Module 6

Rotavirus vaccine AEFI monitoring

Training for rotavirus vaccine introduction

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20232 |

Learning objectivesLearning 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’

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20233 |

What is an AEFI ?11

What is intussusception (IS)?

22

Key issues

How to report an AEFI ?33

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20234 |

What is an AEFI? 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

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20235 |

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

What about Intussusception (IS)? (1/2)What about Intussusception (IS)? (1/2)

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20236 |

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!

Risk of IS against risk of rotavirus infection

Risk of IS against risk of rotavirus infection

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20237 |

Report the identified AEFI through existing AEFI reporting systems established by national immunization programs

National authorities

Community, district, and regional levels

Suspected signs or

symptoms

How to report a AEFI? (1/2) How to report a AEFI? (1/2)

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20238 |

How to report an AEFI? (2/2) 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

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 20239 |

Key messagesKey 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

Rotavirus vaccine AEFI monitoring, Module 6 I 10 April 202310 |

End of moduleEnd of module

Thank youfor your attention !