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Module 6 Rotavirus vaccine AEFI monitoring

Training for rotavirus vaccine introduction. Module 6 Rotavirus vaccine AEFI monitoring. Learning objectives. At the end of the module, the participants will be able to: Identify adverse events following immunization (AEFIs), including intussusception (IS) Explain how to report AEFIs

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Module 6 Rotavirus vaccine AEFI monitoring

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  1. Training for rotavirus vaccine introduction Module 6 Rotavirus vaccine AEFI monitoring

  2. Learning objectives • At the end of the module, the participants will be able to: • Identify adverse events following immunization (AEFIs), including intussusception (IS) • Explain how to report AEFIs • Duration • 15’

  3. 1 What is an AEFI? 2 What is intussusception (IS)? 3 How to report an AEFI? Key issues

  4. What is an AEFI? • At the end AEFI = Adverse event following immunization • A medical incident • Takes place after an immunization • Causes concern • Is believed to be caused by immunization • AEFI can be categorized into • Vaccine reaction • Programme error • Coincidental • Injection reaction • Unknown

  5. What about Intussusception (IS)? (1/2) • In the past, the first rotavirus vaccines (RotashieldTM) caused IS, a serious but very rare bowel obstruction • With the new rotavirus vaccines, there seems to be a very small increased risk of IS in infants following rotavirus vaccination • The increased risk appears to occur mainly in the first 1- 7 days following the first dose of rotavirus vaccine

  6. Risk of IS against risk of rotavirus infection • Whether the new rotavirus vaccine affects the overall incidence of IS has not yet been established • The risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children!

  7. How to report a AEFI? (1/2) • Report the identified AEFI through existing AEFI reporting systems established by national immunization programs Community, district, and regional levels Suspected signs or symptoms National authorities

  8. How to report an AEFI? (2/2) • AEFI report should contain • Client information • Immunization event(s) description • Adverse event(s) description • Relevant medical and treatment • history • Associated event(s) • Reporter 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 effects • The risk of IS after rotavirus vaccination is much lower than the risk of severe rotavirus disease in unvaccinated children • AEFIs should be reported through the existing AEFI reporting systems/forms • Reassure the caretaker- Admit uncertainty, investigate fully, and keep the community informed

  10. End of module Thank you for your attention!

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