Title: Adverse events following immunizations
1Adverse events following immunizations
- Presentation to NESI Training Meeting, Nairobi, 9
11 Dec 2002 - Dr R Eggers
2Overview
- Safety of HepB Hib vaccines
- Definitions and surveillance
- Media interaction
- Crisis communication
- Acknowledgements
- John Clemens, Phillipe Duclos, WHO/HQ
- Pem Namgyal, WHO/HQ
3Safety 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
4Safety 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
5Safety 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
6Safety 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
7An 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
8Causality Assessment Difficulties
- Challenge / rechallenge / dechallenge
- Dose related effect
- Lack of specific marker
- Lack of pathognomonic syndrome
- Complex composition
- Immunology versus pharmacology
- Simultaneous vaccinations
9Specificity 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- Media hear first
- Crisis situation
- Hasty regulatory action detrimental to the
immunization program
11Important 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
12Important 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
13Spontaneous 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
14From the medias point of view.
15Who are the media?
- Print - magazines, newspapers
- Electronic - radio, TV, internet
- Editorial system (editor to reporters)
16We work to...
- Gather and spread balanced information
- Act as the public watchdog
- Sell newspapers (copy)
- Highlight controversy
- Expose malpractice and negligence
17What 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
18We 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
19We like a spokesperson who is...
- polite, informed and authoritative
- accurate and reliable
- articulate
- available
- trustworthy (honest)
20We do not like....
- evasive people
- unavailable people
- being shunted about (fobbed off)
- being spoken down to (patronised)
- academic jargon and complexity
21Some 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
22Editorial System
- More than just the journalist
- Includes
- journalist and photographer
- news editor chief photographer
- sub-editor
- chief sub-editor
- assistant editors
- editor
23CRISIS 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
24WHY HAVE A CRISIS PLAN FOR YOUR PROGRAMME?
- A Crisis Communications Plan can help you
anticipate and prepare for adverse events
25Steps
- 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