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Immunizations: Safe and Very Neccessary Jeffrey R. Boscamp, MD Chair, Department of Pediatrics Physician-in-Chief The Joseph M. Sanzari Children’s Hospital.

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Presentation on theme: "Immunizations: Safe and Very Neccessary Jeffrey R. Boscamp, MD Chair, Department of Pediatrics Physician-in-Chief The Joseph M. Sanzari Children’s Hospital."— Presentation transcript:

1 Immunizations: Safe and Very Neccessary Jeffrey R. Boscamp, MD Chair, Department of Pediatrics Physician-in-Chief The Joseph M. Sanzari Children’s Hospital Hackensack University Medical Center Community Medicine and School Health: Hot Topics For 2009 American Academy of Pediatrics/ NJ Chapter October 28, 2009

2 Vaccine Refusal, Mandatory Immunization and the Risks of Vaccine-Preventable Diseases Omer, SB, Salmon, DA, Orenstein WA, deHart, MP and Halsey, N N Engl J Med, May 7, 2009; 360: 1981-8

3 CASE STUDY: ASHLAND, OREGON Population: 20,000; SW Oregon Population: 20,000; SW Oregon 28% vaccine exemption rate; Alternative school: 67% 28% vaccine exemption rate; Alternative school: 67% One mother: “One of the basic tenets of my decision-making is mistrust of the government, a mistrust of the pharmaceutical companies, and mistrust of the big-blanket thing that says this is what everybody has to do” One mother: “One of the basic tenets of my decision-making is mistrust of the government, a mistrust of the pharmaceutical companies, and mistrust of the big-blanket thing that says this is what everybody has to do” “I get the public health standpoint; I am still questioning vaccines’ safety” “I get the public health standpoint; I am still questioning vaccines’ safety”

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5 New York Times, 10/20/09 Audrey Opdyke, 27 year old waitress, pregnant Audrey Opdyke, 27 year old waitress, pregnant June 27, 2009, mild flu symptoms. Discharged from the hospital beginning of October. June 27, 2009, mild flu symptoms. Discharged from the hospital beginning of October. 5 weeks in a coma, 6 ptx, seizure, prolonged ventilator support 5 weeks in a coma, 6 ptx, seizure, prolonged ventilator support Delivered via c/s, 26 weeks, baby died in 7 minutes Delivered via c/s, 26 weeks, baby died in 7 minutes Opdykes wanted to publicize what they went through. “We have friends who get flu symptoms and say, ‘Oh, I’m not going to a doctor,’ Mr. Opdyke added. “And we say, ‘Do you not understand what we went through? I can’t imagine why there is such nonchalance.” Opdykes wanted to publicize what they went through. “We have friends who get flu symptoms and say, ‘Oh, I’m not going to a doctor,’ Mr. Opdyke added. “And we say, ‘Do you not understand what we went through? I can’t imagine why there is such nonchalance.”

6 New York Times, 10/20/09 That nonchalance strikes close to home. As they said this, Ms. Opdyke was doing her daily physical therapy, struggling to lift one-pound weights. Her therapist interrupted to announce she opposed flu shots. “Have you ever read the labels?” she asked. “They’re so full of toxins.” Asked if she realized that a shot, had it existed in June, might have saved her client and her baby, she frowned and went back to her clipboard.

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15 Those who cannot remember the past are condemned to repeat it. - George Santayana, 1905

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17 Much of the decline in infant mortality in the 20 th century was due to treatment and prevention of infectious diseases

18 DIPHTHERIA Sore throat, fever, swollen neck Sore throat, fever, swollen neck Throat membrane Throat membrane Pneumonia, heart failure, unable to swallow, kidney failure, death Pneumonia, heart failure, unable to swallow, kidney failure, death 5% die, many more with permanent damage 5% die, many more with permanent damage 1920’s: 100,000 – 200,000 cases/year 1920’s: 100,000 – 200,000 cases/year 1999: 1 case 1999: 1 case Immunization rates down (Eastern Europe, states of former USSR): Tens of thousands of cases Immunization rates down (Eastern Europe, states of former USSR): Tens of thousands of cases

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21 TETANUS Toxin producing spores; soil and animal intestines Toxin producing spores; soil and animal intestines Not person-to-person Not person-to-person Contaminated wound, unimmunized Contaminated wound, unimmunized Severe muscle contractions, “Lockjaw” Severe muscle contractions, “Lockjaw” Late 1940’s: 500 – 600 cases per year Late 1940’s: 500 – 600 cases per year Now: 40 – 60 cases per year Now: 40 – 60 cases per year World War II, US troops: 12 Cases (6 not immunized) World War II, US troops: 12 Cases (6 not immunized)

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27 INFLUENZA Highly contagious Highly contagious Fever, muscle aches, HA, nasal congestion Fever, muscle aches, HA, nasal congestion Pneumonia Pneumonia Annual: 36,000 deaths; 200,000 hospitalizations Annual: 36,000 deaths; 200,000 hospitalizations 1918 pandemic: 21 million deaths worldwide; 500,000 in US 1918 pandemic: 21 million deaths worldwide; 500,000 in US Hospitalization rates: 65 years Hospitalization rates: 65 years Flu activity in children <5 years old predictive of pneumonia deaths in general population Flu activity in children <5 years old predictive of pneumonia deaths in general population Children main source of transmission Children main source of transmission

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30 Influenza A, Subtype H1N1 Novel H1N1 Virus (CDC) Novel H1N1 Virus (CDC) Pandemic H1N1/09 Virus (WHO) Pandemic H1N1/09 Virus (WHO) Swine Flu Swine Flu Reassortment of genes from different influenza viruses Reassortment of genes from different influenza viruses Swine (American, Europe/Asia), Avian, Human Swine (American, Europe/Asia), Avian, Human Mexico, April 2009 Mexico, April 2009 Pandemic, WHO, June 11, 2009 Pandemic, WHO, June 11, 2009

31 POLIO Intestinal virus, person to person Intestinal virus, person to person Pre-vaccine: 13,000–20,000 people paralyzed; 1000 died Pre-vaccine: 13,000–20,000 people paralyzed; 1000 died Now eradicated from western hemisphere Now eradicated from western hemisphere Ultimate herd immunity: OPV immunized everyone Ultimate herd immunity: OPV immunized everyone

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33 Martha Mason, Who Wrote Book About Her Decades in an Iron Lung, Dies at 71 (NYT, 5/9/09)

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37 MENINGOCOCCAL DISEASE Bacteria leads to life threatening infections Bacteria leads to life threatening infections Bloodstream, meningitis Bloodstream, meningitis Fever, stiff neck, HA, rash, shock, seizures Fever, stiff neck, HA, rash, shock, seizures If survive, 10-20% deaf, brain damage, circulation/gangrene If survive, 10-20% deaf, brain damage, circulation/gangrene 2600 cases/year, most < 5 years 2600 cases/year, most < 5 years Vaccine not protective of all types Vaccine not protective of all types

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42 HEMOPHILUS INFLUENZAE, TYPE B (HIB) Bacteria causes meningitis, epiglottitis, bloodstream infection, bones/joints Bacteria causes meningitis, epiglottitis, bloodstream infection, bones/joints Person-to-person, respiratory droplets Person-to-person, respiratory droplets HIB meningitis: blindness, deafness, learning disabilities, mental retardation, death HIB meningitis: blindness, deafness, learning disabilities, mental retardation, death Pre-vaccine: 20,000 invasive infections, 1,000 deaths Pre-vaccine: 20,000 invasive infections, 1,000 deaths Vaccines: 1985, 1987 Vaccines: 1985, 1987 Now rare (<50 cases/year) Now rare (<50 cases/year) Worldwide now: 203 million cases; 386,000 deaths Worldwide now: 203 million cases; 386,000 deaths Vaccine decreases carriage Vaccine decreases carriage

43 Hemophilus Influenzae, Type B, 2008-2009 Hemophilus Influenzae, Type B, 2008-2009 Minnesota, 2008: 5 children, 5mo-3yr, invasive HIB disease. Most cases in Minnesota since 1992 Minnesota, 2008: 5 children, 5mo-3yr, invasive HIB disease. Most cases in Minnesota since 1992 3 received no vaccine; 5 mo. old-2 doses; 1 with hypogammaglobulinemia 3 received no vaccine; 5 mo. old-2 doses; 1 with hypogammaglobulinemia Philadelphia, 2008-2009: 5 cases HIB- 2 deaths Philadelphia, 2008-2009: 5 cases HIB- 2 deaths All unimmunized or underimmunized All unimmunized or underimmunized 1 child, unvaccinated 4 year old, died of meningitis (3/09). 1 child, unvaccinated 4 year old, died of meningitis (3/09).

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47 MEASLES MEASLES Highly contagious virus Highly contagious virus Pneumonia, encephalitis Pneumonia, encephalitis Survivors of encephalitis: blindness, deafness, brain damage Survivors of encephalitis: blindness, deafness, brain damage SSPE SSPE Pre-vaccine: universal disease Pre-vaccine: universal disease 1958: 763,000 infections, 532 deaths 1958: 763,000 infections, 532 deaths 2008 (Jan-July): 131 cases; 42 in 2007 2008 (Jan-July): 131 cases; 42 in 2007 Worldwide now: 350,000-750,000 children die per year Worldwide now: 350,000-750,000 children die per year Priority for UNICEF Priority for UNICEF African mothers/naming of children African mothers/naming of children Possible world eradication: need high % vaccine coverage Possible world eradication: need high % vaccine coverage –Could eliminate need for future vaccine

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51 WHY IMMUNIZE? To prevent common infections To prevent common infections To prevent infections that could easily re-emerge To prevent infections that could easily re-emerge To prevent infections that are common in other parts of the world To prevent infections that are common in other parts of the world

52 Are Vaccines Safe? Are Vaccines Safe? Risk vs. Benefit Risk vs. Benefit Vaccine Adverse Events Reporting System (VAERS) Vaccine Adverse Events Reporting System (VAERS) Vaccine Safety Data Link (VSD)- Background rate of side effects Vaccine Safety Data Link (VSD)- Background rate of side effects Clinical Immunization Safety Assessment (CISA)- Safety collaborative Clinical Immunization Safety Assessment (CISA)- Safety collaborative Licensure: FDA approval- Animals, adults, children Licensure: FDA approval- Animals, adults, children Concomitant use studies Concomitant use studies Recommendations: Advisory Committee on Infectious Diseases-ACIP Committee on Infectious Diseases-COID, AAP American Academy of Family Physicians-AAFP Recommendations: Advisory Committee on Infectious Diseases-ACIP Committee on Infectious Diseases-COID, AAP American Academy of Family Physicians-AAFP

53 Do Vaccines Overwhelm the Immune System? Too Many Vaccines? Children exposed to fewer immunologic components of vaccines than in the past Children exposed to fewer immunologic components of vaccines than in the past Smallpox (200 proteins) vs. current recommended vaccines (about 150 proteins/polysaccharides) Smallpox (200 proteins) vs. current recommended vaccines (about 150 proteins/polysaccharides) 30 years ago: 7 vaccines, 3000 proteins 30 years ago: 7 vaccines, 3000 proteins Now: 14 vaccines, 150 proteins/polysaccharides Now: 14 vaccines, 150 proteins/polysaccharides 11 or 12 vaccines in 1 st 2 years of life is a miniscule challenge compared to tens of thousands of environmental challenges that babies manage every day 11 or 12 vaccines in 1 st 2 years of life is a miniscule challenge compared to tens of thousands of environmental challenges that babies manage every day

54 Aluminum Most abundant metal; 9% of earth’s crust Most abundant metal; 9% of earth’s crust Pots, pans, soda cans, foil Pots, pans, soda cans, foil Food: Adults ingest 7-9 mg/day Food: Adults ingest 7-9 mg/day Adjuvant in vaccines Adjuvant in vaccines Vaccine aluminum same as in 1 qt. infant formula Vaccine aluminum same as in 1 qt. infant formula Infants receive: 4.4 mg- vaccines (1 st 6 months) 7 mg-breast feeding 38 mg-formula fed 117 mg-soy formula Infants receive: 4.4 mg- vaccines (1 st 6 months) 7 mg-breast feeding 38 mg-formula fed 117 mg-soy formula Important in developing fetus: Blood level at birth> mother’s Important in developing fetus: Blood level at birth> mother’s

55 Formaldehyde Formaldehyde Concern: High concentrations can damage DNA; cause cancer in cells in lab Concern: High concentrations can damage DNA; cause cancer in cells in lab Residual formaldehyde in some vaccines Residual formaldehyde in some vaccines Not shown to cause cancer in humans or lab animals Not shown to cause cancer in humans or lab animals

56 Formaldehyde Formaldehyde Formaldehyde essential in human metabolism; required for synthesis of DNA/Amino acids Formaldehyde essential in human metabolism; required for synthesis of DNA/Amino acids All humans have detectable formaldehyde (2.5 micrograms/ml of blood) All humans have detectable formaldehyde (2.5 micrograms/ml of blood) Total formaldehyde in infant: 1.1 mg Total formaldehyde in infant: 1.1 mg Avg. quantity in immunization at one time: 0.2 mg Avg. quantity in immunization at one time: 0.2 mg Animals have been safely given 600X the amount in vaccine doses Animals have been safely given 600X the amount in vaccine doses

57 MMR and AUTISM MMR and AUTISM 1998- Andrew Wakefield, published in Lancet 1998- Andrew Wakefield, published in Lancet Reported 8 children who developed autism after MMR Reported 8 children who developed autism after MMR Measles virus particles visualized in intestines Measles virus particles visualized in intestines All of the children had symptoms before MMR All of the children had symptoms before MMR 2004: 10 of 13 authors of Lancet paper requested paper be withdrawn; “Data was insufficient” 2004: 10 of 13 authors of Lancet paper requested paper be withdrawn; “Data was insufficient” Later, hundreds of thousands of children studied +/- MMR: Autism rate the same Later, hundreds of thousands of children studied +/- MMR: Autism rate the same

58 THIMEROSAL and AUTISM THIMEROSAL and AUTISM Ethylmercury (vaccine) vs. methylmercury (environment) Ethylmercury (vaccine) vs. methylmercury (environment) Numerous studies +/- thimerosal: Autism rate the same Numerous studies +/- thimerosal: Autism rate the same Most thimerosal removed in USA by 2001 Most thimerosal removed in USA by 2001 Denmark removed thimerosal in 1991; increase in autism after removal Denmark removed thimerosal in 1991; increase in autism after removal Exclusively breast-fed infant: Total ingestion: 2x the mercury ever in vaccines, 15x the amount in influenza vaccine Exclusively breast-fed infant: Total ingestion: 2x the mercury ever in vaccines, 15x the amount in influenza vaccine

59 Top 10 Reasons Why to Immunize Your Child Against Influenza Top 10 Reasons Why to Immunize Your Child Against Influenza Children are at the epicenter of annual outbreaks Children are at the epicenter of annual outbreaks To prevent deaths To prevent deaths To prevent hospitalizations and morbidities To prevent hospitalizations and morbidities To protect fragile children To protect fragile children To protect fragile adults To protect fragile adults Because it works Because it works Because it is safe Because it is safe Because it is cost-effective Because it is cost-effective Because it decreases ear infections Because it decreases ear infections Because staph aureus and influenza go together Because staph aureus and influenza go together Might save a grandparent’s life…think about it!

60 Novel H1N1: Statistics Who knows? Who cares? Who knows? Who cares? Testing issues Testing issues Age 25 and under; few cases over age 64 (<7% of hospitalizations since 9/1/09, ? x-reactivity with prior flu) Age 25 and under; few cases over age 64 (<7% of hospitalizations since 9/1/09, ? x-reactivity with prior flu) Projections: Projections: 2 billion cases next 2 years (WHO) 2 billion cases next 2 years (WHO) U.S.: 1.8 million hospitalizations U.S.: 1.8 million hospitalizations Up to 90,000 deaths (? young people) Up to 90,000 deaths (? young people) Up to 50% of U.S. population: 150 million Up to 50% of U.S. population: 150 million ICU utilization ICU utilization

61 Novel H1N1 vs. Seasonal Flu: What’s different? Age distribution/severity (ARDS) Age distribution/severity (ARDS) Time of year Time of year Fever Fever Vomiting/diarrhea Vomiting/diarrhea Rapid antigen test Rapid antigen test

62 Novel H1N1: Symptoms Fever (? reliable) Fever (? reliable) Cough Cough Sore throat Sore throat Body aches, HA Body aches, HA Chills Chills Fatigue Fatigue Vomiting/diarrhea Vomiting/diarrhea Progression to respiratory distress, seizures, disorientation Progression to respiratory distress, seizures, disorientation

63 Novel H1N1: When To Seek Medical Attention Rapid breathing or trouble breathing Rapid breathing or trouble breathing Bluish skin color (cyanosis) Bluish skin color (cyanosis) Not drinking enough fluids Not drinking enough fluids Not waking up or interacting Not waking up or interacting Child irritable to the point of not wanting to be held Child irritable to the point of not wanting to be held Flu-like symptoms improve but then return with fever, worsening cough Flu-like symptoms improve but then return with fever, worsening cough Fever with a rash Fever with a rash

64 Novel H1N1: Avoidance Wash hands Wash hands Avoid contact with people who are ill Avoid contact with people who are ill Cover cough/sneeze (not with hands!) Cover cough/sneeze (not with hands!) Stay home from school or work if ill -No fever for >24 hrs (off meds) -7 days if flu more severe than spring ’09 Stay home from school or work if ill -No fever for >24 hrs (off meds) -7 days if flu more severe than spring ’09 Vaccine Vaccine Environmental sanitation (lives 2-8 hrs on surfaces) Environmental sanitation (lives 2-8 hrs on surfaces)

65 Novel H1N1: Vaccine New vaccine, shipments now arriving New vaccine, shipments now arriving 45-50 million doses initially, then 20 mill/week 45-50 million doses initially, then 20 mill/week Revised down to 30 mill doses by end Oct ‘09 Revised down to 30 mill doses by end Oct ‘09 200 million doses total, possibly 800 mill doses 200 million doses total, possibly 800 mill doses Younger than age 10, 2 doses, 3-4 weeks apart Younger than age 10, 2 doses, 3-4 weeks apart Inactivated vaccine vs. live vaccine (Flumist) Inactivated vaccine vs. live vaccine (Flumist) Don’t forget about seasonal influenza vaccine! Don’t forget about seasonal influenza vaccine!

66 Novel H1N1: Vaccine Safety Same manufacturing process as seasonal Same manufacturing process as seasonal No adjuvant in U.S. No adjuvant in U.S. Thimerosal Thimerosal Guillain-Barre Syndrome Guillain-Barre Syndrome

67 H1N1 Nasal Mist Vaccine: Contraindications Younger than 2 yrs; 50 and older Younger than 2 yrs; 50 and older Egg allergy Egg allergy Pregnancy Pregnancy Immunodeficiency Immunodeficiency Chronic illness: heart, lung kidney, liver disease; diabetes, blood disorders, asthma Chronic illness: heart, lung kidney, liver disease; diabetes, blood disorders, asthma Children < age 5 with 1 episode of wheezing in the past year Children < age 5 with 1 episode of wheezing in the past year Neuromuscular disease Neuromuscular disease Contact of severely immunocompromised pt. Contact of severely immunocompromised pt. Long term aspirin Long term aspirin

68 Novel H1N1: Initial Target Groups Persons aged 6 mo-24 yrs (20x more common than >65) Persons aged 6 mo-24 yrs (20x more common than >65) Caretakers of infants < 6 months of age Caretakers of infants < 6 months of age Pregnancy Pregnancy Health care workers Health care workers Non-elderly adults (25-65) with risk factors (asthma, obesity, immune compromised, etc.) Non-elderly adults (25-65) with risk factors (asthma, obesity, immune compromised, etc.)

69 Novel H1N1: Treatment Oseltamivir (Tamiflu) Oseltamivir (Tamiflu) Zanamivir (Relenza) Zanamivir (Relenza) Oseltamivir resistance Oseltamivir resistance Treatment not indicated unless at high risk of complications or hospitalized Treatment not indicated unless at high risk of complications or hospitalized Best if within 48 hrs of onset of symptoms Best if within 48 hrs of onset of symptoms

70 Novel H1N1: High Risk for Complications Children <2 years old Children <2 years old Adults 65 or older Adults 65 or older Pregnancy Pregnancy Chronic medical conditions Chronic medical conditions Younger than 18 on aspirin Younger than 18 on aspirin Immunosuppressed Immunosuppressed Obesity (BMI 40+) Obesity (BMI 40+)

71 Novel H1N1: Severe Disease 25% of hospitalized needed ICU; 10+% died 25% of hospitalized needed ICU; 10+% died Children and teens >50% of hospitalized; more than 50% with severe disease previously healthy Children and teens >50% of hospitalized; more than 50% with severe disease previously healthy Pregnancy: As of 8/09, 100 required ICU, 28 deaths Pregnancy: As of 8/09, 100 required ICU, 28 deaths As of 10/15/09, 86 childhood deaths, usually 50 deaths in whole season; since 8/30/09, 43 pediatric deaths As of 10/15/09, 86 childhood deaths, usually 50 deaths in whole season; since 8/30/09, 43 pediatric deaths Life threatening pneumonia progressing to ARDS more common than in seasonal flu Life threatening pneumonia progressing to ARDS more common than in seasonal flu ? Young women> men, controlling for pregnancy ? Young women> men, controlling for pregnancy Oscillators, ECMO Oscillators, ECMO

72 Novel H1N1: Resources www.cdc.gov www.cdc.gov www.cdc.gov www.flu.gov www.flu.gov www.flu.gov www.nj.gov/health/flu/h1n1 www.nj.gov/health/flu/h1n1 www.nj.gov/health/flu/h1n1 www.aap.org www.aap.org

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74 FACT: If a significant proportion of the population opts-out of immunization programs, vaccine-preventable diseases will re-emerge and cause childhood illness and deaths. Been there, done that.

75 FACT: Immunization is a critical public health issue No vaccine has 100% take. We depend on high immunization rates to protect immunized children and those who cannot be immunized. We depend on vaccines for the overall health of our country and world.

76 Thank you to Paul Offit, M.D and the Vaccine Education Center Vaccine.Chop.edu Vaccine.Chop.edu

77 If you would like a copy of this presentation, e-mail me at : jboscamp@humed.com jboscamp@humed.com


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