Safety monitoring of vaccines. Jeremy Labadie MD vaccine safety specialist
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1 Safety monitoring of vaccines Jeremy Labadie MD vaccine safety specialist
2 vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and AEFI
3 vaccines are special X ADR AEFI = Medical incident that takes place after an immunization which causes concern and is believed to be caused by immunization (WHO)
4 biologicals GMP, WHO requirements Vaccines vaccines are special production variability Lot / Batch release fragile temperature (cold chain), sunlight
5 vaccines are special Summary of Product Characteristics: pharmacokinetics data : immune responses pharmacodynamics data : absent Vaccines are difficult to regulate NRA functions relating to vaccines 1. Marketing authorization and licensing activities 2. Post-marketing surveillance (including AEFI surveillance) 3. NRA lot release 4. Laboratory access 5. Regulatory inspections 6. Oversight of clinical trials
6 vaccines are special 59 countries have a functional NRA to regulate vaccines (2010): NRA functional NRA not functional or no data available Countries where AEFI system have documented progress or and is functional Adapted from:
7 vaccines are special preventive health care (most cost effective public health intervention) vaccines usually given to healthy individuals administered by trained person uniform dose & frequency (immunisation schedule) low tolerance for adverse reactions large number of vaccinations potentially many coincidental events
8 vaccines are special Combination vaccines (Hexavalent: diphtheria, tetanus, acellular pertussis, haemophilus influenzae type B, poliovirus and hepatitis B ) Causality assessment? Simultaneous administration of vaccines Causality assessment?
9 lot-by-lot surveillance vaccines are special need for vaccine distribution data progammatic used products - childhood immunisation programme - occupational immunisation programme (health care professionals, military) programmatic errors Vaccines
10 vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and AEFI
11 Expanded Programme on Immunization Vaccines and schedule BCG, OPV: at birth DPT, OPV, Hepatitis B : weeks Measles: 9 months In some countries: yellow fever, rubella, Haemophilus influenzae type B, pneumococcal and meningococcal vaccines Tetanus toxoid to women at/before child bearing age
12 Evolution of Immunization Programme and Prominence of Vaccine Safety Developing programme Programmatic Errors: bacterial abscess severe local reaction high fever or sepsis BCG lymphadenitis toxic shock syndrome clusters of AEFIs From RT Chen, CDC
13 Evolution of Immunisation Program and Prominence of Vaccine Safety From RT Chen, CDC
14 public perception: BENEFIT < RISK UK: Whole cell pertussis vaccine & neurological damage
15 public perception: BENEFIT < RISK UK: Measles, Mumps, Rubella (MMR) vaccine & autism
16 public perception: BENEFIT > RISK problems media seeking controversy consumer groups internet! parents of vaccine-injured(??) children solutions official immunization information: - handling of vaccine safety concerns - vaccine risk communication - educate healthcare professionals
17 vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and AEFI
18 pharmacovigilance & vaccines spontaneous reporting system [SRS] separate for vaccines: Australia, Denmark, India, Italy, Mexico, USA, SRS for all drugs [vaccines included]: France, New Zealand, Sweden, United Kingdom, Netherlands.. lack of communication: drug (ADR) - vaccine (AEFI) NRA/PV - NIP/EPI
19 Potential objectives for AEFI Surveillance System detect, correct, and prevent programme errors identify problems with vaccine lots or brand prevent false blame from coincidental events maintain confidence by properly responding to parent /community concerns while increasing awareness (public and professional) about vaccine risks generate new hypotheses about vaccine reactions that are specific to the population estimate rates of occurrence on AEFI in the local population, compared with trial and international data improving coverage, effectivity and safety
20 vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI
21 classification of AEFI Vaccines vaccine reaction event caused or precipitated by the vaccine when given correctly; caused by inherent properties of the vaccine progammatic error caused by error in vaccine preparation, handling, or administration coincidental event happens after immunization but not caused by it a chance association injection reaction event from anxiety about or pain from the injection itself rather than the vaccine unknown whose cause can not be determined
22 immune response & AEFI common ADR concepts? - de-challenge? - re-challenge? - allergic reaction? vaccine specific ADR concepts? - autoimmune disease? - allergic constitution?
23 age & AEFI age specific immune responses [polysaccharide vaccines immunogenic > 2 years of age] age specific infectious disease risks [Mumps infection complications in adolescents & adults] age specific AEFI - HHE [first year of life] - febrile convulsions [first 5 years of life]
24 AEFI notification Vaccines vaccine (type) manufacturer lot number expiry date shipped from... to... route / site of administration time to onset nr. of previous doses vaccinated at?
25 AEFI notification special reporting form (example Canada)
26 vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and AEFI
27 causality & AEFI in short: can it? did it? will it?
28 vaccines: cause of AEFI? antigen adjuvans preservative stabilisor antibiotics others [aluminium salts, ASO3, AS04, MF59] [thimerosal] [gelatine] - ph - osmolarity [neomycine]
29 Case definitions for AEFI Nr of Studies (N=120)* Vaccines / Temperature C *Some studies with >1 cut off When is fever FEVER? From Jan Bonhoeffer
30 vaccines are special immunization programmes pharmacovigilance & vaccines vaccines & AEFI causality assessment of AEFI UMC and AEFI
31 Global monitoring of AEFI
32 UMC and AEFI countries with >1000 AEFI reports in the database 80% Improving global monitoring of vaccine safety: A quantitative analysis of adverse event reports in the WHO Adverse Reactions Database Megan Letourneau, George Wells, Wikke Walop and Philippe Duclos Vaccine, Volume 26, Issue 9, 26 February 2008, Pages
33 UMC and AEFI Top 10 drugs in <1 year of age Reported drug Male Female Diphtheria and tetanus toxoids and pertussis Poliovirus vaccine live oral Haemophilus B conjugate vaccine Hepatitis B vaccine Diphtheria/Tetanus/Pertussis/Haemophilus B vaccine Poliomyelitis vaccine inactivated Measles, mumps and rubella vaccine Varicella virus vaccine, live Palivizumab Haemophilus influenzae B
34 UMC and AEFI AEFI reports (n = 246,877) versus Other reports (n = 2,440,241 Improving global monitoring of vaccine safety: A quantitative analysis of adverse event reports in the WHO Adverse Reactions Database Megan Letourneau, George Wells, Wikke Walop and Philippe Duclos Vaccine, Volume 26, Issue 9, 26 February 2008, Pages
35 UMC and AEFI Global PMS Network Members (12) Albania, Brazil, China, India (1 State), Iran, Kazakhstan, Mexico, Senegal, Sri Lanka, Tunisia, Uganda, Vietnam Uppsala Monitoring Centre (UMC) WHO Collaborating Centre for International Drug Monitoring Network Secretariat & Management Group WHO (HQ, Regions), UMC UNICEF + PAHO Revolving Fund Representation of Member Countries Technical Oversight Committee Funding source: Gates Foundation PQ grant (approx 3.8 million USD)
36 UMC and AEFI Global PMS Network: Expected outputs Improved reporting and analysis of vaccine safety data at global level Quality of data WHO-UMC tools and resources for vaccines Signal generation Improved assessment of causality Investigation capacity Individual case causality assessment Assessment of signals (special studies as needed) No. 27, 2006, 81,
37 UMC and AEFI Pharmacovigilance training course 2001
38
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