1 / 21

Vaccine Safety

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

rachel-puckett
Download Presentation

Vaccine Safety

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Vaccine Safety Epidemiology and Prevention of Vaccine-Preventable Diseases National Immunization Program Centers for Disease Control and Prevention Revised January 2006

  2. 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

  3. Disease Pre-vaccine Era* 2000 % change Diphtheria 31,054 1 -99 Measles 390,852 86 -99 Mumps 21,342 338 -99 Pertussis 117,998 7,867 -93 Polio (wild) 4,953 0 -100 Rubella 9,941 176 -98 Cong. Rubella Synd. 19,177 9 -99 Tetanus 1,314 35 -97 Invasive Hib Disease** 24,856 112 -99 Total 566,706 8,624 -98 Vaccine Adverse Events 0 13,497 ^ +++ Comparison of Maximum and Current Reported Morbidity, Vaccine-Preventable Diseases andVaccine Adverse Events, United States * Maximum cases reported in pre-vaccine era + Estimated because no national reporting existed in the prevaccine era ^ Adverse events after vaccines against diseases shown on Table = 5,296 ** Invasive type b and unknown serotype

  4. Importance of Vaccine Safety • Ongoing safety monitoring needed for the development of sound policies and recommendations

  5. Prelicensure Vaccine Safety Studies • Laboratory • Animals • Humans

  6. 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

  7. 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

  8. Postlicensure Vaccine Safety Activities • Phase IV Trials • ~10,000 participants • better but still limited • Large-Linked Databases • Clinical Immunization Safety Assessment Network

  9. 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

  10. 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

  11. Adverse Event Classification • Vaccine-induced • Vaccine-potentiated • Programmatic error • Coincidental

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Contraindication A condition in a recipient that increases the chance of a serious adverse reaction

  18. 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

  19. 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)

  20. 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

  21. National Immunization ProgramContact Information • Telephone 800.CDC.INFO • Email nipinfo@cdc.gov • Website www.cdc.gov/nip

More Related