BY

Mrs. K.SHAILAJA., M. PHARM.,

LECTURER
DEPT OF PHARMACY PRACTICE,
SRM COLLEGE OF PHARMACY
` Decreases in disease risks and increased attention on
vaccine risks
` Public confidence in vaccine safety is critical
` Low tolerance for vaccine risks
◦ Higher standard of safety is expected
◦ Vaccinees generally healthy (vs. ill for drugs)
◦ Lower risk tolerance = need to search for rare reactions
` Vaccinations universally recommended or
mandated

` Ongoing safety monitoring needed for the

development of sound policies and
recommendations
` Laboratory

` Animals

` Humans
` Phases I, II, II trials
` Common reactions are identified
` Vaccines are tested in thousands of people before being
licensed and on the market allowed
` Poorly detected reactions:
◦ Rare
◦ Delayed onset
◦ Subpopulations
` Identify rare reactions
` Monitor increases in known reactions
` Identify risk factors for reactions
` Identify vaccine lots with increased rates of reactions
` Identify signals
` Phase IV Trials
◦ ~10,000 participants
◦ better but still limited
` Large Linked Databases
` Clinical Evaluation Network
` Jointly administered by CDC and FDA

` National reporting system

` Passive (depends on health care providers and others to

report)

` Receives ~10,000 reports per year

` Detects
◦ new or rare events
◦ increases in rates of known events
◦ patient risk factors
` Additional studies required to confirm VAERS signals
` Not all reports of adverse events are causally related to
vaccine
` Vaccine-induced

` Vaccine-potentiated

` Programmatic error

` Coincidental
` Large-linked database
` Links vaccination and health records
` Population under “active surveillance”
◦ 7 HMOs
◦ 2.5% of the U.S. population
` Powerful tool for monitoring vaccine safety
` Improve understanding of vaccine safety issues at
individual level
` Evaluate individuals who experience adverse health
events
` Gain better understanding of events
` Develop protocols for health care providers
` Established by National Childhood Vaccine Injury Act
(1986)

` “No fault” program

` Covers all routinely recommended childhood vaccines

` Vaccine Injury Table

` Immunization providers can help to ensure the safety and
efficacy of vaccines through proper:
◦ vaccine storage and administration
◦ timing and spacing of vaccine doses
◦ observation of precautions and contraindications
` Immunization providers can help to ensure the safety and
efficacy of vaccines through proper:
◦ management of vaccine side effects
◦ reporting of suspected side effects to VAERS
◦ vaccine benefit-risk communication
` A condition in a recipient which greatly increases
the chance of a serious adverse event.
` A condition in a recipient which may increase the chance
or severity of an adverse event, or

` May compromise the ability of the vaccine to produce

immunity
z Mild illness
z Mild/moderate local reaction or fever following
prior dose
z Antibiotic therapy
z Disease exposure or convalescence
z Pregnancy in the household
z Premature birth
z Breastfeeding
z Allergies to products not in vaccine
z Family history unrelated to immunosuppression
` Opportunities for questions should be provided before
each vaccination

` Vaccine Information Statements

◦ must be provided before each dose of vaccine
◦ public and private providers
◦ available in multiple languages
` Many factors contribute to the need for an active and
ongoing vaccine safety program

` Vaccines undergo extensive safety and efficacy

evaluations prior to licensure

` Post-licensure evaluation is critical

` Provider’s play an important role in helping to ensure
vaccine safety

` Effective vaccine benefit-risk communication is

important