Impact of Adverse Events Following Immunization On Immunization Programmes

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Impact of Adverse Events Following
ImmunizationOn Immunization Programmes

• Strategic Communication Workshop
• Public Trust and Adverse Events Following
  Immunization
• Delhi, August 9-10, 2004
• Dr Anne Golaz
• Regional Advisor, Immunization
• UNICEF Regional Office for South Asia
• Kathmandu

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Impact?

• Any documented impact of real AEFI or rumors of
  AEFI, on coverage, disease incidence, national
  vaccine policies?
• Impact of AEFI reported mostly from
  industrialized countries, very little written
  from developing countries
• Few documented examples from Europe and Africa,
  found in medical journals, and UN publications
• After this presentation, examples from South
  Asian countries Afghanistan, Bangladesh, India,
  Pakistan

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Nigeria, KANO state immunization
boycottInternational impact on polio
eradication

• August, 2003 OPV immunization halted in Kano
  state, Northern Nigeria, after rumors circulated
  by hardline religious clerics stating that
• OPV vaccine could cause sterility in girls

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Nigeria Kano state from local to international
impact
Soon after boycott started, Kano became epicenter
of big and fast growing outbreak of polio, spread
to whole country 83 global cases from
Nigeria then to neighboring countries, including
10 that previously had been free of polio

• Polio spread from Kano, to 10 countries
• Ivory Coast
• Ghana
• Togo
• Benin
• Burkina Faso
• Cameroon
• Central African Republic
• Chad
• Sudan
• Botswana

Wild virus type 1
Wild virus type 3
Endemic countries
Importations
Importations
Polio cases as of June 15, 2004
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Long-term impact of Kano boycott?

• July, 2004 11-month ban on OPV lifted campaign
  re-started
• Small fraction of hardliners in local government
  councils still not accept the vaccine because
  governor succumbed to pressure of the federal
  government
• Controversy over safety of polio vaccine
  generated rejection of all vaccines could
  potentially threatened the acceptance of other
  beneficial health programs
• African countries with imported virus risk
  resurgence of disease as routine OPV3 lt50
• Conspiracy theories spread to other Islamic
  states Pakistan and Afghanistan

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Local impact DPT3 and NID OPV reported
coverage, 1997by Province, KENYA
Combatting Anti-vaccination RumoursLessons
Learned from Case Studies in East Africa UNICEF
Publication 2002

• - Central province educated population highest
  routine coverage
• - Lowest NID OPV coverage, why?
• 1) Militant Catholic bishop led campaign against
  OPV spread rumors about OPV associated with
  devil worship (color of OPV red, snake on the WHO
  logo)
• 2) Home to the political opposition political
  atmosphere bred fear and distrust since
  government never gave anything to people of the
  Central province, why OPV?

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Mbarara district, UGANDADTP3 reported coverage,
1989-2000
NID dates changed, coinciding with malaria peak
season

Fears created by the deaths from malaria right
after children received OPV in 1997, led to
association of child deaths with NID season, and
routine vaccination. Temporal association became
a causal association in the mind of many
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UGANDA NIDs 1997-1999Reported OPV coverage
Anti-OPV radio broadcast 2
Anti-OPV radio broadcast 1

Difference? In 1999, rumors broadcast made little
impact officials had a plan of action to counter
rumors and educate people about immunization
starting at the community level
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Jordan AEFI outbreak, 1998Small cluster of
events major national impact

• September 1998 during annual nationwide
  school-based Td campaign gt800 teenagers believed
  they had suffered from side-effects of Td vaccine
  administered at school 122 admitted at hospitals
• Schools were told to stop using the vaccine
  event had started in 1 school, with a few
  affected students, and led to the interruption of
  the school-based immunization program in Jordan!
• Information spread outside school TV and radio
  appeared on scene and rapidly disseminated story
  throughout country parents panicked
• Investigation established that for a vast
  majority, symptoms did not result from vaccine,
  but mass psychogenic illness (hysteria), only
  ten cases true AEFI rate AEFI found within the
  expected range of AEFI for Td
• After the investigation, the Jordanian Ministry
  of Health reinstated the Td vaccine and restored
  the public health confidence in immunization
  programme
• S Kharabsheh et al. Mass psychogenic illness
  following tetanus-diphtheria toxoid vaccination
  in Jordan. WHO Bulletin, 2001, 79(8)764-70.

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Jordan Context/background very important

• Number of negative rumors circulating about
  immunization at the time background of
  suspicion
• Before outbreak of AEFI, strong anti-government
  feeling related to public water debate just
  before on contamination of water detrimental to
  childrens health
• When press reported students hospitalized, bad
  vaccine given by the government to our children
  government was to blame yet again

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VACCINE REACTIONS

• Local Reactions
• Systemic Reactions
• Allergic Reactions
• Emotional

Jordan Mixture of genuine mild side-effects from
Td vaccine and psychologically-induced effects
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Jordan lessons learned

• Immunization campaign large number of doses
  given over short period of time more AEFI seem
  to occur
• Actual AEFI rate remains within expected range,
  sheer numbers involved during that period can
  produce clustering effect
• Relationship with media cannot be built up
  quickly during a crisis long-term investments
  provide the media with a continuous flow of
  information
• Rapid and clear response called for in a crisis
• AEFI surveillance system needed

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Pertussis vaccination in Europe Impact
anti-vaccine movements in 1970-80s

• Sustained use of DTP
• Low pertussis incidence
• Hungary
• Poland
• East Germany
• USA
• Efficacy whole-cell pertussis vaccine!
  Vaccination controls pertussis!

• Decreasing coverage
• Pertussis incidence increasing
• Sweden
• Japan
• UK
• Italy
• West Germany
• Anti-vaccine movements!
• UK 1974 report on 36 neurological reactions to
  pertussis vaccine

Gangarosa E. et al. Impact of anti-vaccine
movements on pertussis control the untold story.
Lancet, vol 351, January 31,1998
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• Incidence of pertussis in countries affected by
• active anti-vaccine movements - England and Wales

Active anti-vaccine lobby
DTP introduced
500
400
81
81
93
300
Vaccine uptake
Incidence per 100,000
Cases per 100,000
200
31
100
0
1940
1950
1960
1970
1980
1990
1940
1950
1970
1980
1990
1960
Year
Year
Gangarosa E. et al. Impact of anti-vaccine
movements on pertussis control the untold story.
Lancet, vol 351, January 31,1998
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Sweden impact on national policies

• Pertussis vaccination started in 1950s
• In 1967, influential medical leader pertussis
  milder disease because of social, medical
  progress questioned need for vaccine
• By 1975, pediatricians lost confidence in
  pertussis vaccine cases occurred in vaccinated
  children and some neurological events were blamed
  on the vaccine
• ? DTP coverage decreased from 90 in 1974 to 12
  in 1979
• 1979 National policy change abandon pertussis
  vaccine
• 1980s Sweden reported gt 10000 case /year
  gt100/100000

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Sweden
Whole-cell pertussi vaccine coveragesubstantially
decreased
1940 55 70 85
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Sweden and Norway
National policy changed DPT not recommended
Gangarosa et al., Lancet
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? DTP coverage fell from 80 in 1974 to 10 in
1976 ? Pertussis epidemic occurred in 1979 with
gt 13000 cases/ 41 deaths, complications
(pneumonia, encephalopathy, seizures)
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Current vaccine scares Potential threats to
national and international immunization programs
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UK MMR and autism

• 1997, considerable national media interest in
  possible adverse effects of MMR
• In Wales, MMR uptake declined 14 in the
  distribution area of a local newspaper covering
  MMR story aggressively, as compared to 2.4
  decline in other areas of Wales
• In 3 months, local paper had published 5 front
  page headline articles, 3 opinions, 18 other
  articles on MMR
• B. Mason et al. Impact of a local newspaper
  campaign on the uptake of MMR vaccine. J
  Epidemiol Community Health, 200 54473-74
  Dec20(4)1099-106

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MMR and autism Lessons learned

• Most people learn about medicine and science from
  newspaper, magazine stories, radio, TV programmes
  and the internet
• Most parents trust health care providers in
  Attitudes, Knowledge and Practice survey of
  physicians in Italy most important factor in
  decision of parents to vaccinate
• Health care workers must be trained to be well
  informed of both benefits of immunization as well
  as issues of parental concern regarding vaccine
  safety
• Engage the news media, train health care workers!

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Impact of AEFI Summary lessons learned

• Local impact ?? national ?? international
• To build public trust in vaccine
• Importance of media and health care providers in
  giving correct information about vaccine
• Importance of background of trust lack of
  information, religious opposition, distrust of
  central government on other issues (poverty and
  marginalisation of underserved population at the
  root of popular disgruntlement refusal of
  vaccine)
• Importance AEFI surveillance for monitoring of
  immunization safety

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Evolution of Immunization Programs and Prominence
of Vaccine Safety
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4
3
2
1
Prevaccine
Increasing
Loss of
Eradication
Resumption of
Coverage
Confidence
Confidence
Disease
Incidence
Vaccine
Outbreak
Coverage
Adverse
Events
a
Eradication
b

• Maturity

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Conclusions

• Take AEFI seriously they can have serious impact
  on immunization programmes
• Paradox successful disease-control encourages
  complacency as VPD become rarer, attention shift
  from disease to adverse events set the stage for
  movements opposed to vaccination
• Loss of confidence ? resurgence of disease

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Thank you!
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