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Vaccine Adverse Events and Risk Communication In Vaccination

Vaccine Adverse Events and Risk Communication In Vaccination. Najwa Khuri-Bulos MD,FIDSA Jordan University Hospital Amman, Jordan. explaining properly the benefits and risks of a recommended vaccine; addressing public concerns and upcoming or persistent rumours about vaccine safety;

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Vaccine Adverse Events and Risk Communication In Vaccination

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  1. Vaccine Adverse Events and Risk Communication In Vaccination Najwa Khuri-Bulos MD,FIDSA Jordan University Hospital Amman, Jordan

  2. explaining properly the benefits and risks of a recommended vaccine; addressing public concerns and upcoming or persistent rumours about vaccine safety; preparing to address vaccine safety crises if and when they occur.

  3. The recommended criteria fall into four categories: Essential criteria (i.e. with respect to credibility) Important criteria (i.e. with respect to content) Practical criteria (i.e. with respect to accessibility) Desired criteria (i.e with respect to design)

  4. Vaccine Adverse Events and Risk Communication In Vaccination Najwa Khuri-Bulos Jordan University Hospital

  5. Jenner

  6. Strong Tools Available/Expected

  7. Impact of the EPI Case Study, Jordan, a great success story Diphtheria Measles poliomyelitis

  8. Comparison of Annual and Current Reported Morbidity, Vaccine-Preventable Diseases and Vaccine Adverse Events, United States Total 1,064,8457,515 -99.29 Vaccine Adverse Events 0 13,497^ +++ Disease 20th Century Annual Morbidity* 2000** % change Diphtheria 175,885 4 -99.99 Measles 503,282 81 -99.98 Mumps 152,209 323 -99.79 Pertussis 147,271 6,755 -95.41 Polio (wild) 16,316 0 -100 Rubella 47,745 152 -99.68 Cong. Rubella Synd.823 7 -99.15 Tetanus 1,314 26 -98.02 Invasive Hib Disease 20,000 1 67 -99.16 * Maximum cases reported in pre-vaccine era and year + Estimated because no national reporting existed in the prevaccine era ^ Adverse events after vaccines against diseases shown on Table = 5,296 ** Provisional

  9. Vaccines don’t prevent disease Vaccination prevents disease

  10. Evolution of Immunization Program and Prominence of Vaccine Safety Concerns

  11. Trust “It takes many good deeds to build a reputation, and only one bad one to lose it” Benjamin Franklin “It is far easier to build trust before it is needed”. WHO

  12. Trust and how to build it • Transparency and Key points on vaccine adverse events • 1. There is no such thing as a “perfect” vaccine • 2. effective vaccines may produce some undesirable effect which are mostly mild • 3. The majority of events thought to be related to administration of a vaccine are actually not related to it • 4. It is not possible to predict every individual who might have a mild or serious reaction

  13. Trust and how to build it • Evidence based support from international organizations • Transparency in vaccine licensing and clarity of why recommendations are made • Transparency on collaboration and conflict of interest • For that to happen must establish relations with stakeholders before one needs it

  14. Requirements for Successful vaccination on a wide scale • Trust is at the core of the relationship between the patient and the health system which • Recommends • Procures • Stores • Transports • Administers • And conducts surveillance for vaccine use, impact and adverse events Disruption in any of the above shakes that trust

  15. But still vaccination, while the best health intervention may carry some small risk for adverse event following immunization (AEFI) • Some of these may be due to the vaccine itself, but many if not most are coincidental and have no relationship to the vaccine itself • Must distinguish between vaccine adverse effects and vaccine adverse events

  16. Vaccine hesitancy and refusal • While anti vaccine sentiment is not new, and did occur even in the nineteenth century, the ease with which information is globalized via the internet, social media, television, radio and other means makes it mandatory that practitioners who are convinced of the value of vaccination to be prepared to advocate fully on behalf of vaccines.

  17. History of some adverse effects in the 20th century • Vaccine effects are related biologically to vaccines. These are rare • Kyoto disaster 1948 Japan Diptheria vaccine incompletely inactivated 68/606 died • Cutter incident 1955 USA Administration of polio vaccine which was not completely inactivated caused paralysis

  18. Examples of Vaccine adverse events Vaccine adverse events may be coincidental and not necessarily related to the vaccines • DTP and encephalopathy UK in mid 1970s • Tetanus and sterility in Filipinas 1994 • MMR and autism 1998 • Polio and sterility in Nigeria in 2001 • None of these was proved to be due to vaccines but all led to major disruption of immunization on a wide scale and disrupted public health with increased attack rates

  19. Diseases reappear when coverage drops

  20. EPI, case study Jordan • 1979, EPI started with DTP,OPV,BCG • 1982 Measles • 1995 HBV • 2000 MMR • 2001 HIB • 2005 IPV • Uptake more than 85% for all vaccines • In private sector, a different agenda • MMR since 1990, HIB since 1993, Pneumo, Rota,Hep A and VZV since 2006

  21. Vaccination schedule Jordan 2007 age vaccine 1st contact BCG 2 months DTP + HepB1 +Hib1 + IPV 3 months DTP+HepB2+Hib2 + OPV +IPV 4 months DTP+HepB3+Hib3 + OPV 9 months 18 Months measles + OPV MMR +DTP booster1+OPV booster1

  22. Examples of Vaccine adverse events in a developing country, Jordan • Td mass vaccination in schools 1998 • The polio immunization days and parents concern in 2000 • The MMR and the politics of the EPI 2012

  23. 1st Experience * Mass psychogenic illness following tetanus-diphtheria toxoid vaccination • A total of 25,667 Td doses given through school immunization for 1st and 10th grades, using Td vaccine • More than 800 students reported AEFI • Out of them 122 hospitalized • Discharged within 48 hours * Source: Bulletin of the WHO, 2001, 79 (8)

  24. Number of Td doses administered per day, 7 - 29 September 1998 Total doses administered 25,667 Up to 27 Sept. 19,578 doses were administered with NO report of adverse events September 1998 • Source: Bulletin of the WHO, Clemens, Kharabsheh S, Jarour, Khuri-Bulos et al 2001, • 79 (8)

  25. Life Cycle of a Vaccine Safety Concern Risk/benefit policy Case report Controlled studies Case series Standard assessment • Plausibility • Alternative hypothesis Communications • Societal • Individual + • Treatment • Compensation • Safer vaccine • Appropriate C/I • Screening (Communications) Pathophysiology Risk factors

  26. MOH Response • Ask for expert help from national and international agencies • Stop school vaccination (Td )vaccination • Comprehensive case investigation and crisis control • Case definition • Standard form • Vaccine samples sent for testing to reference laboratories • Press releases • Respond to Parliament inquires & questions • Investigation by Independent team

  27. Cause of the Td AEFI • The cause of the outbreak Clustering of the adverse events was due to the fact that a large number of Td doses was given over a short period of time rather than an increased attack rate * Source: Bulletin of the WHO, 2001, 79 (8)

  28. Action taken to restore public confidence • Media Plan was developed in the beginning of 1999 For re-launch of the Td immunization to be disseminated by varied media, TV, radio and newspapers • Adoption of a more proactive media policy to foster partnership with media • A series of Seminars were conducted to educate the media about EPI • Training of the EPI manager in communication skills

  29. Lesson Learned • Public must be assured that the team is knowledgeable and has expertise. Ask for help if need be • Openness and honesty The communicator must be trustworthy • Concern and care to the cases must be provided. All cases were hospitalized at no expense at MOH hospitals

  30. Threat to Polio vaccine 1999

  31. POLIOMYELITIS IN JORDAN 1978-2001 140 EPI started 120 Outbreak 100 No. of Cases 80 60 40 20 0 1978 1979 1980 1981 1982 1983 1984 1985 1988 1989 1990 1991 1992 1993 1994 2001 Years 1978 data added by Khuri-Bulos . Melnick and Hatch (bull WHO 1984)

  32. Vaccine policy changed in 1995 following outbreak • NIDs + routine vaccination starting 1995 • 2 OPV mass vaccination yearly for all children <5 years of age (15 OPV doses by age 5 yrs of age) • National Certification Committee (NCC) to monitor coverage and disease (AFP) 1996 • Performance was above 90% till 1999 • NCC chairman was informed of vaccine refusal for the NID dose in some centers

  33. Response • Assemble the National expert group • Identify reason for drop in immunization coverage • Advise on what to do and implement soonest Budget was set aside for this by MOH

  34. Identify reason for decreased coverage.. Ask the public • Rapidly set up pilot survey at the JUH over a three week period between April 9-27, 2000, Convenience sample used • 43 Parents (mothers) of children who are hospitalized at the JUH pediatric ward interviewed by the same interviewer • Immunization card reviewed • Open and closed questions on • Vaccine and provider used • Knowledge of side effects • Knowledge of dangers • Source of information on benefits to use vaccines • Source of information on vaccine dangers • Most trusted source of information when in doubt

  35. Health Facilities used in Vaccination

  36. Dangers of vaccines perceived by 43 Parents JUH 2000 Sterility Growth Retardation Spoilt/contaminated/expired Mental Retardation

  37. Vaccine and Dangers • Vaccine most implicated: OPV • OPV was the only one implicated in sterility • 6 of those who thought sterilitywas a danger refused OPV in the NID

  38. Trusted Sources of information by 43 Parents, JUH 2000 • Pediatrician31 • Nurse 3 • Other health professional 1 • Own knowledge 1 • Television 2 • Books 1 • Note that the internet and social media did not exist on a wide scale at that time

  39. Action taken • Media campaign started immediately using TV, Radio and newspapers reminding the public about the dangers of polio • Media campaign continued for several months • Media campaign included medical community with lecture tours by the committee members to Medical associations and lay public • Coordination with the whole EPI team was done in order to prevent similar problem with other vaccines

  40. Rumor reported Rumor

  41. Lessons learned • Must pay attention to vaccine rumors before they get “out of hand” • Must have political support and help and budget for these activities • Independent team with the NCC was able to help the EPI • Must be attentive to local concerns

  42. The MMR and Sterility!! 2012 • Political Payback

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