Guangdong Provincial People’s Government on Issuing Vaccines in Guangdong Province
Notice of Emergency Plan for Safety Events (for Trial Implementation)
Yue Fu Han [2019] No.430
People’s governments at the local and municipal levels, departments and institutions directly under the provincial government:
The Emergency Plan for Vaccine Safety Events in Guangdong Province (for Trial Implementation) is hereby printed and distributed to you, please earnestly organize its implementation. Please report the problems encountered in the implementation process to the Provincial Food and Drug Administration.
people’s government of guangdong province
December 30, 2019
Emergency Plan for Vaccine Safety Events in Guangdong Province (Trial)
catalogue
1 General rules
1.1 Purpose of compilation
one.2 compilation basis
one.3 Scope of application
one.4 grading standard
one.5 disposal principle
2 organizational system
2.1 emergency command system
2.one.1 provincial vaccine safety incident in emergency headquarters
2.one.2 emergency headquarters office
2.one.3 responsibilities and composition of on-site command organization (working group)
2.one.three.1 Comprehensive Coordination Group
2.one.three.2 incident investigation team
2.one.three.3 Hazard Control Group
2.one.three.4 medical treatment group
2.one.three.5 emergency support group
2.one.three.6 publicity and reporting section
2.2 expert group
2.3 technical support institutions
3 Monitoring, early warning, reporting and evaluation
three.1 monitoring
three.one.1 Report the responsible subject
three.one.2 vaccine safety event information content
three.2 Early warning
three.3 report
three.three.1 reporting procedures and time limits
three.three.2 Report content and method
three.4 event evaluation
4 hierarchical response
four.1 Ⅰ level response
four.2 Ⅱ response
four.3 Ⅲ response
four.Level iv response
four.5 end of response
four.6 information release
four.six.1 release principle
four.six.2 release requirements
four.six.3 release form
5 Risk communication
five.1 Communication purpose
five.2 communication principle
five.3 communication methods
6 post-disposal
six.1 event assessment
six.2 Work summary
six.3 aftermath and recovery
7 safeguard measures
seven.1 information security
seven.2 personnel and technical support
seven.3 material and financial security
seven.4 emergency drills
seven.5 emergency publicity
8 Plan implementation
Appendix 1 Classification Criteria and Response Levels of Vaccine Safety Events
Appendix 2 Report Form of Important Information on Vaccine Safety (Preliminary Report)
Appendix 3 Report Form of Important Information on Vaccine Safety (Continued)
Appendix 4 Information Report on Vaccine Safety Emergencies
Annex 5 Emergency Response Process for Major Vaccine Safety Events
Appendix 6 Emergency Disposal Process of General Vaccine Safety Events
1 General rules
one.1 Purpose of compilation
In order to establish and improve the emergency response mechanism of vaccine safety incidents in our province, effectively prevent and actively respond to vaccine safety incidents, efficiently organize emergency response work, minimize the harm of vaccine safety incidents, safeguard public health and life safety, and maintain normal social and economic order, this plan is formulated in combination with the actual situation in our province.
one.2 compilation basis
People’s Republic of China (PRC) Emergency Response Law, People’s Republic of China (PRC) Drug Administration Law, People’s Republic of China (PRC) Vaccine Administration Law, Regulations on the Management of Vaccine Circulation and Vaccination, Opinions on Reforming and Perfecting the Vaccine Management System, Emergency Management Measures for Market Supervision, Emergency Plan for Drug and Medical Device Safety Emergencies (Trial), Emergency Plan for Vaccine Quality and Safety Incidents (Trial), National Monitoring Plan for Suspected Vaccination Abnormal Reaction and other relevant regulations.
one.3 Scope of application
The vaccine safety incidents mentioned in this plan refer to the vaccine safety information that is suspected of vaccination reaction and group adverse events, suspected to be related to vaccine quality after investigation, or found in daily supervision and inspection and risk monitoring, and other vaccine safety incidents that seriously affect public health.
This plan is applicable to the prevention, response and emergency handling of vaccine safety incidents involving our province in the administrative area of our province or outside the province.
one.4 grading standard
Vaccine safety incidents are divided into four levels: particularly significant, major, major and general, which correspond to level I, II, III and IV responses in turn (see Annex 1 for specific standards).
one.5 disposal principle
Follow the principles of unified leadership, graded responsibility, prevention first, rapid response, coordinated response, standardization according to law and scientific disposal.
2 organizational system
2.1 emergency command system
The province’s vaccine safety emergency command system is composed of emergency headquarters and its offices at all levels of the province, city and county (district), and is responsible for organizing, coordinating and guiding the vaccine safety emergency response work at the corresponding event level according to the principle of graded responsibility.
Emergency headquarters at the provincial level is responsible for responding to vaccine safety incidents of larger and above in its administrative area; The municipal headquarters with districts is responsible for responding to the general vaccine safety incidents in this administrative region.
2.one.1 provincial vaccine safety incident in emergency headquarters
Commander: Deputy Governor in charge
Deputy Commander: Deputy Secretary-General in charge of the provincial government, principal responsible comrades of the Provincial Food and Drug Administration and the Health and Wellness Committee.
Members: Provincial Party Committee Propaganda Department, Political and Legal Committee, Foreign Affairs Office, Taiwan Affairs Office, Provincial Education Department, Public Security Department, Civil Affairs Department, Justice Department, Finance Department, Health and Wellness Committee, Market Supervision Bureau, Hong Kong and Macao Affairs Office, Food and Reserve Bureau, Food and Drug Administration, Guangdong Branch of General Administration of Customs, Provincial Communications Administration, Guangdong Banking Insurance Regulatory Bureau and other units in charge of responsible comrades and heads of self-discipline and co-governance groups of provincial vaccine production enterprises.
The commander may, according to the actual situation, transfer the responsible comrades of relevant provincial units as members.
Each member unit shall, according to the emergency response level and the unified deployment of the provincial headquarters, cooperate with the emergency response of vaccine safety emergencies according to their duties.
Propaganda Department of the Provincial Party Committee: responsible for guiding the publicity and reporting of vaccine safety incidents and guiding public opinion.
Political and Legal Committee of the Provincial Party Committee: responsible for guiding, coordinating and urging political and legal organs to handle vaccine safety crime cases according to law.
Provincial Department of Education: responsible for assisting relevant provincial departments to investigate the causes of vaccine safety incidents among students in schools (including kindergartens) and organize emergency response.
Provincial Public Security Department: responsible for the maintenance of public order in the incident area; Traffic control of surrounding roads, ensuring smooth emergency rescue roads and urban public passenger traffic; Do a good job in investigating suspected criminal cases and severely crack down on crimes that endanger vaccine safety according to law.
Provincial Civil Affairs Department: responsible for the basic life assistance work of people who are affected by vaccine safety incidents and have difficulties in life and meet the conditions of social assistance.
Provincial Department of Justice: the legal adviser responsible for the decision-making of the provincial government on vaccine safety incidents.
Provincial Department of Finance: responsible for the fund guarantee for emergency rescue and emergency disposal of vaccine safety incidents.
Provincial Health and Wellness Committee: responsible for organizing and coordinating relevant medical institutions, disease prevention and control institutions and vaccination units to carry out medical treatment for patients with vaccine safety incidents.
Foreign Affairs Office of the Provincial Party Committee, Taiwan Affairs Office and Provincial Hong Kong and Macao Affairs Office: responsible for assisting the relevant regulatory authorities in emergency handling of vaccine safety incidents involving foreign countries, Hong Kong, Macao and Taiwan.
Provincial Market Supervision Bureau: responsible for investigating and handling trademark infringement and other illegal acts involved in vaccine safety incidents, and taking necessary emergency measures.
Provincial Grain and Reserve Bureau: responsible for the implementation of provincial plans and instructions for the use of important materials and emergency reserve materials.
Provincial Food and Drug Administration: responsible for the daily work of the provincial headquarters office; Responsible for collecting and reporting information on vaccine safety incidents; Coordinate relevant departments (units) to carry out emergency response work; Related vaccines involved in emergency control; Responsible for the investigation and handling of vaccine quality and safety incidents and related technical appraisal.
Guangdong Branch of the General Administration of Customs: responsible for coordinating the customs in the province to inform the relevant departments of the import and export links involved in vaccine safety incidents in a timely manner, and investigating and handling illegal acts in import and export vaccine safety incidents in border port areas within their jurisdiction; Organize relevant tests and take necessary emergency measures according to law; Carry out risk assessment of relevant vaccine safety incidents; Submit the report on the cause, disposal process and risk assessment of the incident.
Provincial Communications Administration: according to the written opinions issued by the drug supervision and administration, health and health supervisors and online information departments, cooperate with the investigation and punishment of illegal Internet sites and applications involved in vaccine safety incidents according to law; Responsible for organizing and coordinating all telecom operators to support the emergency command and communication support and ensure the smooth communication of the emergency command system.
Guangdong Banking Insurance Regulatory Bureau: responsible for urging all insurance institutions in the province to timely carry out insurance claims related to vaccine safety.
Provincial vaccine production enterprise self-discipline and co-governance group: responsible for guiding vaccine marketing license holders to formulate and implement emergency plans for vaccine safety incidents and carry out vaccine safety-related education; Assist relevant regulatory authorities to carry out incident investigation and handling.
2.one.2 emergency headquarters office
The office of emergency headquarters Province is located in the Provincial Food and Drug Administration, and the main responsible comrades of the bureau also serve as the office director. Responsibilities are as follows:
(1) to undertake the daily work of emergency headquarters Province, organize and implement the work arrangements of emergency headquarters Province, and establish working mechanisms such as issuing documents, consulting, information release, expert group management and work supervision for emergency response to vaccine safety incidents.
(2) Check and urge relevant regions and departments to do all kinds of emergency disposal work, control the hazards in a timely and effective manner, and prevent the situation from spreading.
(3) Collect, summarize and analyze the emergency response information of vaccine safety incidents of all relevant departments, and report and inform the provincial headquarters of the emergency response work in a timely manner.
(4) to organize and coordinate the prevention, early warning and emergency response of vaccine safety incidents in the whole province, and organize relevant publicity, training and drills.
(5) organize the revision of the emergency plan for vaccine safety incidents.
(6) Organize the establishment and management of an expert group for emergency response to vaccine safety incidents.
(7) to complete other tasks assigned by the provincial headquarters.
Emergency headquarters and its office shall be established at the city and county levels to be responsible for organizing, coordinating and guiding the emergency work of vaccine safety incidents in their respective administrative areas.
2.one.3. Responsibilities and composition of on-site command organization (working group):
After the occurrence of general and major vaccine safety incidents, the people’s government at the place where the incident occurred set up an on-site command organization composed of responsible comrades of the people’s government at the same level and responsible comrades of relevant departments to organize, command and coordinate the on-site emergency response of emergencies in a unified way. The on-site command organization can set up a comprehensive coordination group, an incident investigation group, a hazard control group, a medical treatment group, an emergency support group and a publicity and reporting group according to the needs of emergency treatment, and adjust its setting and personnel composition according to the situation. It can also absorb the personnel and experts of the city and county headquarters, the person in charge of the emergency treatment team and the person in charge of the incident unit.
2.one.three.Comprehensive coordination group: led by the drug supervision and administration department, with the cooperation of health and finance departments. Responsible for the daily work of the on-site command organization; Collect, sort out and report information on handling vaccine quality and safety incidents; Organize an expert group meeting; Coordinate and provide necessary financial guarantee; Authorized by the on-site command organization, release the disposal work dynamics; To undertake other tasks assigned by the on-site command organization.
2.one.three.Incident investigation team: led by the drug supervision and administration department, with the cooperation of the departments of politics, law, public security and health. Responsible for investigating the causes of vaccine safety incidents, evaluating the impact of the incidents, making investigation conclusions and putting forward preventive opinions; For those suspected of committing crimes, the provincial public security department is responsible for supervising and guiding the public security organs involved in the case to file a case for investigation, find out the facts and investigate criminal responsibility according to law. According to the actual needs, the incident investigation team can be set up at the incident site or sent to the scene to carry out the investigation.
2.one.three.Hazard control group: led by the drug supervision and administration department, it is responsible for dispatching an emergency team to supervise and guide the relevant government departments in the incident area to recall, take off the shelves and seal up the vaccines, raw materials and related products involved, and strictly control the circulation channels to prevent the spread of hazards.
2.one.three.Medical treatment group: led by the health department, it is responsible for organizing and coordinating relevant medical institutions, dispatching medical treatment and public health experts, implementing the treatment of patients with vaccine safety incidents, assisting relevant departments in sanitary treatment of the incident site, organizing the allocation and guarantee of provincial emergency medical reserves, and strengthening the management of vaccine use.
2.one.three.5. Emergency Support Group: led by the departments of grain and reserve, drug supervision and administration, finance, etc., it provides emergency rescue funds and assists in the requisition of vehicles, and is responsible for coordinating and dispatching emergency rescue facilities, properly resettling the affected people, maintaining the safety and rescue order at the emergency site, strengthening public security management, maintaining social stability, and ensuring the customs clearance of entry-exit emergency equipment and materials.
2.one.three.6. Publicity and reporting group: led by the propaganda department, with the cooperation of the departments of drug supervision and management, health and communication management, including the Foreign Affairs Office, the Taiwan Affairs Office, the Hong Kong and Macao Affairs Office and other departments when involving foreign affairs, Hong Kong, Macao and Taiwan. According to the information released by the on-site command organization, organize and coordinate the news media to do a good job in news reports on emergency response to vaccine safety incidents, and actively guide public opinion.
2.2 expert group
After the larger and above vaccine safety incidents, the Provincial Food and Drug Administration took the lead in selecting relevant experts from the provincial drug expert database to set up a provincial vaccine safety emergency expert group. Improve the relevant consultation mechanism to provide technical support for the emergency work of vaccine safety incidents at large and above levels.
2.3 technical support institutions
The units directly under the Provincial Food and Drug Administration or the entrusted units shall carry out emergency sampling, inspection and testing, data and information collection and analysis according to their duties. According to the authorization or entrustment, organize the evaluation and judgment of the nature, development trend and harmful impact of the incident. The units directly under the Provincial Food and Drug Administration shall designate relevant departments to be responsible for the emergency work of vaccine safety incidents.
3 Monitoring, early warning, reporting and evaluation
three.1 monitoring
Vaccine management departments shall, in accordance with their duties, carry out routine vaccine safety supervision and inspection, sampling inspection, risk monitoring, public opinion monitoring and other work, collect, analyze and judge information on potential risks that may lead to vaccine safety incidents, notify relevant departments and regions when necessary, and relevant regulatory authorities shall take effective control measures according to law.
Vaccine marketing license holders and vaccine entrusted storage and distribution enterprises shall implement the main responsibility of vaccine safety according to law, establish and improve risk monitoring and prevention measures, conduct self-examination on a regular basis, and carefully investigate and eliminate hidden dangers of vaccine safety risks. Disease prevention and control institutions and vaccination units strengthen the standardized management of vaccination, strengthen the professional training of vaccination personnel, and improve the level of vaccination services. When there are hidden dangers of vaccine safety incidents, it is necessary to immediately report to the local drug regulatory authorities and related business regulatory authorities.
three.one.1 Report the responsible subject
(1) Disease prevention and control institutions and vaccination units in case of vaccine safety emergencies;
(2)AEFI (suspected abnormal reaction to vaccination) monitoring institution;
(3) drug supervision and administration departments at all levels;
(4) Other units and individuals.
three.one.2 vaccine safety event information content
(1) information about suspected abnormal reaction to vaccination and suspected vaccine-related information after investigation;
(2) information on vaccine safety incidents found in daily supervision and inspection and risk monitoring;
(3) instructions given by superior leaders on vaccine safety incidents;
(4) information on vaccine safety incidents assigned or supervised by higher authorities;
(5) Information on vaccine safety incidents notified by relevant departments at home and abroad;
(6) information on vaccine safety incidents reflected by complaints and reports from the masses;
(7) Public opinion information that belongs to or may form a vaccine safety incident;
(8) Vaccine safety incident information obtained from other channels.
three.2 Early warning
Emergency departments of drug supervision, health and other vaccine safety incidents at all levels should play the role of expert groups and technical support institutions, analyze the risk factors related to vaccine safety incidents, and put forward analysis and evaluation opinions on risk factors, risk levels, scope of influence, urgency and possible hazards that may endanger public health. If a vaccine safety incident may occur or relevant information is received, the vaccine risk warning or guidance information shall be issued through the headquarters office, and the emergency department at the next lower level and the unit where the incident may occur shall be notified to take targeted preventive measures. At the same time, according to the characteristics, harm degree and development trend of possible incidents, the emergency response team and relevant units are instructed to enter the standby state, and a working group is sent to conduct on-site supervision as appropriate to check the implementation of preventive response measures.
three.3 report
three.three.1 reporting procedures and time limits
(1) Initial report. After the suspected vaccine safety incident occurs, the drug supervision and administration departments at all levels and listed companies should grasp the situation as soon as possible and report the emergency information in time. Especially serious and major vaccine safety incidents should be reported by telephone within 30 minutes and written within 1 hour after learning the relevant information; Large-scale vaccine safety emergencies should be reported in writing to the Provincial Food and Drug Administration within 6 hours after learning the relevant information; Other emergencies that may involve vaccine safety shall be reported in writing within 24 hours after receiving relevant information.
The Provincial Food and Drug Administration shall track and coordinate the information of the general vaccine safety incidents received, and report the preliminary situation to the people’s government of National Medical Products Administration and the province in time and report the details in writing.
(2) Continued reporting. After the initial report, the drug supervision and administration departments at the local level and listed on the market should strengthen the tracking and verification of relevant information, organize analysis and judgment, and timely report relevant information according to the development of events and emergency response. Especially important and major vaccine safety incidents should be reported at least once a day. If significant progress is made in the disposal process or key information can be determined, the progress should be reported within 24 hours.
(3) Final report. It should be reported within 7 working days after the end of emergency handling.
(4) nuclear report. Upon receipt of the information required for verification, the drug supervision and administration department at the place where the incident occurred shall promptly verify it and feed back the relevant information according to the time limit. In principle, the information required by National Medical Products Administration and the provincial party committee and government should be reported by telephone within 20 minutes; If written information is explicitly requested, it shall be reported within 50 minutes. For the information required by the Provincial Food and Drug Administration, it is necessary to give telephone feedback within 30 minutes; If it is explicitly required to submit written information, feedback shall be given within 1 hour.
three.three.2 Report content and method
Report the information of vaccine safety incidents to National Medical Products Administration, and submit it in the form of "Report Form of Major Information on Vaccine Safety" (Annexes 2 and 3), which is divided into initial report and continuation report. After the initial report, according to the development of the incident and emergency response, timely report. The initial report includes the time, place, current situation, degree of harm, pre-treatment and development trend of the incident. The contents of the continuation report include the progress of the incident, follow-up measures, investigation details, cause analysis, etc.
Report the vaccine safety incident information to the provincial people’s government, and submit it in the form of "Information Report on Vaccine Safety Emergencies" (Annex 4).
Event information reports generally take the form of fax. When submitting information, you can first report the main situation of the incident by telephone, SMS, etc., and then submit relevant written materials in time. When reporting, you should ensure that the information is correct. The report of confidential information shall be handled in accordance with the relevant provisions on confidentiality.
three.4 event evaluation
After the occurrence of a vaccine safety incident, the drug supervision and administration department shall organize an incident assessment according to law, preliminarily determine whether it is a vaccine safety incident, and verify the level of the incident, and report the relevant information to the headquarters at the same level, and the headquarters shall put forward suggestions to the people’s government at the same level to start emergency response. The evaluation contents mainly include:
(1) the possible health hazards and the scope involved, whether the consequences and severity of health hazards have been caused;
(2) the scope and severity of the incident;
(3) The development and spread trend of the incident.
4 hierarchical response
four.1 class I response
In case of particularly serious vaccine safety incidents, according to the deployment requirements of the State Council and the national joint inter-ministerial conference on vaccine management, under the unified command of National Medical Products Administration, the provincial food and drug administration should promptly ask the provincial people’s government to set up the provincial emergency headquarters, and the provincial emergency headquarters will start the Class I response and do a good job in emergency response.
four.one.1. After receiving the notification or notification from National Medical Products Administration, emergency headquarters immediately notified all levels of drug supervision and administration departments and health departments, disease prevention and control institutions, and relevant vaccine business and use units within their respective administrative areas to immediately stop purchasing, distributing and using the vaccines involved; Organize the local storage of vaccines involved, check the procurement and distribution channels, track the flow direction and make summary statistics; Make statistics on the related vaccine adverse events within the administrative area.
four.one.2. If the incident occurred within the administrative region of this province, the Provincial Food and Drug Administration shall coordinate with relevant units to implement the work according to the deployment requirements of National Medical Products Administration; Coordinate the health department to carry out medical treatment for patients; Take emergency control measures for vaccines involved in this administrative area according to law.
four.2 Ⅱ response
In case of major vaccine safety incidents, under the unified command of National Medical Products Administration, the Provincial Food and Drug Administration shall promptly ask the provincial people’s government to set up a provincial emergency headquarters, and the provincial emergency headquarters will start the level II response and immediately carry out the disposal work according to the procedures.
four.2.Emergency headquarters, the first province, immediately notified all levels of drug supervision and administration departments and health departments, provincial centralized drug procurement platforms, disease prevention and control institutions, related vaccine distribution enterprises and inoculation units within their respective administrative areas to immediately stop purchasing, distributing and using vaccines; Organize the local storage of vaccines involved, check the procurement and distribution channels of vaccines, track the flow direction and make summary statistics; Make statistics on the related vaccine adverse events within the administrative area.
four.2.2. If the incident occurred within the administrative region of this province, the Provincial Food and Drug Administration shall coordinate with relevant units to implement the work according to the deployment and requirements of National Medical Products Administration; Coordinate the health department to carry out medical treatment for patients; Take emergency control measures for vaccines involved in this administrative area according to law.
four.3 Ⅲ response
In the event of a major vaccine safety incident, the Provincial Food and Drug Administration should promptly ask the provincial people’s government to set up a provincial emergency headquarters, and the provincial emergency headquarters will start a level III response.
four.three.1. The office of emergency headquarters Province will report the relevant information to the people’s government of National Medical Products Administration Province in a timely manner, and continue to report the relevant information in a timely manner.
four.three.Each member unit and on-site command organization in emergency headquarters Province will report the work information to the office of emergency headquarters Province every day, and major emergencies should be submitted immediately. The Office of emergency headquarters Province compiles and distributes the Information Report on Vaccine Safety Emergencies daily, which is submitted to National Medical Products Administration, the provincial party committee and the provincial government, and distributed to the member units of emergency headquarters Province.
four.three.Emergency headquarters, 3 provinces, held regular meetings to report the progress of the work and study and deploy major issues in emergency response.
four.three.According to the patient’s treatment, the medical treatment team coordinated the provincial health and appointed a provincial medical team to rush to the incident to guide the medical treatment.
four.three.5 according to the situation of the incident, send working groups and expert groups to the incident to guide the disposal; The person in charge of emergency headquarters Province rushed to the scene of the incident as appropriate.
four.three.Where the incident occurred in our province and the holder of the vaccine marketing license was in other provinces, the Provincial Food and Drug Administration timely notified the provincial drug supervision and administration department where the holder of the vaccine marketing license was located and put forward the emergency response requirements.
four.three.7. The Hazard Control Group verifies the varieties and production batch numbers of the vaccines involved, and guides the disease prevention and control institutions, vaccine distribution enterprises and inoculation units to take emergency control measures such as on-site storage, checking vaccine procurement and distribution channels, tracking the flow direction and summarizing statistics according to law; Organize sampling inspection of relevant vaccines.
four.three.According to the progress of the investigation, the incident investigation team organized an expert group meeting in a timely manner to judge the nature and causes of the incident and make a conclusion.
four.three.9. The news propaganda group will release warning information to the society in time, and set up and publicize the consultation telephone number; Make a news report plan and release the event information in a timely, objective and accurate manner; Pay close attention to social and online public opinion and do a good job in guiding public opinion.
four.three.Pay close attention to social trends, do a good job in appeasing relatives of vaccinators, receiving letters and visits, etc., to ensure social stability.
four.three.11 The drug supervision and administration departments at the prefecture level and listed on the market shall take the following measures:
After receiving the notice or notification from the Provincial Food and Drug Administration, the drug supervision and administration departments at all levels, disease prevention and control institutions, vaccine distribution enterprises and inoculation units within their respective administrative areas will be notified at the first time; Coordinate relevant departments to conduct on-site verification of the incident, including the time and place of occurrence, the name and production batch number of the vaccine, the performance of adverse events, the number of cases involved in the incident and the number of deaths; Coordinate the health department to carry out medical treatment for patients; Organize on-site investigation on the production, distribution and use of vaccines; Take emergency control measures for the vaccines involved in this administrative area according to law, organize the local storage of the vaccines involved, check the procurement and distribution channels of vaccines, track the flow and make summary statistics; Relevant information shall be reported to the Provincial Food and Drug Administration in a timely manner.
The drug supervision and administration department where the vaccine marketing license holder is located shall assist in organizing on-site investigation on the production and circulation of related drugs; Supervise enterprises to recall vaccines involved; In accordance with the requirements of the Provincial Food and Drug Administration, organize sampling and inspection of vaccine samples of vaccine marketing license holders. Relevant information shall be reported to the Provincial Food and Drug Administration in a timely manner.
four.Level iv response
In the event of a general vaccine safety incident, the municipal drug supervision and administration department at the place where the incident occurred shall promptly ask the Municipal People’s Government to set up a municipal emergency headquarters, start a level IV response, and report the disposal of the incident step by step. The Provincial Food and Drug Administration will closely follow the incident and give guidance and support to the disposal.
four.four.1 emergency headquarters will report the relevant information to the provincial people’s government and the provincial food and drug administration in a timely manner, and continue to report the relevant information in a timely manner.
four.four.2 emergency headquarters member units and working groups shall report their work information to the comprehensive coordination group every day, and major emergencies shall be submitted immediately. The comprehensive coordination group compiles and distributes the Information Report on Vaccine Safety Emergencies daily, which is submitted to the provincial party committee, the provincial government and the provincial food and drug administration, and distributed to all members of the municipal headquarters.
four.four.Emergency headquarters held regular meetings to report the progress of the work and study and deploy major issues in emergency response.
four.four.According to the patient’s treatment, the medical treatment team coordinated to send medical experts to the incident site to guide the medical treatment.
four.four.5 according to the situation of the incident, send an incident investigation team and an expert group to the incident site to guide the handling; The person in charge of emergency headquarters rushed to the scene of the incident as appropriate.
four.four.Where the incident occurred in our province and the holder of the vaccine marketing license was in other provinces, the Provincial Food and Drug Administration timely notified the provincial drug supervision and administration department where the holder of the vaccine marketing license was located and put forward the emergency response requirements.
four.four.7. The Hazard Control Group verifies the variety and batch number of the vaccines involved, and guides relevant departments, medical institutions and production and business units to take emergency control measures such as sealing, tracing the source and tracing the flow direction according to law; Organize sampling inspection of relevant vaccines.
four.four.According to the progress of the investigation, the incident investigation team organized an expert group meeting in a timely manner to judge the nature and causes of the incident and make a conclusion.
four.four.9. The news propaganda group will release warning information to the society in time, and set up and publicize the consultation telephone number; Make a news report plan and release the event information in a timely, objective and accurate manner; Pay close attention to social and online public opinion and do a good job in guiding public opinion.
four.four.Pay close attention to social trends, do a good job in appeasing relatives of vaccinators, receiving letters and visits, etc., to ensure social stability.
four.5 end of response
After the cause of the incident is clearly investigated, the potential safety hazard or related hazardous factors are eliminated or the disposal is finished, the headquarters that announced the start of the emergency response will announce the end of the emergency response and lift the emergency state. Emergency headquarters, the superior, should hand over all the work with emergency headquarters, the subordinate, and be responsible for guiding emergency headquarters, the subordinate, to do the follow-up work.
four.6 information release
four.six.1 release principle
Adhere to the principles of seeking truth from facts, being timely and accurate, and being scientific and fair.
four.six.2 release requirements
The level I response was released by the the State Council and the National Inter-ministerial Joint Conference on Vaccine Management.
Level II response is related information released by National Medical Products Administration.
For level III response and level IV response, the headquarters that announced the start of emergency response will release relevant information according to the requirements of the plan.
Without authorization, other units and individuals have no right to release information on vaccine safety incidents.
four.six.3 release form
Information release includes authorized release, organizing reports, accepting interviews with reporters, holding press conferences, and reporting on key news websites or government websites.
5 Risk communication
five.1 Communication purpose
Respond to social concerns, strengthen positive guidance, avoid rumors, and create a good public opinion environment.
five.2 communication principle
Follow the basic principles of active preparation, timely initiative, true information, consistent caliber and concern.
five.3 communication methods
Level I response According to the requirements of the the State Council and the National Inter-Ministerial Joint Conference on Vaccine Management, National Medical Products Administration should communicate the corresponding risks; For level II response, National Medical Products Administration will designate a special person to communicate the risks to the outside world; The level III and IV responses shall be communicated with the outside according to the pre-plan requirements of the provincial people’s government and the people’s governments at the local level. Communication methods include press conference, TV interview and written interview.
6 post-disposal
six.1 event assessment
Headquarters offices at all levels shall make an objective, true and comprehensive investigation and evaluation of vaccine safety incidents in a timely manner according to regulations, including the basic information such as the cause, nature, impact, consequences and responsibilities of the incident, the conclusion of the incident and the risk assessment.
six.2 Work summary
After the emergency treatment of vaccine safety incidents, the headquarters at all levels should summarize the incident, main measures taken, disposal work, cause analysis and main practices in time, and put forward improvement measures.
six.3 aftermath and recovery
The headquarters at all levels shall, according to the harm degree and losses caused by the vaccine safety incident, put forward opinions on the aftermath and report them to the people’s government at the same level for approval. The people’s government of the place where the incident occurred is responsible for organizing the aftermath, including the disposal of the injured and affected personnel, condolences, medical treatment, compensation (compensation), requisition of materials and compensation for rescue expenses, etc., to eliminate the impact as soon as possible, restore the order of production and operation, and ensure social stability.
7 safeguard measures
seven.1 information security
Information monitoring institutions of vaccine safety incidents at all levels should establish and improve the information collection and reporting system, pay close attention to the problems of signs and tendencies, and ensure that the information is submitted accurately and timely when the incident occurs. Found that the release of false information, spreading rumors, etc., should be promptly notified to the relevant departments.
seven.2 personnel and technical support
Drug supervision and management, health and health departments at all levels should strengthen the construction of emergency response capacity and improve the rapid response capacity and technical level. Improve the team of experts, and provide talent guarantee for incident investigation, risk assessment and other related technical work.
seven.3 material and financial security
The reserve and transfer of facilities, equipment and materials required for emergency treatment of vaccine safety incidents should be guaranteed. The funds required for emergency handling of vaccine safety incidents, product sampling and inspection shall be included in the annual financial budget to ensure emergency funds.
seven.4 emergency drills
The Provincial Food and Drug Administration and the Health and Health Commission take the lead in regularly organizing emergency drills for major vaccine safety incidents and constantly improving emergency plans. Drug supervision and administration, health and health departments at all levels should organize relevant personnel to carry out vaccine safety emergency management training in a planned way every year.
seven.5 emergency publicity
Through radio, television, internet and other forms, the laws, regulations and related common sense of vaccine safety emergency management are widely publicized to enhance the public’s sense of social responsibility and self-protection ability.
8 Plan implementation
(1) This plan is formulated by the provincial people’s government, interpreted by the Provincial Food and Drug Administration, and revised in time according to relevant laws, regulations and policies, as well as problems found in the implementation process.
(2) This plan shall come into force as of the date of promulgation, with a trial period of 2 years.
Attachment: 1.Classification standard and response level of vaccine safety events
2.Report Form of Important Information on Vaccine Safety (Preliminary Report)
three.Report Form of Important Information on Vaccine Safety (Continued)
four.Information report on vaccine safety emergencies
five.Emergency handling process of major vaccine safety incidents
six.Emergency handling process of general vaccine safety incidents
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