Transcript Investigating AEFI - Vanderbilt University Medical Center

Investigating Adverse Events
Following Vaccination
Robert C. Sparks, Research Coordinator
Vanderbilt Vaccine Research Program
Vanderbilt University Medical Center
1161 21st Ave. South, CCC 5319 Medical Center North
Nashville, TN. 37232-2573
Investigating AEFI
• Adverse Event Following Immunization
• Who? What? When? Where? Why?
• Who? Can be any patient of any age, gender, race, or
ethnicity…..patients have been as young as 2 months
old up to 70+ years of age. Totally non-discriminatory,
although some populations are more susceptible to AE’s,
such as those with known hypersensitivity or predisposing illness/disease
• What? Any vaccine…MMR, Rotavirus, DtaP, Hep B,
HiB, PCV, Influenza, Varicella, Hep A, Meningioccocal,
YF…any vaccine or combination could be a likely culprit.
Investigating AEFI
• When? Typically the event occurs within 24 to 48 hours
following administration….but it can be immediate as in
the case of anaphylaxis, or delayed longer…even
months after the vaccine has been given.
• Where? The body as a whole, or specific localization is
possible. For example, influenza vaccine has been
associated with Guillain-Barre Syndrome (GBS),
(systemic), DtaP, has been linked with “big leg
syndrome” (localized)
• Why? It could be hypersensitivity to specific
components, adjuvants, preservatives, medium of
transport, predisposition due to illness, age,
administration error, etc. etc….
Investigating AEFI
• Information Sources:
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CISA (Clinical Immunization Safety Assessment)
VAERS (Vaccine Adverse Event Reporting System)
PUBLISHED ARTICLES
SUBJECT MATTER EXPERTS
ALLERGISTS / IMMUNOLOGISTS
• PATIENT AND / OR PARENT (often the best source)
CISA
• Clinical Immunization Safety Assessment
• Sponsored and underwritten by CDC
• A network of principal investigators, coordinators, subject
matter experts, associate fellows and others working
together to collectively attempt to answer questions
surrounding AEFI, such as causality, re-challenge, etc…
Located at sites around the country, each group has
unique resources available, and each month, sites
discuss the more unique AEFI’s in a working group
teleconference
CISA…cont.
Affiliate sites:
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Boston Medical Center
Columbia University Medical Center
Johns Hopkins University
Northern California Kaiser Permanente
Stanford University
Vanderbilt University Medical Center
CISA…cont.
Key Partners:
• NCIRD (National Center for Immunization and Respiratory
Diseases)
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NVAC (National Vaccine Advisory Committee)
FDA (Food and Drug Administration)
HRSA (Health Resources and Services Administration)
ACIP (Advisory Committee on Immunization Practice)
NVPO (National Vaccine Program Office)
DoD (Department of Defense)
VAERS
• A passive database sponsored by CDC that allows the
investigator to enter certain criteria or parameters to
search for cases that are similar in nature. This allows
the group or individual to see if there is a “trend” in
regards to a certain vaccine, group of symptoms, or an
age or gender group. The investigator can enter groups
of criteria including symptoms, vaccines, age groups,
gender, U.S. reports, foreign reports, military reports,
etc., and the database will search within those
parameters.
VAERS….cont.
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VAERS LINE LIST
VACCINES: PER,PPV,ROT,FLUN
MedDRA PTs: ERYTHEMA MULTIFORME
REPORT DATE RANGE: 01/01/2004 to 01/01/2009
Primary Records Only: YES
Non-Foreign Reports Only: YES
AGE IN MOS: > 6
Current Date: MAR 03, 2009(Based on VAERS data as
of MAR 02, 2009)
VAERS….cont.
A serious spontaneous report of erythema multiforme has been received from a
physician concerning a three-year-old female, subsequent to FLUMIST. Concomitant
medications included mometasone furoate, loratadine and montelukast for allergic
rhinitis and congestion (patient had a prescription but physician was not sure if the
patient took montelukast). On 17-Oct-2008, the patient received FLUMIST. She
never received FLUMIST before. The following day on 18-Oct-2008, the child
developed a rash which progressed and was described as a bullseye rash all over
body. On 19-Oct-2008, the patient was hospitalized for erythema multiforme. The
patient was hospitalized for three days. The reporting physician did not have the
patient's hospital records. On 24-Oct-2008, the patient recovered from erythema
multiforme. Additional information received on 25-Nov-2008 was incorporated into
the above narrative: a diagnosis, concomitant medication, medical history, and
demographics.Erythema multiforme A non-serious spontaneous report of erythema
multiforme has been received from a Registered Nurse concerning a two year-old
male subsequent to FLUMIST. This case is submitted in accordance with
MedImmune's post-marketing commitment on accelerated reporting for the newly
indicated population of 2 years to 59 months of age for FLUMIST. The patient
received FLUMIST on 21-Oct-2008. The patient received a total of one dose before
onset of the event which occurred three days later. On 24-Oct-2008 the child was
diagnosed with erythema multiforme. It was described as "raised lesions on buttocks,
legs and abdomen." The event remains unresolved with the rash present.
Published Articles
Vaccine adverse event monitoring systems across the European Union
countries: Time for unifying efforts.
Zanoni G, Berra P, Lucchi I, Ferro A, O'Flanagan D, Levy-Bruhl D, Salmaso S,
Tridente G.
Vaccine. 2009 Feb 5. [Epub ahead of print]
PMID: 19200851 [PubMed - as supplied by publisher]
Acute cerebellar ataxia in the Netherlands: A study on the association
with vaccinations and varicella zoster infection.
Vaccine. 2009 van der Maas NA, Bondt PE, de Melker H, Kemmeren JM.
Mar 18;27(13):1970-3. Epub 2009 Jan 30.
PMID: 19186201 [PubMed - in process]
Factors determining utilization of a Web site by parents in order to report
side effects of vaccines.
Kimpton A, Dubé E, Sauvageau C, De Serres G.
Can J Public Health. 2008 Nov-Dec;99(6):456-9. French.
PMID: 19149385 [PubMed - indexed for MEDLINE]
Published Articles…cont.
Safety and efficacy of a novel microneedle device for dose sparing
intradermal influenza vaccination in healthy adults.
Van Damme P, Oosterhuis-Kafeja F, Van der Wielen M, Almagor Y,
Sharon O, Levin Y.
Vaccine. 2009 Jan 14;27(3):454-9. Epub 2008 Nov 18.
PMID: 19022318 [PubMed - indexed for MEDLINE]
Adverse events after anthrax vaccination reported to the Vaccine
Adverse Event Reporting System (VAERS), 1990-2007.
Niu MT, Ball R, Woo EJ, Burwen DR, Knippen M, Braun MM; VAERS
Working Group.
Vaccine. 2009 Jan 7;27(2):290-7. Epub 2008 Nov 6.
PMID: 18992783 [PubMed - indexed for MEDLINE]
Subject Matter Experts,
Allergists/Immunologists
• Kathryn Edwards, MD Sarah Sell Chair in
Pediatrics, Vice Chair Pediatrics, Director
Vanderbilt Vaccine Research Program
• Melvin Berger, MD, PhD, Senior Medical
Director Clinical R&D, CSL Behring, LLC
• Stephen C, Dreskin, MD Professor of Medicine,
Univ of Colorado,Practice Director, Allergy and
Immunology
• Jim Sejvar, MD, Neuroepidemiologist, CDC,
Brighton Collaboration
Subject Matter Experts,
Allergists/Immunologists (cont.)
• Collin Marchant, MD, Boston Medical Center
• Phil LaRussa, MD, Columbia University Medical
Center
• Neal Halsey, MD, Johns Hopkins University
• Nicky Klein, MD, Roger Baxter, MD, Northern
California Kaiser Permanente
• Cornelia Dekker, MD, Stanford University
Investigating AEFI
• Many facets of investigation and information
gathering go into critically examining an AEFI to
determine if a causative factor can be
determined, as well as attempting to reach a
consensus in treatment of the event, and/or
preventing a recurrence, particularly in cases
where multiple doses are required to convey
immunity. Sometimes that is not possible, as the
information conflicts itself, such as is evidenced
in published articles, or the risk of rechallenge is
too great as in the case of known anaphylaxis.
Investigating AEFI
• Conclusion: Multiple avenues are available to answer the
questions associated with “AEFI”. While a “perfect”
approach to a solution is not always possible, the
questions that do arise, often support more research to
that end. A mixture of databases, published articles that
address related issues, and a network of recognized
leaders in the field all work in a collective effort to seek
an answer. Each case must be looked at separately and
the approach, while structured, often varies, but an open
ended approach is key to attempting to find a causative
factor, and addressing the question of future
immunization.