Decree 13/2026/TT-BYT Regulating Activities of Vaccination and Evaluation of Serious Adverse Events During the Use of Compulsory Vaccines and Medical Supplies

CIRCULAR
Regulations on Vaccination Activities

 

Based on the Law on Disease Prevention No. 114/2025/QH15;

Based on Decree No. 42/2025/NĐ-CP on the Functions, Powers, Tasks, and Organizational Structure of the Ministry of Health;

Based on Decree No. 165/2026/NĐ-CP on Detailed Provisions and Guidelines for Implementing Certain Articles of the Law on Disease Prevention;
In accordance with the proposal by the Director of the Department of Disease Prevention;

The Minister of Health promulgates this Circular to regulate vaccination activities.

Chapter I

GENERAL PROVISIONS
Article 1. Scope of Application

This Circular details paragraph 4, clause 2, and paragraph 7 of Articles 22, 23, and 52 respectively of the Law on Disease Prevention No. 114/2025/QH15; Decree No. 165/2026/NĐ-CP dated May 15, 2026, of the Government on Detailed Provisions and Guidelines for Implementing Certain Articles of the Law on Disease Prevention, including:

1. The list of diseases requiring the use of vaccines and biological products in mandatory vaccination programs as specified under point a, paragraph 4, Article 22 of the Law on Disease Prevention.

2. Routine vaccinations, catch-up vaccinations, campaign vaccinations, and other vaccination organization methods within the Expanded Immunization Program; epidemic prevention vaccinations as specified under point b, paragraph 4, Article 22 of the Law on Disease Prevention.

3. Organization of vaccinations as specified under point c, paragraph 4, Article 22 of the Law on Disease Prevention.

4. Information and reporting systems for vaccination activities as specified in clause 2, Article 23 of the Law on Disease Prevention.
5. Establishment, organization, and operation of the Professional Advisory Council for evaluating serious adverse events during vaccine and biological product use as specified under paragraph 7, Article 52 of Decree No. 165/2026/NĐ-CP.

Article 2. Interpretation of Terms

National Vaccination Information Management System

is an information system to serve the management, updating, storage, utilization, and sharing of vaccination activity data nationwide, including subsystems for managing vaccinated individuals, vaccines, biological products, vaccination procedures, statistics, reports, and other management-related subsystems.

1. Adverse Event Following Immunization is an abnormal health phenomenon including local or systemic manifestations occurring after immunization that are not necessarily due to the use of vaccines or biological products, including both common reactions following immunization and serious adverse events following immunization.

2. Common Reactions Following Immunization are clinical manifestations commonly encountered, which can resolve on their own without causing long-term effects, occurring after the use of vaccines or biological products.

3. Chapter II LIST OF DISEASES REQUIRING VACCINES AND BIOLOGICAL PRODUCTS FOR MANDATORY VACCINATION THROUGH THE EXTENDED IMMUNIZATION PROGRAM

Article 3. List of diseases requiring vaccines and biological products for mandatory vaccinations through the Expanded Immunization Program

1. Hepatitis B virus infection.

2. Tuberculosis.

4. Pertussis.

5. Tetanus.

10. Japanese encephalitis.

12. Pneumococcal disease.

13. Human papillomavirus (HPV) infection in humans.

14. Other diseases as determined by the Minister of Health.

Article 4. List of diseases requiring vaccines and biological products for epidemic prevention vaccinations

1. Diphtheria.

2. Poliomyelitis.

3. Pertussis.

4. Rubella.

5. Measles.

6. Dysentery.

7. Japanese encephalitis.

8. Rabies.

9. Influenza.

10. COVID-19.

11. Other infectious diseases as recommended by the World Health Organization and determined by the Minister of Health.

10. COVID-19 disease.

11. Other infectious diseases as recommended by the World Health Organization and determined by the Minister of Health.

Chapter III

METHODS OF ORGANIZING VACCINATION IN THE EXTENDED IMMUNIZATION PROGRAM; VACCINATION AGAINST DISEASES

Article 5. Routine Vaccination

1. Subjects: as provided in points a and c of paragraph 1, Article 48, Decree No. 165/2026/NĐ-CP.

2. Method of Implementation: organized on a monthly basis or by campaigns for subjects according to the vaccination schedule in the Expanded Immunization Program.

3. List of Diseases: as provided in Article 3 of this Circular.

4. Vaccination Schedule and Use of Vaccine, Biological Products: carried out in accordance with the manufacturer's instructions, professional guidance from the Department of Disease Prevention.

Article 6. Catch-up Dose Vaccination

1. Subjects: those subjects specified in paragraph 1, Article 5, this Circular who have not been vaccinated or have not received sufficient doses according to the routine vaccination schedule.
2. Method of Implementation: organized after reviewing the vaccination history of the subjects specified in paragraph 1, Article 5, this Circular.

3. List of Diseases: as provided in Article 3 of this Circular.

4. Vaccination Schedule and Use of Vaccine, Biological Products: carried out in accordance with the manufacturer's instructions, professional guidance from the Department of Disease Prevention.

Article 7. Proactive Campaign Vaccination

1. Subjects: as provided in points a and c of paragraph 1, Article 48, Decree No. 165/2026/NĐ-CP.

2. Method of Implementation: organized according to the vaccination plan aimed at proactively enhancing community immunity.

3. List of Diseases: as provided in Article 3 of this Circular.

4. Vaccination Schedule and Use of Vaccine, Biological Products: carried out in accordance with risk assessment results, plans, and professional guidance from the Department of Disease Prevention.

Article 8. Vaccination to Combat Epidemics

1. Subjects: as provided in point b of paragraph 1, Article 48, Decree No. 165/2026/NĐ-CP.

2. Method of Implementation:

a) When the disease falls under the circumstances specified in points a of paragraphs 2 and 3, Article 15, Law on Disease Prevention: The People's Committee Chairman at the commune level decides to organize vaccination against epidemics within the managed area;

b) When the disease falls under the circumstances specified in point b of paragraph 3, Article 15, Law on Disease Prevention: The People's Committee Chairman at the provincial level decides to organize vaccination against epidemics within the managed area;

c) When the disease falls under the circumstances specified in points c and d of paragraph 3, Article 15, Law on Disease Prevention: Competent authorities decide to implement vaccination against epidemics in accordance with the provisions of the Civil Defense Law and the State of Emergency.

3. List of Diseases: as provided in Article 4 of this Circular.

4. Vaccination Schedule and Use of Vaccine, Biological Products: carried out in accordance with manufacturer's instructions, epidemic vaccination plan, and professional guidance from the Department of Disease Prevention.

Article 9. Other Methods of Organizing Vaccination within the Expanded Immunization Program

Other methods of organizing vaccination within the Expanded Immunization Program are implemented in accordance with the guidelines issued by the Minister of Health.

Chapter IV

 

ORGANIZATION OF VACCINATION

Article 10. Management of Subjects

1. Content of subject management includes personal information of the vaccination subjects; of the parents, guardian, or legal representative in cases where the vaccinated person is a child, a person without civil capacity, or a person with limited civil capacity and other relevant information as required by professional guidance from the Department of Disease Prevention.

2. Organization of subject management

a) Subjects under mandatory vaccination:

- The commune health station coordinates with relevant agencies and organizations in the locality for investigation, compilation, and updating of lists of subjects under mandatory vaccination and notifies such subjects to participate in vaccination;

- Vaccination facility: issues and fills out individual vaccination tracking records; compiles a list of vaccinated subjects at the facility and updates complete, accurate, and timely information on vaccinated subjects in the National Immunization Information Management System to ensure no duplication of vaccination subjects.

b) Subjects under voluntary vaccination: the vaccination facility issues and fills out individual vaccination tracking records; compiles a list of vaccinated subjects at the facility and updates complete, accurate, and timely information on vaccinated subjects in the National Immunization Information Management System to ensure no duplication of vaccination subjects.

c) For subjects under the management of the Ministry of Public Security or the Ministry of Defense: subject management is carried out according to guidelines from health authorities within the Ministry of Public Security or the Ministry of Defense. When such subjects come for vaccination at a facility managed by the Ministry of Public Security or the Ministry of Defense, the vaccination facility implements the provisions in this paragraph b.

c) For vaccination subjects under the management of the Ministry of Public Security or the Ministry of Defense, the entities under the Ministry of Public Security or the Ministry of Defense responsible for health management shall manage such subjects in accordance with the guidelines provided by the relevant health management entity within their respective ministries. Where a subject not managed by the Ministry of Public Security or the Ministry of Defense arrives at a vaccination facility under the jurisdiction of these ministries, the vaccination facility shall comply with the provisions set forth in point b hereof.

Article 11. Reception and Management of Vaccines and Biological Products

1. The reception, transportation, and storage of vaccines and biological products for mandatory and voluntary immunization: shall be carried out in accordance with the regulations of the Minister of Health on Good Distribution Practice (GDP) and Good Storage Practice (GSP) for medicines.

2. For the reception and management of vaccines and biological products at the commune health station and vaccination points:

a) The reception and storage of vaccines and biological products under the Expanded Immunization Program shall be carried out in accordance with the professional guidelines issued by the Disease Prevention Bureau;

b) Equipment and tools for storing vaccines and biological products must meet temperature storage requirements as per the manufacturer's instructions and belong to the list of vaccine and biological product storage equipment pre-qualified by the World Health Organization (WHO).

3. Vaccines and biological products shall not be stored together with other products.

Article 12. Implementation of Immunization in Fixed and Mobile Vaccination Facilities for Mandatory and Voluntary Immunizations

1. The arrangement, scheduling, organization of the immunization session, counseling, and communication on immunization shall be carried out in accordance with the professional guidelines issued by the Disease Prevention Bureau.

2. The administration of vaccines and biological products must comply with the following steps:

a) Prior to vaccination: conduct pre-vaccination screening as per the instructions of the Minister of Health;

b) During vaccination: administer each type of vaccine or biological product according to the manufacturer's instructions; ensure vaccination safety in accordance with professional guidelines issued by the Disease Prevention Bureau;

c) After vaccination: monitor the vaccinated individual at the vaccination point for at least 30 minutes, provide guidance to parents or guardians or legal representatives regarding follow-up care for children, individuals without civil capacity, those with limited civil capacity, or other vaccinated individuals; record immunization information in accordance with professional guidelines issued by the Disease Prevention Bureau.

3. Handling of severe adverse events occurring during vaccination sessions:

a) Immediately cease the vaccination session to provide emergency treatment and preliminary assessment of the cause of the severe adverse event; if beyond capacity, transfer the individual experiencing the severe adverse event to an appropriate medical facility;

b) Fully record relevant information on the case of severe adverse events in accordance with professional guidelines issued by the Disease Prevention Bureau and report according to the provisions at Clause 5 of this Circular.

4. Medical facilities receiving cases of severe adverse events following vaccination must provide emergency treatment, care, and report in accordance with the provisions at Clause 5 of this Circular.

5. The temporary suspension of vaccine or biological product use shall be carried out as follows:

a) For mandatory and voluntary immunizations: if the Professional Advisory Committee evaluates that the cause of severe adverse events during the use of vaccines or biological products in a province, city (hereinafter referred to as the provincial-level committee) is related to the quality of the vaccine or biological product, the head of the health authority under the People's Committee at the provincial level must issue a decision temporarily suspending the use of that batch of vaccines or biological products within its jurisdiction after obtaining written approval from the Ministry of Health. If the provincial-level committee concludes that the cause of severe adverse events is not related to the quality of the vaccine or biological product, the head of the health authority under the People's Committee at the provincial level must report to the Ministry of Health and decide to resume use of the batch of vaccines or biological products after obtaining written approval from the Ministry of Health;

b) For immunizations administered by military vaccination facilities: if the preliminary cause of severe adverse events is related to the quality of the vaccine or biological product, follow the guidelines issued by the health authority under the Ministry of National Defense.

Article 13. Monitoring, Investigation, and Evaluation of Causes of Severe Adverse Events Following Vaccination

1. Monitoring of severe adverse events following vaccination includes detection, statistics, handling, and reporting of such events in accordance with the professional guidelines of the Department of Disease Prevention.

2. Investigation and evaluation of causes of severe adverse events following vaccination:

a) For mandatory and voluntary vaccinations:

- Within 24 hours from receipt of a report on a case of severe adverse event following vaccination, the health authority at the provincial people's committee shall be responsible for establishing an investigation team for severe adverse events following vaccination and conducting such investigations in accordance with the professional guidelines of the Department of Disease Prevention;

- The health authority at the provincial people's committee shall be responsible for establishing a provincial council in accordance with the provisions of this Decree's Circular Article 17 and organizing the evaluation of the causes of severe adverse events, reporting results in accordance with the professional guidelines of the Department of Disease Prevention.

b) For vaccinations administered by military vaccination facilities: investigation and evaluation of causes of severe adverse events following vaccination shall be conducted in accordance with the guidance of the health management authority under the Ministry of National Defense.

Chapter V

PROVISIONS ON INFORMATION AND REPORTING OF VACCINATION ACTIVITIES

Article 14. Information on Vaccination Activities

1. Persons to be vaccinated:

a) Shall provide information in accordance with the provisions of paragraph 1 of Circular Article 10 of this Decree;

b) Information shall be provided directly or through telephone or other communication methods between the person to be vaccinated and the vaccination facility.

2. Vaccination facilities are responsible for updating the information of persons to be vaccinated on the National Vaccination Information Management System in accordance with the provisions of paragraph 2 of Circular Article 10 of this Decree.

1. Forms of reporting: shall be conducted by written document or through the National Vaccination Information Management System; in case of emergency or technical issues, reports may be submitted in writing according to regulations.
2. Frequency and content of reports:

a) Daily report: report on the number of persons vaccinated daily, number of vaccines, biological products, vaccination supplies, common reactions, and severe adverse events during active vaccination campaigns and disease prevention vaccinations;

b) Regular monthly and annual reports:

- For mandatory vaccinations: report on vaccine, biological product usage in the Expanded Immunization Program; vaccination results; communicable diseases with vaccines, biological products in the Expanded Immunization Program; common reactions during the use of vaccines, biological products; severe adverse events during the use of vaccines, biological products;

- For voluntary vaccinations: vaccine and biological product usage; vaccination results; common reactions during the use of vaccines, biological products; severe adverse events during the use of vaccines, biological products.

c) Emergency reports on: cases of severe adverse events following vaccination; actual incidence rates of common reactions exceeding usual statistical rates; reporting individual or cluster reactions that may have a serious impact on public health.

3. Specific forms and content of report templates to be conducted in accordance with the professional guidelines of the Department of Disease Prevention.

4. Procedures and timeframes for regular reporting on vaccine usage:

a) Vaccination facilities: report to the local commune health station within three days of the following month for monthly reports, by January 13th of the following year for annual reports;
b) Commune health stations: report to the provincial disease control center based on reports from vaccination facilities in their jurisdiction within five days of the following month for monthly reports, by January 15th of the following year for annual reports;

c) Provincial disease control centers: report to the health authority at the provincial people's committee, the Institute of Epidemiology and Pasteur Institutes assigned by the Minister of Health for guidance in the field of vaccination within fifteen days of the following month for monthly reports, by January 31st of the following year for annual reports;

d) The Institutes of Epidemiology and Pasteur: report to the Department of Disease Prevention by the twentieth day of the following month for monthly reports, by February 15th of the following year for annual reports.

5. Procedures and timeframes for emergency reporting on severe adverse events:

a) Within 24 hours from the time of recording a severe adverse event following vaccination, the vaccination facility or healthcare facility receiving such cases must report to the health authority at the provincial people's committee simultaneously with the Provincial Disease Control Center where the facility is located;

b) Weekly, after completing reporting as per point (a) above, if no investigation conclusion has been reached: the Provincial Disease Control Center shall report on the progress of the investigation and handling process to the health authority at the provincial people's committee by the fourth day of the following week.

6. Procedures and timeframes for daily reporting during active vaccination campaigns and disease prevention vaccinations:

a) Vaccination facilities: report to the local commune health station before 5:00 PM each day;

b) Commune health stations: report to the provincial disease control center by 9:00 AM the next day;

c) Provincial disease control centers: report to the health authority at the provincial people's committee, the Institute of Epidemiology and Pasteur Institutes assigned by the Minister of Health for guidance in the field of vaccination, and the Department of Disease Prevention by 2:00 PM the next day.

7. The National Vaccination Information Management System is a component of the disease prevention information system, including hardware, software, and data related to disease prevention. Data extraction, connection, sharing, and interoperability between hospital information systems and the National Vaccination Information Management System shall be conducted in accordance with the professional guidelines of the Department of Disease Prevention.

c) Provincial Disease Control Center: report to the competent health agency under the People's Committee of the same level, the Institute of Epidemiology and the Pasteur Institute assigned by the Minister of Health for guidance on the vaccination line within 14:00 hours of the following day.

7. The national immunization information management system is a component of the disease prevention information system, comprising hardware, software, and data related to disease prevention. Data extraction, connection, sharing, and interoperability between hospital information systems and the national immunization information management system shall be carried out in accordance with the professional guidelines provided by the Disease Prevention Bureau.

8. The database on vaccination and the National Immunization Information System must ensure cybersecurity in accordance with the provisions of the Cybersecurity Law and other relevant regulations.

9. Personal data of vaccine recipients must be protected in accordance with the provisions of the Personal Data Protection Law and other relevant regulations.

1. Vaccination facilities under the Ministry of Public Security, Ministry of Defense shall report in accordance with the guidelines issued by the health management authority under the Ministry of Public Security, Ministry of Defense, except as provided for in paragraph 2 of this Article.

2. When citizens not under the administration of the Ministry of Public Security, Ministry of Defense receive vaccinations at vaccination facilities under these ministries, such facilities shall report and provide information in accordance with the provisions of Articles 14 and 15 of this Circular.

CHAPTER VI

ESTABLISHMENT, ORGANIZATION AND OPERATIONS OF THE EXPERT ADVISORY BOARD FOR EVALUATING CAUSES OF SEVERE ADVERSE EVENTS DURING VACCINE USE

Article 17. Establishment of the Expert Advisory Board for Evaluating Causes of Severe Adverse Events During Vaccine Use

1. The Minister of Health shall establish the Expert Advisory Board for Evaluating Causes of Severe Adverse Events During Vaccine Use at the Ministry of Health (hereinafter referred to as the "Ministry Level Board").

2. The head of the health authority under the People's Committee of a province or city shall establish the Provincial Board.

3. The term of office for both the Ministry Level Board and the Provincial Board is five years; members of the subsequent term inherit from the previous term.

4. The head of the health management authority under the Ministry of Defense shall establish the Expert Advisory Board for Evaluating Causes of Severe Adverse Events During Vaccine Use at the Ministry of Defense, with functions and powers equivalent to those of the Ministry Level Board.

Article 18. Functions, Duties, Powers, and Composition of the Ministry Level Board

1. The function of the Ministry Level Board:

To provide specialized advice to the Minister of Health on handling cases of severe adverse events during vaccine use.

2. The duties of the Ministry Level Board:

a) Evaluate the national situation of severe adverse events following vaccination, monitor post-vaccination reaction surveillance activities, and make recommendations to the Provincial Board;

b) Re-evaluate the conclusions of the Provincial Board in cases where there are complaints from organizations or individuals regarding the conclusions of the Provincial Board, or when deemed necessary. The conclusion of the Ministry Level Board is the final determination related to severe adverse events following vaccination.

3. Powers of the Ministry Level Board:

a) Request the Provincial Board, relevant organizations, individuals, and units to provide information related to severe adverse events following vaccination;

b) Ensure the necessary conditions for performing its duties.

4. Composition of the Ministry Level Board

The Ministry Level Board shall have at least twelve members who meet the criteria set out in paragraph 5 below, ensuring the following composition:

a) Chairperson: an independent expert with experience in vaccination and not affiliated with Vietnam's National Regulatory Authority (NRA);

b) Deputy Chairperson: a leader of a specialized hospital in pediatrics or infectious diseases relevant to severe adverse events following vaccination;

c) Members:

- Representatives from the Department of Medical Examination, Department of Disease Prevention, Department of Drug Management, Legal Affairs Division, Planning and Finance Division, National Institute for Vaccine and Serum Research.

- Experts from the Institute of Epidemiology, Pasteur Institutes, representatives from medical education institutions, experts in pharmaceuticals, vaccines, biologics, epidemiology.

- Clinical specialists from various fields such as obstetrics, immunology, pediatrics, intensive care at hospitals.

d) Secretariat Team consisting of representatives from the Department of Disease Prevention and the Central Institute of Epidemiology. The secretariat team is responsible for collecting, summarizing relevant documents on severe adverse events following vaccination, preparing meeting content for the Board, and finalizing minutes after each meeting.

e) In cases where necessary and depending on specific circumstances, the Chairperson of the Ministry Level Board may invite additional experts in finance, forensic medicine, intensive care, law, and other relevant fields to participate in the Board.

5. Criteria for Members of the Ministry Level Board:

a) Possess the necessary experience, knowledge, and skills related to evaluating causes of severe adverse events following vaccination;

b) Individuals directly involved in administering vaccinations in cases of severe adverse events or those with direct involvement in organizations implementing vaccinations, vaccine or biologics, or with conflicts of interest shall not be part of the Ministry Level Board.

Article 19. Functions, Tasks, Powers, and Composition of the Provincial Council

1. Functions of the Provincial Council:

To provide specialized advice to the head of the competent authority for health under the People's Committee of the province regarding handling cases of serious adverse events following immunization within its jurisdiction.

2. Tasks of the Provincial Council:

a) Implement tasks specified in Clause 3, Article 52, Decree No. 165/2026/NĐ-CP;

b) Periodically assess the situation of serious adverse events following immunization within its jurisdiction.

3. Powers of the Provincial Council:

a) Request relevant organizations, individuals, and units to provide information related to serious adverse events following immunization;

b) Be guaranteed the conditions necessary to perform their tasks;

c) Propose that the Provincial Council at the Ministry level re-evaluate the conclusions of the Provincial Council in cases where it is deemed necessary.

4. Composition of the Provincial Council

The Provincial Council shall have at least ten members who meet the criteria specified in Clause 5 hereof, ensuring a composition as follows:

a) Chairman of the Council: leader of the competent authority for health under the People's Committee of the province;

b) Deputy Chairman of the Council: leader of a provincial general hospital or a regional general hospital;

c) Members of the Council:

- Leaders of specialized business departments within the competent authority for health under the People's Committee of the province.

- Clinical specialists in obstetrics, pediatrics, emergency care; representatives from the Institute of Epidemiology and the Pasteur Institute according to their assigned areas of responsibility by the Ministry of Health.

d) The Secretariat consisting of representatives from the competent authority for health under the People's Committee of the province, the provincial center for disease control, and a provincial general hospital. The Secretariat shall be responsible for collecting, summarizing relevant documents related to serious adverse events following immunization, preparing meeting agendas for the Council, and finalizing minutes after each meeting.

d) In cases where necessary and depending on specific circumstances, the Chairman of the Provincial Council may invite additional experts in finance, forensic medicine, emergency care, law, and other relevant fields related to serious adverse events following immunization.

5. Criteria for Members of the Provincial Council:

a) Possess the necessary experience, knowledge, skills, and ability to evaluate the causes of serious adverse events following immunization;

b) Individuals directly involved in administering vaccinations where a serious adverse event has occurred, or those associated with the organization implementing vaccination, or related to vaccines, immunization supplies, or having a conflict of interest shall not be part of the Provincial Council.

Article 20. Regulations on Operations of the Council

1. Operational Principles of the Council:

a) The Council operates collectively, objectively, and independently;

b) Conclusions of the Council are based on the majority opinion of its members (two-thirds of the voting members at the meeting). In cases where there is not a two-thirds agreement among the members, the Chairman of the Council makes the decision.

2. Operational Methods of the Council:

a) The Council operates through meetings. Meetings are convened only when at least two-thirds of the formal members are present. If a member cannot attend, they must provide a reason and authorize in writing another person to participate on the basis of the Chairman's consent. The substitute must meet the criteria for council members as specified in Clause 5 of Article 18 and Clause 5 of this Circular and shall be entitled to vote as a formal member;

b) All discussed content, including opinions not aligned with the Council’s conclusion and proposals by the Council, must be fully recorded in the minutes of the meeting. Minutes of the meetings at the Ministry level are prepared in two copies, one retained by the permanent office of the provincial council, and one reported to the leadership of the ministry. Minutes of the meetings at the provincial level are also prepared in two copies, one retained by the permanent office of the provincial council, and one reported to the head of the competent authority for health under the People's Committee of the province.

3. The Provincial Council meets regularly once a year; it may convene extraordinary meetings upon request from the permanent body of the Council when there are issues that need resolution.

4. Expenses for organizing meetings of the Council shall be allocated in the annual budget for health sector activities according to the budget hierarchy and other funding sources (if applicable).

Article 21. Standing Committees of the Councils

1. The Standing Committee of the Central Council assists the Central Council located at the Department of Disease Prevention and uses the seal of the Department of Disease Prevention.

2. The Standing Committee of the Provincial Council assists the Provincial Council located at the Provincial Center for Disease Control and Prevention and uses the seal of the Provincial Center for Disease Control and Prevention.

3. The duties of the standing committees of all levels:

a) Direct, guide units and individuals to provide relevant documents in accordance with the proposals of the respective Councils;

b) Allocate lawful financial resources for the activities of the respective Councils;

c) Prepare logistical and administrative support for the respective Councils;

d) The Standing Committee of the Central Council reports to the Minister of Health, while the Standing Committee of the Provincial Council reports to the head of the competent health authority under the People's Committee of the province on the results of meetings;

e) Store records in accordance with regulations;

f) Annually review and propose measures for strengthening the Councils as necessary.

Chapter VII

IMPLEMENTATION RESPONSIBILITIES

Article 22. Responsibilities of Departments under the Ministry of Health

1. Department of Disease Prevention:

a) Issue professional guidelines in the field of disease prevention as assigned in this Circular;

b) Coordinate and cooperate with departments, units related to guide, supervise, urge, and direct the implementation of this Circular; organize specialized inspections on the use of vaccines and biological products nationwide; disseminate information and publicize vaccine safety, benefits of using vaccines and biological products, and possible reactions during their use;

c) Serve as the main body for establishing, managing, operating, utilizing, guiding, implementing, and ensuring the security and safety of the National Immunization Information Management System;

d) Propose to the Minister of Health to develop and promulgate a list of diseases specified in paragraph 14 of Article 3 and paragraph 11 of Article 4 of this Circular;

e) Compile and report on vaccination activities as required.

2. Other Departments and units under the Ministry of Health:

a) Provide advice for issuing professional guidelines by the Ministry of Health in their respective fields and guide the implementation of vaccination, vaccine and biological product-related activities assigned in this Circular;

b) Direct and organize the implementation of other activities related to vaccination, vaccine and biological products according to their functions and duties;

c) Cooperate in establishing, managing, operating, utilizing, ensuring security and safety of the National Immunization Information Management System.

Article 23. Responsibilities of Institutes Epidemiology Institute, Pasteur Institute

1. Direct, provide technical guidance, formulate vaccination plans, monitor vaccine and biological product use in localities, direct lower levels in the field of vaccination to ensure quality and safety in vaccination work; monitor adverse events following immunization; supervise cold chain management.

2. Organize receipt, storage, and distribution of vaccines and biological products for expanded immunization programs in assigned localities; organize receipt, operation, and storage of cold chain equipment at the central level and areas directly managed by the unit.

3. Organize training on vaccination, vaccine and biological product use in expanded immunization programs and epidemic control; on operating and storing cold chain equipment.

4. Participate in joint investigation, conclude causes of severe adverse events during vaccine and biological product use in assigned localities, promptly handle severe adverse events during their use.

5. Guide, compile, and report on vaccination activities within the managed area.
6. The Central Epidemiology Institute serves as the main body, coordinates with other Epidemiology Institutes, Pasteur Institutes, and relevant units to develop content for professional guidelines related to disease prevention in the field of immunization and submit them to the Department of Disease Prevention for issuance procedures.

The Central Institute of Epidemiology is the coordinating entity, working in conjunction with other Institutes of Epidemiology, Pasteur Institutes, and relevant units to develop specialized guidance content related to disease prevention activities involving vaccination and submitting such content to the Disease Prevention Bureau for the necessary procedures to be carried out.

Article 24. Responsibilities of Health Specialized Agency under People's Committee at Provincial Level, Provincial Disease Control Center (if any), and District Health Center; Rural Health Station

1. Responsibilities of Health Specialized Agency under People's Committee
at Provincial Level:

a) Submit to the People's Committee at Provincial Level for approval the demand for vaccines and biological products for implementation of Expanded Immunization Program in accordance with point (a) clause 1 Article 58 Decree No. 165/2026/NĐ-CP.

b) Direct the implementation of immunization activities and organize, implement inspections on compliance with this Circular within its jurisdiction;

c) Organize evaluation of causes, conclude, and announce the cause of serious adverse events during the use of vaccines and biological products in the province;

d) Decide on facilities to conduct routine vaccinations, supplementary doses, campaign-based vaccinations, and epidemic prevention vaccinations within the province;

e) Direct, organize implementation of other activities related to immunization according to functions and tasks assigned.

2. Responsibilities of Provincial Disease Control Center and District Health Center (if any):

a) Implement the use, storage, distribution of vaccines and biological products ensuring quality and meeting the vaccination needs of the public;

b) Organize training and refresher courses on immunization, vaccine and biological product usage for personnel involved in administering mandatory vaccinations;

c) Participate in investigating and evaluating causes of serious adverse events during the use of vaccines and biological products within the province;

d) Collect samples from vaccines and biological products when serious adverse events occur during their use;

e) Direct, guide implementation, and cooperate with inspections on vaccine and biological product usage at local level;

 

f) Compile and report vaccination work in the province.

3. Responsibilities of Rural Health Station:

a) Organize immunization activities within its jurisdiction according to regulations;

b) Cooperate with inspections on immunization activities within its jurisdiction;

c) Compile and report on vaccination work in the area.

Article 25. Responsibilities of Vaccination Facilities

1. Implement mandatory and voluntary vaccinations according to regulations.

2. Public vaccination facilities, according to their functions and tasks assigned, must carry out vaccinations for vaccines and biological products under the Expanded Immunization Program and epidemic prevention vaccinations.

3. Public medical institutions outside the provisions of paragraph 2 of this Article, private medical institutions, and private vaccination facilities may administer mandatory vaccines and biological products in the Expanded Immunization Program upon assignment by the Health Specialized Agency under People's Committee at Provincial Level; implement epidemic prevention vaccinations when required by competent state management agency.

4. Carry out activities related to immunization as stipulated in this Circular and other relevant documents.

5. Adhere to professional technical procedures for vaccine and biological product use and vaccination safety.

6. Cooperate with organizations and groups to promote and encourage public participation in disease prevention through vaccination.

7. Collaborate with relevant units to conduct investigations into serious adverse events following immunization and facilitate such investigations.

8. Implement the National Immunization Information Management System according to professional guidance from the Disease Prevention Bureau. In case of using a separate system, ensure real-time connectivity and data sharing with the National Immunization Information Management System while ensuring information security in accordance with regulations, except for data managed by the Ministry of Public Security or the Ministry of Defense.

9. Compile and report on vaccination work.

10. Maintain and manage documents and records related to vaccinations and adverse events following immunization according to regulations.

Article 26. Responsibilities of Healthcare Facilities for Vaccination Services

Healthcare facilities for vaccination services, in addition to complying with the provisions set forth in Article 25 of this Circular, shall also:

1. For healthcare facilities with a birthing room: organize and implement the administration of hepatitis B vaccine within 24 hours after birth and other vaccines and biological products according to the professional guidance provided by the Department of Disease Prevention.

2. Administer required vaccines and biological products for mandatory vaccination programs to specified individuals at healthcare facilities as directed or requested by competent state management agencies.

3. Participate in training on screening, handling adverse events following immunization for vaccination centers as required by the Ministry of Health and specialized health agencies under provincial people's committees.

4. Cooperate in investigating and concluding the causes of severe vaccine-related incidents.

Chapter VIII

IMPLEMENTATION PROVISIONS

Article 27. Effective Date

1. This Circular shall take effect on July 1, 2026.

2. The following Circulars shall cease to have effect from the date this Circular takes effect:

a) Circular No. 24/2018/TT-BYT dated September 18, 2018, by the Minister of Health on the establishment, organization, and operation of the Advisory Committee for Evaluating the Causes of Severe Adverse Events During Vaccine Use;

b) Circular No. 34/2018/TT-BYT dated November 12, 2018, by the Minister of Health on detailed provisions of certain articles of Decree No. 104/2016/NĐ-CP dated July 1, 2016, by the Government on vaccination activities;

c) Circular No. 5/2020/TT-BYT dated April 3, 2020, by the Minister of Health amending and supplementing certain articles of Circular No. 24/2018/TT-BYT dated September 18, 2018, on the establishment, organization, and operation of the Advisory Committee for Evaluating the Causes of Severe Adverse Events During Vaccine Use;

d) Circular No. 52/2025/TT-BYT dated December 31, 2025, by the Minister of Health on the list of notifiable infectious diseases, target groups, and scope for mandatory use of vaccines and medical biological products.

Article 28. Implementation Responsibilities

The Director of the Office of the Ministry, Directors of the Department of Disease Prevention and the Department of Healthcare Management, Heads of Departments and Bureaus under the Ministry of Health, Heads of subordinate agencies and units of the Ministry of Health, Heads of health management agencies under the Ministry of Public Security and the Ministry of Defense, Chairpersons of people's committees at provincial and municipal levels, and relevant organizations and entities are responsible for implementing this Circular.

In the course of implementation, if any difficulties or obstacles arise, it is requested that such issues be promptly reported to the Ministry of Health (through the Department of Disease Prevention) for consideration and resolution./.
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