# Presentation: 706516

## Vaccine Safety

**Epidemiology and Prevention of Vaccine-Preventable Diseases**
**National Immunization Program**
**Centers for Disease Control and Prevention**

**Revised January 2006**

## Importance of Vaccine Safety

**Decreases in disease risks and increased attention on vaccine risks**
**Public confidence in vaccine safety is critical**
**higher standard of safety is expected of vaccines**
**vaccinees generally healthy ****(vs. ill for drugs)**
**lower risk tolerance = need to search for rare reactions**
**vaccination universally recommended and mandated**** **

## Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases andVaccine Adverse Events, United States

***   Maximum cases reported in pre-vaccine era **
**+  Estimated because no national reporting existed in the prevaccine era**
****  Invasive type b and unknown serotype**

- Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases andVaccine Adverse Events, United States

## Importance of Vaccine Safety

**Ongoing safety monitoring needed for the development of sound policies and recommendations**

## Prelicensure Vaccine Safety Studies

**Laboratory**
**Animals**
**Humans**

## Prelicensure Human Studies

**Phases I, II, III trials**
**Common reactions are identified**
**Vaccines are tested in thousands of persons before being licensed and allowed on the market**

## Postlicensure Surveillance

**Identify rare reactions**
**Monitor increases in known reactions**
**Identify risk factors for reactions**
**Identify vaccine lots with unusual  rates or types of events**
**Identify signals**

## Postlicensure Vaccine Safety Activities

**Phase IV Trials **
**~10,000 participants**
**better but still limited**
**Large-Linked Databases**
**Clinical Immunization Safety Assessment Network**

## Vaccine Adverse Event Reporting System (VAERS) 

**National reporting system**
**Jointly administered by CDC ****and FDA**
**Passive (depends on healthcare providers and others to report)**
**Receives ~15,000 reports per year**

## Vaccine Adverse Event Reporting System (VAERS) 

**Detects**
**new or rare events**
**increases in rates of known side effects**
**patient risk factors **
**Additional studies required to confirm VAERS signals**
**Not all reports of adverse events are causally related to vaccine**

## Adverse Event Classification

**Vaccine-induced**
**Vaccine-potentiated**
**Programmatic error**
**Coincidental**

## Vaccine Safety Datalink (VSD)

**Large-linked database**
**Links vaccination and health records**
**“****Active surveillance”**
**8 HMOs**
** ****~2% of the U.S. population**
**Powerful tool for monitoring vaccine safety**

## Clinical Immunization Safety Assessment (CISA) Network

**Improve understanding of vaccine safety issues at individual level**
**Evaluate persons who experience adverse health events**
**Gain better understanding of events**
**Develop protocols for healthcare providers**

## Vaccine Injury Compensation Program (VICP)

**Established by National Childhood Vaccine Injury Act (1986)**
**“****No fault” program**
**Covers all routinely ****recommended childhood ****vaccines**
**Vaccine Injury Table **

## The Provider’s Role

**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 contraindications and precautions**

## Contraindication

**   ****A condition in a recipient that increases the chance of a serious adverse reaction**

## Precaution

**  ****A condition in a recipient that might **
**Increase the chance or severity of an adverse reaction, or**
**Compromise the ability of the vaccine to produce immunity**

## Invalid Contraindications to Vaccination

**Minor illness**
**Mild/moderate local reaction or fever following a prior dose**
**Antimicrobial therapy**
**Disease exposure or convalescence**
**Pregnancy or immunosuppression in the household**
**Premature birth**
**Breastfeeding**
**Allergies to products not in vaccine**
**Family history (unrelated to immunosuppression) **

## The Provider’s Role

**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 and risk communication**

## Benefit and Risk Communication

**Opportunities for questions should ****be provided before each vaccination**
**Vaccine Information Statements (VISs)**
**must be provided before each dose ****of vaccine**
**public and private providers**
**available in multiple languages**

## National Immunization ProgramContact Information

**Telephone****	****	****800.CDC.INFO**** **
**Email****	****	****	****nipinfo@cdc.gov**** **
**Website****	****	****www.cdc.gov/nip**