Vaccine Safety: the risk of undermining our successes at the global level

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Ambrose Hancock
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1 Vaccine Safety: the risk of undermining our successes at the global level Pan-American Vaccine Safety Summit May 10,

nsafe vaccine can have serious consequences Safety crises derail immunization programs Real incidents: Tuberculosis following oral BCG. Polio following IPV. Swine flu campaign and GBS.

2 nsafe vaccine can have serious consequences Safety crises derail immunization programs Real incidents: Tuberculosis following oral BCG. Polio following IPV. Swine flu campaign and GBS. Real safety issues: Programme errors. Anaphylaxis. VAPP. Disseminated BCG disease. Rumours, poor science and over-reaction: Pertussis vaccine coverage in the UK. MS and hepatitis B vaccine in France. OPV and chronic diseases in Nigeria. Thiomersal and neuro-developmental disorders. Pentavalent vaccine in Asian countries. 2

3 Pertussis in the U.K. Gay N, Miller E, Lancet 2000;355:1553 3

4 Resurgence of polio in Nigeria 4

http://derbypatriot.blogspot.com/2011/01/gu illain-barre-syndrome-and-flu-jab.

Syndrome and Leukaemia. Miss KW, who turned 17 on Christmas Day, died ( ) on December 28th.

I have to admit that my first thought was, did this young woman have the swine flu jab at the beginning of 2010?

5 illain-barre-syndrome-and-flu-jab.html This morning I read the heartbreaking story of a young local woman who died following contracting Guillain-Barre Syndrome and Leukaemia. Miss KW, who turned 17 on Christmas Day, died ( ) on December 28th. ( ) Miss W was diagnosed with the illness after becoming paralysed in February I have to admit that my first thought was, did this young woman have the swine flu jab at the beginning of 2010? If she did then it is all the more reason not to have the vaccination. My belief is that vaccines cause as many problems as they cure, and even though I am in the high risk category and should have the jab, I don t; I d rather take my chances. 5

6 Pentavalent vaccines in Asian countries Pentavalent DTwP-HepB-Hib vaccine introduced in >170 countries to date. In three Asian countries, serious AEFI in the first week after introduction raised concerns and in 2 countries led to a suspension of vaccine use for more than one year. Investigations did not identify any causal relationship between vaccine use and serious AEFI. 6

7 Pentavalent vaccine in Asian countries Country AEFI Action from authorities A B C 5 deaths in temporal association with vaccine (Manufacturer X) over first four months of introduction. Assessment suggest SIDS. 5 cases with a history of fever and central nervous system symptoms starting 1 to 4 days after vaccine (Manufacturer Y) administration during first two months of introduction, including four deaths. 3 deaths in temporal association with vaccine (Manufacturer X) over first two months of introduction. Provincial suspension as precautionary measure. WHO investigation within one month of suspension does not identify causal relationship. Suspend vaccine and reintroduce after 21 months. Suspend vaccine and reintroduce after 15 months. Resumption of vaccination activities and extension to whole country. 7

8 New vaccines Coming soon: malaria, dengue, Japanese encephalitis, typhoid conjugate, new TB vaccine, etc 8

9 Way forward Strong methodologies to address concerns: Harmonized tools. Methodological excellence. Adjusted to local circumstances. Information exchange (including industry). International collaborations: Multicenter studies. Training curriculums. Laboratory access. Expert scientific advice: Local, regional and global committees. Networks for technical support. 9

Industry perception. 5. Descriptive analysis of 11 countries. 6.

10 1. Experts perception of gaps and needs. 2. SWOT of existing international activities. 3. Regulators perception. 4. Industry perception. 5. Descriptive analysis of 11 countries. 6. NRA assessment data. 7. Financial analysis. ttp://whqlibdoc.who.int/hq/2012/who_ivb_12.04_eng.pdf 10

WHO and partners technical resources to support vaccine pharmacovigilance Immunization safety: www.who.

11 WHO and partners technical resources to support vaccine pharmacovigilance Immunization safety: Surveillance guidelines. Aide-mémoires. Position papers. Other technical docs. Useful links. 11

Brighton Collaboration: Standard AEFI case definitions Context: Lack of standardized case definitions in the literature between: Countries (but WHO definitions exist for reporting).

12 Brighton Collaboration: Standard AEFI case definitions Context: Lack of standardized case definitions in the literature between: Countries (but WHO definitions exist for reporting). National passive systems versus clinical trials versus industry etc. Goals are: Developing case definitions for AEFI. Not to filter reporting but to improve analysis and comparability of clinical trial and surveillance data. Promoting global implementation of these definitions. 12

CIOMS/WHO Working Group on vaccine phamacovigilance Created Nov 2005 Completed Nov 2010.

13 CIOMS/WHO Working Group on vaccine phamacovigilance Created Nov 2005 Completed Nov Vaccine experts, scientists from drug (and vaccine) regulatory authorities, industry, international organizations and academia. Key Terms of Reference: Endorsement of Brighton Collaboration definitions. Development of general definitions: vaccine pharmacovigilance (Oct 2007). AEFI and types of AEFI including "misuse/programme error/medication error". vaccination failure (Position paper, April 2008). reviewing current tools and terminology for causality assessment. 13

lobal Advisory Committee on Vaccine afety (GACVS)

14 lobal Advisory Committee on Vaccine afety (GACVS) Advisory body to WHO/IVB. Response to vaccine safety issues of potential global importance: promptly, efficiently, with scientific rigor. Broad expertise. Independence. Decisions and recommendations based on best available evidence. ports and statements: 14

15 15

WHO Programme for International Drug Monitoring Functions include: Global database of ADRs from National Pharmacovigilance Centers (drugs, vaccines, herbals).

16 WHO Programme for International Drug Monitoring Functions include: Global database of ADRs from National Pharmacovigilance Centers (drugs, vaccines, herbals). Signal detection and signal strengthening. Harmonization and standardization: Definition of terminologies (events, reaction, signal). WHO Adverse Reaction Terminology (WHO-ART). WHO Drug Dictionary. WHO Collaborating Centre since 1978 Forum for national centers to share experience. 16

17 California Estimated Prevalence of Autism and Estimated Mercury Exposure in Vaccines From Stehr-Green P et al. Am J Prev Med 2003; 25: Slide by W. Orenstein A tale of two vaccines, available 17

18 Epidemiologic Studies of Autism and Vaccines Ecologic: Compare secular trends over time with trends in vaccine coverage rates, thimerosal exposure, etc Weakest kind of study. Case-Control: Select cases, determine vaccine and/or thimerosal exposure. Select controls and compare exposures in cases and controls. Measure odds ratio which approximates relative risk. Cohort: Compares rates of autism in children exposed and not exposed to vaccines. Can look for a dose-response effect. Measure relative risk. Slide by W. Orenstein A tale of two vaccines, available 18

19 Rate Ratio of Autism and Autism Spectrum Disorders (ASD) by Exposure to Thimerosal in Vaccines Thimerosal in vaccines Person- Years No Autism Other ASD None 1,660, dose (25µg Hg) 2 doses (75µg Hg) 3 doses (125µg Hg) Trend per 25µg Hvid et al. JAMA 2003; 290: , , , ( ) 0.70 ( ) 0.96 ( ) 0.98 ( ) 0.95 ( ) 1.20 ( ) 1.13 ( ) 1.03 ( ) Slide by W. Orenstein A tale of two vaccines, available 19

20 Methodological Evaluation of Studies Addressing Link of Autism and Thimerosal Studies NOT supporting a Methodological Score relationship Andrews et al /8 Heron et al /8 Hviid et al /8 Verstraeten et al /8 Studies supporting a relationship Geier and Geier /8 Geier and Geier /8 Geier and Geier /8 Parker SK et al. Pediatrics 2004; 114: Slide by W. Orenstein A tale of two vaccines, available 20

21 EFI of particular interest for pandemic flu vaccination campaigns e Lancet 2009;374: Epub 31 October

22 umber of coincidences following vaccination 22

23 eningococcal A conjugate in West Africa 2010 Ouandaogo et al. Vaccine 2012 Vaccine developed for Meningitis Belt countries through technology transfer and BMGF funding. Initial introduction through mass immunization campaigns with a single dose in all people aged 1 to 29 years. Vaccine never used before post-licensing. Clinical trials involved <5,000 individuals who received the vaccine. Between September and December, 11.5 million people vaccinated in Burkina Faso. 23

24 Spontaneous reporting of AEFI 24

25 Attack rate of main AEFI reported 25

26 Comparison of AEFI attack rates with baseline occurrence in country 26

27 Active surveillance 27

28 Conclusions Ensuring the safest possible use of vaccines should be the standard for all immunization programs. Proactive communication should be the norm: Know risks and benefits of vaccines are presented. Systems for continuous monitoring of safety are described. Local stakeholders ensure first line communication. Risk management plans are part of vaccine safety strategies. Expertise available among many stakeholders, but insufficient information exchange. 28

29 Conclusions Global vaccine pharmacovigilance stakeholders: National immunization programs, regulatory authorities and pharmacovigilance centers. Technical agencies, academia, other research organizations. Procurement agencies. Multilateral organizations. Industry. Donors. Concerted effort can lead to: Efficiency gains. Capacity building. Predictable and sustainable funding. 29

Strengthening Global Capacity for Vaccine Pharmacovigilance. The GVS Initiative

Strengthening Global Capacity for Vaccine Pharmacovigilance The GVS Initiative Africa Pharmacovigilance Meeting 2012 20 April 2012 1 Vaccine pharmacovigilance for all Vaccine pharmacovigilance is defined