Vaccine safety monitoring is a critical aspect of pharmacovigilance, particularly given the widespread use of vaccines to prevent infectious diseases. Robust surveillance systems are essential to detect and assess any potential adverse events following vaccination. Here are some key pharmacovigilance strategies employed for vaccine safety monitoring: Passive Surveillance Systems: Passive surveillance systems rely on healthcare providers, patients, and other stakeholders to voluntarily report adverse events following vaccination. These reports are collected in databases such as the Vaccine Adverse Event Reporting System (VAERS) in the United States or the Vaccine Adverse Event Surveillance System (VAESS) in other countries. While these systems are valuable for signal detection, they may suffer from underreporting and reporting bias. Active Surveillance Systems: Active surveillance involves proactively monitoring a defined population for adverse events following vaccination. This can be done through electronic health records (EHRs), claims databases, and other health data sources. The Vaccine Safety Datalink (VSD) in the United States is an example of an active surveillance system that uses large databases to continuously monitor vaccine safety. Enhanced Surveillance and Cohort Studies: Enhanced surveillance involves more intensive monitoring of a specific population or group of interest. Cohort studies are prospective studies that follow a group of vaccinated individuals over time to assess vaccine safety. These studies provide more detailed and controlled data compared to passive or active surveillance. Comparative Effectiveness Research: Comparative effectiveness research compares the safety of different vaccines or vaccination schedules. By analyzing large datasets, researchers can evaluate the relative risks and benefits of vaccines and identify any safety concerns. Signal Detection and Analysis: Data mining and statistical techniques are used to identify potential safety signals from adverse event reports. Signals are further investigated through in-depth analysis to determine if there is a causal relationship between the vaccine and the adverse event. Causality Assessment: Similar to general pharmacovigilance, causality assessment methods (such as the Naranjo Algorithm, WHO-UMC System, and Bayesian methods) are used to evaluate the likelihood of a causal relationship between a vaccine and an adverse event. Risk Communication and Public Awareness: Effective communication strategies are crucial to ensure that healthcare providers and the public are informed about vaccine safety. This involves providing clear and accurate information about potential risks and benefits.

1. Welcome
VACCINE SAFETY MONITORING:
PHARMACOVIGILANCE STRATERGIES
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Name : Fathma Mohammed
Qualification: B.Pharmacy
Student ID :120/0723

2. INDEX
• INTRODUCTION
• VACCINE SAFETY PROGRAM
• METHODS OF MONITORING VACCINE SAFETY
• STEPS OF VACCINE PHARMACOVIGILANCE
• ADVERSE EVENTS FOLLOWING IMMUNIZATION
• ASSESSMENT OF CAUSALITY
• REPORTING OF AEFI
• THE IMMUNIZATION PROVIDERS ROLE
• REFERENCE
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3. INTRODUCTION:
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DEFINATIONS
 VACCINE
 A preparation that is used to stimulate the body’s immune
response against diseases.
 Vaccines are usually administered through needle
injections, but some can be administered by mouth or
sprayed into the nose.
 VACCINE PHARMACOVIGILANCE:
According to the CIOMS/WHO Working Group on Vaccine
Pharmacovigilance, Vaccine pharmacovigilance is defined as
“the science and activities relating to the” Detection,
Assessment, Understanding and Communication of adverse
events following immunization and other vaccine- or
immunization-related issues, and to the prevention of
untoward effects of the vaccine or immunization

4. VACCINE SAFETY SYSTEM
• As new vaccine products become available to prevent new
diseases in various parts of the world, the demand for effective
pharmacovigilance systems in low- and middle-income
countries (LMIC) is increasing.
• To help establish such systems in all countries, WHO developed
the Global Vaccine Safety Blueprint in 2011.
• The Blueprint sets three main strategies to optimize the safety
of vaccines through effective use of pharmacovigilance
principles and methods:
a. To ensure minimal vaccine safety capacity in all
countries
b. To provide enhanced capacity for specific
circumstances
c. To establish a global support network to assist
national authorities with capacity building and crisis
management.
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GOALS
RISK SAFETY
ASSESSMENT
DETECTION
OF ADR
MANAGEMEN
T AND
TREATMENT
OF ADR
DETERMINE
THE
MECHANISM
OF ADR
PREVENTION
OF ADR
COMMUNICA
TE ADRS

5. METHODS OF MONITORING VACCINE
SAFETY
PRE LICENSURE STUDIES
• Carried out in animal and humans
• In humans it involves 3 phases of clinical
trials
• If vaccine are safe and effective in 3
phases then the manufacture applies for
the license from FDA
POST LICENSURE STUDIES
• Identify rare reactions
• Identify risk factors for reaction
• Identify vaccine lots with increased rate of
reactions
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6. STEPS OF VACCINE PHARMACOVIGILANCE
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7. ADVERSE EVENT FOLLOWING
IMMUNIZATION(AEFI)
• The WHO defines an adverse event following immunization (AEFI) as “ untoward medical
occurrence which follows immunization and does not necessarily have a casual relationship with
the usage of the vaccine
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PRODUCT RELATED
• Extensive limb swelling following DPT Vaccination
QUALITY DEFECT RELATED
• Failure by the manufacturer to completely inactivate a lot of inactivated polio vaccine
leads to case of paralytic polio
ERROR RELATED
• Transmission of infection by contaminated multidose vial
ANXIETY RELATED
-vasovagal syncope in an adolescent during /following vaccination
COINCIDENTAL EVENTS
-A fever occurs at the time of the vaccination (temporal association ) but is in fact caused by
malaria

8. ASSESSMENT OF CAUSALITY
 Assessment of vaccine associated adverse events is not possible unless
• A vaccine specific clinical syndrome is observed
• Recurrences upon rechallenge
• Vaccine specific laboratory finding
• Epidemiologic studies are necessary to assess whether vaccinated persons are at
higher risk than unvaccinated persons if adverse event occur in absence of
vaccination.
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9. REPORTING OF AEFI :
• Serious AEFI
• Newly introduced vaccine
• AEFI caused by
immunization error
• Significant events of
unexplained cause occurring
within 30 days after a
vaccination
• Swelling, redness ,soreness
lasts more than3 days at the
site of injection
• swelling extends beyond
nearest joints
Vaccine adverse event
reporting system
• National reporting system and
jointly administered by CDC and
FDA
• Detects
i. New or rare events
ii. Increase in rates of known
events
iii. Patient risk factors
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WHAT TO BE REPORTED WHERE TO BE REPORTED

10. REPORTING SYSTEM ALL OVER THE
WORLD:
1. Monitoring system for adverse events following immunization
MSAEFI (CDC), U.S.A.
2. VAAE (CANADA)
3. IMPACT (CANADA)
4. Yellow card reporting system (U.K.)
5. Boston collaborative drug surveillance BCDSP (U.S.A.)
6. Aberdeen Dundee monitoring system (SCOTLAND)
7. Indian Council of Medical Research ICMR (INDIA)
8. UPPSALA (SWEDEN)
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11. THE IMMUNIZATION PROVIDERS ROLE
• Vaccine storage and handling
• Vaccine administration
• Timing and spacing of vaccine doses
• Observation of precautions and contraindications
• Management of vaccine side effects
• Reporting of suspected side effects
• Communication about vaccine benefits and risks
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12. CONCLUSION
• Vaccine safety monitoring system is crucial so as to prevent any SAE
related to vaccine
• Make sure that the provided vaccine is safe and effective to minimize
the AEFI related to it
• Effective pharmacovigilance systems must be established especially in
LMIC to ensure that the effects of the vaccines are been properly
monitored
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13. REFERENCE
• Ananda Amarasinghe, Steve Black, Jan Bonhoeffer, Sandra M. Deotti Carvalho, Alexander Dodoo,
Juhani Eskola, Heidi Larson, Sunheang Shin, Sten Olsson, Madhava Ram Balakrishnan, Ahmed
Bellah, Philipp Lambach, Christine Maure, David Wood, Patrick Zuber, Bartholomew Akanmori,
Pamela Bravo, María Pombo, Houda Langar, Dina Pfeifer, Stéphane Guichard, Sergey Diorditsa,
Md. Shafiqul Hossain, Yoshikuni Sato,Effective vaccine safety systems in all countries: A challenge
for more equitable access to immunization,Vaccine,Volume 31, Supplement 2,2013,Pages B108-
B114,ISSN 0264-410X,https://doi.org/10.1016/j.vaccine.2012.10.119.
• Global Vaccine Safety Blueprint 2.0 2021–2023
• Budhiraja S, Akinapelli R. Pharmacovigilance in vaccines. Indian J Pharmacol. 2010
Apr;42(2):117. doi: 10.4103/0253-7613.64488. PMID: 20711383; PMCID: PMC2907013.
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14. ThankYou!
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