Ministry of Health's guidelines for monitoring adverse events after Covid-19 vaccination in Vietnam

Recently, the Ministry of Health of Vietnam issued Decision 1464/QD-BYT dated March 5, 2021 on guidelines for receiving, preserving, distributing and using COVID-19 vaccine.

Ministry of Health's guidelines for monitoring adverse events after Covid-19 vaccination in Vietnam (Illustration)

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;

(1) 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 104/2016/ND-CP dated July 1, 2016 of the Government of Vietnam.

Article 6. Investigation, reporting and announcement of investigation result, response to post-vaccination serious injuries

1. Within 24hours from the occurrence of a serious injury, the Provincial Department of Health shall carry out an investigation. Within 05 working days from the receipt of the investigation report, the Provincial Department of Health shall hold a meeting with the provincial advisory council to assess the cause to:

a) assess and give a conclusion about the cause of the serious injury;

b) determine eligibility for compensation as prescribed in Clause 6 r 30 of the Law on Prevention and treatment of infectious diseases and Clause 2 Article 15 of this Decree;

c) determine whether the serious injury is related to the manufacture, sale, storage or handling.

2. Within 24 hours from the time the minutes of meeting with the provincial advisory council is completed, the Director of the Provincial Department of Health shall:

a) announce the cause of the serious injury and send a report to the Ministry of Health; and

b) inform the patient’s family of the cause of the serious injury.

3. Where it is suspected that the serious injury is because of the vaccine quality, the Director of the Provincial Department of Health shall issue a decision to suspend the use of the vaccine batch in the province after receiving a written agreement from the Ministry of Health. After the provincial advisory council concludes that the vaccine quality is related to the serious injury, the Director of the Provincial Department of Health shall permit the use of the vaccine batch and send a report to the Ministry of Health of Vietnam.

4. Where necessary, the Ministry of Health shall hold a meeting with the ministerial advisory council to evaluate the conclusion given by the provincial advisory council

5. The Minister of Health of Vietnam shall elaborate this Article.

- Implementation period: During and after immunization.

(2) 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 104/2016/ND-CP dated July 1, 2016 of the Government and Circular 34/2018/TT-BYT dated November 12, 2018 of Ministry of Health of Vietnam.

+ 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 24/2018/TT-BYT dated September 18, 2018 and Circular 05/2020/TT-BYT on amendments to Circular 24/2018/TT-BYT dated September 18, 2018 of Ministry of Health of Vietnam 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 51/2017/TT-BYT dated December 29, 2017 of Ministry of Health of Vietnam 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.

More details can be found in: Vietnam's Decision 1464/QD-BYT effective from March 5, 2021.

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