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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?
"Slide 1 - Reserve Officers Association"