Slide 1 - Reserve Officers Association

					           Vaccine Healthcare Centers Network




Vaccination Adverse Events &
the Vaccine Healthcare Center

    Reserve Officers’ Association
          Medical Seminar

      Jay R. Montgomery MD, FAAFP, FAAAAI
    Richard E. Shope Vaccine Healthcare Center
                 01 February 2009

                    UNCLASSIFIED
                Vaccine Healthcare Centers Network


                       Terrorism
  “Terrorism is an anxiety-inspiring
 method of repeated violent action”
 that disrupts the cohesive functions
 within a society (civilian or military)
  Man-made terror
  – IEDs, suicide bombers, biowarfare, ...
  Natural terror
  – Forces of nature (tsunami, earthquake, hurricane, …)
  – Pandemics/epidemics (plague, typhoid, 1918 flu, …)

An ounce of PREVENTION is worth a pound of cure
                         UNCLASSIFIED
                 Vaccine Healthcare Centers Network


                  Board Question
1.   Lumbar puncture is indicated?
     a. True
     b. False

2.   Drug of choice is:
     a. Chloramphenicol
     b. Cidofovir
     c. High-dose Aspirin




                          UNCLASSIFIED
                  Vaccine Healthcare Centers Network


                   Board Question
1.   Diagnosis?
     a. Foreign body
     b. Cleft palate repair
     c. Klebs-Löffler Bacillus

2. Treatment of choice is:
     a.   Penicillin
     b.   Anti-toxin
                                              Copyright American Academy of Pediatrics
     c.   A and B
     d.   None of the above

                           UNCLASSIFIED
                   Vaccine Healthcare Centers Network


      Vaccine-Preventable Diseases
Disease                     20th Century           2005     Decrease
                       Max Cases per Year
Diphtheria                         175,885            0     100.00 %
Measles                            503,282           62      99.99%
Mumps                              152,209          262      99.83%
Pertussis                          147,271       20,462       86.11%
Polio (paralytic)                   16,316            1      99.99%
Rubella                             47,745           17      99.96%
Congenital rubella syndrome            823            1      99.88%
Tetanus                              1,314           19      98.56%
H. influenzae type b
  and unknown (< 5 y/o)              20,000             6    99.97%




                              UNCLASSIFIED
           Vaccine Healthcare Centers Network




Vaccination Ain’t Rocket Science
                              – Or Is It?

                    Theory of Relativity
                    How a thing appears depends
                    upon your plane of reference




                    UNCLASSIFIED
              Vaccine Healthcare Centers Network


       The trouble with success



           Disease
          Incidence


                       BUT…                          Adverse
                                                     Events




Plane of Reference:                   Plane of Reference:
Vaccination GOOD                      Vaccination BAD




                       UNCLASSIFIED
Vaccine Healthcare Centers Network


Vaccine Concerns
As Old As Vaccines Themselves




         “The Cow Pock - the Wonderful Effects of the New Inoculation!”
                                  J. Gillray, 1802




         UNCLASSIFIED
    Vaccine Healthcare Centers Network


Vaccines … Still a HOT topic
         •   Controversy Over Vaccines Remains
         •   Consumers are better Informed, but
             sources vary tremendously in accuracy
         •   Fears & Concerns Surrounding
             Vaccines:
              • Risk Vs. Benefit
              • Multiple Vaccinations in Children
              • Intussusception, Guillain-Barré, Allergic
                Rxns
              • Autoimmune reactions
              • Autism, learning disorders, SIDS, etc.??




             UNCLASSIFIED
      Vaccine Healthcare Centers Network


History of Immunization Delivery

             •     Little to no physician oversight
             • Poorly staffed vaccination sites
             •     Largely invisible to performance
                   improvement review
             • Poor documentation
             •     Competency of personnel
             •     Lack of adherence to standards
                   that apply to prescription drugs


                 UNCLASSIFIED
                      Vaccine Healthcare Centers Network


     Quality Standards & Program Evaluation
                            MMWR March24, 2000/49(RR01);1-13

This report provided guidance on how to safely administer vaccines to adults in
      nontraditional settings (e.g., pharmacies, supermarkets, & churches)

 • Standard 1: Information & Education
 • Standard 2: Storage & Handling
 • Standard 3: Screening Medical History
 • Standard 4: Contraindications
 • Standard 5: Record keeping
 • Standard 6: Vaccine Administration
 • Standard 7: Adverse Events
 Competencies: included in new Joint Regulations for
   Immunizations & Chemoprophylaxis

                                UNCLASSIFIED
               Vaccine Healthcare Centers Network


   Congressional Challenge (to DoD)

• Enhance vaccine safety surveillance
• Enhance vaccine safety through improved screening
  process & education of vaccinees and vaccinators &
  access to expert review
• Increase provider knowledge in vaccine safety
  assessment and medical exemptions
    – Regional centers of excellence to support mission
• Improve vaccine adverse events reporting
    – Break down barriers to reporting
    – Improve quality of adverse events reporting
• CDC-DoD collaboration in support of VAERS

                        UNCLASSIFIED
             Vaccine Healthcare Centers Network




                               The Vaccine Healthcare Centers
                               (VHC) Network was established in
                               September 2001 as a network of
                               congressionally-directed centers of
                               excellence that support programs and
                               services that enhance vaccine
                               safety, efficacy and acceptability
                               for service members and Department
                               of Defense beneficiaries.
                               The VHC Network is the clinical arm
                               of MILVAX; DoD line-item funded.
                               The VHC Network’s regional sites:
                               (1) Naval Medical Center Portsmouth
                               (2) Walter Reed Army Medical Center
                               (3) Womack Army Medical Center
                               (4) Wilford Hall Medical Center

“We’re from the Government
  and we’re here to help”

                      UNCLASSIFIED
                          Vaccine Healthcare Centers Network


                  VHC Network Activities
• Vaccine Clinical Support &                         • Support for Research
 Consultation Services                                  • Clinical focus, post-
   • Adverse events case management,                      licensure to “enhance
     (acute/chronic), VAERS, exemptions                   vaccine safety, efficacy,
       • Supporting MTF’s world-wide, deployed &          acceptability”
         home-ported tri-service operational units
                                                     • Advocate For
• Vaccine Safety                                        • Quality immunization
   • Surveillance, reporting, adverse                     healthcare delivery
     events registry, long term follow-up               • Care of complex AEFI’s
• Immunization Healthcare                            • MTF-linked regional sites
 Education                                            not service-specific
   • For Health Care Workers & Service                  • Outreach & Support 24/7
     Members, Beneficiaries, DoD leaders
       • Health Fairs: ships and MTFs
       • Physician lecture series
       • Contribute to Fleet/FMF Newsletters

                                      UNCLASSIFIED
                Vaccine Healthcare Centers Network


      Clinical Consultative Support
• Clinical consultation and management of vaccine adverse
 events 24/7 via internet or phone
• HIPPA-compliant secure E-mail support (AskVHC)
• Digital picture review
• Specialty collaboration (Neurology, Rheumatology, etc.)
• On-site assessment, evaluation and treatment
• Vaccine exemption recommendations
• Participation in vaccine-related research as patient desires


                         UNCLASSIFIED
   Vaccine Healthcare Centers Network


Education and Outreach




                                                2007
                                               Edition




                                   www.VHCinfo.org
                                   www.vaccines.mil
            UNCLASSIFIED
              Vaccine Healthcare Centers Network


                      Definitions
• Adverse Reaction
  – Extraneous effect caused by the vaccine
     • Side effects
         – Local reactions
              » Pain, swelling and redness at the injection site.
         – Systemic reactions
              » Fever, irritability, drowsiness, malaise, rash, etc.
     • Hypersensitivities Reactions
         – Gelatin, egg, antibiotic allergies (IgE)
         – Arthus reactions (IgG/IgM)

• Adverse Event
  – Any event following a vaccination
     • May be a true adverse reaction
     • May be only coincidental

                            UNCLASSIFIED
                 Vaccine Healthcare Centers Network


                  Real Life Case #1

Patient presents to your
clinic for his Flu shot.
This was him last year
after receiving his Flu
shot (this could be a
child or an adult) –

What would you do?

                             Humantics Foundation @ www.humanticsfoundation.com/shari.htm




                           UNCLASSIFIED
                        Vaccine Healthcare Centers Network


                          Real Life Case #1
Remember: not all reactions are “allergic”!
But, what’s in vaccines that you can be allergic to?
•   Hepatitis B – soy, yeast - a few allergic rxn reports.
•   Flu - egg, gelatin, Neomycin, Polymyxin B, Gentamicin - few allergic rxn reports
•   MMR – gelatin, Neomycin - some allergic rxn reports.
       – Egg sensitivity is no longer a concern.
•   Polio - Neomycin, Polymyxin B, Streptomycin - a few allergic rxn reports.
•   Tetanus - Formaldehyde, Gelatin, some allergic rxn reports.
•   Typhoid – several reports of severe reactions, but not c/w anaphylaxis, rather
    involving high fever, headache, and vomiting.
•   Varicella – gelatin, Neomycin - some allergic rxn reports.
•   Latex – read package insert.
•   Thimerosal, formaldehyde – DTH rxn, not contraindication to vaccination

Caution: vaccines in other countries may contain different components!
                                   UNCLASSIFIED
                Vaccine Healthcare Centers Network


                 Real Life Case #2

Child presents to your
clinic with sores on face

Treat with Bactroban &
send home?




                         UNCLASSIFIED
          Vaccine Healthcare Centers Network


           Real Life Case #2




Lesion Progression 08 March through 01 May 2007

                   UNCLASSIFIED
                   Vaccine Healthcare Centers Network


                    Real Life Case #3

Mother calls your office —
“Can my daughter safely get the
  2nd MMR shot?”
• Received MMR at 16 months of
  age & within 10 days developed
  rash and bruising
    – Platelet count < 20,000
    – Treated with immunoglobulin
    – Two months later, platelet
      count 287,000
• Family PCS’ing to Measles-
 endemic part of Europe.

What would you do?
                               UNCLASSIFIED
                              Vaccine Healthcare Centers Network


                                 Real Life Case #3

    – Serologic titers for measles, mumps, and rubella?
    – Measles/Rubella non-protective, now what?
    – Risk of recurrence?
           • Absolute risk within 6 weeks after MMR: 1 in 22,300-25,000
           • Risk with natural measles, rubella ~1:3,000 cases
    – All options discussed with Mom.
    – Chose to administer only the necessary vaccines one at
      a time at 1-2 months intervals following platelet counts.
    – Child responded well, without recurrence of
      thrombocytopenia.

                Miller E, et.al., Idiopathic thrombocytopenic purpura and MMR vaccine. ARCH DIS CHILD 2001;84:227-229
Black C, et.al., MMR Vaccine and idiopathic thrombocytopenia purpura. BR.J.CLIN PHARMACOL. 2003 Jan; 55(1):107-11

                                              UNCLASSIFIED
                      Vaccine Healthcare Centers Network


                        Real Life Case #4

FP watch called to ER
• 21 yr old athletic male presents
    with chest pain after working out
•   No history of cardiac disease
•   Received SPV shot 10 days ago

Send him home with Motrin
for his costochondritis?
What would you do?




                                UNCLASSIFIED
      Vaccine Healthcare Centers Network


Vaccinia Related Myopericarditis
                                              IMPORTANT
                                                   • Get EKG
                                                   • Draw cardiac enzymes
                                                   • Draw viral studies



                                              CARDIOLOGY CONCERN
                                              Myocarditis - Limited activity
                                              for 6 months after diagnosis
                                              Pericarditis - Limited activity
                                              for 6 weeks after recovery


                                              Enroll all cases in DoD-VHC
                                              Myopericarditis Natural History
                                              Registry

                         Ver. 6, March 2008




               UNCLASSIFIED
                                 Vaccine Healthcare Centers Network


             Vaccine Related Myopericarditis
                                                         2006*                                        2008‡
Smallpox                                              45% (17)                                    93% (251)
Influenza                                             29% (11)                                       3% (9)
Hepatitis B                                             8% (3)                                       1% (3)
Meningococcus                                           5% (2)                                      <1% (1)
DPT                                                     5% (2)                                       1% (2)
Yellow Fever                                            3% (1)                                      <1% (1)
Cholera                                                 3% (1)                                      <1% (1)
Rabies                                                  3% (1)                                      <1% (1)
Time of onset                                         1-30 days                                   1-22 days



                                      * M Barton, et. al., Myocarditis Temporally Associated with Vaccines, CPS Poster presentation
   ‡ M Barton, et. al., Eosinophilic myocarditis associated with [MCV & HBV] in children, Pediatr Infect Dis J. 2008 Sep;27(9):831-5

                                                   UNCLASSIFIED
                      Vaccine Healthcare Centers Network


                        Real Life Case #5

“Sickcall; BAS, Baghdad”
• 19 yr old male Army Pvt. noted
    numbness in legs yesterday.
•   Claims he can’t walk or void today.
•   Received Smallpox vaccination 15
    days ago.

Malingering?
Conversion Disorder?

Now What?



                                UNCLASSIFIED
                     Vaccine Healthcare Centers Network


                        Real Life Case #5

• Post-vaccination neurologic adverse events:
   – Usually inflammatory demyelination of the central and/or peripheral
     nervous system white matter with peri-venous microglial
     proliferation.
       • Encephalitis, transverse myelitis, acute disseminated encephalomyelitis,
         Guillain-Barré Syndrome, Brachial neuritis, facial nerve palsies, optic
         neuropathy, and neuromyelitis optica (Devic’s disease).
   – The presumed mechanism, whether viral or vaccine related, is
     antibody-mediated demyelination, although immune-complex
     mediated vasculitis has also been postulated.




                                 UNCLASSIFIED
                                   Vaccine Healthcare Centers Network


                                      Real Life Case #5

 • Not a new occurrence: ‘‘Neuroparalytic accidents’’ noted in
   patients receiving Jenner’s smallpox vaccine in 1853 and
   with Pasteur’s rabies vaccine in 1885.
 • Post-vaccination ADEM: rabies, diphtheria–tetanus–
   pertussis, smallpox, measles, mumps, rubella, Japanese
   encephalitis, polio, flu, & hep B vaccines.
 • The estimated incidence of serious neurological illness
   after vaccination is 0.1-0.2 per million immunizations.
 • Outcome of ADEM is significantly improved due to measles
   vaccine and early use of steroids.
 • Consider high-dose, rapid-infusion IVIG in refractory cases.
Huynh W, Post-vaccination encephalomyelitis: Literature review and illustrative case J Clin Neurosci. 2008 Dec;15(12):1315-22
                       Fu DC, High-dose, rapid-infusion IVIG in post-vaccination [ADEM], Neurology. 2008 Jul 22;71(4):294-5

                                                   UNCLASSIFIED
               Vaccine Healthcare Centers Network


   Vaccine Adverse Event Reporting System
                        VAERS
The National Childhood Vaccine Injury Act of 1986 led
to the creation of a unified national system to collect,
manage, and evaluate the reports of possible adverse
events that occur after the administration of US
licensed vaccines. This passive post-marketing safety
surveillance program, initiated in 1990, is jointly
managed by the CDC and FDA.




                        UNCLASSIFIED
             Vaccine Healthcare Centers Network


              VAERS Objectives

• Trigger and define the need for further studies
   • VAERS is a passive surveillance system
   • VAERS provides a signal for further investigation
   • VAERS does not provide rates or incidence data
• Detect previously unrecognized reactions
   • May be difficult in very rare adverse AE’s
• Detect lot-related vaccine concerns
   • Contamination




                      UNCLASSIFIED
                  Vaccine Healthcare Centers Network


                Establishing Causality

                                                           Illness or Syndrome

                                                              Yes      No




                                       Vaccination
Rate in Vaccinated      = a/a+b                      Yes       a       b


Rate in Unvaccinated = c/c+d                         No        c       d



VAERS provides only “a”, therefore only 25% of information
needed for the comprehensive assessment of a vaccine safety issue




                            UNCLASSIFIED
               Vaccine Healthcare Centers Network


       When is a VAERS Form Filed?

• VAERS filing is mandatory when:
   • There is a hospitalization temporally associated with a vaccine
   • There is loss of 24 hours of duty due to illness, injury, or
     reaction temporally associated with a vaccine
   • Event is on the VAERS reportable events table
   • Contamination of a vaccine lot is suspected
   • Autoinoculation or contact transmission w/ SPV
• VAERS may be submitted when:
   • The patient or provider finds an event unacceptable
   • There is any suspected vaccine-related event
• Immunization & Chemoprophylaxis instruction (2-
  10)* has recommendations for VAERS submission
• There is no time restriction
• Submitter need not prove causality
                     * AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F

                         UNCLASSIFIED
                     Vaccine Healthcare Centers Network


      Reportable Vaccine-Associated Events
•   Tetanus: Anaphylaxis or anaphylactic shock w/in 7 days
•   IPV: Anaphylaxis/shock w/in 7 days
•   Hep B: Anaphylaxis/shock w/in 7 days
•   Pertussis: Anaphylaxis/shock or Encephalopathy/itis w/in 7 days
•   MMR: Anaphylaxis/shock w/in 7 days, Encephalopathy/itis w/in 15 days
•   Rubella: Chronic arthritis w/in 42 days
•   Measles: Thrombocytopenic purpura w/in 7-30 days, Vaccine-strain
    measles infection in an immunodeficient recipient w/in 6 months
•   OPV: Paralytic polio
      – in a non-immunodeficient recipient w/in 30 days
      – in an immunodeficient recipient w/in 6 months
•   Rotavirus: Intussusception w/in 30 days
•   Others: AE described in package insert as contraindications to
    additional doses.
                       42 USC 300aa-25(July 01,2005) [http://vaers.hhs.gov/pdf/ReportableEventsTable.pdf]

                                  UNCLASSIFIED
Vaccine Healthcare Centers Network




                             Journalism 101
                             • Who?
                             • What?
                             • Where?
                             • When?
                             • Why?




         UNCLASSIFIED
             Vaccine Healthcare Centers Network


       Submitting the VAERS form

• Mail, Fax, Telephone, or Internet
   •   Mail: PO BOX 1100, Rockville, MD 20849-1100
   •   Fax: 1-877-721-0366
   •   Telephone: 1-800-822-7967
   •   Electronically: www.vaers.hhs.gov
• Send copies to pharmacy/P&T committee & military
   offices (NMCPHC, et. al.) according to regulations*
• If need help to complete/submit VAERS, or if the problem
  persists, is serious, or requires in-depth review for
  medical exemption…
                     CONTACT THE VHC Network!
                   * AR 40–562/BUMEDINST 6230.15A/AFJI 48–110/CG COMDTINST M6230.4F

                      UNCLASSIFIED
                     Vaccine Healthcare Centers Network


                           Contact Us
The VHC is standing by 24/7 to assist with provider, patient, or
family member questions or referrals


 • Regional Sites:
    –   NMC Portsmouth, VA       757-953-9150
    –   Walter Reed AMC, DC      202-782-0411
    –   Wilford Hall MC, TX      210-292-0482
    –   Womack AMC, NC           910-432-4015

 • Web Site: www.vhcinfo.org
    – Link on website to securely e-mail us

 • DoD Vaccine Call Center:     866-210-6469
    – 24 hour global vaccine clinical support

                              UNCLASSIFIED
QUESTIONS?

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:1
posted:8/1/2012
language:English
pages:38