Vaccine_Safety_Surveillance_With_Placeholders.pptx

Vaccine safety surveillance

1. Vaccine Safety Surveillance Presented By: Daiwik Virdi B. Pharma 8 th Semester

2. Introduction to Vaccine Safety Vaccines reduce disease burden significantly. Safety monitoring maintains trust and public health. WHO and national bodies ensure compliance.

3. Vaccine Pharmacovigilance Definition- According to the CIOMS/WHO working group on vaccine
pharmacovigilance, Vaccine pharmacovigilance is defined as “the science and activities
relating to the”
o Detection,
o Assessment,
o Understanding and
o Communication
of adverse events following immunization and other vaccine or
immunization-related issues, and
to the prevention of untoward effect of the vaccine or immunization.

4. Vaccine Pharmacovigilance Monitoring and prevention of vaccine-related adverse effects. Passive: Public/professional reports. Active: Research-driven data.

5. Objectives of Vaccine Pharmacovigilance Identify adverse events. Monitor severity and frequency. Assess risk-benefit. Reinforce public trust.

6. Stakeholders in Vaccine Safety WHO, regulatory bodies, healthcare professionals, and manufacturers all contribute to safe vaccine delivery.

7. VACCINE PROVIDED BY GOVT OF INDIA Govt. Of India is providing vaccination to prevent 7-
vaccine preventable disease (VPDS) namely, Diphtheria,
Pertussis,
Tetanus,
Polio,
Measles,
Hepatitis B,
BCG
OJE vaccination, Hib (given as pentavalent containing Hib+DPT+Hep B

8. Monitoring Vaccination Failure Surveillance, antibody testing, reporting tools ensure failures are caught early.

9. Adverse Events Following Immunization (AEFI) AEFI: Any medical issue post-vaccine. Minor: mild pain, fever. Severe/serious: hospitalization, life-threatening.

10. Classification of AEFI Product-related, quality defects, errors, anxiety-induced, coincidental.

11. Classification of AEFI Vaccine product-related reaction – An AEFI that is caused or precipitated
by a vaccine
due to one or more of the inherent properties of the vaccine product.
Extensive limb
e.g. Swelling following DTP vaccination. Vaccine quality defect-related reaction – An AEFI that is caused or
precipitated by a
vaccine that is due to one or more quality defects of the vaccine product
inducing its
administration device as provide by the manufacturer.
Ex. Failure by the manufacturer to completely inactivate a lot of inactivated
polio vaccine leads
to cases of paralytic polio.

12. Classification of AEFI Immunization error-related reaction – An AEFI that is caused by inappropriate
vaccine handling, prescribing or administration.
Ex. Transmission of infection by contaminated multidose vial.
Immunization anxiety-related reaction – An AEFI from anxiety about the
immunization.
E.g. Vasovagal syncope in an adolescent following vaccination. Coincidental event - An AEFI that is caused by something other than the
vaccine
product, immunization error or immunization anxiety.
E.g. A fever after vaccination (temporal association) and malarial parasite isolated
from blood

13. AEFI Surveillance Systems Passive: Voluntary reports. Active: Structured studies. Critical for quick response.

14. Importance of AEFI Monitoring Ensures safety, improves programs, builds trust, enables early interventions.

15. Conclusion Continuous monitoring supports safe immunization. Stakeholder collaboration is essential for success.

16. Thank You!!!