Circular No. 34/2018/TT-BYT detailing certain provisions of the Government Decree No. 104/2016/NĐ-CP dated July 1, 2016 on vaccination activities.

CIRCULAR

DETAILING CERTAIN PROVISIONS OF DECREE NO. 104/2016/NĐ-CP

DATED JULY 1, 2016 OF THE GOVERNMENT ON IMMUNIZATION ACTIVITIES

Pursuant to Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on immunization activities;

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

Considering the proposal of the Director of the Preventive Medicine Department;

The Minister of Health issues this Circular guiding in detail certain provisions of Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on immunization activities.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the acceptance, transportation, storage of vaccines; organization of immunization; surveillance, investigation of causes of severe adverse events following immunization; reporting systems and management of records related to immunization activities.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Cold box is a container holding cold packs for storing vaccines and diluents during transportation or storage for up to 4 to 7 days depending on the use of cold packs.

2. Vaccine carrier is a container holding cold packs for storing vaccines and diluents during transportation or storage for up to 1 to 2 days depending on the use of cold packs.

3. Temperature-sensitive label (VVM) is a label affixed to vaccine vials that changes color when the vials are exposed to temperatures higher than permissible limits for each type of vaccine.

4. Electronic freeze indicator is a device used to indicate whether the vaccine storage equipment has reached or is at a temperature that can cause freezing of the vaccine.

5. Temperature monitoring card is a tool recording the temperature of vaccine storage during transportation and storage.

6. Common reactions following immunization are mild symptoms that may resolve spontaneously, usually occurring after vaccine administration, including local symptoms such as itching, pain, swelling, or redness, or both swelling and redness at the injection site; systemic symptoms such as fever below 39°C and other symptoms (irritability, fatigue, loss of appetite).

Chapter II

REGULATIONS ON ACCEPTANCE, TRANSPORTATION AND STORAGE OF VACCINES

Article 3. Distribution and Acceptance of Vaccines

1. When distributing vaccines, the distributor must check and retain information according to the model prescribed in Appendix I attached to this Circular at the distribution unit. If any abnormalities in the information related to the vaccine are found, both parties involved in the handover must prepare a record of the actual condition of the vaccine and handle it according to regulations.

2. When accepting vaccines, the recipient must check and retain information according to the model prescribed in Appendix I attached to this Circular, and shall not accept if there are any abnormalities in the information related to the vaccine.

Article 4. Storage of Vaccines and Diluents in Cold Chain Equipment

1. Storage of Vaccines:

Vaccines must be stored in accordance with Article 8 of Decree No. 104/2016/NĐ-CP dated July 1, 2016 of the Government on immunization activities (hereinafter referred to as Decree No. 104/2016/NĐ-CP) and the specific provisions below:

a) Vaccines must be stored separately in cold chain equipment, not stored together with other products;

b) Vaccines must be arranged properly to avoid freezing;

c) Hygiene must be ensured when handling vaccine boxes and vials;

d) Daily monitoring of the cold chain equipment's temperature for vaccine storage (including holidays and rest days) and recording in the temperature monitoring log at least twice a day, in the morning at the start of work and in the afternoon before the end of work, must be conducted;

đ) For vaccines in the expanded immunization program: In addition to complying with the provisions of points a, b, c, and d of this Clause, there must be a temperature alarm system for the cold room, automatic temperature logging for the vaccine storage warehouse at the central and regional levels; electronic freeze indicators and thermometers for the vaccine storage refrigerators at the provincial and district levels; thermometers for the vaccine storage refrigerators, cold boxes, or vaccine carriers at the commune level.

2. Storage of Diluents:

In cases where they are not packaged together with the vaccines, diluents may be stored outside the cold chain equipment but must comply with the manufacturer's storage requirements and meet the following conditions:

a) Diluents must not be frozen;

b) They must be cooled from +2°C to +8°C 24 hours before use for reconstitution.

Article 5. Vaccine Storage During Vaccination Sessions

1. Use vaccine carriers, cold boxes, or refrigerators to store vaccines throughout the vaccination session in accordance with points a, b, c, and đ Clause 1 Article 4 of this Circular, and ensure that the temperature remains between +2°C and +8°C.

2. Unopened vaccine bottles after the vaccination session must be continued to be stored in the cold chain equipment and used first in the next vaccination session.

Article 6. Transporting Vaccines

1. The transportation of vaccines shall be carried out in accordance with points b and d Clause 1 Article 8 of Decree No. 104/2016/NĐ-CP.

2. The storage of vaccines during transportation shall be conducted in accordance with points a, b, and c Clause 1 Article 4 of this Circular; it is necessary to maintain continuous appropriate temperatures for each type of vaccine as indicated on the label or the vaccine user guide throughout the transportation process.

3. For vaccines in the expanded immunization program, temperature monitoring must be conducted using thermometers and electronic freezing indicators during the entire transportation process at the central, regional, and provincial levels. At the district and commune levels, temperature monitoring must be conducted continuously throughout the transportation process using thermometers.

Article 7. Maintenance of Cold Chain Equipment, Monitoring of Vaccine Storage in the Cold Chain

1. Cold chain equipment must be regularly inspected, monitored for operational status, maintained periodically according to the manufacturer's instructions, repaired or replaced as required by the manufacturer to ensure that vaccines are always kept at the correct temperature throughout the storage, transportation, and usage processes as indicated on the label or the vaccine user guide.

2. Regular maintenance and calibration of cold chain equipment and temperature monitoring devices for vaccines must be performed in accordance with Decree No. 36/2016/NĐ-CP dated May 15, 2016, of the Government on medical equipment management.

Chapter III

ORGANIZATION OF VACCINATION

Article 8. Management of Recipients

1. The content of recipient management shall be implemented in accordance with Article 4 of Decree No. 104/2016/NĐ-CP.

2. Reporting, managing recipients, recording in writing, and the National Immunization Information Management System. The implementation time for reporting through the National Immunization Information Management System shall follow the guidelines of the Ministry of Health.

Article 9. Arrangement and Layout at Fixed and Mobile Vaccination Sites

1. Organize vaccination sessions such that no more than 50 recipients are vaccinated per site per session. In cases where only one type of vaccine is administered in a session, the number of recipients may not exceed 100 per session. Adequate healthcare personnel must be arranged to conduct pre-vaccination screening examinations.

2. Each vaccination facility can organize from one to multiple fixed vaccination sites and must ensure sufficient area, personnel, facilities, and equipment.

3. At each vaccination site, there must be a specific task assignment for each staff member.

4. Arrange vaccination sites following the one-way principle in the following order: Pre-vaccination waiting area → Reception and guidance desk → Pre-vaccination screening and counseling desk → Vaccination desk → Record-keeping and vaccination log desk → Post-vaccination observation and adverse event management area.

Article 10. Pre-vaccination screening and counseling

1. Pre-vaccination screening for children shall be conducted in accordance with the regulations of the Ministry of Health; observe the overall condition and assess the current health status of adults.

2. Inquire and record information from the vaccination subject regarding their medical history, allergy history, and previous vaccination history.

3. Advise the vaccination subject, parents, or guardians of children about the effects and benefits of using vaccines and explain possible reactions following vaccination.

4. Inform the vaccination subject, parents, or guardians of children about the effects, dosage, and route of administration of the vaccine to be administered before each vaccination.

Article 11. Implementation of Vaccination

1. The dosage and route of administration for each type of vaccine must comply with the usage instructions on the label or the accompanying vaccine instruction leaflet.

2. Freeze-dried vaccines must be reconstituted according to the provisions set out in Appendix II issued together with this Circular.

3. Vaccines should be used based on the principle that those with shorter expiration dates should be used first, those received earlier should be used first, or according to the temperature indication on the vaccine vial which needs to be used first as directed by the manufacturer, or leftover vaccines from the previous vaccination session must be stored properly and used first.

4. Liquid vaccines, once opened, should be stored at temperatures between +2°C and +8°C and used during the vaccination session.

5. The diluent for a particular vaccine can only be used for that specific vaccine. Reconstituted freeze-dried vaccines may only be used within six hours or as directed by the manufacturer.

6. Conducting vaccinations:

a) Check the vaccines, diluents, syringes, and needles before use;

b) Allow the vaccination subject or parents, guardians of children to view the vaccine vial before vaccination;

c) Administer the vaccine to the correct designated recipient, with the correct vaccine, dose, route, and timing;

d) Immediately place used syringes, needles, and sharp objects into a safety container after injection without covering the needle cap.

7. End of the vaccination session:

a) Store unopened vials of vaccines and diluents according to the provisions of Article 4 of this Circular;

b) Unused syringes must be stored according to regulations for future use;

c) Unfinished multi-dose vials opened but not fully used, and fully used vials after the vaccination session must be disposed of according to Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015, jointly issued by the Ministry of Health and the Ministry of Natural Resources and Environment on the management of healthcare waste;

d) For cases where vaccination is delayed in expanded immunization programs, reschedule the vaccination for the same month.

Article 12. Post-Vaccination Monitoring

1. Monitor the vaccination subject for at least 30 minutes post-vaccination at the vaccination site.

2. Guide families or vaccination subjects:

a) Continue monitoring at home for at least 24 hours post-vaccination for signs such as overall condition, mental state, eating, sleeping, breathing, rash, local reaction symptoms, and report to healthcare personnel if there are any unusual signs;

b) Immediately transport the vaccination subject to a hospital or healthcare facility if post-vaccination they exhibit any of the following signs: high fever (≥39°C), convulsions, screaming, prolonged crying, lethargy, poor feeding, refusal to feed, difficulty breathing, cyanosis, rash, or other abnormal manifestations, or when common reactions persist for more than 24 hours post-vaccination.

3. Record:

a) Fully document the information on the vaccination card or book of the vaccination subject and on the National Immunization Information Management System, and schedule the next vaccination appointment;

b) Record the date of vaccination for each type of vaccine administered to the vaccination subject and document post-vaccination reactions on the National Immunization Information Management System.

Article 13. Organization of vaccination campaigns and home vaccinations

1. The organization of vaccination campaigns shall be carried out in accordance with the guidelines of the Ministry of Health for each campaign.

2. Only vaccination facilities that have been announced to meet the vaccination conditions as stipulated in Decree No. 104/2016/NĐ-CP shall be permitted to implement campaigns.

3. Home vaccinations shall only be applied to vaccination activities under the Expanded Immunization Program and disease control vaccinations in remote and extremely difficult socio-economic areas.

Chapter IV

 SURVEILLANCE AND INVESTIGATION OF CAUSES OF SEVERE ADVERSE EVENTS FOLLOWING IMMUNIZATION

Article 14. Detection, handling, and reporting of severe adverse events following immunization

1. The detection and handling of severe adverse events following immunization during the implementation of vaccinations shall be carried out in accordance with the provisions of Clause 2, Clause 3, and Clause 4 of Article 5 of Decree No. 104/2016/NĐ-CP.

2. Statistics on information related to cases of severe adverse events following immunization:

a) Name, age, gender, address, telephone number (if available) of the vaccinated individual or the parents of the child;

b) Date and time of vaccination;

c) Type of vaccine; name of vaccine; registration number for circulation or import permit number; batch number; expiration date; manufacturer; supplier; storage condition upon receipt;

d) Date and time of occurrence of severe adverse event following immunization; main symptoms; treatment results; conclusion on cause (if available).

3. Statistics on the total quantity of vaccines (name of vaccine, batch number, expiration date) used during the vaccination session; the number of individuals vaccinated according to each type and batch of vaccine during that session, and the health status of the vaccinated individuals.

4. Medical examination and treatment facilities receiving cases of severe adverse events following immunization must carry out:

a) Emergency care, handling, and treatment in accordance with regulations;

b) Reporting to the Department of Health in accordance with Clause 3 of Article 5 of Decree No. 104/2016/NĐ-CP;

5. District and provincial levels: receive reports, compile information, and report to higher levels in accordance with Articles 18 and 20 of this Circular.

Article 15. Investigation of severe adverse events following immunization

1. The Department of Health establishes an investigation team consisting of: the Team Leader being a representative of the Center for Disease Control or Provincial Health Center (hereinafter referred to as the Center for Disease Control), members including representatives from the Department of Health Affairs - Department of Health, representatives from the Infectious Disease Control Department of the Center for Disease Control, representatives from the Intensive Care Unit, Obstetrics/Pediatrics Department of the Provincial General Hospital or Provincial Obstetrics/Pediatrics Hospital, and other relevant experts and staff.

2. Investigation process:

a) Specific investigation steps as prescribed in Appendix III issued together with this Circular;

b) Using investigation forms as prescribed in Appendix IV issued together with this Circular;

c) Reporting the investigation results to the Department of Health.

3. Sampling of vaccines:

a) Sampling vaccines for all cases of severe adverse events following immunization;

b) Sampling, sealing, storing, and sending samples of vaccines in accordance with the provisions of Appendix V issued together with this Circular;

c) Testing the quality of vaccines when there is suspicion of the cause of severe adverse events due to vaccines or at the request of the Expert Advisory Committee evaluating causes of adverse events following immunization;

d) If the vaccine sample does not fall within the category requiring testing, it may continue to be used locally.

4. Facilities detecting and receiving cases of severe adverse events following immunization shall collect specimen samples if necessary to determine the cause of adverse events following immunization.

Article 16. Evaluation of Causes of Severe Adverse Events Following Immunization (AEFI) and Notification of Results

1. The evaluation of causes shall be conducted for the following cases:

a) Severe adverse events following immunization;

b) Actual rates of common reactions exceeding statistical incidence rates;

c) A single case or cluster of reactions that may have a serious impact on the community.

2. The evaluation of causes of severe adverse events following immunization shall be carried out according to the form prescribed in Appendix VI attached hereto and classify causes according to the provisions set forth in Appendix VII attached hereto.

3. The Department of Health shall be responsible for:

a) Establishing and organizing meetings of the specialized advisory board to evaluate causes of severe adverse events following immunization within its jurisdiction and notify the causes of severe adverse events following immunization in accordance with Clause 1 and Clause 2, Article 6 of Decree No. 104/2016/NĐ-CP and guidelines issued by the Ministry of Health.

b) Evaluating causes for the cases specified in Points b and c, Clause 1 of this Article.

Chapter V

REGIME OF REPORTING AND MANAGEMENT OF RECORDS

Article 17. Reporting System

1. Periodic reports: monthly, quarterly, and annual reports on vaccine usage, immunization results, cases of common reactions, and cases of severe adverse events following immunization.

2. Emergency reports: cases specified in Clause 1 of Article 16 of this Circular.

3. Daily reports: when implementing vaccination against epidemics.

Article 18. Forms and Contents of Reports

1. Forms of reports:

a) Periodic reports: in writing and through the National Immunization Information Management System;

b) Emergency reports: In urgent situations, report directly or via telephone or email, and submit a written report within 24 hours;

c) Daily reports: in writing or via email.

2. Content of the report:

a) Periodic reports:

- Report on the use of vaccines in the Expanded Program on Immunization (EPI) according to Form No. 1 prescribed in Appendix VIII attached hereto;

- Report on the use of service-based immunization vaccines according to Form No. 2 prescribed in Appendix VIII attached hereto;

- Report on immunization results according to Forms No. 1, 2, and 3 prescribed in Appendix IX attached hereto;

- Report on cases of common reactions following immunization according to the form prescribed in Appendix X attached hereto;

- Report on cases of severe adverse events following immunization according to the form prescribed in Appendix XI attached hereto.

b) Emergency reports: For vaccination facilities, report according to the form prescribed in Appendix XII attached hereto or as required by competent authorities. For healthcare facilities receiving cases of severe adverse events following immunization, report contents according to Clause 3, Article 5 of Decree No. 104/2016/NĐ-CP.

c) Daily reports: Report the number of subjects, vaccines, injection supplies, cases of common reactions, and cases of severe adverse events following immunization during epidemic vaccination.

Article 19. Procedures and Timeframes for Periodic Reporting

1. For vaccines in the Expanded Program on Immunization (EPI):

a) Vaccination facilities: report to the District Health Center before the 5th day of the next month for monthly reports, the 5th day of the first month of the next quarter for quarterly reports, and before January 15 of the following year for annual reports;

b) District Health Centers: report to the Disease Control Center before the 10th day of the next month for monthly reports, the 10th day of the first month of the next quarter for quarterly reports, and before January 25 of the following year for annual reports;

c) Disease Control Centers: report to the Department of Health, Regional Expanded Program on Immunization Project at Central Institute of Hygiene and Epidemiology, Ho Chi Minh City Pasteur Institute, Nha Trang Pasteur Institute, West Central Hygiene and Epidemiology Institute (hereinafter referred to as Regional Institutes) under the management of the Minister of Health, and simultaneously report to the National Expanded Program on Immunization Project - Central Institute of Hygiene and Epidemiology before the 15th day of the next month for monthly reports, the 15th day of the first month of the next quarter for quarterly reports, and before January 31 of the following year for annual reports;

d) The National Expanded Program on Immunization Project shall compile reports to the Preventive Medicine Department before the 20th day of the next month for monthly reports, the 20th day of the first month of the next quarter for quarterly reports, and before February 15 of the following year for annual reports.

2. For service-based immunization vaccines:

a) Vaccination facilities: report to the District Health Center before the 5th day of the next month for monthly reports, the 5th day of the first month of the next quarter for quarterly reports, and before January 15 of the following year for annual reports;

b) District Health Centers: report to the Disease Control Center before the 10th day of the next month for monthly reports, the 10th day of the first month of the next quarter for quarterly reports, and before January 25 of the following year for annual reports;

c) Disease Control Centers: report to the Department of Health, Regional Institutes, and the Preventive Medicine Department before the 15th day of the next month for monthly reports, the 15th day of the first month of the next quarter for quarterly reports, and before January 31 of the following year for annual reports.

Article 20. Emergency Reporting Procedure and Timeframe

1. Within twenty-four hours from the time of recording severe adverse events following immunization (AEFI), the vaccination facility or healthcare facility receiving the severe AEFI case must report to the Department of Health while simultaneously reporting to the Disease Control Center and the District Health Center where the facility is located.

2. Weekly, after implementing the reporting as stipulated in Clause 1 of this Article, if there has been no investigative conclusion, then:

a) The vaccination facility must submit a report on the progress of the investigation and handling process for the week on the second day of the following week;

b) The Disease Control Center must submit a report on the progress of the investigation and handling process for the week on the fourth day of the following week.

Article 21. Daily Reporting Procedure and Timeframe

1. Vaccination facilities: report to the District Health Center before 5:00 PM daily.

2. District Health Centers: report to the Disease Control Center before 9:00 AM the next day.

3. Disease Control Centers: report to the Department of Health, Regional Institutes, and the Preventive Medicine Department before 2:00 PM the next day.

Article 22. File Management

1. Vaccination facilities must store and manage professional documents and records including:

a) Regulations and professional guidelines on vaccine usage, task assignments;

b) Vaccination follow-up logs for vaccinated individuals or information on managing vaccinated individuals if managed through information technology;

c) Logs and reports submitted periodically, urgently, and daily at the facility.

2. The Department of Health and the Disease Control Center must store and manage professional documents and records including:

a) Regulations and professional guidance materials on vaccination;

b) Periodic, urgent, and daily reports within their jurisdiction.

3. National Institute of Hygiene and Epidemiology, Pasteur Institutes, and Expanded Immunization Program Projects must store and manage professional documents and records including:

a) Regulations and professional guidance materials on vaccine usage and vaccination;

b) Periodic, urgent, and daily reports within their area of responsibility.

4. Records, reports, and follow-up logs must be complete, easily searchable, and managed and stored according to legal regulations on archiving.

Chapter VI

RESPONSIBILITIES FOR IMPLEMENTATION

Article 23. Responsibilities of Departments and Bureaus under the Ministry of Health

1. Preventive Medicine Bureau:

a) Lead and coordinate with relevant Departments and Bureaus to direct, guide, inspect, and audit specialized activities regarding vaccine usage nationwide; provide information and publicize about vaccine safety, benefits of vaccine usage, and possible reactions after vaccination;

b) Lead or coordinate with related units to develop professional guidelines on vaccine usage, monitoring, and investigating causes of severe adverse events following immunization, and submit them to competent authorities for issuance;

c) Serve as the focal point for managing and directing the implementation of the National Immunization Information Management System.

2. Drug Administration:

a) Advise the Ministry of Health Leadership on temporarily suspending and allowing the resumption of vaccine usage nationwide, and coordinate with the Department of Health to review the temporary suspension of vaccine batches as prescribed;

b) Manage vaccine supply and quality of vaccines circulating in Vietnam;

c) Coordinate with related units in auditing and inspecting vaccine usage as prescribed;

d) Guide the implementation of vaccine recall, storage, and destruction as prescribed;

e) Provide a list of new vaccines and sera for disease prevention within five working days from when the vaccine is licensed for circulation in Vietnam to the Preventive Medicine Bureau for updating into the National Immunization Information Management System.

3. Medical Examination and Treatment Administration Bureau:

a) Lead and coordinate with the Maternal and Child Health Department to guide pre-vaccination screening examinations for children and management of severe adverse events following immunization. Direct healthcare facilities to cooperate with the Disease Control Center to support vaccination facilities in conducting pre-vaccination screenings, managing severe adverse events following immunization, and investigating causes of such events;

b) Direct and monitor vaccination activities within the medical examination and treatment system;

c) Coordinate with related units in auditing and inspecting vaccine usage as prescribed;

d) Direct healthcare facilities with vaccination facilities or healthcare facilities authorized to conduct vaccinations to participate in implementing the National Immunization Information Management System according to the Ministry of Health's guidelines.

Article 24. Responsibilities of the National Expanded Immunization Project and Institutes

1. Responsibilities of the National Expanded Immunization Project:

a) Develop plans for vaccine usage needs, propose vaccines and immunization schedules for the Expanded Immunization Program;

b) Organize the purchase, receipt, storage, and supply of Expanded Immunization Program vaccines to using units in accordance with regulations;

c) Build and unify training materials on immunization for approval by competent authorities. Organize training on immunization in expanded immunization and epidemic prevention;

d) Coordinate in investigating causes of severe adverse events following immunization, promptly handle severe adverse events following immunization, store data on Expanded Immunization Program vaccine usage and post-immunization reaction data;

đ) Coordinate in training on surveillance and investigation of post-immunization reactions for the Provincial Expert Advisory Committee on Severe Adverse Events Following Immunization;

e) Summarize and report on immunization work in accordance with regulations;

g) Organize information dissemination and propaganda on immunization safety, benefits of vaccine use, and post-immunization reactions according to the Ministry of Health's directives;

h) Manage and use compensation funds for cases compensated by the State in accordance with Decree No. 104/2016/NĐ-CP;

i) Guide, organize implementation, inspect, and supervise the implementation of the Expanded Immunization Program and disease surveillance within the program;

k) Coordinate with the Preventive Medicine Department to direct and guide the implementation of the National Immunization Information Management System according to the Ministry of Health's guidelines;

l) Serve as the permanent Secretariat of the National Steering Committee for Immunization.

2. Responsibilities of Regional Institutes:

a) Direct technical expertise, monitor vaccine usage at localities within their assigned management areas by the Ministry of Health to ensure quality and safety in immunization work, monitor post-immunization reactions;

b) Organize the receipt, storage, and supply of Expanded Immunization Program vaccines to localities within their assigned management areas by the Ministry of Health;

c) Organize training on immunization and vaccine usage in the Expanded Immunization Program and epidemic prevention;

d) Participate in coordinating investigations and concluding causes of severe adverse events following immunization in localities within their assigned management areas by the Ministry of Health, promptly handle severe adverse events following immunization;

đ) Summarize and report on immunization work within their management areas;

e) Coordinate with the Preventive Medicine Department to guide the implementation of the National Immunization Information Management System according to the Ministry of Health's guidelines.

3. Responsibilities of the National Institute for Vaccine and Medical Biological Control:

a) Implement quality and safety monitoring of vaccines nationwide;

b) Coordinate with relevant units in inspecting and supervising vaccine usage.

Article 25. Responsibilities of the Department of Health, Disease Control Centers, District Health Departments, and District Health Centers

1. Responsibilities of the Department of Health:

a) Direct the implementation of immunization activities in accordance with the Ministry of Health's regulations, organize and implement inspections and audits of this Circular's implementation within their jurisdiction;

b) Organize the evaluation, conclusion, and announcement of causes of severe adverse events following immunization within the province;

c) Direct information dissemination and propaganda on immunization safety, benefits of vaccine use, and post-immunization reactions;

d) Decide on temporarily suspending vaccines based on the Drug Administration Bureau's opinions and resume vaccine use within their jurisdiction, notify the Drug Administration Bureau about this;

đ) Direct the implementation of the National Immunization Information Management System according to the Ministry of Health's guidelines within their jurisdiction.

2. Responsibilities of Disease Control Centers:

a) Implement vaccine usage, storage, and distribution to ensure quality and meet the population's preventive vaccination needs;

b) Organize training and retraining on immunization and vaccine usage in the Expanded Immunization Program and epidemic prevention;

c) Participate in investigating and evaluating causes of severe adverse events following immunization within the province;

d) Collect vaccine samples when severe adverse events following immunization occur;

đ) Direct, guide implementation, coordinate with the Health Department Inspectorate to inspect and audit vaccine usage activities locally;

e) Summarize and report on immunization work within their jurisdiction;

g) Direct and implement the National Immunization Information Management System according to the Ministry of Health's guidelines within their jurisdiction.

3. Responsibilities of the District Health Department:

a) Coordinate with the District Health Center to direct the organization of immunization activities within their jurisdiction in accordance with the Ministry of Health's regulations;

b) Implement inspections and audits of immunization activities within their jurisdiction.

4. Responsibilities of the District Health Center:

a) Implement vaccine storage, transportation, and distribution to ensure quality and direct, guide health stations to implement vaccine usage according to regulations;

b) Coordinate with the District Health Department to inspect and audit immunization activities within their jurisdiction;

c) For District Health Centers with preventive medicine and medical examination and treatment service functions, they are responsible for implementing the provisions of Article 26 of this Circular;

d) Summarize and report on immunization work within their jurisdiction;

đ) Direct and guide the implementation of the National Immunization Information Management System according to the Ministry of Health's guidelines within their jurisdiction.

Article 26. Responsibilities of Obstetric Hospitals, Pediatric Hospitals, and State General Hospitals

1. Participate in training on screening examinations for vaccination facilities as directed by the Ministry of Health and the People's Committee Health Departments.

2. Cooperate in investigating and concluding the causes of serious adverse events following immunization.

3. Organize the implementation of hepatitis B vaccine administration within 24 hours after birth at facilities with delivery rooms, in accordance with regulations, and organize the administration of other vaccines under the Expanded Immunization Program when required by competent state management authorities.

4. Implement the National Immunization Information Management System according to the guidelines of the Ministry of Health for vaccination facilities.

5. Summarize and report on the vaccination activities of the unit (if applicable).

Article 27. Responsibilities of Vaccination Facilities and Vaccinators

1. Responsibilities of vaccination facilities:

a) Be responsible under the law for implementing professional activities in accordance with assigned functions and tasks;

b) Adhere to professional technical procedures regarding vaccine usage and safe vaccination;

c) Organize the implementation of hepatitis B vaccine administration within 24 hours after birth at healthcare facilities with delivery rooms, in accordance with regulations, and organize the administration of other vaccines under the Expanded Immunization Program when required by competent state management authorities;

d) Collaborate with organizations and associations to promote and encourage public participation in vaccination for disease prevention;

e) Collaborate with related units to conduct and facilitate investigations into the causes of serious adverse events following immunization;

f) Implement the National Immunization Information Management System according to the guidelines of the Ministry of Health;

g) Summarize and report on the vaccination activities of the unit.

2. Responsibilities of vaccinators: comply strictly with the professional procedures of the Ministry of Health for vaccination and relevant provisions in this Circular.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 28. Effective Date

1. This Circular takes effect from January 1, 2019

2. Circular No. 12/2014/TT-BYT dated March 20, 2014, guiding the use of vaccines in immunization issued by the Minister of Health shall cease to be effective from the date this Circular comes into force.

Article 29. References

In cases where the referenced documents in this document are replaced or amended, implementation shall be in accordance with the replacement or amended document.

Article 30. Responsibility for Implementation

The Director of the Ministry’s Office, the Director of the Preventive Medicine Department, the Heads of Departments, Directors of Cucultures, and General Directors under the Ministry of Health, Heads of subordinate agencies and units of the Ministry, Directors of Provincial Health Departments under central cities and provinces, and Heads of health units under ministries, sectors, and organizations and individuals are responsible for enforcing this Circular.

In the course of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report to the Ministry of Health for consideration and resolution./.