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,
1. Mishandling of vaccines during transportation due to the lack of cold storage (i.e., temperature
program) leads to inactivation of vaccine potency.
2. Poor quality of vaccines
3. 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 Reaction
Depending upon the frequency of occurrence and severity, vaccine reactions are classified
into minor and severe vaccine reactions.
1) 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
2) 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
authorizatio
n 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/.