1 Module 6 Rotavirus vaccine AEFI monitoring Training for rotavirus vaccine introductionModule 6Rotavirus vaccine AEFI monitoring
2 Learning objectivesAt the end of the module, the participants will be able to:Identify adverse events following immunization (AEFIs), including intussusception (IS)Explain how to report AEFIsDuration15’
3 Key issues 1 2 3 What is an AEFI? What is intussusception (IS)? How to report an AEFI?3To the facilitator:Explain to the participants the key issues raised in this module.It is important to monitor and report AEFIs so that the community continues to have confidence in the immunization program.We will provide you with answers to the following questions:What are the AEFIs of rotavirus vaccine?What is Intussusception (IS)?How to report an AEFI?
4 What is an AEFI?At the end AEFI = Adverse event following immunizationA medical incidentTakes place after an immunizationCauses concernIs believed to be caused by immunizationAEFI can be categorized intoVaccine reactionProgramme errorCoincidentalInjection reactionUnknownTo the facilitator:Explain to the participants the adverse event following immunization of rotavirus vaccine.An adverse event following immunization (AEFI) is a medical incident that takes place after an immunization, causes concern, and is believed to be caused by the immunization. The safety profile of the rotavirus vaccines currently available is good. Most infants who get the rotavirus vaccine do not experience any side effects.Intussusception has been associated with Rotavirus vaccine and can result in severe illness or death.
5 What about Intussusception (IS)? (1/2) In the past, the first rotavirus vaccines (RotashieldTM) caused IS, a serious but very rare bowel obstructionWith the new rotavirus vaccines, there seems to be a very small increased risk of IS in infants following rotavirus vaccinationThe increased risk appears to occur mainly in the first days following the first dose of rotavirus vaccineTo the facilitator:Explain to the participants what intussusception (IS) is, its symptoms, and link with rotavirus vaccine.IS is a rare type of bowel obstruction that occurs when one portion of the bowel slides into an immediately adjacent segment (also known as telescoping or prolapse).Symptoms of IS include stomach pain with severe crying (which may be brief); several episodes of vomiting; blood in the stool; weakness, or irritability.With the old Rotavirus vaccine called the RotashieldTM vaccine, studies suggested that the Rotavirus vaccine may be associated with a slight increased risk of IS in infants after they receive the vaccine, during the first week, especially.5
6 Risk of IS against risk of rotavirus infection Whether the new rotavirus vaccine affects the overall incidence of IS has not yet been establishedThe risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children!To the facilitator:Explain to the participants what intussusception (IS) is, its symptoms, and link to rotavirus vaccine.Whether the new rotavirus affects the overall incidence of IS has not yet been established.The rotavirus vaccine offers tremendous benefits by protecting infants and children from rotavirus disease. Rotavirus is the most common cause of severe diarrhea among infants and young children. According to the U.S. Centers for Disease Control and Prevention, the risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children. Hence, rotavirus vaccine is strongly recommended to prevent rotavirus disease in infants and young children.
7 How to report a AEFI? (1/2)Report the identified AEFI through existing AEFI reporting systems established by national immunization programsSuspected signs or symptomsCommunity, district, and regional levelsNationalauthoritiesTo the facilitator:Explain to the participants what should be done for adverse events following immunization (AEFIs).Similar to all other vaccines, rotavirus vaccine needs to be monitored for safety and adverse events following immunization.Health workers should ask parents to immediately report any reaction that may be related to the vaccine. Report the AEFI through the existing AEFI reporting systems established by national immunization programs. Health workers should report AEFI to the upper level of the health system. The National Authorities will then decide if further investigation is required.7
8 How to report an AEFI? (2/2) AEFI report should containClient informationImmunization event(s) descriptionAdverse event(s) descriptionRelevant medical and treatmenthistoryAssociated event(s)Reporter detailsTo the facilitator:Explain to the participants what information should be included in an AEFI report.An AEFI report should contain:Client – unique identifier, date of birth and genderImmunization event(s) – province where given, date, all vaccines given including name, manufacturer, lot number, administration site and route, as well as the number in series of vaccine doses if relevantAdverse event(s) – description, including time of first onset following immunization, duration, health care utilization, treatment and outcomeRelevant medical and treatment history – underlying disease, known allergies, prior AEFI, concomitant medicationAssociated event(s) – acute illness, injury, exposure to environmental toxinsReporter details
9 Key messages The current safety profile of rotavirus vaccines is good Many infants who get the rotavirus vaccine do not experience any side effectsThe risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated childrenAEFIs should be reported through the existing AEFI reporting systems/formsReassure the caretaker- Admit uncertainty, investigate fully, and keep the community informedTo the facilitator:Explain to the participants that this is the main information to keep in mind.
10 End of module for your attention! Thank you To the facilitator: This is the end of the module.You have been introduced to “Rotavirus vaccine AEFI monitoring” module. The following module is titled “Rotavirus vaccine communication with caretakers”.Thank you for your attention!