Disclosures. Vaccines Save Lives, So Why the Pushback and What to do About It? Learning Objectives. ACIP History and Charge

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1 Disclosures s Save Lives, So Why the Pushback and What to do About It? David W. Kimberlin, M.D. University of Alabama at Birmingham I have no actual or potential conflict of interest in relation to this program I participate as one of dozens of sites for clinical trials conducted by GSK, Cellex, and Cubist. All funds from these efforts go to my university and not to me. I do intend to discuss an unapproved/investigative use of a commercial product/device in my presentation Learning Objectives Discuss the Advisory Committee on Immunization Practices (ACIP) process for recommending new immunization schedules. Review the scientific data on vaccine safety. Discuss strategies to counsel parents effectively on vaccine safety and effectiveness. Discuss the frequency in which pediatricians deal with parental concerns on vaccine safety. ACIP History and Charge Established by the Surgeon General in 964 Provide expert external advice to the CDC Director on use of vaccines in the U.S. civilian population Develop written policy recommendations for FDA-licensed vaccines and related biologics to prevent infectious diseases Smith et al. Ann Intern Med 29;:4 Factors Considered by ACIP Disease burden (i.e., incidence, morbidity, mortality) safety and efficacy Cost effectiveness ACIP Members Voting members with various expertise (n=) Ex officio members representing federal agencies (n=8) Liaison organizations with interests in vaccine development, licensure, and administration (n=26)

2 Selected Liaison Organizations American Academy of Pediatrics (AAP) American Academy of Family Physicians (AAFP) American College Health Association (ACHA) American College of Obstetricians and Gynecologists (ACOG) American Medical Association (AMA) Council of State and Territorial Epidemiologists (CSTE) Infectious Diseases Society of America (IDSA) National Association of Pediatric Nurse Practitioners (NAPNAP) Pharmaceutical Research and Manufacturers of America (PhRMA) ACIP Recommendations Provisional recommendations approved by ACIP are posted on the CDC website Recommendations are then reviewed by CDC and approved by CDC Director Final recommendations are published in MMWR Ten Greatest Public Health Achievements United States, Vaccination Motor-vehicle safety Safer workplaces Control of infectious diseases Decline in deaths from coronary heart disease and stroke Safer and healthier foods Healthier mothers and babies Family planning Fluoridation of drinking water Recognition of tobacco use as a health hazard MMWR 999;48: Smallpox Pertussis (paralytic) Congenital Syndrome Reduction in -Preventable Diseases, United States Disease 2th Century Annual Morbidity 29, 2,3 3,27 62,344 2,72 6,36 47,74 Haemophilus influenzae 2, 243 MMWR 2;8(,2):48-46 JAMA 27;28: Reported Cases ,6 4 4 Percent Decrease % % > 93% > > 98% Prevention in the 2 th Century At the beginning of the 2 th century Infectious diseases were the t serious threat to human life and well-being 6 out of every, children born at the turn of the century died of an infectious disease before the age of years At the end of the 2 th century (my experience) 989: cases per year of Hib meningitis at CMC Dallas every 2-3 days 992: case of Hib meningitis for entire year at CMC Dallas Progression of an Immunization Program Decreased incidence of vaccine-preventable disease Decreased awareness of risks associated with disease Increased relative prominence of vaccine adverse events Media attention Loss of public confidence Chen, in s, Plotkin and Orenstein (eds), 998,

3 Prevaccine Increasing Loss of Resumption Eradication Coverage Confidence of Confidence Coverage Progression of an Immunization Program Disease Adverse Events Outbreak Eradication Immunization Stopped Chen, in s, Plotkin and Orenstein (eds), 998, Risk Perception Individuals differ in their perception of risk depending on personality, education, and life experience Voluntary risks are usually more acceptable than involuntary risks Many persons prefer the consequences of inaction rather than action CDC, 999 Concerns: Not A New Phenomenon In 736 I lost one of my Sons a fine Boy of 4 Years old, by the SmallPox taken in the common way. I long regretted bitterly and still regret that I had not given it to him by Inoculation; this I mention for the Sake of Parents, who omit that Operation on the Supposition that they should never forgive themselves if a Child died under; my Example showing that the regret may be same either way, and that therefore the safer should be chosen. Benjamin Franklin Concerns: Not A New Phenomenon The Cow Pock or the Wonderful Effects of the New Inoculation! J. Gillray, 82 Recommended Childhood Immunization Schedule, 983 mo yrs 4-6 yrs,, Pertussis Td (trivalent),, MMR 3

4 Recommended Childhood Immunization Schedule -6 Years, 2 Recommended Childhood Immunization Schedule 7-8 Years, 2 9 Smallpox ~ 2 ~ 2 Immunogenic Proteins and Polysaccharides in s 96 Smallpox WC Pertussis ~ 2 ~ 3 ~ WC Pertussis ~ 3 9 ~ 34 AC Pertussis Hib conj. Varicella Pneumo conj. Hepatitis B AC Pertussis 2-9 Hib conj. 2 Varicella 69 Pneumo conj. 8 Hep A and B Rotavirus Influenza Are Infants Too Young to be Vaccinated? From birth, infants are challenged by bacteria in the environment (colonizing bacteria on intestines, skin, and throat; bacteria inhaled on dust) Vigorous siga responses within the first week of life keeps colonizing bacteria from invading 4

5 Aluminum The alternative schedule suggests only one aluminum containing vaccine at a time in infant years. By spreading out the shots, you spread out the exposure so infants can process the aluminum without it reaching toxic levels. Aluminum Aluminum is the third t abundant element on the earth s surface, and the t abundant metal As a consequence, aluminum is in the air we breathe, the food we eat, and the water we drink Robert Sears, The Book, p. 239 Aluminum in Food Aluminum is found in breast milk and infant formulas By 6 months of age: s 4 mg Breast milk mg Infant formula 3 mg Soy formula 2 mg Harm in Alternative Schedule Not science- or evidence-based More likely to induce needle phobia Increase time during which children are susceptible to vaccine-preventable diseases Responsibility to the waiting room No benefit Take-Home Points s save hundreds of thousands of lives every year Scientific evidence has proven vaccines are safe Despite proof, parents are more anxious than ever We must speak plainly, directly, and passionately, emphasizing: The need to vaccinate each and every child The safety of vaccines