STC on COVID and NRA for EPI

Job title: VN008 Short term consultant to support COVID-19 vaccine deployment and capacity strengthening of National Regulatory Authority (NRA) for vaccines and medicines

1. Background

Since the COVID-19 pandemic occurred, research and development of COVID-19 vaccines had been started as a potential useful tool of mitigating COVID-19 pandemic impact. Vaccine development projects had been running all over the world in unprecedented speed in response to high demand, and several countries already certified as emergency approval for some vaccines and started using them from late 2020, and as of Jan 2021 one candidate vaccine was certified as WHO Emergency Use List. WHO, together with GAVI and CEPI, global alliances, formulated vaccine pillar under the Access to COVID-19 Tools (ACT) Accelerator called COVAX, aiming equitable and affordable vaccines delivery to all countries as united effort to combat the pandemic. COVAX Facility, the pooled procurement mechanism was also established with total of 190 participating countries to provide support to LICs and MLICs including Vietnam through COVAX Advanced Market Commitment (AMC). General Department of Preventive Medicine (GDPM)/MOH Vietnam has been nearly finalized the National Deployment and Vaccination Plan (NDVP) of Vietnam in line with consultations with WHO, partners and in-country experts, aiming to be approved by Health Minister in February 2021. Series of documents such as technical guidelines, standard operational procedures, training materials are being or need to be developed, for subsequent trainings and implementation of vaccine deployment with proper supervision at immunization sites. WHO has been providing technical support GDPM/MOH in finalizing NDVP and necessary technical documents and in providing trainings to provinces and implementing levels for Viet Nam to be ready for COVID-19 vaccine deployment. Together with COVAX, UNICEF and World Bank, Vaccine Readiness Assessment Tool (VRAT) was developed for countries to do self-assessment and monitor of their readiness, as well as to report it regularly through UNICEF/WHO COs to COVAX. Vaccine allocation from COVAX is being decided by reviewing NDVP/VRAT together with Vaccine Request from the country to COVAX. COVID-19 vaccine deployment requires multi-sector engagement and high-level coordination and planning beyond traditional Expanded Program on Immunization as targeting different populations at variety of immunization site. Therefore, VIRAT is made as a comprehensive tool which covers 50 activities of 10 areas. While WHO, UNICEF and other partners jointly support the country’s readiness, the main leading areas are shared between WHO and UNICEF in Vietnam where WHO takes a main or co-leading role in planning, budgeting, regulatory, prioritization, service delivery, training, evaluation, and safety surveillance. Within WHO VNM CO, VDI team and Universal Health Coverage (UHC) team are collaborating to provide cross-cutting support while VDI has been assigned as focal point of COVId-19 vaccine deployment. Among the supporting areas, Regulatory and Safety surveillances are linked to key areas of strengthening National Regulatory Authority (NRA) of Viet Nam. Due to complicated procedures which are not fully in line with WHO standards, Viet Nam had issues on pandemic influenza vaccine deployment, and timely delivery of medicines such as for diphtheria or botulinum. Pharmacovigilance (including safety surveillance, AEFI management and causality assessment, reporting) functions also have had gap in recent years; which is critical for COVID-19 vaccines, the new vaccine to any countries. While NRA was just certified as Maturity level 3 for vaccines in Dec 2020, it needs to further improve as firm system and to expand its function for other medicines and medical products, towards an autonomous agency like Food and Drug Administration (FDA) in future. Thus, it is critical opportunity that WHO to support COVID-19 vaccine deployment which strengthens country’s health system capacity in pandemic response including regulatory system and immunization system. Therefore, WHO VNM CO commissions a contract with one consultant to support WHO and MOH VNM in supporting their readiness and implementation of COVID-19 vaccines in WHO supporting areas, for successful COVID vaccine deployment in Viet Nam.

2. Planned timelines

Start date: 1/03/2021 End date: 15/08/2021

3. Work to be performed

Method(s) to carry out the activity The consultant is required to report to the WHO Representative Office in Viet Nam at full time basis and work closely with Disease Control and Health Emergency (DC-HE) Team members under the direct supervision of the Technical Officer VDI and overall guidance from DC-HE Team and the WHO Representative in Viet Nam. Output 1: Technical support provided to relevant departments of MOH in COVID-19 vaccine deployment readiness Deliverables o 1.1.: Technical guidelines for COVID-19 vaccine deployment o 1.2.: Materials and tools for COVID-19 vaccine implementation Output 2: Regular assessment and update on the country readiness using VRAT Deliverables o 1.1.: VRAT update in regular basis as required in collaboration with MOH with short summary updates and any recommendations Output 3: Technical support provided to relevant departments of MOH in NRA capacity strengthening through COVID-19 vaccine deployment Deliverables o 1.1.: Regulatory pathway for emergency approval, receipt and release of the vaccines in the emergency established for COVID-19 vaccines

4. Specific requirements

Qualifications required: - Education: o Essential: University Degree in relevant areas including medicine, pharmacy or public health from a recognized university o Desirable: Post-graduate degree in relevant areas including medicine, pharmacy or public health from a recognized university - Experience: o Essential: At least five (05) years of experience in public health or pharmaceutical related field o Desirables: Experience in Vietnamese NRA or supporting Vietnamese NRA system strengthening at international setting o Desirables: Experience in being involved in development phase of Vietnamese NDVP and VRAT - Skills / and knowledge: o Knowledge on the COVID-19 vaccine readiness assessment tool and Vietnamese NDVP o Basic knowledge on WHO Global Benchmarking Tool for evaluation of national regulatory systems o Expertise in project management, evaluation and monitoring o High level of computer literacy particularly Microsoft Office products - Language requirements: o Essential: High level of proficiency in English and in Vietnamese, both verbal and written

5. Competencies

o Producing results: Produces and delivers quality results on time. Ability to work independently as well as collaboratively in a team and with counterparts. o Moving forward in a changing environment: Is open to new approaches and ideas, adapts positively to change. o Communicating in a transparent, credible and effective way: expresses oneself clearly in conversations and interactions with others; listens actively.

6. Place of assignment

Hanoi, Viet Nam

7. Medical clearance

The selected Consultant will be expected to provide a medical certificate of fitness for work.

8. Travel

Some domestic duty travel is expected

9. Budget

Please take note of the following when submitting application: The contractor will be responsible for paying taxes, if any. Those who are interested can contact our focal person with contact detail at the end of the announcement before/by 24 February 2021 and should be addressed to: Administrative Officer World Health Organization UN Building, 304 Kim Ma Street, Hanoi, Viet Nam OR wpvnmapplicants@who.int For further information on this TOR, please contact: wpvnmwr@who.in