Great Colleges to Work For 2023 Survey Overview
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Common Vaccine Myths and Misconceptions Robert M Jacobson, MD, FAAP Professor of Pediatrics, Mayo Clinic Consultant, Community Pediatric and Adolescent Medicine Medical Dir, Mayo Clinic s Primary Care Practice Immunization Program in Rochester, Kasson, and SE MN Region
Disclosures Potential conflicts Safety Review Committee Quadrivalent HPV vaccines in males (Merck) Nonavalent HPV vaccine (Merck) Data and Safety Monitoring Board 15-valent pneumococcal conjugate vaccines (Merck) No off-label use discussion
Disclosures Other potentially more concerning conflicts Robert Bror Jacobson Martin Bror Johan Jacobson Reverend Henning Jacobson Jacobson v Massachusetts
Learning Objectives At the completion of this activity, participants will be able to: Address the myth regarding autism and vaccines Counter the myth regarding immune system overload Respond to several other common immunization myths
Myth #1 2015 Gallup poll From what you have read or heard, do you personally think certain vaccines do or do not cause autism in children, or are you unsure? 6% Yes, a cause 41% No, not a cause 52% Unsure
But What about Parents? 2015 Gallup poll From what you have read or heard, do you personally think certain vaccines do or do not cause autism in children, or are you unsure? Overall <H.S. educated 6% Yes, 64% Unsure 18-29 years old 9% Yes, 60% Unsure Parents of <18 8% Yes, 53% Unsure 6% Yes, 52% Unsure
Origin of the Myth Originated in 1997 Andrew Wakefield, UK surgeon, Lancet Reported series of children with chronic enterocolitis and regressive developmental disorder Claimed 2/3 d had onset of behavioral symptoms following measles-mumps-rubella vaccine
Dozens of Studies Refute Claim From countries from all over the world Various types of methodology Mayo Clinic did two of those studies No associations found Onset Severity GI symptoms including IBD IOM, WHO, AMA, AAP all concur: No connection
And Wakefield? Wakefield s study completely discredited Flawed research methods Undisclosed financial conflicts of interest Ethical violations Wakefield lost license, paper retracted
Cause(s) of Autism Twin studies indicate congenital and genetic Of note some examples with congenital injury Thalidomide Congenital rubella infection of mother Symptoms manifest long before 12 mos old Accelerated diagnosis strongly correlated in US New diagnostic criteria Federal law requiring schools to provide assistance
Myth #2 Salmon 2009 I am concerned that children s immune systems could be weakened by too many immunizations Among exempting parents 65% agreed or strongly agreed Among vaccinating parents 34% agreed or strongly agreed
Myth #2: Vaccines Weaken the Immune System Variations on this myth Vaccines can overwhelm the immune system Infants cannot handle all these vaccines Giving vaccines all at once is unsafe
Infant Immune Systems Stronger than you might think Biggest antigen exposure in life occurs with first feeding Capacity to respond to 10,000 vaccines at once If all 14 vaccines given at once, Would use less than 0.1% infant s immune capacity Not even sure this is limit System manages countless bacteria, viruses each day
Immune System Overload What we know versus what is feared Immune system can refuse to see a vaccine Result is that antigen is discarded without impact When a second MMR given too soon after first Or when MMR or VAR given before 12 months Doesn t overwhelm, just fails to impress Same problem with polysaccharide antigens PPSV23 and infants less than 2 years of age
Now versus Then Smallpox vaccine antigens Whole-cell DTwP antigens Current vaccine schedule Much more refined Much less reactive Far less antigens than from past vaccines
Timing of the Vaccines The ideal vaccination would occur Before the person is exposed to risk With a time enough to develop a full response In a person old enough to respond to the vaccine With just one dose to minimize the effort
Timing of the Vaccines In reality Often cannot protect person early enough Balance between risk and responsiveness Often need repeated doses to prime, then boost
Vaccines Being Given Together? Prelicensure studies Test vaccine at age to be given Test vaccine with other vaccines due at that age US FDA requires Proof of both effectiveness and safety Proof that other vaccines still work just as well Some vaccines fail the tests Live vaccines either simultaneous or 28 days apart PCV before PPSV23 and widely separated
Variation on Overload Clinicians often misunderstand Vaccines do not worsen existing disease Existing diseases are not contraindications Diarrhea (except for the rotavirus vaccines RV1 and RV5) Minor URIs (including otitis media) with or without fever Antibiotic use (except for antivirals and some live vaccines) Convalescing from an acute moderate or serious illness Exposure to a contagious disease Premature birth (except for weight with HepB) Vaccines don t require clearance with a physical exam
Vaccines and Illness Mild illness Studies show safety and efficacy Skipping vaccines results in major delays Use of every visit to update vaccines critical Moderate and severe illness Avoids incriminating vaccines with illness s sequelae Avoids complicating illness with transient AEs Vaccinate as soon as in convalescent phase
Myth #3 We don t need to vaccinate because infection rates are already so low in the US Gallup polls 14 years apart How important is it that parents get their children vaccinated? 2001 Extremely or very important 94% 2015 Extremely or very important 84%
Basis for Some Parents Exemptions Salmon 2009 Reasons for claiming non-medical exemptions 37% My child not at risk for the disease(s) 20% Disease(s) not dangerous
The Reality Vaccinations success own worst enemy As vaccines work to reduce disease, individuals No longer read or hear about the disease Continue to hear about vaccines and various myths Begin to question if vaccines still necessary Begin to question if diseases they prevent really that bad
Herd Immunity Herd immunity helps Protects those with weakened immune systems Protects those who can t get the vaccines Protects those in whom immunity has waned Herd immunity is imperfect Doesn t work for tetanus Requires disease-specific rates of herd immunity Vaccine-preventable dx just a plane ride away
More Problems with the Herd Individual decisions put others at risk School age children bring flu into community Middle schoolers expose babies to pertussis Toddlers put adults at risk for hepatitis A Refusing families tend to cluster geographically Some of us at risk despite our vaccinating Immunocompromised due to meds or illness Too young or old to be vaccinated Vaccine just didn t take
The Current Risk Vaccine-preventable diseases just a flight away International travel put everyone at risk When vaccine rates drop, disease goes up Only one eradicated vaccine-preventable disease Smallpox Upon proof of eradication Stopped routine vaccination Polio and measles might be next Can t stop until proof of world wide eradication of all cases
Myth #4 Better hygiene and sanitation are actually responsible for disease infections, not vaccines Timing of reduction in specific diseases Vaccine specific Related to vaccine uptake Not related to major changes hygiene, sanitation Hygiene, healthier lifestyles great, But can t provide disease-specific immunity Won t protect against vaccine-preventable disease
Measles in the USA Pre 1963 4,000,000 infections a year 48,000 children hospitalized a year 500 deaths a year 1963 First measles vaccine introduced 1970 25,000 cases a year
Haemophilus influenzae type b 1990 For years in US ~20,000 cases a year Primarily young infants Serious disease: meningitis and septicemia Frequently lifelong complications, sometimes death Hib vaccines introduced 1993 1,500 cases a year
Annual Disease Rates in US Disease Pre-Vaccine Vaccine Era 1921 102,791 2009 1921 206,000 2009 1943 175,000 2009 16,858 1948 600 2009 1952 29,000 2009 1962 503,000 2009 1964 212,000 2009 1969 57,686 2009 70 2009 1980 20,000 2009 Smallpox Diphtheria Pertussis Tetanus Polio Measles Mumps Rubella Congenital Rubella 1970 Hib 0 0 18 0 71 1,991 3 2 38
Myth #5 Salmon 2009 Reasons for claiming non-medical exemptions 38% Better to get natural disease than a vaccine
The Reality with Natural Disease Stronger immunity than the vaccine? Can be the case (measles, mumps, rubella, varicella) Not always the case (HPV, Hib, pneumo, and tetanus) With all diseases Risk of complications is always much, much higher Occurrence is unpredictable With most diseases Contagion to others unlike vaccines Risk for others who may suffer more than you
Measles as Example Once universal illness Measles as a natural disease Frequent cause of hospitalization Otitis media, pneumonia, encephalitis Risk of death 1 out of 500 Death from measles-containing vaccination Severe allergic reaction Risk of death 1 out of a million
MMR and Thrombocytopenia MMR does increase risk of thrombocytopenia Drop in platelets Usually self-limited and not life-threatening Rarely serious bleeding, requiring transfusions 1/40,000 Rubella as a viral illness in children, adults Risk of thrombocytopenia 1/3,000
Chicken Pox Chicken pox poster child of this claim 21st century manifestations Chicken pox parties Chicken pox lollipops
Chicken Pox Pre-Vaccine Era 1970-1994 Deaths 105 deaths in the U.S. each year 2.0 to 3.6 deaths per 100,000 cases Primarily children with normal immune systems Hospitalizations 10,632 hospitalization in the U.S. each year 2.3 to 6.0 hospitalizations per 100,000 cases Primarily infants and adults > 20 Skin and soft tissue infections, pneumonia, dehydration, and encephalitis
Shingles as Another Example 1996-2001 Olmsted County residents N=1669 Attributable healthcare utilization for the year Shingles without complications (83%) 1.8 outpatient visits 3.1 prescribed medications Cost of $720 Shingles with complications (17%) 7.5 outpatient visits 14.7 prescribed medications Cost of care $3998 Extrapolated for all of U.S. $1.1 billion
Myth #6 Salmon 2009 Reasons for claiming non-medical exemptions 57% Vaccines might cause harm
Vaccines Might Cause Harm? Vaccines are biologics All interventions carry risk But benefits of vaccines greatly outweigh risks
Basis for Statement Prelicensure studies with vaccine Conducted at age of indication Conducted with other vaccines recommended Conducted in very large numbers as RCTs FDA Licensure Insures validity, reliability, and generalizability Insures safe and uniform manufacture Advisory Committee on Immunization Practices Assures balance of benefit, cost and risk
ACIP Advisory Committee on Immunization Practices 15 members 14 infectious disease and public health experts 1 layperson as patient representative Supported by CDC and FDA Meets three times a year Harmonizes federal recs with medical academies Only fraction of FDA licensed vaccines routinely recommended Basis is GRADE of evidence
GRADE Grading of Recommendations Assessment, Development and Evaluation ACIP uses with every recommendation Considers the factors important to the decision Evaluates the strength of the evidence Determines the recommendation Strength of the recommendation Direction of the recommendation
More on Statement Post-licensure studies mandated by FDA, CDC Vaccine Adverse Events Reporting System Vaccine Safety Link Program Mandated Phase IV studies No other drug or biologic gets such scrutiny
Facts Immediate risks (1/10,000-1/50,000) Allergic reactions Other severe side effects Thrombocytopenia following MMR Risks of death from these so rare, incalculable Estimate of risk of death from severe allergic rx 1/1,000,000 to 1/2,000,000
IOM Study of Worlds Literature Examined strength of causality Measles, mumps, and rubella (MMR) Varicella Influenza Hepatitis A Hepatitis B Human papillomavirus (HPV) Meningococcal Diphtheria-toxoid-, tetanus toxoid-, and acellular pertussis-containing vaccines
IOM Conclusions Vaccines are very safe Serious adverse events are very rare Updated vaccine injury tables Used by Nat l Vaccine Injury Compensation Program
Evidence Favors Rejection MMR Influenza Influenza MMR DT, TT, or aP containing Autism Bell s Palsy Asthma Type 1 Diabetes Type 1 Diabetes
Evidence Favors Acceptance HPV MMR Influenza Anaphylaxis Temporary Joint Pain Oculorespiratory syndrome
Evidence Convincingly Supports Injection Related Event Injection Related Event Meningococcal Tetanus Toxoid Hepatitis B Influenza Varicella MMR Deltoid bursitis Syncope Anaphylaxis Anaphylaxis Anaphylaxis Anaphylaxis Anaphylaxis Anaphylaxis
