PHARMACOEPIDEMIOLOGIC           STUDIES OF VACCINE SAFETY                    BY : VIJIT AGRAWAL &                         ...
Introduction• Vaccine safety is a prime concern for the public,  manufacturers, immunization providers, and  recipients of...
Importance of Vaccine Safety• Decrease in disease risks and increased attentions on  vaccine risks• Public confidence in v...
Methods             of    Monitoring   VaccineSafetyVaccines, like otherpharmaceuticalproducts,      undergoextensive safe...
8/4/2013   5
• If the vaccine is shown to be safe and effective in  Phase III, the manufacturer applies for a license from  the FDA.• T...
• Even the largest prelicensure trials (more  than 10,000 persons) are inadequate to  assess the vaccine’s potential to in...
Manufacturers     must           submit samples of each           vaccine lot and results           of their own tests for...
• Today, Phase IV trials and large-linked databases (LLDBs)  have been added to improve the capability to study rare  risk...
8/4/2013   10
• The Vaccine Adverse Event Reporting System  (VAERS) is a national reporting system, jointly  administered by CDC and FDA...
• VAERS receives about 28,000 US reports per  year.• For serious reports, letters to obtain  information about recovery st...
VAERS      data    are           publicly available on           the     Internet    at           http://vaers.hhs.gov,   ...
8/4/2013   14
8/4/2013   15
8/4/2013   16
Adverse Event Classifications and         Assessment of Causality• Adverse events following vaccination can be  classified...
8/4/2013   18
8/4/2013   19
• Vaccine-induced:  Due to the intrinsic characteristic of the  vaccine preparation and the individual  response of the va...
• Vaccine-potentiated:  The event would have occurred anyway, but  was precipitated by the vaccination  (e.g., first febri...
• Programmatic error:  Due to technical errors in vaccine  storage, preparation, handling, or  administration.8/4/2013    ...
• Coincidental:  The reported event was not caused by  vaccination but happened by chance  occurrence or due to underlying...
An adverse health event can be causally attributed                            tovaccine more readily if:1) The health prob...
Vaccine Safety Datalink• In 1990, CDC established the Vaccine Safety  Datalink (VSD) project to improve scientific  unders...
•      Group Health Cooperative of Puget Sound, Seattle, Washington•      Harvard Pilgrim Health Care, Boston, Massachuset...
• Each participating organization gathers data  on vaccination (vaccine type, date of  vaccination,                       ...
8/4/2013   28
Vaccine Safety Datalink (VSD)Strengths                       Weaknesses• Meets need : Scientifically   • Records incomplet...
• In 2005, the Vaccine Safety Datalink (VSD)  project team launched an active surveillance  system called Rapid Cycle Anal...
Clinical Immunization                             Safety Assessment• Goals                        Network (CISA) To study...
CISA Network Sites•   Boston University Medical Center•   Columbia University Medical Center•   Johns Hopkins University• ...
Vaccine Analytic Unit• The VAU is a collaborative vaccine safety  research infrastructure between the  Department of Defen...
• CDC established the VAU in 2003 .• The Vaccine Analytic Unit (VAU) complements  the other critical CDC vaccine safety  s...
8/4/2013   35
The Immunization Provider’s Role• Immunization provider, also play a key role in helping  to ensure the safety and efficac...
Vaccine Storage• To achieve the best possible results from vaccines, carefully  follow the recommendations for storage, ha...
Vaccine Administration• Never administer a vaccine later than the  expiration date.• Never mix vaccines in the same syring...
Timing and Spacing• The timing and spacing of vaccine doses are two of  the most important issues in the appropriate use o...
Observe Valid Contraindications and               Precautions•     In general, a vaccine should not be    administered whe...
Communicate About Vaccine Benefits            and Risks• Before you administer each  dose of certain vaccines, you  are re...
Report Suspected Side Effects to                  VAERS8/4/2013                                 42
8/4/2013   43
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Pharmacoepidemiologic studies for vaccine safety

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Pharmacoepidemiologic studies for vaccine safety

  1. 1. PHARMACOEPIDEMIOLOGIC STUDIES OF VACCINE SAFETY BY : VIJIT AGRAWAL & CHINNU SOSA GEORGE V Pharm.D8/4/2013 JSS College of Pharmacy, Mysore 1
  2. 2. Introduction• Vaccine safety is a prime concern for the public, manufacturers, immunization providers, and recipients of vaccines.• No vaccine is completely safe or completely effective, while almost all known vaccine adverse events are minor and self-limited, some vaccines have been associated with very rare but serious health effects.8/4/2013 2
  3. 3. Importance of Vaccine Safety• Decrease in disease risks and increased attentions on vaccine risks• Public confidence in vaccine safety is critical * Higher standard of safety is critical * Vaccines generally healthy * Lower risk tolerance = Need to search for a rare reaction * Vaccination universally recommended and mandated• Ongoing safety monitoring needed for the development of the sound policies and recommendations8/4/2013 3
  4. 4. Methods of Monitoring VaccineSafetyVaccines, like otherpharmaceuticalproducts, undergoextensive safety andefficacy evaluationsin the laboratory, inanimals, and insequentially phasedhuman clinical trialsprior to licensure.8/4/2013 4
  5. 5. 8/4/2013 5
  6. 6. • If the vaccine is shown to be safe and effective in Phase III, the manufacturer applies for a license from the FDA.• The FDA licenses the vaccine itself (the “product license”) and licenses the manufacturing plant where the vaccine will be made (the “establishment license”).• During the application, the FDA reviews everything: The clinical trial results, Product labeling, The manufacturing plant itself, and8/4/2013 The manufacturing protocols. 6
  7. 7. • Even the largest prelicensure trials (more than 10,000 persons) are inadequate to assess the vaccine’s potential to induce possible rare side effects.• Therefore, it is essential to monitor reports of vaccine-associated adverse events once the vaccine has been licensed and released for public use.8/4/2013 7
  8. 8. Manufacturers must submit samples of each vaccine lot and results of their own tests for potency and purity to the FDA before releasing them for public use.8/4/2013 8
  9. 9. • Today, Phase IV trials and large-linked databases (LLDBs) have been added to improve the capability to study rare risks of specific immunizations.• Phase IV studies can be an FDA requirement for licensure.• These trials include tens of thousands of volunteers and may address questions of long-term effectiveness and safety or examine unanswered questions identified in Phase III clinical trials.• In 2001, the Clinical Immunization Safety Assessment (CISA) Network was established which works to increase understanding of vaccine reactions at the individual patient level.8/4/2013 9
  10. 10. 8/4/2013 10
  11. 11. • The Vaccine Adverse Event Reporting System (VAERS) is a national reporting system, jointly administered by CDC and FDA.• VAERS was created in 1990 to unify the collection of all reports of adverse events after vaccination.• VAERS is a passive reporting system and accepts reports from health professionals, vaccine manufacturers, and the general public.8/4/2013 11
  12. 12. • VAERS receives about 28,000 US reports per year.• For serious reports, letters to obtain information about recovery status are mailed to the reporters at 60 days and 1 year after vaccination.• Despite some limitations, VAERS has been able to fulfill its primary purpose of detecting new or rare vaccine adverse events, increases in rates of known side effects, and patient risk factors for particular types of adverse events.8/4/2013 12
  13. 13. VAERS data are publicly available on the Internet at http://vaers.hhs.gov, or at http://wonder.cdc.go v/vaers.html at no cost.8/4/2013 13
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  17. 17. Adverse Event Classifications and Assessment of Causality• Adverse events following vaccination can be classified by Frequency (common, rare), Extent (local, systemic), Severity (hospitalization, disability, and death), Causality, and Preventability (intrinsic to vaccine, faulty production, faulty administration).8/4/2013 17
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  20. 20. • Vaccine-induced: Due to the intrinsic characteristic of the vaccine preparation and the individual response of the vaccinee.• These events would not have occurred without vaccination . (e.g., vaccine-associated paralytic poliomyelitis after oral polio vaccine).8/4/2013 20
  21. 21. • Vaccine-potentiated: The event would have occurred anyway, but was precipitated by the vaccination (e.g., first febrile seizure in a predisposed child).8/4/2013 21
  22. 22. • Programmatic error: Due to technical errors in vaccine storage, preparation, handling, or administration.8/4/2013 22
  23. 23. • Coincidental: The reported event was not caused by vaccination but happened by chance occurrence or due to underlying illness.8/4/2013 23
  24. 24. An adverse health event can be causally attributed tovaccine more readily if:1) The health problem occurs during a plausible time period followingvaccination; 2) The event confirms to a specific clinical syndrome whose association withvaccination has strong biologic plausibility (e.g., anaphylaxis) or occursfollowing the natural disease;3) A laboratory result confirms the association (e.g., isolation of vaccine strainvaricella virus from skin lesions of a patient with rash);4) The event recurs on re-administration of the vaccine (“positive rechallenge”);5) A controlled clinical trial or epidemiologic study shows greater risk of aspecific adverse event among vaccinated versus unvaccinated (control) groups 8/4/2013 24
  25. 25. Vaccine Safety Datalink• In 1990, CDC established the Vaccine Safety Datalink (VSD) project to improve scientific understanding of vaccine safety.• This project involves partnerships with 10 large managed care organizations (MCOs) to monitor vaccine safety.8/4/2013 25
  26. 26. • Group Health Cooperative of Puget Sound, Seattle, Washington• Harvard Pilgrim Health Care, Boston, Massachusetts• HealthPartners Research Foundation, Minneapolis, Minnesota• Kaiser Permanente Northwest, Portland, Oregon• Kaiser Permanente Medical Care Program of Northern California, Oakland, California• Kaiser Permanente Colorado, Denver, Colorado• Kaiser Permanente of Georgia, Atlanta, GA• Marshfield Clinic Research Foundation, Marshfield, Wisconsin• Southern California Kaiser Permanente Health Care Program, Los Angeles, California 8/4/2013 26
  27. 27. • Each participating organization gathers data on vaccination (vaccine type, date of vaccination, concurrent vaccinations), medical outcomes (outpatient visits, inpatient visits, urgent care visits), birth data, and census data.8/4/2013 27
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  29. 29. Vaccine Safety Datalink (VSD)Strengths Weaknesses• Meets need : Scientifically • Records incomplete rigorous safety data • Retrospective in nature• Relatively timely efficient • Delays in data availability• Access to fairly large population• Infrastructure for other studies8/4/2013 29
  30. 30. • In 2005, the Vaccine Safety Datalink (VSD) project team launched an active surveillance system called Rapid Cycle Analysis (RCA).• Its goal is to monitor adverse events following vaccination in near real time, so the public can be informed quickly of possible risks. The RCA data contain no personal identifiers. Further information about VSD is available at http://www.cdc.gov/vaccinesafety.vsd8/4/2013 30
  31. 31. Clinical Immunization Safety Assessment• Goals Network (CISA) To study the pathophysiologic basis of adverse events following immunization using hypothesis-driven protocols. To study risk factors associated with developing an adverse event following immunization using hypothesis-driven protocols, including genetic host-risk factors. To provide clinicians with evidence-based guidelines when evaluating adverse events following immunization. To provide clinicians with evidence-based vaccination or revaccination guidelines. To serve as a regional referral center to address complex vaccine safety inquiries.8/4/2013 31
  32. 32. CISA Network Sites• Boston University Medical Center• Columbia University Medical Center• Johns Hopkins University• Northern California Kaiser Permanente• Stanford University• Vanderbilt University For more information about CISA, visit http://www.cdc.gov/vaccinesafety/ Activities/cisa.html8/4/2013 32
  33. 33. Vaccine Analytic Unit• The VAU is a collaborative vaccine safety research infrastructure between the Department of Defense (DoD) and CDC with input from the FDA.8/4/2013 33
  34. 34. • CDC established the VAU in 2003 .• The Vaccine Analytic Unit (VAU) complements the other critical CDC vaccine safety surveillance systems (VAERS, VSD, and CISA).• Current projects focus on specific vaccines (AVA, Tdap, Menactra) and specific potential vaccine-associated diseases (autoimmune thyroid disease, diabetes, Guillain Barré syndrome).8/4/2013 34
  35. 35. 8/4/2013 35
  36. 36. The Immunization Provider’s Role• Immunization provider, also play a key role in helping to ensure the safety and efficacy of vaccines through proper: 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 risks8/4/2013 36
  37. 37. Vaccine Storage• To achieve the best possible results from vaccines, carefully follow the recommendations for storage, handling, and administration found in each vaccine’s package insert. Carefully select and use the proper vaccine storage units to store vaccines. Have a properly calibrated thermometer or temperature recording device inside each storage compartment. Inspect vaccines upon delivery and monitor refrigerator and freezer temperatures. Rotate vaccine stock so the oldest vaccines are used first. If errors in vaccine storage and administration occur, take corrective action immediately to prevent them from happening again and notify public health authorities.8/4/2013 37
  38. 38. Vaccine Administration• Never administer a vaccine later than the expiration date.• Never mix vaccines in the same syringe unless they are specifically approved for mixing by the Food and Drug Administration (FDA).• Record vaccine and administration information, including lot numbers and injection sites, in the patients record.8/4/2013 38
  39. 39. Timing and Spacing• The timing and spacing of vaccine doses are two of the most important issues in the appropriate use of vaccines.• To ensure optimal results from each immunization, follow the currently recommended immunization schedules for children, adolescents and adults.• The recommended childhood immunization schedule and influenza immunization recommendations are updated each year.8/4/2013 39
  40. 40. Observe Valid Contraindications and Precautions• In general, a vaccine should not be administered when a contraindication is present. A precaution is a condition in a patient that may increase the chance of a serious side effect or render a vaccine less effective.8/4/2013 40
  41. 41. Communicate About Vaccine Benefits and Risks• Before you administer each dose of certain vaccines, you are required by law to provide a copy of the most current Vaccine Information Current VISs are available on Statement (VIS) to either the CDCs Vaccine Information adult vaccinee or to the child’s Statements page. Translations parent/legal representative. in over 45 languages are available at www.immunize.org/vis/• VIS are developed by the CDC and discuss the benefits and risks associated with specific vaccines. 8/4/2013 41
  42. 42. Report Suspected Side Effects to VAERS8/4/2013 42
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