สถานการณ์ดา้นวัคซนีและชวีวตัถใุนประเทศไทยและอาเซยีน ๒๐ สงิหาคม ๒๕๖๒, ๑๓.๐๐-๑๔.๐๐ น. Current situation on Vaccines and Biologicals in Thailand and ASEAN 20 August 2019, 13:00-14:00

การพฒันานโยบาย เพือ่ความม ัน่คงและการพึง่ตนเองดา้นวคัซนีในภมูภิาคอาเซยีน

ASEAN Vaccine Security and Self-Reliance

(AVSSR) นพ.สมชาย พรีะปกรณ์ ทีป่รกึษากรมควบคมุโรค

Dr. Somchai Peerapakorn, Technical Advisor, DDC/MOPH/THA Slide 1

Human vaccines in Thailand & ASEAN……

Slide 2

• Why AVSSR? • What has been done?

• Where are we now? • What remains to be done?

Why AVSSR?

Slide 3

• ASEAN and Thailand • Development, sustainability and self-reliance of countries

and group of countries • Biotechnology, Vaccines and Biologicals • People’s Health and Vaccine Security • Vaccine value chain: Research & Development, production,

regulation and immunization

AVSSR – What has been done?

Slide 4

• 2013 – Initiation of the AVSSR concept by Thailand National Vaccine Committee, in preparation for the forthcoming “ASEAN Post-2015 Health Development Agenda” which would be in place after the ending of MDGs era

• 2014 until 2018 – The National Vaccine Institute (Public Organization) of Thailand sponsored 3 workshops to elaborate the AVSSR concept and activities with strong support from regional and global experts, stakeholders and officials

• 2014 until early 2017 – ASEAN was busy completing all needful preparation to implement “ASEAN Post-2015 Health Development Agenda”

• 2016 July - the AVSSR concept was adopted and placed within ASEAN’s pharmaceutical development workplans under cluster 3 in health priority issue 17

• 2017 July – The “ASEAN Health Cluster 3 Work Plan for 2016-2020: Strengthening Health Systems and Access to Care”, within which all AVSSR activities are placed, began its implementation

Planned AVSSR activities for 2016-2020 and current status

Activities* Planned implementation* Status

as of 15 Aug 2019 2016 2017 2018 2019 2020 1. Conduct ASEAN Vaccine Baseline Survey (AVBS)

Obtain ASEAN

SOMHD endorsement

1. Done - Report endorsed Nov 2018

2. Develop AVSSR Strategic and Action Plans

2. Postponed until after the ALD on AVSSR is made

3. Develop ASEAN Leader’s Declaration (ALD) on AVSSR

3. On-going - Scheduled for AHMM endorsement, 29 Aug 2019, Cambodia. Declaration is tentatively set for Nov 2019 in Thailand.

4. Deploy AVSSR Strategic and Action Plans

4. Postponed until after the ALD on AVSSR is made

5. Monitoring and Evaluation 5. Postponed until after the ALD on AVSSR is made

AVSSR – Where are we now?

Slide 5 * From the ASEAN Health Cluster 3 Work Plan for 2016-2020: Strengthening Health Systems and Access to Care

ASEAN Leaders’ Declaration on AVSSR

Slide 6

This 18-article, one-and-a-half page draft of ASEAN Leaders’ Declaration has been through 6 revisions and scheduled for

AHMM endorsement in Cambodia on 29 Aug 2019

Declaration is tentatively set for Nov 2019 in Thailand

ASEAN Vaccine Baseline Survey 2017

Slide 7

…….aimed to describe the most current capacity, gap and/or challenges in relation to the whole vaccine value chain, i.e. research and development (R&D), production, regulation and immunisation, at regional and country levels within ASEAN……….

This 30-page final report was endorsed by SOMHD in Nov

2018, currently ready to print by ASEC Health Division

AVBS 2017: How data were collected

Slide 8

Four data collection channels were used: 1. A self-administered survey template officially sent to AMSs

through ASEC. The template asked for data on R&D, Production, Regulation (vaccine quality control), and Immunization

2. Country experts interviews – Indonesia (1), Myanmar (1), Philippines (2) – as chances allowed

3. Country visits to potential vaccine manufacturers in selected AMSs – Myanmar, Philippines, Viet Nam

4. Secondary data retrieval from official websites and from a summary report of 2009 Indonesia study visit and relevant records of a similar survey in 2014.

Slide 9

AVBS 2017 findings:

AMSs population profile (2018

estimates)

Indonesia 265.30 Brunei Darussalam 0.43

Myanmar 53.02 Cambodia 16.25

Singapore 5.74 Lao PDR 6.78

Thailand 69.18 Malaysia 32.50

Viet Nam 94.58 Philippines 108.39

Vaccine Producing countries Non-vaccine producing countries

ASEAN Population (652.19 millions)

Slide 10

AVBS 2017 findings:

Current capacity on vaccine research

and development in vaccine

producing AMSs

ASEAN countries Capacity on vaccine R&D Research Institues/organizations Medical pathogens for vaccine R&D

Indonesia + PT BioFarma Streptococcus pneumoniae or Pneumococcal

Myanmar + Department of Medical Research, Ministry of Health and Sports N/A

Singapore - - - Influenza virus

DiphtheriaTetanusPertussis

Center for Vaccine Development (CVD); Mahidol UniversityChiangmai UniversityVaccine Research Center (VRC); Chulalongkorn UniversityNational Science and Technology Development Agency (NSTDA), Ministry of Science and Technology (MOST)BioNet ASIA

Japanese encephalitis (Live attenuated) Zika virus (ZKV)

Hand Foot Mouth Disease (HFMD) - Enterovirus 71Hepatitis B virus

irindhorn International Institute of Technology (SIIT), Thammasart University and NSTDA Mycobacterium tuberculosis (new TB)

National Biopharmaceutical Facility (NBF) and DOMS Japanese encephalitis (Subunit)Japanese encephalitis (Vero cell) Haemophilus influenzae type B

POLYVAC Inactivated Polio virus (IPV)Seasonal influenza virus (split)

Pandemic influenza virus (H5N1, H7N9)

VABIOTECH

IVAC

Viet Nam +

Government Pharmaceutical Organization (GPO)

Dengue virus

Department of Medical Science (DOMS), Ministry of Public Health

CVD and (GPO)

Thailand +

Slide 11

AVBS 2017 findings:

Company profile of ASEAN vaccine manufacturers

Public State-owned company Joint venture Private

Indonesia PT BioFarma √ N/A

Insein √

Yarthargyi √

Singapore GlaxoSmithKline (GSK) √ -

BioNet ASIA √ -

Greater Pharma √ -

GPO √ Ministry of Public Health

GPO-MBP √ N/A

QSMI-TRCS √ N/A

DAVAC √

IVAC √

POLYVAC √

VABIOTECH √

Original affiliation

Myanmar pharmaceutical industries, Ministry of

Industry

Ministry of HealthViet Nam

Current status of business

ASEAN countries Vaccine manufacturers

Myanmar

Thailand

Slide 12

AVBS 2017 findings:

Production capacity of routine EPI vaccines

among vaccine producing AMSs

Production capacity of non-routine EPI vaccines

among vaccine producing AMSs

Slide 13

AVBS 2017 findings:

National body for NRA National body for NCLMarketing authority

(licensing)

Post marketing

surveillance (pharmacovi

gilance)

System of lot release

Laboratory access (testing)

GMPs inspection Clinical trial

Indonesia + + + + + + + + + +

Myanmar + Department of Food and Drug Administration, Ministry of Health and Sports

N/A + - + + + + + - -

Singapore + Health Sciences Authority (HSA) N/A + + - + + + - + +

Thailand +

1. Food and Drug Administration (FDA);2. Bureau of Epidemiology (BOE), Department of Disease Control, Ministry of Public Health

3. Department of Medical Sciences (DMSC), Ministry of Public Health

+ + + + + + + (Re-NRA

assessment in 2018)

+ +

Viet Nam +

1. Drug Administration of Vietnam (DAV); 2. Administration of Science - Technology and Training (ASTT);3. General Department of Preventive Medicine (GDPM); 4. National Institute for control of vaccine and Biologics (NICVB), Ministry of Health

National Institute for control of vaccine and Biologics (NICVB)

+ + + + + + + (2017) + +

National Agency of Drug and Food Control (NADFC)

ASEAN countries

Current active functions of 6 critical control for regulatory systems

NRA assessment by the WHO

Membership of ASEAN

harmonization schemes

Legal agencies responsible for the NRSsNational

Regulatory Systems (NRS)

Membership of

GMP/PICS

Current capacity on the National Regulatory Authorities (NRA) in vaccine producing AMSs Slide 14

AVBS 2017 findings:

Type of vaccines currently in use and in pipeline (coded in yellow or blue) for the National Immunization Programme (NIP) introduction among AMSs Slide 15

AVBS 2017 findings:

Brunei Darussalam Cambodia Indonesia Lao PDR Malaysia Myanmar Philippines Singapore Thailand Viet Nam

1.1 BCG √ √ √ √ √ √ √ √ √ √ 1.2 Hepatitis B √ √ √ √ √ √ √ √ √ √ 1.3 Polio (OPV/IPV) √ (IPV) √ (bOPV/IPV) √ (bOPV/IPV) √ (bOPV/IPV) √ (IPV) √ (bOPV/IPV) √ (bOPV/IPV) √ (bOPV/IPV) √ (bOPV/IPV) √ (bOPV) 1.4 DTP containing vaccine √ (aP) √ (wP) √ (wP) √ (wP) √ (aP) √ √ (wP) √ (aP) √ (wP) √ (wP) 1.5 Haemophilus influenzae type B √ √ √ √ √ √ √ √ √ 1.6 Pneumococcal (conjugate) √ (PCV-13) √ √ √ (PCV-10) √ √ (PCV-13) 1.7 Rotavirus √ √ 1.8 Measles √ √ √ √ √ √ √ √ √ √ 1.9 Rubella √ √ √ √ √ √ √ √ √ √ 1.10 Human Papilloma Virus (HPV) √ √ √ √ √ √ √

2.1 Japanese encephalitis √ √ √ √ √ √ √ 2.2 Yellow fever 2.3 Tick-borne encephalitis

3.1 Typhoid √ √ 3.2 Cholera √ √ 3.3 Meningococcal √ 3.4 Hepatitis A 3.5 Rabies 3.6 Dengue (CYD-TDV) √

4.1 Mumps √ √ √ √ √ 4.2 Seasonal influenza (inactivated tri-and quadri-valent) √ 4.2 Varicella

4. WHO recommendations for immunization programmes with certain characteristics

ASEAN countriesType of routine EPI vaccines

1. WHO recommendations for all immunization programmes

2. WHO recommendations for certain regions

3. WHO recommendations for some high-risk populations

Slide 16

1. Insufficient qualified staffs, skilled personnel, experts and bioinformaticians for vaccine development 2. Budget constraints3. Lack of essential facilities, machineries, equipment, etc. for vaccine development4. Lack of know-how for vaccine development5. Lack of clear political policy and commitment in supporting vaccine research and development

Vaccine research and development

1. Lack of infrastures or facilities for manufacturing of potential vaccines 2. Lack of qualified staffs, skilled personnel and experts for vaccine production3. Require high vaccine quality improvement to meet international standard i.e. WHO-PQ for exportation4. High competitive market between vaccine produced locally and imported vaccines from multifunctional companies5. Lack of promoting usage of vaccine produced domestically in the NIP/EPI6. Lack of clear political policy in support of vaccine production for national security and self-reliance 7. Lack of firm support on vaccine production from the government8. Survival of local vaccine manufacturers under limited budget allocation from the government9. High turn-over rate of quilified staffs and appropriate measurements for retention

Vaccine productionAVBS 2017 findings:

Challenges and gap analysis

Slide 17

AVBS 2017 findings: Challenges and gap analysis

1. Limited capacity on quality c

ontrol and testing of vaccines both equipment and human resources

2. Limited capacity of lot release, clin

ical trial, and pharmacovigilance

Limited capacity on vaccin

e dossier assement

3. Require new test methods for quality c

ontrol of vaccines due to more new vaccin

es are registered

4. Limited capacity of developing potency te

st methods on identified vaccin

es for the purpose of post-

marketing surveilance (PMS)

5. Difficulty o

f obtaining samples and reference standard materials from Market Authorisation Holder

6. Limited capacity on vaccin

e dossier assessm

ent

7. Limited vaccine experts fo

r dossier reviews

8. Limited knowledge of Quality Management Syste

m (QMS)

9. Limited budget for training, facility

, and equipment

Vaccine quality control (regulation)

1. Rely on supplies from international manufacturers; hence lead to high price of vaccines (cost per dose), uncontrolled logistics and timeline 2. In process of accelerated transitioning phase of graduating from the Gavi support for fully self-financing on vaccine procurement 3. Vaccine refusal at selected areas and countering vaccine hesitant groups (negative campaign, religion issues)4. Limited budget for vaccine purchasing; hence lead to timely fund disbursement and clearance process5. Cold chain control during transportation and storage, including infrastructure for expanded new cold chain equipments6. Shortage of essentnial vaccines at national, regional and global levels7. Discrepancy of Immunization coverage rate and how to maintain a high coverage rate of immunization 9. Data quality related to high drop-out rate10. Discrepancy of vaccination schedule between public and private health sectorsDifferent geographical areas cause of difficulty to access vaccination services 11. Complexity of mechanisms for new vaccine introduction which lead to delayed introduction of essentail vaccines in the EPI12. High turn-over rate of quilified staffs and require continuing capacity building

National immunization programme (NIP)

AVBS 2017: Conclusions

Slide 18

1. ASEAN has substantial resources and growth potential in all the four areas of vaccine value chain. Those resources/potential are available in all member states.

2. More contribution and collaborative efforts from all AMSs, together with additional investment and better strategies would enhance the existing capacity in vaccine development and production of ASEAN, increasing the degree of vaccine security and self-reliance.

AVBS 2017: Conclusions

Slide 19

3. High-level technology is key to the development and production of vaccines and biologicals. In addition to AMSs solidarity, partnership fostering and collaboration with international development partners and stakeholders is strongly needed.

4. Periodic follow-up surveys on all the four areas of vaccine value chain are crucial to monitoring progress towards AVSSR targets, and to the formulation of the next strategic and action plans. Collaborative, multi-country teams should be tasked in the spirit of one ASEAN community.

•High competition global vaccine market •Country’s graduation from Gavi support •Pandemic of emerging infectious diseases

• Global Vaccine Action Plan (GVAP) exists

• Quite a few international development partners e.g. WHO, Gavi, UNICEF, BMGF, etc.

•Insufficient technology transfer/ outdated technologies •Weak regional collaboration on vaccine R&D and production •No regional policy for targeted vaccine development and production •Vaccine procured individually by each country •Budget constraints •Insufficient skilled staffs on R&D and production •Population movement across country

• Harmonization of ASEAN countries as one community

• Availability of research institutes for vaccine development

• Availability of potential vaccine manufacturers

• Availability of NRA network Strengths Weaknesses

Threats Opportunities

AVSSR SWOT ANALYSIS

Slide 20

AVSSR: What remains to be done?

Slide 21

• After the declaration on AVSSR of ASEAN Leaders, the AVSSR strategic and action plans should be developed, taken into account the important findings of AVBS 2017.

• AVSSR strategic and action plans should aim to achieve a healthy ASEAN community through timely, equitable access to affordable, safe, and quality vaccines.

• Appropriate platforms for the operationalization of the AVSSR strategic and action plans should also be developed.

Slide 22