTP-HB-Hib (Pentabio)

5 The licensed locally produced vaccines GPO Inactivated Japanese Encephalitis vaccine, Beijing strain Tetanus Antitoxin (TAT) Antisnake venom BioNet Vaccine R&D Queen Saovabha Memorial Institute,The Thai Red Cross Society BCG Equine rabies immunoglobulins Anti-venom

6 The licensed locally produced vaccines VABIOTECH Hepatitis A (HAVAX - Primary Cell Based vaccine) Hepatitis B (Gene-HBvax - Recombinant vaccine) Japanese Encephalitis (JEVAX - Mouse brain inactivated vaccine) Oral cholera (morvax) POLYVAC OPV Rotavirus vaccine Measles vaccine IVAC DTwP vaccine BCG vaccine

7 Ongoing vaccine development - Egg based influenza vaccine - Cell culture based influenza vaccine - Rubella and MR vaccine - Vero cell derived rabies vaccine - Hib conjugate vaccine - Typhoid Vi conjugate vaccine - Vero cell derived Japanese encephalitis vaccine - IPV - Acellular Pertussis vaccine - EV71 vaccine - Dengue vaccine - Combination vaccines

8 Vaccine security - Cholera - Cholera is a rapidly dehydrating diarrhoeal disease caused by ingestion of toxigenic serogroups (O1 and less commonly O139) of Vibrio cholerae. Humans are the only known natural host for V. cholerae, and the disease is spread mainly by faecal contamination of water and food. - The disease burden is characterized by both endemic disease and epidemics. Cholera occurs endemically in south and south-east Asia and in Africa, but may also cause major outbreaks. - The growing number and frequency of major cholera outbreaks are causing concern. The majority of affected countries report an overall cholera case-fatality rate (CFR) of <5%, but in some locations the CFR may approach 50% during outbreaks among the most vulnerable groups.

9 Vaccine security - Cholera - Oral cholera vaccines of demonstrated safety and effectiveness have recently become available for use by individuals. - Some countries have already used oral cholera vaccines to immunize populations considered to be at high risk for cholera outbreaks (Eg. Vietnam). - Evidence gained on the use of oral cholera vaccines is evolving rapidly. The role of mass vaccination as a public health strategy for protecting at risk populations against cholera is more clear.

10 Security Vaccine Pandemic Influenza An influenza pandemic is an epidemic of an influenza virus that spreads on a worldwide scale and infects a large proportion of the human population. Influenza pandemics occur when a new strain of the influenza virus is transmitted to humans from another animal species. Species that are thought to be important in the emergence of new human strains are pigs, chickens and ducks. These novel strains are unaffected by any immunity people may have to older strains of human influenza and can therefore spread extremely rapidly and infect very large numbers of people.

11 Security Vaccine - Pandemic Influenza - A vaccine probably would not be available in the initial stages of population infection. A vaccine cannot be developed to protect against a virus which does not exist yet. Once a potential virus is identified and a vaccine is approved, it normally takes five to six months before the vaccine becomes available. - Countries which do not manufacture vaccines themselves, including those where a pandemic strain is likely to originate, will be able to purchase vaccine to protect their population. Cost considerations aside, they fear that the countries with vaccine-manufacturing capability will reserve production to protect their own populations and not release vaccines to other countries until their own population is protected.

12 Security Vaccine Pandemic Influenza - The capability to produce vaccines of influenza vaccine manufacturers including Vietnam, Thailand and Indonesia) would be adapted in Pandemic situation. - It is estimated that, in a best scenario situation, 750 million doses could be produced each year, whereas it is likely that each individual would need two doses of the vaccine to become immuno-competent. - Distribution to and inside countries would probably be problematic.

13 Vaccine management in ASIAN region A common regulation for vaccines managements in ASIAN region (formatted vaccine registration process? Fast-tract registration in urgent demand ) Regular meetings and discussion among NRA from all countries in ASIAN region. Regular meeting among leaders of the national immunization programs from ASEAN countries to forecast demand of vaccine. Close collaborations in R&D, sharing experience amongst local manufacturers in the region. Supports from Government level in ASEAN region through the national as well as regional strategies in investments and immunization programs.

14 Thank you! DO TUAN DAT For a healthier life