Vaccine Needs Assessment

Responsive COVID-19 Vaccines for Recovery Project under the Asia Pacific Vaccine Access Facility (RRP INO 54425-001)

VACCINE NEEDS ASSESSMENT

A. Background

1. The Ministry of Health (MOH) of Indonesia is regularly evaluating readiness for the coronavirus disease (COVID-19) vaccination introduction, using the Vaccination Introduction Readiness Assessment Tool (VIRAT). VIRAT was developed by the World Health Organization (WHO), United Nations Children’s Fund (UNICEF) and more recently, World Bank has also been supporting its development as dimensions evolve. VIRAT covers progress, required actions, and responsible parties across key areas.1 The sections below show progress by topic. The VIRAT

1. Vaccination objectives and targets

2. Status. Presidential Regulation No.99/2020, as amended by Presidential Regulation No. 14/2021,2 guides the Vaccination Allocation Plan (VAP) which comprises, among others, access prioritization criteria, procurement plan, and implementation arrangements including a medical waste management plan. These plans are supported by various decrees3 and guidelines,4 incorporating recommendations from the Indonesian Technical Advisory Group on Immunization (ITAGI).5 The VAP consists of government- and employer-funded programs. The government- funded program seeks to vaccinate 181.5 million Indonesians free of charge to attain herd immunity in the quickest manner to aid economic recovery. The employer-funded program seeks to accelerate vaccination coverage by allowing business entities to purchase COVID-19 vaccines from Bio Farma (or other organizations authorized by the Minister of Health) to vaccinate employees and their families free of charge. The central government will regulate and oversee implementation of vaccination under the employer-funded program including by establishing: (i) minimum standards for health facilities providing vaccination services, (ii) a price ceiling for the vaccination that covers vaccines as well as associated services; and (iii) reporting requirements. The timing of vaccination roll-out under the employee-funded program will be subject to vaccine availability. The Health Minister Decree 10/2021 (footnote 3) outlines the urgent need for vaccinations to reduce transmission, morbidity and mortality, and restore economic productivity. COVID-19 vaccinations will be mandatory for eligible targets under the government vaccination program. Such mandates aim to combat vaccine hesitancy, which has been a significant concern

1 A National Deployment and Vaccination Plan from MOH has also partially informed assessment of government’s readiness. MOH. 2020. National Deployment and Vaccination Plan. Jakarta. 2 Government of Indonesia. 2020. Presidential Regulation 99/2020 on Vaccines Procurement and Implementation. Jakarta, as amended by Government of Indonesia. 2021. Amendment (No. 14/2021) to Presidential Regulation Number 99 Year 2020 about Procurement of Vaccines and Implementation of Vaccinations in Handling Coronavirus (COVID-19) Pandemic. Jakarta. 3 Government of Indonesia, Ministry of Health (MOH). 2021. MOH Decree 10/2021 on Implementation of Vaccinations to Control COVID-19 Pandemic. Jakarta; Government of Indonesia, MOH. 2020. MOH Decree 28/2020 on Implementation of Vaccine Procurement in the Control of COVID-19. Jakarta; Government of Indonesia, MOH. 2020. MOH Decree 6573/2020 on the COVID-19 Implementation Team. Jakarta; Government of Indonesia, MOH. 2020. MOH Decree 12758/2020 on Determination of Vaccines for the Implementation of COVID-19 Vaccination. Jakarta; Government of Indonesia, MOH. 2020. MOH decree 18/2020 on Medical Waste Management in Health Service Facilities. Jakarta; and Government of MOH. 2021. Decree 423/2021 of the Director General of Disease Prevention and Control about Technical Instructions for the Implementation of Vaccinations in the Control of COVID- 19. Jakarta. 4 Government of Indonesia, MOH. 2020. Report of the Minister of Health for Handling COVID-19. Jakarta; and Government of Indonesia, MOH. 2020. Technical Guidelines for the Implementation of Vaccinations for Management of COVID-19. Jakarta. 5 The group is composed of 18 vaccines experts from various prominent national (e.g. Indonesian Pediatrics Society, Indonesian Internal Medicine Society, Indonesian Medical Association) and international organizations (e.g., WHO, United Nations Children’s Fund).

2 in the past in Indonesia. Article 13A of Presidential Regulation 14/2021 stipulates eligible targets of the COVID-19 vaccine who do not participate in receiving the vaccine may be subject to administrative sanctions in the form of: postponement or termination of provision of social security or social assistance; suspension or termination of government administration services; and/or a fine. These sanctions will be imposed by ministries, institutions and regional governments or agencies in accordance with their respective authorities. Article 13B of Presidential Regulation 14/2021 stipulates those who do not participate in vaccination as referred to in article 13A, and cause obstruction in the implementation of the prevention of COVID-19, may further be subjected to sanctions in accordance with the provisions under the law on infectious disease outbreaks.6 The regulation states that MOH will determine the target population. Exemptions and postponements are permitted for medical reasons, as outlined in accompanying technical instructions.7 Service providers carry out pre-vaccination screening to determine whether exemptions and postponements apply.8 Additional screening is given to those over 60 years old, including five questions related to mobility, tiredness and illness. Vaccinations may not be administered if concerns on three of five questions are raised. The government’s prioritization of vaccine access is consistent with the WHO Strategic Advisory Group of Experts on Immunization’s recommendations as it first protects health workers, public officers and essential workers, older people, and people at high risk.

3. Remaining steps. There are no remaining steps identified in VIRAT. However, further preparations for the employer-funded program, including listing eligible targets, providing sufficient guidance for employers and targets, listing health providers, securing vaccines supplies and determining service costs are needed. To ensure the vaccination program is properly understood, the government would need to formulate clear guidelines for stakeholders and carry out appropriate information, communication and education campaigns. Seeking feedback particularly from poor and vulnerable populations and Civil Society Organizations will be important.

2. Regulations

4. Status. The government has developed an expedited COVID-19 regulatory pathway for both registration and good manufacturing practice certification which follows emergency use authorization procedures. The procedures, timelines, and maximum number of days for each step of approval has been confirmed by government with WHO. The Indonesian Food and Drug Supervisory Authority or Badan Pengawas Obat dan Makanan (BPOM), and State-Owned Enterprises, Bio Farma and Indofarma are preparing to receive documents from manufacturers as they become available (on safety, quality, and efficacy of vaccines). Alongside, the necessary importation documents and procedures have also been identified, and MOH is coordinating with BPOM to confirm the expedited import approval process, including the production country’s lot release documents and issuance of an import certificate. Once in-country, products will undergo local lot release testing by Bio Farma, and vaccines will be evaluated against the batch or lot release certificate from the country of origin, in conformity with the minimum standards and requirements of BPOM on Good Manufacturing Practice.

6 Law 6/2018 provides for 1 year imprisonment and/or a maximum fine Rp100 million. 7 Government of Indonesia, MOH. 2021. Decree 423/2021 of the Director General of Disease Prevention and Control about Technical Instructions for the Implementation of Vaccinations in the Control of COVID-19. Jakarta. 8 Eligible recipients with heart, chronic kidney, or liver disease and those undergoing cancer treatment shall receive an exemption. Those who exhibit severe allergies from the first dose will be exempted from the second dose. Vaccination will be postponed for those (i) exhibiting temperature above 37.5 Celsius, high blood pressure, fever, cough, runny nose, or shortness of breath in the past 7 days; (ii) who have suffered from COVID-19 in the past 3 months; (iii) receiving treatment for blood clotting disorders or immune deficiencies, and (iv) who are pregnant.

5. Remaining steps. As more vaccines are introduced into Indonesia, BPOM, MOH, and Bio Farma will need to ensure sufficient resources to keep to the expedited timeline. Specific to vaccines entering Indonesia through the COVID-19 Vaccines Global Access (COVAX) facility, BPOM requires a full dossier from manufacturers, but WHO has indicated only the emergency use listing report (not full dossier) would be provided. This needs to be resolved for expeditious provision of COVAX vaccines. Halal certification will also be required prior to vaccine administration.

3. Performance management and monitoring and evaluation

6. Status. A monitoring and evaluation (M&E) framework and tools are in place. M&E will be carried out at each stage of the vaccination process, from pre-implementation (planning, before immunization), implementation (during), to post-implementation (after). Rapid assessments and corrective actions will be conducted throughout. At minimum, monitoring will be carried out on registration, state of readiness of health facilities, vaccination coverage, tracking drop-out between the 1st and 2nd doses, proof of vaccination (issuance of vaccination certificate), and adverse events following immunization (AEFIs). Beneficiary data will be gathered from existing datasets (such as line ministry level data and health insurance data) to identify and verify target populations. Other monitoring tools will include local area monitoring to track vaccine coverage, data quality self-assessment to monitor accuracy of vaccination coverage reports, and effective vaccine management to assess vaccine storage management. Supply data to track location of vaccines from the central storage facility to the point of service will also be available (via Bio Farma’s Logistics Management Information system). The government has piloted an electronic ‘One Data’ portal which integrates all data to facilitate M&E. A post-introduction evaluation and cost effectiveness analysis are planned in the longer term. Audit will be carried out in line with the Minister of Communication and Information Technology Decree 53/2021.9

7. Remaining steps. The Ministry of Communication and Information Technology and MOH will address remaining challenges of target registration; however, linking vaccination coverage data with disease incidence of specific target groups should be strengthened. Subnational level M&E especially for coverage, AEFI reporting, and surveillance data should be strengthened. The government must ensure measures for data protection and governance regulation are in place, as well as training for and fine-tuning of M&E tools, data management, and analysis.

4. Funding

8. Status. The government has allocated $3.98 billion in budgetary resources to support vaccine procurement and implementation.10 The MOH has estimated the required human resources for vaccination rollout based on the number of targets in different locations, and estimates a preliminary budget for operational costs amounting to $70 million. At the provincial level, budgets for demand generation, risk communications, and safety surveillance are being identified.

9. Remaining steps. Funding sources at central and subnational government level still need to be confirmed.

9 Government of Indonesia, Ministry of Communication and Information Technology and Ministry of Health. 2021. Operation of the One Data Vaccination Information System for Corona Virus Disease 2019 (COVID-19). Jakarta. 10 Governor’s letter in the National Vaccination Allocation Plan (accessible from the list of linked documents in Appendix 2 of the report and recommendation of the President).

5. Vaccine logistics and cold chain

10. Status. The government has mapped stakeholders involved in logistics, including relevant ministries, state-owned enterprises (Bio Farma, Kimia Farma, Indo Farma), and the private sector. Under MOH decree 6573/2020, a COVID-19 Vaccine Implementation Team has been formed, including a sub-team responsible for logistics. MOH has tasked Bio Farma to lead on logistics, and they have jointly identified distribution channels (most vaccines will be procured via Bio Farma and Indofarma who will import and deliver to distribution hubs then onto service points) and storage facilities against cold chain and transport capacity. The MOH has carried out a cold chain equipment inventory to assess gaps across Indonesia, and found deficiencies particularly at subnational government level. Such findings are corroborated by a recent UNICEF assessment of 9,750 health facilities which shows that 27 (of 34) provinces need to upgrade their cold chain equipment, and 447 (of 514) districts lack adequate equipment to accommodate the expected volume of COVID-19 vaccines. At the minimum, 110 walk-in cold rooms and 5,400 ice-lined refrigerators are required.11 Other challenges include lack of equipment for temperature monitoring, (equipment is unavailable, not computerized, or inadequate); and capability to maintain cold chain in times of power outages, especially if a natural disaster strikes. To address this, a five-year continuous improvement plan has been shared with all provinces, including additional procurement and repair works. Discussions are underway with the MOH for Bio Farma to enter into contractual arrangements with private logistics companies to provide additional cold- chain capacity. MOH and Bio Farma will ensure security arrangements to safeguard integrity of vaccines and ancillary products throughout the supply chain. Existing vaccine stock management tools will be updated to include COVID-19 vaccines and their characteristics (such as vial size and storage requirements).

11. Remaining steps. These include (i) creating a distribution strategy in close coordination with private sector logistics providers; (ii) mapping and developing plan to provide for infrastructure needs, including for energy (primary and back-up power, especially in cold chain), information technology/communications (including internet connectivity), and water; (iii) assessing dry storage and cold chain capacity and infrastructure needs at all levels and filling identified gaps; and (iv) updating and implementing systems for stock management, delivery, and acceptance protocols.

6. Vaccine waste management

12. Status. The MOH and the Ministry of Environment and Forestry developed COVID-19- specific regulations, guidelines, and standard operating procedures or revised existing ones to incorporate COVID-19 protocols. Health facilities may carry out onsite treatment for infectious waste using an onsite incinerator or autoclave before handing over the waste to a licensed hazardous waste management company. In line with this, almost all government healthcare facilities have cooperation agreements with third party waste management service providers. There is limited availability of licensed hazardous waste treatment facilities, with 20 provinces having at least one licensed facility, but gaps persisting in certain regions (e.g., Papua, Maluku, North Sulawesi, Bengkulu, and West Sumatra).

13. Remaining steps. Given the limited number of licensed incinerators and cement kilns, alternative arrangements for medical waste management are necessary. Availability and capacity in waste management of third-party service providers need to be reviewed and potentially

11 UNICEF. 2021. Cold Chain Assessment. Jakarta.

5 increased. In 2020–2021, the Ministry of Environment and Forestry continues its plans to construct provincial-based healthcare waste management facilities, placing incinerators in five locations (Aceh, East Nusa Tenggara, West Nusa Tenggara, South Kalimantan, and West Sumatra) and expanding to 32 locations by 2024. In addition, WHO, in collaboration with the United Nations Development Programme, is procuring four autoclaves and four incinerators to support medical waste management.

7. Vaccine safety and surveillance

14. Status. Under Presidential Regulation 99/2020 and as amended by Presidential Regulation No. 14/2021, the government will take liability for vaccine safety and quality and has committed to cover treatment costs for AEFI. The MOH has adapted global guidance for AEFI, including assignment of focal points and provincial and national AEFI committees. Guidance includes provisions that require suppliers to implement risk management plans and collect safety data and report to BPOM, investigation, and risk communication. BPOM, with the National Commission, will undertake sampling of suspected products. A pharmacovigilance mechanism is in place such that health facilities or individuals can report directly to BPOM. MOH is working with the national AEFI committee and BPOM to ensure smooth coordination and communication, sufficient budget, and clarity on scope of activities and responsibilities. Bio Farma’s Logistics Management Information system ensures a rapid recall process that can be triggered in case of AEFI. Training for health facility staff on AEFI has begun. A grievance redress mechanism includes a hotline number, “119,” for information and health counselling, and reporting to an online platform ‘LAPOR’, through the ombudsman and AEFI National Commission.

15. Remaining steps. AEFI committee training for AEFI staff at provincial level is required. Given the multiple types of vaccines expected in Indonesia, AEFI surveillance systems will need to be prepared with different reporting forms and data analysis by vaccine type. Such information will be important to help mitigate the risk of vaccine hesitancy due to safety concerns, should an AEFI occur for one type of vaccine. Budgets for covering AEFI costs have not yet been finalized. Compensation (for death and disability) schemes have yet to be established. For vaccines under the COVAX facility, further work on indemnification and liability will need to be carried out.

8. Planning and coordination

16. Status. The government has formed the Committee for Handling COVID-19 and National Economic Recovery which oversees COVID-19 activities according to Presidential regulation 82/2020. Presidential Regulation 99/2020, as amended by Presidential Regulation No. 14/2021, outlines directions on vaccines procurement and implementation. The MOH oversees procurement with delegation powers (including to state-owned enterprise Bio Farma and its subsidiaries), coordination, and conduct of preparatory activities and implementation. ITAGI supports MOH. Further, MOH decree 12758/2020 names potential manufacturers to supply COVID-19 vaccines to Indonesia, based on progress in clinical trials. Under MOH decree 6573/2020, the Minister of Health has formed a COVID-19 Vaccine Implementation Team consisting of sub-teams in (i) service delivery; (ii) cold chain and logistics; (iii) demand generation and communication; (iv) prioritization, targeting and COVID-19 surveillance; (v) M&E: determination and proof of eligibility, proof of vaccination, monitoring of coverage among at-risk groups, and monitoring of vaccine impact; and (vi) safety, including injury prevention and AEFI detection and response. Key ministries, ITAGI, stakeholders and partners have been briefed on vaccination program objectives and their expected roles. Coordination mechanisms between MOH, Bio Farma, and the local governments are in place to ensure a smooth link between procurement, production and manufacturing, delivery, and implementation.

17. Remaining steps. There is a need to identify and plan for the national vaccine procurement and deployment approach, including costs of items, due diligence mechanisms, and ensuring regulatory compliance. The procurement plan and purchasing strategy need to include vaccines, ancillary supplies, and personal protective equipment.

9. Service delivery including training

18. Status. The MOH has identified eligible service providers, identified appropriate healthcare workers and trained at least 30,000 vaccinators, issued a decree on infection prevention and control and technical guidelines for facilities, and piloted layout and service provision in four locations. It has completed the training plan with the Indonesia Training Center to prepare for vaccine introduction.

19. Remaining steps. Additional training materials from WHO and UNICEF will be compiled, and more trainings will be conducted especially at the provincial level. Training plans should incorporate staff security and security at storage facilities and in-transit. MOH needs to plan how to introduce COVID-19 into routine immunizations as part of the national immunization program. Incentives for vaccinators are still being planned.

10. Advocacy and risk communication

20. Status. Data collection systems have been established, including (i) social media listening and rumor management, and (ii) assessing behavioral and social data. UNICEF and WHO have developed a communication strategy for risk communication and community engagement that outlines demand side challenges (advocacy, communication, social mobilization, community engagement), and identified three phases of advocacy required, targeting different groups. Mass media campaigns and advocacy has started, including the televised vaccination of President Widodo. Training on vaccinations have already been provided to 30,000 health workers, with 24,000 also reached via interactive dialogue and consultative sessions. Data on social media activities and behaviors are being collected to feed into the development of messages and materials for public communications and advocacy. The Islamic Cleric council has started to issue halal certification to increase vaccines acceptance.

21. Remaining steps. Implementation of the communication strategy and crisis communications preparedness planning are underway. There is a need for continued engagement with health worker groups, religious organizations, and poor and vulnerable groups to ensure accurate information and knowledge dissemination about vaccines. This is particularly the case with the employer-funded program and potential imposition of sanctions, as outlined in the amended Presidential Regulation.

B. Summary of Remaining Steps and Development Partner Coordination

Remaining steps Responsibility Key partners Preparations for employer-funded Bio Farma, MOH Business entities program Ensure sufficient resources to BPOM, MOH, Bio Farma WHO, DFAT keep to the expedited regulatory timeline.

Remaining steps Responsibility Key partners Ensure registration process is MCIT, MOH ADB for M&E support to smooth, and measures for data Special Delivery Unit to protection and governance MOH, UNICEF regulation are in place, as well as training for and fine-tuning of M&E tools, data management, and analysis. Confirm funding sources at central MOF, MOH, Ministry of Not applicable and subnational government level. Home Affairs Create a distribution strategy in Bio Farma, MOH, MCIT, WHO and UNICEF for close coordination with private line ministries involved in cold chain capacity and sector logistics providers; develop infrastructure updating stock plan to provide for infrastructure management tools; ADB needs; assess dry storage and for logistics support to cold chain capacity and Special Delivery Unit to infrastructure needs at all levels MOH, UNICEF for and fill identified gaps; and update logistics support; ADB and implement systems for stock upgrading the logistics management, delivery, and management information acceptance protocols. system and training for Bio Farma Make additional arrangements for MOEF, MOH United Nations medical waste management. Development Programme, WHO for procurement, training, and monitoring activities Carry out training for AEFI MOF, MOH, AEFI WHO, UNICEF committees. Establish budget for committees, BPOM AEFI treatment costs. Establish compensation schemes and clarify indemnity and liability issues. Identify and plan for the national MOH, Bio Farma ADB, World Bank, WHO, vaccine procurement and UNICEF, DFAT, Japan deployment approach, including International Cooperation purchasing strategy for vaccines, Agency, USAID, World ancillary supplies, and personal Food Programme protective equipment. Compile and conduct training MOH, Government Training WHO, UNICEF, ADB for materials, especially at provincial Institute, MOHA training support to Special level. Training plans should Delivery Unit to MOH incorporate staff security and security at storage facilities and in- transit. Plan how to introduce COVID-19 into routine immunizations. Identify how to give incentives for vaccinators. Implement the communication MOH, MCIT UNICEF, WHO, Civil strategy and continue to engage Society Organizations health worker groups, religious

Remaining steps Responsibility Key partners organizations, and poor and vulnerable groups to ensure accurate information and knowledge dissemination about vaccines program. ADB = Asian Development Bank, AEFI = adverse event following immunization, BPOM = Badan Pengawas Obat dan Makanan (or Indonesian Food and Drug Supervisory Authority), COVID-19 = coronavirus disease, DFAT = Australian Government Department of Foreign Affairs and Trade, M&E = monitoring and evaluation, MCIT = Ministry of Communication and Information Technology, MOEF = Ministry of Environment and Forestry, MOF = Ministry of Finance, MOH = Ministry of Health, MOHA = Ministry of Home Affairs, UNICEF = United Nations Children’s Fund, USAID = United States Agency for International Development, WHO = World Health Organization. Source: ADB.