DECISIONS

GUIDELINES FOR RECEIVING, PRESERVING, DISTRIBUTING AND USING COVID-19 VACCINE

MINISTER OF HEALTH

Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Decision No. 3659/QD-BYT dated August 21, 2020 of Ministry of Health providing guidelines on research, clinical testing, circulation registration and use of COVID-19 vaccine;

Pursuant to Decision No. 983/QD-BYT dated February 1, 2021 approving vaccines for emergency cases in COVID-19 epidemic management on a conditional basis;

At request of Director General of General Department of Preventive Medicine, Ministry of Health

HEREBY DECIDES:

Article 1. “Guidelines on receiving, preserving, distributing and using COVID-19 vaccine” are attached to this Decision

Article 2. These Guidelines serve as the basis for implementation by entities and local governments (these Guidelines shall be updated according to practical epidemic situations and vaccine supply).

Article 3. This Decision comes into effect from the day of signing.

Article 4. Chief of Ministry Office, Director General of General Department of Preventive Medicine, Director General of Drug Administration of Vietnam, Director General of Science and Training Department, Director General of Medical Examination and Treatment Department; Director of Finance and Planning Agency, Director of Communication, Emulation and Commendation; Head of National Institute for Control of Vaccine and Biologicals, Head of National Institute of Hygiene and Epidemiology, Head of Pasteur Institute; Directors of Health Departments of provinces and cities and heads of relevant entities are responsible for implementation of this Decision./.

GUIDELINES

RECEIPT, PRESERVATION, DISTRIBUTION AND USE OF COVID-19 VACCINE
(Attached to Decision No. 1464/QD-BYT dated March 5, 2021 of Ministry of Health)

I. PREFACE

The COVID-19 epidemic caused by the SAR-CoV-2 virus was first detected in Wuhan City, Hubei Province, China. So far, most countries have acknowledged cases of COVID-19 infection and millions of deaths. This is a challenge for manufacturing a vaccine for rapid, safe and effective epidemic prevention.

Vietnam acknowledged the first case of SARS-CoV-2 infection on January 23, 2020 and up to March 4, 2021, Vietnam has seen a total of 2,482 cases of positive to SARS-CoV-2 with 1,533 cases of which are domestically spread.

In order to implement epidemic management which involves the use of vaccine for COVID-19, Ministry of Health requests the Government to promulgate Resolution No. 21/ND-CP dated February 26, 2021 of the Government on purchase and use of COVID-19 vaccine, which prescribes prioritized subjects and areas for immunization.

On March 5, 2021, Ministry of Health promulgates COVID-19 immunization plan for 2021-2022. Mobilize all forces for vaccination including Departments of Health nationwide and medical training facilities to organize a vaccination strategy; organize vaccination as soon as vaccine is accessible; ensure high coverage, vaccination safety and equal access for the general public.

In order to receive, transport, preserve and organize immunization safely and rapidly, Ministry of Health shall provide guidelines on receipt, preservation, distribution and use of COVID-19 vaccine.

II. IMPLEMENTED ACTIVITIES

1. Vaccine receipt

The Extended Program on Immunization finalizes procedures for importing vaccine from overseas or receiving vaccine from Vietnamese suppliers and immunization materials.

2. Transportation, preservation and distribution of vaccine and immunization materials.

Within 7 days after batch release permit is issued, the Extended Program on Immunization shall transport received vaccine to National Institute of Hygiene and Epidemiology, Pasteur Institute and implementing entities to transfer as follows:

- Region level: National Institute of Hygiene and Epidemiology, Pasteur Institute or mobilized distributors, importers transport vaccine to Disease Control and Prevention Centers of provinces and cities within 7 days after receiving vaccine.

- Province level: Disease Control and Prevention Centers of provinces and cities receive and preserve COVID-19 vaccine in provincial storage and distribute vaccine as follows:

+ Distribute vaccine to medical centers of districts at least 3 days before immunization date.

+ Distribute vaccine to central hospitals, regional hospitals, provincial hospitals and specialized hospitals of provinces and cities 1 day before immunization date or immunization session. For hospitals with proper cold chain to preserve vaccine as per the law, preserve vaccine in hospital storage during immunization days. For hospitals without cold chains, Disease Control and Prevention Centers of provinces and cities shall provide vaccine for each immunization session or provide cold boxes and vaccine carriers temporarily for hospitals implementing the program, remaining vaccine after each session in hospitals shall be returned to Disease Control and Prevention Centers of provinces and cities.

- District level: Medical centers of districts shall transport vaccine from provincial storage or Disease Control and Prevention Centers of provinces and cities shall transport vaccine to district governments for preservation and distribution to communes, district hospitals or immunization service locations requesting for assistance 1 day before immunization date or during immunization session.

- Commune level or facilities allowed to perform immunization: Receive vaccine from district governments, preserve vaccine and transport to immunization location during immunization sessions.

In case available cold chains of the extended system for immunization fail to satisfy vaccine transport, preservation demands, the national Extended Program for Immunization shall cooperate with General Department of Preventive Medicine and Drug Administration of Vietnam in proposing solutions for mobilizing cold chains of public and private distributors, importers and immunization service providers.

Number of vaccine, syringe and safety boxes entering and leaving storage at all level shall be recorded and monitored by vaccine logs and transfer records (according to ………….). Vaccine logs shall be updated on a monthly basis at all levels.

3. Training for medical officials

Activity 1: National Extended Program for Immunization, National Institute of Hygiene and Epidemiology shall cooperate with General Department of Preventive Medicine, Department of Medical Examination and Treatment, Institutes of Hygiene and Epidemiology, Pasteur Institute, Disease Control and Prevention Centers of provinces and cities shall develop training plans and materials regarding COVID-19 immunization and supervision for adverse events following immunization 10 days before immunization date.

Activity 2:

- The national Extended Program for Immunization shall take charge and cooperate with General Department of Preventive Medicine, Institutes of Hygiene and Epidemiology and Pasteur Institute in provide training for Extended Program for Immunization of regions, Departments of Heath, Disease Control and Prevention Centers of provinces and cities 5 days before immunization date.

- Disease Control and Prevention Centers of provinces and cities shall take charge and cooperate with Extended Program for Immunization of regions in organizing training regarding implementation of COVID-19 immunization plans at least 3 days before immunization date.

4. Communication.

Activity 1: Department of Communication, Emulation and Commendation shall take charge and cooperate with General Department of Preventive Medicine, Institute of Hygiene and Epidemiology, Pasteur Institute, Disease Control and Prevention Centers of provinces and cities in developing communication plans regarding use of COVID-19 vaccine in order to raise awareness, share information and motivate the general public to participate in immunization.

Activity 2: Department of Communication, Emulation and Commendation shall take charge and cooperate with General Department of Preventive Medicine, Institute of Hygiene and Epidemiology, Pasteur Institute and the national Extended Program for Immunization in developing messages, news articles and communication documents regarding subjects of immunization and information on COVID-19 vaccine.

Activity 3: Department of Communication, Emulation and Commendation shall take charge and cooperate with Central Health Information and Education Center, General Department of Preventive Medicine, Institute of Hygiene and Epidemiology, Pasteur Institute and the national Extended Program for Immunization in organizing training for medical officials and communication officials regarding subjects of immunization and information on COVID-19 vaccine.

Activity 4: Implement communication activities

a) Department of Communication, Emulation and Commendation shall take charge and cooperate with Central Health Information and Education Center, General Department of Preventive Medicine, Institute of Hygiene and Epidemiology, Pasteur Institute, Departments of Health of provinces and cities, Disease Control and Prevention Centers of provinces and cities in gathering information on social network and in community regarding use of COVID-19 vaccine to promptly develop plans for rectifying and responding to media crisis regarding immunization.

b) Department of Communication, Emulation and Commendation shall take charge and cooperate with Central Health Information and Education Center, General Department of Preventive Medicine, national Extended Program for Immunization, Disease Control and Prevention Centers of provinces and cities in implementing communication activities according approved plans, to be specific: Inform press agencies and the general public about individuals prioritized for immunization, type of COVID-19 vaccine, benefits of vaccine, immunization schedule, vaccine safety, adverse event after immunization, immunization plans.

c) Department of Communication, Emulation and Commendation shall take charge and cooperate with Central Health Information and Education Center, Disease Control and Prevention Centers of provinces and cities in monitoring, supervising and assisting communication activities regarding COVID-19 immunization before, during and after immunization.

d) Departments of Health shall implement communication activities based on plans of Ministry of Health and practical situations in local administrative divisions.

5. Immunization

5.1. Guidelines on implementation

- General Department of Preventive Medicine shall take charge and cooperate with Institute of Hygiene and Epidemiology and Pasteur Institute in providing guidelines on implementation for provinces and cities.

- Departments of Health shall provide guidelines for immunization facilities in local administrative divisions.

- Implementation period: From March 5, 2021 to March 7, 2021.

5.2. Investigation and preparation of immunization subjects

- Disease Control and Prevention Centers of provinces and cities shall advise Departments of Health to direct local medical facilities to prepare list of immunization subjects.

- Immunization facilities shall consolidate lists of immunization subjects and inform medical centers of districts.

- Medical centers of districts shall consolidate lists of immunization facilities and number of immunization subjects in local administrative divisions and inform Disease Control and Prevention Centers of provinces and cities.

- Disease Control and Prevention Centers of provinces and cities shall consolidate lists of immunization facilities and immunization subjects in provinces and cities and inform General Department of Preventive Medicine, Central Institute of Hygiene and Epidemiology to receive vaccine.

- Implementation period: From March 7, 2021 to March 10, 2021.

5.3. Development of COVID-19 vaccine use plants in local administrative divisions

- On the basis of plans developed by Ministry of Health, Departments of Health of provinces and cities shall cooperate with ministries and local governments of districts, townlets and towns affiliated to provinces in developing COVID-19 use plans in local administrative divisions and requesting People’s Committees of provinces and cities to approve and direct preparation of lists of immunization subjects based on risk factors and lists of subjects using defined forms.

- Implementation period: 7 days after Ministry of Health promulgates Plan for receiving, transporting, preserving and using COVID-19 vaccine

5.4. Organization of immunization session

Organize immunization session according to instruction to organize immunization session in a manner that satisfies immunization requirements, ensures COVID-19 management and guarantees immunization for immunization personnel

a) Form of immunization

Organize immunization by campaigns in the shortest period of time. Utilize available extended program for immunization, if necessary, Departments of Health of provinces and cities shall mobilize public, private immunization service providers and other facilities eligible for providing immunization.

b) Immunization facilities

For facilities eligible for providing immunization, Disease Control and Prevention Centers of province sand cities shall provide guidelines on organization of immunization as per the law. For medical facilities ineligible for providing immunization, Departments of Health shall direct implementation of mobile immunization facilities eligible for providing immunization to execute local plans.

+ Central, provincial hospitals, district hospitals and medical centers:

- Provide immunization for medical officials and personnel for epidemic management, individuals receiving treatment in hospitals and other individuals as per local plan as long as immunization beneficiaries satisfy regulations and law.

- Organize emergency response teams under their management to assist immunization sites, especially in communes with difficult access and at least 1 mobile response team for every 3-4 communes.

- General hospitals of provinces and cities: During COVID-19 immunization period, hospitals must spare several intensive care beds (at least 5 beds/hospital) to respond to vaccine injury.

+ Medical stations of communes:

- Organize COVID-19 immunization campaigns in stations and mobile immunization sites.

- Provide immunization for medical staff participating in epidemic management, national defense forces, police, teachers, essential service providers, elders of 65 years of age or older and individuals suffering from chronic diseases and not receiving treatment in hospitals and provide immunization for individuals who have not received immunization (immunization beneficiaries must satisfy requirements as per the law).

- Assign equipment and devices for on-site emergency treatment and develop specific measures to provide emergency treatment if necessary.

+ Hospitals, infirmaries, medical facilities, etc. affiliated to ministries:

- Develop plans and provide immunization for individuals within their sector and assist medical sector in implementing for other individuals (if necessary).

- Assign equipment and devices for on-site emergency treatment and develop specific measures to provide emergency treatment if necessary.

+ Immunization service providers:

- Provide immunization for individuals according to assignment of Departments of Health.

- Assign equipment and devices for on-site emergency treatment and develop specific measures to provide emergency treatment if necessary.

+ Other facilities mobilized by Departments of Health to provide immunization according to local plans.

5.5. Supervision and resolution for adverse events following immunization

a) General Department of Preventive Medicine shall take charge and cooperate with Institute of Hygiene and Epidemiology, Pasteur Institute, Departments of Health of provinces, cities, Disease Control and Prevention Centers of provinces and cities in developing guidelines for supervising adverse events following immunization;

b) Active supervision for adverse events following immunization:

- Immunization facilities, General Department of Preventive Medicine, Departments of Health of provinces and cities, Institute of Hygiene and Epidemiology, Pasteur Institute, Disease Control and Prevention Centers of provinces and cities, medical centers of districts shall actively supervise adverse events following immunization according to guidelines developed by Ministry of Health. Supervision system for adverse events following immunization includes implementing entities and cooperating entities at all levels. In case of vaccine injury, procedures for investigating, reporting and notifying results of investigation and resolution of vaccine injury shall conform to Article 6 of Decree No. 104/2016/ND-CP dated July 1, 2016 of the Government.

- Implementation period: During and after immunization.

c) Regular supervision

Immunization facilities, General Department of Preventive Medicine, Departments of Health of provinces and cities, Institute of Hygiene and Epidemiology, Pasteur Institute, Disease Control and Prevention Centers of provinces and cities, medical centers of districts shall monitor, supervise regular response and serious post-immunization complications during vaccine use according to Decree No. 104/2016/ND-CP dated July 1, 2016 of the Government and Circular No. 34/2018/TT-BYT dated November 12, 2018 of Ministry of Health.

+ Specialized consulting councils for assessing causes of serious complications during vaccine use: specialized consulting councils for assessing causes of serious complications during vaccine use in all levels shall be established, organized, functional according to Circular No. 24/2018/TT-BYT dated September 18, 2018 and Circular No. 05/2020/TT-BYT on amendments to Circular No. 24/2018/TT-BYT dated September 18, 2018 of Ministry of Health and trained annually regarding specialized activities for assessing causes of serious complications during vaccine use.

+ Dealing with allergic reaction during vaccine use: procedures for diagnosing and dealing with allergic reactions shall conform to Circular No. 51/2017/TT-BYT dated December 29, 2017 of Ministry of Health providing guidelines on preventing, diagnosing and dealing with allergic reactions. Periodic training regarding the procedures shall be provided for officials participating in immunization process in all levels.

5.6. Management of syringe and biomedical waste after immunization

a) Health Environment Management Agency shall take charge and cooperate with General Department of Preventive Medicine, Departments of Health of provinces, cities, Institute of Hygiene and Epidemiology, Pasteur Institute, Disease Control and Prevention Centers of provinces and cities in developing guidelines on disposing syringes and biomedical wastes at the end of immunization sessions according to Joint Circular 58/2015/TTLT-BYT-BTNM dated December 31, 2015 of Ministry of Health and Ministry of Natural Resources and Environment on management of biomedical waste and characteristics of COVID-19 vaccine.

- Implementation period: March, 2021.

b) Immunization facilities shall develop measures for collecting and disposing syringes, biomedical waste in immunization location according to regulations of Ministry of Health

- Implementation period: During use of vaccine.

5.7. Supervision and report on immunization activities

a) Develop forms for immunization report and supervision: General Department of Preventive Medicine, Departments of Health of provinces and cities, Institute of Hygiene and Epidemiology, Pasteur Institute, Disease Control and Prevention Centers of provinces and cities shall develop forms, methods, contents and procedures for producing reports on use of vaccine and adverse events following immunization.

b) Produce reports: Immunization facilities shall produce daily reports, periodic reports and irregular reports as per the law.

c) Inspect, supervise before, during and after campaigns: General Department of Preventive Medicine, national Extended Program for Immunization and regional Extended Programs for Immunization, Departments of Health and relevant entities shall monitor and supervise COVID-19 immunization activities

III. IMPLEMENTATION

1. People’s Committees of provinces and cities shall issue plans, allocate expenditure and direct organization and implementation of immunization in local administrative divisions.

2. Request ministries to cooperate in:

2.1. Ministry of Finance shall take charge and cooperate with Ministry of Health in regulating expenses and affair fees for implementation in all level.

2.2. Ministry of Public Security, Ministry of National Defense shall provide immunization for eligible individuals within their competence and assist Ministry of Health if necessary.

2.3. Ministry of Education and Training, Ministry of Foreign Affairs, Ministry of Transport and other ministries shall organize cooperation or cooperate with Ministry of Health and assist Ministry of Health when necessary.

3. General Departments/Departments and entities affiliated to Ministry of Health:

3.1. General Department of Preventive Medicine shall take charge and cooperate with relevant entities in developing guidelines on organizing immunization sessions including medical examination and treatment establishments; supervising adverse events following immunization; issuing report form for vaccine use and adverse events following immunization and monitor plan execution.

3.2. Vietnam Administration of Medical Services is responsible for directing implementation of this plan in medical examination and treatment establishments. Cooperating in developing guidelines on organizing immunization sessions in medical examination and treatment; conducting pre-immunization screening and dealing with adverse events following immunization. Guiding implementation of Circular No. 51/2017/TT-BYT dated December 29, 2017 of Ministry of Health guiding prevention, diagnosis and solutions for allergic reactions.

3.3. Drug Administration of Vietnam are responsible for importing, guiding and adopting procedures for issuing circulation permit and import permit for COVID-19 vaccine as soon as practicable in order to enable vaccine to be used promptly as per the law.

3.4. Department of Science and Training is responsible for guiding research and clinical testing for COVID-19 vaccine as per the law and up to progress; directing medical training facilities to organize immunization campaigns.

3.5. Health Environment Management Agency shall be responsible for developing guidelines, directing adoption of waste disposal procedures for wastes produced during use of COVID-19 vaccine a per the law.

3.6. Department of Planning – Finance shall advise and request Ministry of Health to guarantee, meet expense demands for activities within COVID-19 vaccine use plans; guiding provinces and cities to allocate expenditure on implementation

3.7. Department of Communication, Emulation and Commendation shall take charge developing and implementing communication activities regarding COVID-19 immunization.

3.8. The national Extended Program for Immunization-Central Institute of Hygiene and Epidemiology shall purchase, receive, preserve, distribute and organize COVID-19 immunization; develop and implement plans for improving cold chains in all levels.

3.9. Institutes within preventive medicine system are responsible for receiving, transporting and preserving vaccine; providing training, participating in communication affairs, organizing implementation and supervising immunization as per assignment; monitoring and dealing with adverse events following COVID-19 immunization. National Institute for Control of Vaccine and Biologicals is responsible for accrediting vaccine while adhering to progress and procedures approved.

3.10. Central Health Information and Education Center shall cooperate with press agencies in conducting communication affairs regarding use of COVID-19 vaccine.

4. Departments of Health shall develop, request People’s Committees to issue plans and allocate human resources for implementation. Direct and cooperate with relevant entities in implementing, expediting facilities to guarantee immunization conditions.

5. Vaccine distributers and importers shall develop plans for importing, preserving and transporting vaccine at request of Ministry of Health; be responsible for preserving, transporting vaccine and supplying vaccine according to plan.

6. Central hospitals, provincial general hospitals, provincial preventive medical centers/Disease Control and Prevention Centers, medical centers of districts, hospital of districts, medical stations of communes, public and private immunization facilities, and mobilized entities are responsible for implementing COVID-19 immunization plan of Ministry of Health and People’s Committees of provinces and cities.

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