QuestionsQuestions (DOH ADMINISTRATIVE ORDER NO. 2010-0017)
It provides comprehensive guidelines to guide stakeholders on the early detection, proper investigation, and quick response to adverse events following immunization (AEFIs), strengthening AEFI surveillance and management at all levels.
Health professionals from public and private sectors providing vaccination nationwide; DOH offices and attached agencies; epidemiology and surveillance units; private and government health facilities; LGUs; and the community involved in AEFI surveillance and management.
No. It applies to all vaccines administered under the Expanded Program on Immunization (EPI) program and other vaccines given by DOH.
A medical incident occurring after immunization, causing concern, and believed to be caused by immunization.
Serious AEFIs are life-threatening events and those resulting in hospitalization (or prolonged hospitalization), disability (or potential for disability), or death. Minor AEFIs are those not included/categorized as serious AEFIs.
Serious AEFIs, deaths, and unusual events must be reported to the National Epidemiology Center (NEC) within 24 hours, through the fastest means of communication.
Disease Surveillance Coordinators (DSCs) perform preliminary investigation in all private and public health facilities using the AEFI case investigation form as soon as possible within 48 hours. Assessment should be completed within 48 hours after each investigation at their level.
The Immunization Safety Board (ISB) conducts the final causality assessment of Serious AEFIs.
A cluster is two or more cases of the same or similar event related in time, geography, and/or vaccine administered. Clustering of minor AEFIs must be reported to the ISB, and serious AEFIs or clusters must be thoroughly investigated by the AEFI team at the next higher level.
To validate the existence of the event and to establish the causality of the reported event.
The FDA must issue, within 24 hours after due process, an order to temporarily withdraw the implicated vaccine lot/batch from the market pending ISB final recommendations. Only the Secretary of Health can stop any vaccination activities.
To develop and implement a risk communication plan directed to the affected family and the general public.
The local health office immediately implements corrective actions based on investigation findings or recommendations of the regional AEFI committee or ISB. The CHD and PHO provide technical and logistical assistance to the LGUs.
The LGU must ensure immediate assistance (e.g., hospitalization, transport to medical facility). For serious AEFIs, the LGU collaborates with the CHD to discuss appropriate assistance; and if post mortem examination is required, DOH assistance is provided.
Government health facilities, including DOH-retained and other government hospitals, shall not charge any fee to patients with AEFI.
Health professionals shall not be held liable for any AEFI as long as DOH standard operating procedures on immunization safety practices are complied with.
National level: the Secretary of Health (or duly designated official). Local level: the LCE (or duly designated official). Media coverage must be coursed through OSEC-MRU at national level and HEPO-PIO at regional level, which refer concerns to appropriate offices.