Vaccine Adverse Events and Risk Communication In Vaccination

Najwa Khuri-Bulos MD,FIDSA Jordan University HospitalAmman, Jordan

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.

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)

VACCINE ADVERSE EVENTS AND RISK COMMUNICATION IN VACCINATIONNajwa Khuri-BulosJordan University Hospital

Jenner

STRONG TOOLS AVAILABLE/EXPECTED

1960 1980 2000// //Diphtheria

Pertussis

Tetanus

YF Influenza

Polio

Measles

JERubella HepBHib (conj)

Typhoid

Cholera Pneumo (conj)RotavirusHPVMening (conj)

Dengue

Malaria TB

HIV/AIDS

Traditional EPI

UnderutilizedVaccines

Future

1960 1980 2000// //Diphtheria

Pertussis

Tetanus

YF Influenza

Polio

Measles

JERubella HepBHib (conj)

Typhoid

Cholera Pneumo (conj)RotavirusHPVMening (conj)

Dengue

Malaria TB

HIV/AIDS

1960 1980 2000// //Diphtheria

Pertussis

Tetanus

YF Influenza

Polio

Measles

JERubella HepBHib (conj)

Typhoid

Cholera Pneumo (conj)RotavirusHPVMening (conj)

Dengue

Malaria TB

HIV/AIDS

Traditional EPI

UnderutilizedVaccines

Future

0

1000

2000

3000

4000

5000

6000

7000

8000

No

. of

case

s

0

20

40

60

80

100

120

Co

vera

ge

rate

No. of Cases 1st dose Measles coverage

2nd dose measles coverage (MMR)

2nd

dose

Measles poliomyelitis

Impact of the EPI

Reported poliomyelitis & VAPP 1979-2008 Jordan

0

5

10

15

20

25

# C

ases

polio wild

VAPP

NIDs SNIDs

OPV

Case Study, Jordan, a great success storyImmunization Coverage for Infants and MMR1

1990-2008, Jordan

0

20

40

60

80

100

120

% C

overa

ge

Measles

OPV 3

OPV 4

DPT 3

HBV 3

Hib 3

MMR

Diphtheria

Diphtheria 175,885 4 -99.99Measles 503,282 81 -99.98Mumps 152,209 323 -99.79Pertussis 147,271 6,755 -95.41Polio (wild) 16,316 0 -100Rubella 47,745 152 -99.68Cong. Rubella Synd.823 7 -99.15Tetanus 1,314 26 -98.02Invasive Hib Disease 20,000 1 67

-99.16

Disease 20th Century Annual Morbidity* 2000** % change

* 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

Total 1,064,8457,515 -99.29

Vaccine Adverse Events 0 13,497^ +++

Comparison of Annual and Current Reported Morbidity, Vaccine-Preventable Diseases and Vaccine Adverse Events, United States

Vaccines don’t prevent diseaseVaccination prevents disease

Maturity

Incidence

Disease

VaccineCoverage

AdverseEvents

Prevaccine IncreasingCoverage

1

Loss ofConfidence

Outbreak

VaccinationsStopped

Eradication

Eradication

2 3 4 5

Resumption of Confidence

Evolution of Immunization Program and Prominence of Evolution of Immunization Program and Prominence of Vaccine Safety ConcernsVaccine Safety Concerns

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

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

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

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

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

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.

History of some adverse effects in the 20th century Vaccine effects are related biologically to

vaccines. These are rare Kyoto disaster 1948 JapanDiptheria vaccine incompletely inactivated 68/606 died Cutter incident 1955 USA Administration of polio vaccine which

was not completely inactivated caused

paralysis

Examples of Vaccine adverse eventsVaccine 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

Diseases reappear when coverage drops

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

Vaccination scheduleJordan 2007

age vaccine

1st contact2 months3 months

4 months

9 months18 Months

BCGDTP + HepB1 +Hib1 + IPV

DTP+HepB2+Hib2 + OPV+IPVDTP+HepB3+Hib3 + OPV

measles + OPVMMR +DTP booster1+OPV booster1

Vaccination Coverage for Infants 1990 - 2005 Jordan

0

20

40

60

80

100

120

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Measles

OPV 3

OPV 4

DPT 3

HBV 3

Hib 3

MMR

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

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)

Number of Td doses administered per day, 7 - 29 September 1998

September 1998

Total dosesadministered

25,667 Up to 27 Sept.

19,578 doses were

administeredwith NO report ofadverse

events•Source: Bulletin of the WHO, Clemens, Kharabsheh S, Jarour, Khuri-Bulos et al 2001,•79 (8)

Life Cycle of a Vaccine Safety Concern

Casereport Standard

assessment

Caseseries • Plausibility

• Alternative hypothesis

+(Communications)

Controlledstudies Communications

Pathophysiology

Risk factors

Risk/benefit policy

• Societal• Individual

• Treatment

• Compensation

• Safer vaccine

• Appropriate C/I

• Screening

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

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)

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

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

Vaccination Coverage for Infants 1990 - 2005 Jordan

0

20

40

60

80

100

120

1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Measles

OPV 3

OPV 4

DPT 3

HBV 3

Hib 3

MMR

Threat to Polio vaccine 1999

140

120

100

80

60

40

20

019781979198019811982198319841985198819891990199119921993

Years

No.

of

Cases

POLIOMYELITIS IN JORDAN1978-2001

19942001

1978 data added by Khuri-Bulos . Melnick and Hatch (bull WHO 1984)

EPI startedOutbreak

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

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

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

Vaccines used by 43 parents, JUH 2000

43 4341

34

19

670

5

10

15

20

25

30

35

40

45

50

Health Facilities used in Vaccination

The use of vaccination facilities

MOH +Private (32.6%)

UNRWA + Private (2.3%)MOH + UNRWA (7.0%)MOH alone (41.9%)

UNRWA alone (11.6%)Private alone (4.7%)

Factors that encouraged 43 parents to vaccinate children, JUH 2000

212

324042

05

1015202530354045

Total number of times vaccine danger implicated by 43 parents, JUH 2000

15

45

15

0

2

4

6

8

10

12

14

16

Sterility

Growth

Retardation

Mental

Retardation

Spoilt/contaminated/

expired

Dangers of vaccines perceived by 43 Parents JUH 2000

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

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

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

0

20

40

60

80

100

120

140

1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2001 2003 2005

Years

Cas

es

0

20

40

60

80

100

120

Imm

uniz

atio

n C

over

age

%

polio cases coverage %

Poliomyelitis & Vaccination coverage (OPV3) 1978 –2005 Jordan

NIDsSNIDs

Rumorreported

Rumor

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

The MMR and Sterility!! 2012 Political Payback

MMR ( Chiron) withdrawal 2005

121309 students vaccinated with MMR Chiron AEFI Investigation of the AEFI reported

20 mumps like illness 2 mild skin allergy One anaphylaxis

Response Stop vaccination Immunization committee meeting & press release Active surveillance for any AEFI Communication Discard unused vaccine (but it was already

paid for)

Political payback and the charges of corruption In 2012, parliament review of

government actions in 2005 for corruption charges.

TV appearance by member of parliament, head of the health committee accusing the previous government in 2005 of negligence and corruption by obtaining vaccines that render children sterile naming the MMR

Government accused for profiteering from a “poorly” made cheaper vaccine

Response

Jordan NITAG Chairman and the Head of the Primary health care requested immediate media TV coverage time to answer the charge

WHO GACVS e mail query if there were any other similar global claims, answer received in time for TV appearance

E mail and other scientific evidence discussed on live TV with MOP and relationship of sterility to MUMPS disease explained but not MMR.

Offer made for willingness to appear in front of the committee.

No invitation made and no more media complaint

MMR uptake remained unchanged

Lessons learned

Must respond immediately to political pressure Increase credibility by obtaining support from

international organizations Keep all lines of communication open since

political instability may hurt well established programs

The whole public, politicians included must be made aware of the great benefit of this program and maintain its integrity in the interest of their own families children in addition to those of the public

Conclusions

Public trust is fragile and is necessary for vaccination programs

Vaccine adverse events even if not related to vaccines and not scientifically sound can disrupt programs

Communication strategy should include educating the parents and the public about the DISEASES prevented and the vaccines

Prompt action is needed due to the increased use of the internet and social media in developing countries

Above all maintain credibility and choose a trusted messenger

The pediatrician is ideally suited to play a central role.

Risk communication strategy Be sensitive Be sincere Be credible and knowledgeable Be prepared

Thank you