ALTERNATE VACCINE SCHEDULES WHATS THE BIG DEAL Dr

ALTERNATE VACCINE SCHEDULES – WHAT’S THE BIG DEAL? Dr. Vanessa Slots Division chief general pediatrics, Renown Children’s hospital

Objectives Review current CDC guidelines Discuss safety and efficacy of vaccines Discuss Alternate Vaccine Schedules and the concerns with “Spreading out” vaccines Address common concerns

CDC 2018 VACCINE SCHEDULE

COMBINED 7 SERIES 4 DTAP: 3 IPV: 1 MMR: 3*HIB: 3 HEPB: 1 VAR: 4 PCV

WHY ONLY 70% UTD? 28% of parents had doubts about vaccines (Gust et al, Pediatrics 2008) 2013 AAP Periodic Survey stated 87% of pediatricians reported encountering parents who delayed/refused vaccinations 2006 survey showed 74. 6% 13% of parents delay or select out of certain vaccines (Leask, Pediatrics 2015)

“SPREADING OUT” VACCINES Kempe, et al (Pediatrics 2015; 135) surveyed Family Medicine and Pediatric Providers 93% reported parents requested spreading out vaccines in a typical month More commonly reported by pediatrics vs family medicine 2015 study showed 37% often/always agreed to spread out vaccines (2009 survey showed 13%) 82% thought it would build trust 80% thought families might leave their practice 35% felt like it sent mixed message 40% reported that these requests decreased their job satisfaction

A Lot, % Some, % A Little/Not at All, % Concern that their child will suffer long-term complications from vaccinesa 57 29 15 General worries about vaccines without a specific concerna 43 37 20 Belief that their child is unlikely to get a vaccine-preventable diseasea 42 32 27 Concern that their child will suffer immediate, short-term effects (such as fever, pain, or excessive crying) from vaccines 40 31 29 Parental concern that their child could develop autism as a result of vaccinationa 36 39 25 The belief that they should play a central role in medical decisions for their child 34 32 34 Concern that vaccines will weaken their child’s immune systema 30 35 35 A friend or relative’s positive experience with an “alternative schedule”a 26 42 32 Parental desire to decrease the pain associated with multiple injectionsb 25 33 42 Parental concern about possible ill effects of thimerosal 21 42 37 Belief that vaccine-preventable diseases are not severe enough to warrant vaccinationa 19 36 45 Belief that vaccines are not effective 4 25 71

VACCINE SAFETY DEVELOPMENT Vaccines must demonstrate both safety and efficacy before licensure Identification of a need for vaccine and demonstrate an understanding of immunity against that disease Preclinical studies Submission to FDA that describes the manufacturing and testing process, summarize the lab reports and describe proposed studies Phase I, II and III trials

VACCINE SAFETY MONITORING Long term safety must be monitored Vaccine Adverse Events Reporting System (VAERS) Voluntary, passive reporting Vaccine Safety Datalink Millions involved so can detect rare events Post-Licensure Rapid Immunization Safety Monitoring System Uses insurance claims of millions to monitor safety Clinical Immunization Safety Assessment Project

CURRENT CDC SCHEDULE Prevents 42000 deaths Prevents 20 million cases of disease Saves $14 billion direct medical costs (Zhou, et al. Pediatrics 2014; 133)

SCHEDULE SAFETY The current vaccine schedule is the ONLY recommended schedule Safety of the CDC administration schedule was strongly affirmed by Institute of Medicine in 2013 and the Agency for Healthcare Research and Quality NO alternative vaccine schedules have been evaluated and found to provide better safety or efficacy

DR. SEARS SCHEDULES

THE PROBLEM Sears wants parents to make informed decisions but has written a book that largely misinforms them Good vs bad science Fails to distinguish studies on the basis of their quality Parents fears trump science Risks from vaccines VAERS reports often represent coincidental and not causal associations and can be misleading Companies list ALL adverse events that occurred after receipt of vaccines even if they occurred at the same rates as placebo (Offit and Moser, Pediatrics, 2009; 123)

UNDERSTANDING THE RESEARCH “Doctors, myself included, learn a lot about diseases in medical school but we learn very little about vaccines…” – Dr. Robert Sears Experts in virology, microbiology, statistics, epidemiology and pathogenesis evaluate data from research and provide recommendations Advisory Committee on Immunization Practices (ACIP) advises the CDC Committee on Infectious disease advises the AAP

NATURAL INFECTION Natural immunity is often better than vaccine induced immunity HOWEVER, the risk of natural immunity can be severe and fatal During the past century, vaccines have increased the lifespan in the United States by ~30 years

CONJUGATED PNEUMOCOCCAL VACCINE Became part of the routine schedule in 2000 Pre-vaccine 17, 000 cases/year of invasive disease in children <5 years 700 cases of meningitis 200 deaths (CDC MMWR Recomm Rep. 2000)

EFFICACY OF VARICELLA VACCINE

VARICELLA DEATHS BY AGE GROUP Pre-Vaccine: 16 deaths/yr in 1 -4 and 5 -9 Post-Vaccine: 3 deaths/yr in 1 -4 and 5 -9 Decline noted in all groups under the age of 50 Greatest reduction of 92% in 1 -4 years of age (Marin et al. Pediatrics 2011; Nguyen et al. NEJM 2005)

HERD IMMUNITY “I also warn not to share their fears with their neighbors because if too many people avoid the MMR, we’ll likely see the disease increase significantly. ” – Dr. Robert Sears Low immunization rates leads to decreased herd immunity and puts the entire community at risk Herd immunity contingent on a significant proportion of the population in a community being immune 30 -95% of individuals required to achieve herd immunity depending on the disease

TESTING OF VACCINES “A new medication goes through many years of trials in a select group of people to make sure it is safe…Vaccines, on the other hand, don’t receive the same type of in-depth short-term testing or long-term safety research. ” – Dr. Robert Sears

Vaccine pipeline: prelicensure and postlicensure vaccine development activities. From Hardt K, Schmidt-Ott R, Glismann S, Adegbola RA, Meurice F. Sustaining vaccine confidence in the 21 st century. Vaccines. 2013; 1(3): 204– 224. Copyright © 2013 by the authors; licensee MDPI, Basel, Switzerland. Reproduced under the terms and conditions of the Creative Commons Attribution license (http: //creativecommons. org/licenses/by/3. 0/).

TESTING OF VACCINES Vaccines are tested in larger numbers for longer periods of time than medications HPV tested in 30, 000 women Conjugate pneumococcal tested in 40, 000 children Rotavirus tested in 70, 000 children

Causation vs Correlation “Sometimes infants and children develop medical problems within days or weeks of a vaccination…Although it can be highly suspected that the vaccine was the cause, it can’t be proven. I’m sure the truth of the matter is somewhere in between causality and coincidence. ” — Dr. Robert Sears Epidemiological studies Measles containing vaccines CAN cause thrombocytopenia Dtap CAN cause seizures Thimerosal does NOT cause autism There is NO middle ground between coincidence and causality

CORRELATION DOES NOT IMPLY CAUSATION

COMMON CONCERNS Overloading the immune system Neurological side effects including Autism Preservatives

OVERLOADING THE IMMUNE SYSTEM An infants immune system has the capacity to respond to thousands of antigens at any given time Exposed every day via toys, shopping carts, playground equipment Immune system constantly replenished so can’t be overwhelmed While the amount of immunizations have increased, children receive fewer antigens than their parents The response to multiple vaccines is similar to the response that occurs when vaccines are given separately (Offit et al. Pediatrics 2002; 109)

1900 1960 1980 2000 Vaccine Proteins/Polysaccharides Smallpox ∼ 200 Diphtheria 1 Total ∼ 200 Diphtheria 1 Tetanus 1 WC-Pertussis ∼ 3000 AC-Pertussis 2– 5 WC-Pertussis ∼ 3000 Polio 15 Measles 10 Total ∼ 3217 Mumps 9 Rubella 5 Total ∼ 3041 Hib 2 Varicella 69 Pneumococcus 8 Hepatitis B 1 Total 123– 126

NEURODEVELOPMENT “Some studies have been published in recent years that have failed to show statistical proof of a relationship between vaccines and autism. However, by the same token, it is also difficult to prove that there is not a connection” — Dr. Robert Sears Institute of Medicine has shown that increased number of vaccines has NOT resulted in higher prevalence of neurodevelopment problems 2010 the 1998 report alleging the link between MMR and Autism was retracted Several studies since have shown NO link between Autism and Vaccines and autism show a TEMPORAL link not a CAUSAL link MMR is given around the same time autism is often diagnosed/become apparent despite being present earlier

PRESERVATIVES THIMEROSAL Thimerosal - mercury containing preservative that prevents bacterial and fungal contamination in vaccines Thompson et al (NEJM, 2009) studied the quantity of mercury exposure from thimerosal in >1000 children before and after birth All children subjected to >40 tests and found no difference between those that received a higher or lower dose No link between Thimerosal and autism and was never in the MMR vaccine Precautionary measures were taken given rising parental concerns and Thimerosal was removed from all individual dose vaccines in 2001

PRESERVATIVES ALUMINUM SALTS “When a baby gets the first big round of shots at two months, the total dose of Aluminum can vary from 295 micrograms to 1225 micrograms” — Dr. Robert Sears Aluminum salts - used to enhance the immune response from vaccines Safety is well established Abundant in our environment breast milk - 6700 micrograms ingested by 6 months infant formula - 37800 micrograms ingested by 6 months soy formula - 116600 micrograms ingested by 6 months (Offit and Moser, Pediatrics, 2009; 123)

THE CONCERN WITH ALTERNATE SCHEDULES Increases the number of vaccines More painful for children Increases the number of office visits Decreases the immunization rates Increases the time during which children are susceptible to vaccine preventable diseases

A STRONG RECOMMENDATION 80% of parents stated that their decision to vaccinate was positively influenced by their provider Kennedy, et al. Pediatrics, 2010 Presumptive vs Participatory Recommendations Presumptive – more likely to see parents accept vaccines “Today your child is due for MMR and Varicella” “It’s time for the annual flu vaccine. Your child is old enough to receive either the inactivated shot or the live nasal spray” Participatory “Do you want to vaccinate your child today” Opel, et al. Pediatrics, 2013

PROVIDER RESOURCES CDC www. cdc. gov/vaccines/hcp/conversations/index. html AAP have resources for vaccine conversations Communicating with Families and Parental Refusal to Vaccinate www. aap. org/en-us/advocacy-and-policy/aap-healthinitiatives/immunization/Pages/communicating-parents. aspx Navigating Vaccine Hesitancy www. aap. org/enus/Documents/immunizations_hesitancy. pdf Immunization Action Coalition immunize. org

RESOURCES Children’s Hospital of Philadelphia Vaccine Education Center http: //www. chop. edu/centers-programs/vaccineeducation-center#. Vr. FWesdmb. FI vaccinateyourbaby. org Books and articles by Dr. Paul Offit