Evaluation of vaccine safety surveillance.pptx

Evaluation of vaccine safety surveillance

1. Evaluation of vaccine safety surveillance A Pharmacovigilance Project Report Presented By: Anurag Gupta Hygia Institute of Pharmaceutical Education & Research

2. Contents Vaccine Vaccine Pharmacovigilance Vaccine Failure Adverse Event Following Immunization Types of Vaccine related reaction Establishment of Vaccine Safety Surveillance Types of Surveillance References

3. Vaccine Vaccines are the complex biological immune-boosting preparations which contain antigens, live disease-causing microbes that are either inactivated or attenuated (killed).

4. Vaccine Pharmacovigilance The science and activities related to detection, assessment, understanding, preventing and communication.

5. Vaccine Failure When the host or vaccine recipient contracts a disease in spite of getting vaccinated, then it is referred as vaccine failure. There are two main factors responsible for vaccine failure, The first is failure to vaccinate in which vaccines lose their potency due to following reasons, Mishandling of vaccines during transportation due to the lack of cold storage (i.e., temperature program) leads to inactivation of vaccine potency. Poor quality of vaccines Improper vaccine administration or usage of vaccine beyond expiry date. Primary vaccine failure refers to inadequate production of antibodies after vaccination which does not elicit immune response to the vaccine. The second factor for vaccine failure is host related of which host genetics, age, immune power, nutritional status may be linked to primary or secondary vaccine failure (also called as waning of immunity) & it is the gradual loss of protection after initial effectiveness.

6. Adverse Event Following Immunization Any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding symptom or disease.

7. Cause-Specific Related AEFI (Vaccine reaction) Definition 1. Vaccine product related reaction An adverse event occurring due to inherent (essential properties of one or more vaccine product) 2. Vaccine quality defect related reaction Any adverse event occurring due to one or more defects due to quality . 3. Immunization error related reaction An adverse event occurring due to negligence during handling or administration of vaccine 4. Immunization anxiety related reaction An adverse event occurring due to anxiety about immunization 5. Coincidental events An adverse event occurring due to underlying health problems which is not relevant to vaccine product, immunization error or anxiety Cause-Specific Related AEFI

8. Types of Vaccine Related R eaction Depending upon the frequency of occurrence and severity, vaccine reactions are classified into minor and severe vaccine reactions. Minor Vaccine Reactions: An ideal vaccine induces uncompromising immunity by triggering immune system to react to vaccine while causing no or minor reactions that are common and may occur one or two days after immunization and may last for a couple of days Severe Reactions: Severe reactions include onset of symptoms that are very rare but sometimes can be potentially fatal. The symptoms include seizures, thrombocytopenia, Hypotonic Hyporesponsive Episodes (HHE), prolonged crying and anaphylactic shock. Though severe reactions can result in hospitalization, they do not leave any long-term effect on the body. However, these conditions should not be left untreated because anaphylaxis can prove to be fatal

9. Establishment of Vaccine Safety Surveillance Vaccine Safety Surveillance is conducted by National Regulatory Authority (NRA) and National Immunization Programme (NIP). Apart from NRA and NIP, vaccine manufacturers and National Control Laboratories can also be the part of Vaccine Safety Surveillance system in countries which produce their own vaccines

10. Functions of NRA relevant to source of vaccine Source of vaccine Functions of NRA Marketing authorization and licensing Post-marketing surveillance including vaccine safety surveillance Lot release Lab access Regular inspection Clinical evaluation Vaccine procured from UN agencies Mandatory Mandatory Non-Mandatory Non-Mandatory Non-Mandatory Non-Mandatory Vaccine procured from NRA Mandatory Mandatory Mandatory Mandatory Non-Mandatory Non-Mandatory Produced Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory

11. Types of Surveillance Targeted clinical investigations Active Surveillance Passive Surveillance Stimulated reporting Comparative Observational Studies

12. References S.K. Gupta. Textbook of Pharmacovigilance. 2nd Edition. Jaypee Brothers Medical Publishers. 2019. Elizabeth B. Andrews, Nicholas Moore. Mann’s Pharmacovigilance. 3rd Edition. Wiley Blackwell. 2014. Borton Cobert . Cobert’s Manual of Drug Safety and Pharmacovigilance. 2nd Edition. Jones and Bartlett Learning Kalaiselvan V, Mishra P, Singh GN. Helpline facility to assist reporting of adverse drug reactions in India. WHO South East Asia J Public Health. 2014;3:194. Kalaiselvan V, Prasad T, Bisht A, Singh S, Singh GN. Adverse drug reactions reporting culture in pharmacovigilance programme of India. Indian J Med Res. 2014;140:563–4. [PMC free article] [PubMed]. CIOMS Guide to active vaccine safety surveillance: report of CIOMS Working Group on Vaccine Safety. Geneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2017. Kim J.H., Marks F., Clemens J.D. Looking beyond COVID-19 vaccine phase 3 trials. Nat Med. 2021;27:205–211. doi : 10.1038/s41591-021-01230-y. [PubMed] [ CrossRef ] [Google Scholar] https://www.who.int/initiatives/act-accelerator/covax. https://www.towerxchange.com/the-first-covid-19-vaccines-are-coming-how-canyou-help-overcome-the-cold-storage-challenge/.