Adverse events following immunizations

1
Adverse events following immunizations

• Presentation to NESI Training Meeting, Nairobi, 9
  11 Dec 2002
• Dr R Eggers

2
Overview

• Safety of HepB Hib vaccines
• Definitions and surveillance
• Media interaction
• Crisis communication
• Acknowledgements
• John Clemens, Phillipe Duclos, WHO/HQ
• Pem Namgyal, WHO/HQ

3
Safety of HepB vaccine

• Hepatitis B vaccine is very safe
• Mild, transient side-effects may occur after
  immunization, they include
• soreness at injection site (3-9)
• fatigue, headache irritability (8-18)
• fever, gt37.70C (0.4-8)
• These transient side-effects usually start within
  a day after the vaccine has been given and last
  from 1 to 3 days

4
Safety of HepB vaccine

• Serious allergic reactions to the vaccine, ie
  hives, difficulty in breathing shock are rare
  (affecting about 1 child in 600,000 vaccinated)
• There is no scientific evidence to link HepB
  vaccination to occurrence of chronic conditions
  such as multiple sclerosis, chronic fatigue
  syndrome, rheumatoid arthritis, diabetes or
  autoimmune disorders

5
Safety of Hib vaccine

• Hib vaccine, either as single antigen or in
  combination with other antigens, is very safe and
  has not been associated with any serious side
  effects.
• However, minor reactions may occur and they
  include
• redness, pain and swelling (in 25) may occur
  where injection was given
• less commonly fever and irritability may occur
  for a short period after immunization
• when given at same time as DTP, the rate of fever
  and/ or irritability is no higher than when DTP
  is given alone

6
Safety of Hib vaccine

• There is no scientific evidence to link Hib
  vaccine with serious reactions such as
  anaphylaxis, thrombo-cytopenia or transverse
  myelitis
• it is one of the safest vaccines currently
  available

7
An Adverse Event is an Untoward Event Temporally
Associated with Immunization that Might or Not Be
Caused by the Vaccine or the Immunization Process

• Programme-related
• Reactions related to the inherent properties of
  the vaccines
• Coincidental

8
Causality Assessment Difficulties

• Challenge / rechallenge / dechallenge
• Dose related effect
• Lack of specific marker
• Lack of pathognomonic syndrome
• Complex composition
• Immunology versus pharmacology
• Simultaneous vaccinations

9
Specificity of the Surveillance of Adverse
Events Following Immunization Compared with the
Surveillance of Adverse Events to Drugs

• Vaccine disease prevention in a healthy person
• Reporting pathways
• Specific expertise
• Causality assessment
• Risks and benefits (link with disease
  surveillance)

10

• No Surveillance System

• Media hear first
• Crisis situation
• Hasty regulatory action detrimental to the
  immunization program

11
Important Considerations - 1

• Systems sufficiently active, sensitive and timely
• Passive surveillance
• readiness to conduct a field investigation
• At a minimum routine surveillance coordinated at
  the national level
• more targeted active surveillance as needed
• Spontaneous reporting mostly useful to generate
  hypothesis, for lot by lot monitoring and to
  detect programmatic errors. To interpret data
  one needs a rational epidemiological approach
• Need for speedy analysis and identification of
  potential problems

12
Important Considerations - 2

• Although there is a need for collaboration with
  industry, one cannot rely on manufacturers
• Does not need to be performed by the national
  control authority but by the structure with
  better contact with the public health system and
  medical professions
• Need for good and formal collaboration between
  the National Control Authority and the Expanded
  Program on Immunization. Both need to be
  informed of problematic issues
• Spontaneous reporting must be integrated to
  disease surveillance programs and vaccine
  evaluation activities
• Need for international collaboration

13
Spontaneous Reporting Systems Limitations

• Underreporting
• Lack of sufficient data on the case
• Reporting bias
• Injection
• Temporal reporting bias
• Media coverage, new programs, new age groups
• Lack of standardization
• Background rate
• Large number of doses being used specially during
  campaigns
• Limited duration of follow-up

14
From the medias point of view.
15
Who are the media?

• Print - magazines, newspapers
• Electronic - radio, TV, internet
• Editorial system (editor to reporters)

16
We work to...

• Gather and spread balanced information
• Act as the public watchdog
• Sell newspapers (copy)
• Highlight controversy
• Expose malpractice and negligence

17
What is newsworthy?

• Dramatic (e.g. thalidomide)
• Many people affected
• Unexpected (measles vaccine and autism)
• Polarities
• Conflict (minister versus industry)
• Location (close to own country or hospital)
• Discourse (miracle drug or poison, stereotypes to
  fall back on)
• Celebrity link

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We like.

• Accuracy and simplicity
• Statistics with explanation, if possible
• Context
• Comments or explanation form the highest
  authority possible
• Controversial issues
• To investigate both sides of story
• A fast response

19
We like a spokesperson who is...

• polite, informed and authoritative
• accurate and reliable
• articulate
• available
• trustworthy (honest)

20
We do not like....

• evasive people
• unavailable people
• being shunted about (fobbed off)
• being spoken down to (patronised)
• academic jargon and complexity

21
Some basic questions we will ask you.

• WHO - is affected responsible
• WHAT has happened
• WHERE has it happened
• WHAT is being done about it
• WHEN - did it happen
• WHY - did it happen
• WILL - it happen again

22
Editorial System

• More than just the journalist
• Includes
• journalist and photographer
• news editor chief photographer
• sub-editor
• chief sub-editor
• assistant editors
• editor

23
CRISIS COMMUNICATIONTHE BASICS

• Communications is severely tested in crisis
  situations when there is a high degree of
  uncertainty
• Have a Crisis Communications Plan in place before
  it arises

24
WHY HAVE A CRISIS PLAN FOR YOUR PROGRAMME?

• A Crisis Communications Plan can help you
  anticipate and prepare for adverse events

25
Steps

• Write a brief description of the goal of your
  crisis communication plan
• Establish a crisis communications team
• Prepare a list of those inside and outside the
  organization who should be informed when a crisis
  occurs
• Prepare a list of key spokespersons
• Ensure all employees know who the designated
  spokespersons are
• List possible crisis situations and outline
  appropriate communication responses
• Ensure all the spokespeople obtain media training