Update on Vaccine Recommendations. Objectives. Childhood Immunization Schedule At the Turn of the Century. New Horizons in Pediatrics April 30, 2017

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Centers for for Disease Disease Control Control and and Prevention Prevention National Center for Immunization and Respiratory Diseases Update on Vaccine Recommendations New Horizons in Pediatrics April 30, 2017 Amanda Cohn, MD Executive Secretary, Advisory Committee on Immunization Practices National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention Objectives Discuss vaccine changes made to the 2017 immunization schedule Highlight recent changes to childhood immunization Discuss current immunization challenges ) Childhood Immunization Schedule At the Turn of the Century

* This chart takes into account General Recommendations on Immunization, recommendations for health care professionals, the annual recommended Number of ACIP Vaccine Recommendations, By Year, Since 1965* routine childhood immunization schedule (1995 present), the annual recommended routine adult immunization schedule, and recommendations pertaining to vaccines such as those for rabies, yellow fever, smallpox, and Japanese encephalitis that are not part of any routine immunization schedule in the United States. 2017 Childhood and Adolescent Immunization Schedule Schedules are revised and approved annually by several organizations: ACIP (CDC), AAP, AAFP, ACOG. The schedule reflects recommendations for use of vaccines licensed by the FDA. Major Changes to the 2017 Vaccine Schedule Two dose 9vHPV HBV vaccine to newborns in first 24 hours Meningococcal ACWY for HIV infected

Three Major Parts to the 2017 Immunization Schedule for Children 0 through 18 Years of Age Schedule for people 0 through 18 years of age Schedule for people 0 through 18 years of age based on medical conditions Footnotes: three exciting pages which are single spaced and displayed in very small font. 2017 Childhood and Adolescent Immunization Schedule Contains 3 figures plus footnotes: Figure 1 (recommended schedule) is similar to 2016 schedule Figure 2 (catch up) is similar to 2016 schedule Figure 3 is new and contains vaccines indicated for children and adolescents through 18 years of age based on specific medical indications Revised footnotes for 8 vaccines Footnotes are riveting

Newly Added Figure 3 Includes: Pregnancy Immunocompromised conditions including HIV Renal and heart disease CSF leaks and cochlear implants Spleen and complement deficiencies Chronic liver disease Diabetes mellitus

Vaccines of the Past LAIV removed from the 2017 schedule Three dose HPV vaccine is gone for younger age group 2vHPV and 4vHPV vaccines are gone PCV7 is off the market, replaced by PCV13 Meningococcal polysaccharide (MPSV4) is gone HibMenCY (MenHibrix) will be gone New Vaccine Recommendations

HPV Vaccine Recommendation CDC recommends routine vaccination at age 11 or 12 years to prevent HPV cancers The vaccination series can be started at age 9 years Two doses of vaccine are recommended The second dose of the vaccine should be administered 6 to 12 months after the first dose. Prevalence of genital HPV in adults aged 18 69: Any strain: 45.2% (males) and 39.9% (females) High risk strains: 25.1% (males) and 20.4% (females) Prevalence of oral HPV in adults aged 18 69: Any strain: 11.5% (males) and 3.3% (females) High risk strains: 6.8% (males) and 1.2% (females) CDC. You are the Key to HPV Cancer Prevention slide set. https://www.cdc.gov/hpv/hcp/speaking colleagues.html NCHS Data Brief. Prevalence of HPV in Adults Aged 18 69: United States, 2011 2014. No. 280. April 2017. Evidence Supports Importance of Strong Recommendation from Clinicians Younger adolescents less likely to receive a strong recommendation Boys are less likely to receive a strong recommendation Parents value the HPV vaccine Clinicians underestimate the value that parents place on HPV vaccine Incidence of Meningococcal Disease by Age and Serogroup: 2005 2012 1.6 Incidence per 100,000 1.2 0.8 0.4 Serogroup B Serogroup C Serogroup Y 0 <1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Age (years)

ACIP Recommendations for Use of Serogroup B Meningococcal Vaccines Routine immunization of persons aged 10 years and older at increased risk - Complement deficiency (including eculizumab users) - Functional / anatomic asplenia - Microbiologists routinely exposed to the organism - Outbreak response No serogroup B vaccine preference This is a Category A or routine recommendation for all persons designated at increased risk Targets persons at increased risk, small populations ACIP Recommendations for Use of Serogroup B Meningococcal Vaccines: Adolescents Very low disease burden in 18 23 year olds - Estimated 30 50 cases (4 7 deaths) per year currently - More cases in non college than college students Many unknowns about the vaccines (i.e., effect on carriage; duration of protection; strain coverage) MenB may be administered to healthy adolescents and young adults 16 through 23 years of age (preferred ages are 16 through 18 years) to provide short term protection against most strains of serogroup B meningococcal disease - Discussion with healthcare provider and parent - Same vaccine for all doses - VFC (up to age 19 years) or insurance will cover cost This is a Category B recommendation that leaves vaccination up to individual clinical decision making: Non routine Maternal Tdap Tdap vaccine (updated guidance Oct 2016 a ): - Tdap should be administered between 27 and 36 weeks gestation, although it may be given at any time during pregnancy - Vaccinating earlier in the 27 through 36 week window will maximize passive pertussis antibody transfer to the infant a October 2016 meeting of the Advisory Committee on Immunization Practices b Grohskopf et al, MMWR. Morb Mortal Wkly.2013.

Active Evaluation: Evaluating Safety of Tdap During Every Pregnancy Active evaluation of the recommendation to vaccinate with Tdap during every pregnancy Rapid safety evaluation supports ongoing use of Tdap during every pregnancy Rates of Moderate+Severe Reactions Among Pregnant Women With and Without Prior Tdap Receipt within 7 days after vaccination 25 20 No Prior Tdap Prior Tdap Percent 15 10 5 0 All comparisons for moderate/severe or severe reactions met non-inferiority criteria 23 Immunization Challenges

Childhood Immunization Disparities In spite of high national childhood immunization coverage rates, there are still concerning disparities Children living below the poverty level continued to have lower coverage with rotavirus, PCV, Hib, and DTaP vaccines Children living in more rural areas have lower coverage with DTaP, polio, varicella, PCV, hepatitis A, and rotavirus vaccines CDC is currently working to identify reasons for disparities and evidencebased interventions Vaccination Coverage Among Children Aged 19 35 Months United States, 2015. MMWR Weekly / October 7, 2016 / 65(39);1065 1071 Measles Cases in the U.S. The majority of people who got measles were unvaccinated Measles is still common in many parts of the world including some countries in Europe, Asia, the Pacific, and Africa Travelers with measles continue to bring the disease into the U.S. Measles can spread when it reaches a community in the U.S. where groups of people are unvaccinated Measles Cases and Outbreaks. https://www.cdc.gov/measles/cases outbreaks.html Morbidity and Mortality Weekly Report (MMWR), Notifiable Diseases and Mortality Tables. https://www.cdc.gov/mmwr/publications/index.html Measles, U.S. 2016 and 2017 Provisional total for 2016: 69 cases reported by 15 states - 29 cases in Arizona - Total of 4 outbreaks reported in 2016 (defined as 3 or more linked cases) - 72% of cases reported were outbreak related. So far in 2017-21 cases reported in first 8 weeks of the year by 6 states (CA, CO, FL, NJ, NY, PA, UT) - 2 outbreaks reported - 48% of cases are outbreak related CDC Division of Viral Diseases

160000 Reported Mumps Cases, United States, Vaccine Era, 1968 2016 100 140000 90 Reported Mumps Cases 120000 100000 80000 60000 40000 1977 1 st Dose ACIP Recommendation 1989 2 nd Dose MMR ACIP Recommendation 1 st Dose 2 nd Dose 2006 Midwest Outbreak 2009 Northeast Outbreak 80 70 60 50 40 30 2016 Arkansas Outbreak 20 MMR vaccine coverage 20000 10 0 0 1968 1982 Vaccine Implementation 1983 1992 Resurgence Source: National Notifiable Diseases Surveillance System (cases, passive surveillance); National Immunization Survey (NIS) (1 st dose coverage 19 35 year olds), National Health Interview Survey & NIS Teen (2 nd dose coverage); 2016 case data is preliminary (Feb 9, 2017) and 4subject to change Reported Mumps Cases and Outbreaks, United States, 2016 (n=5,642) Stars indicate states that notified CDC of mumps outbreaks Source: National Notifiable Diseases Surveillance System (cases, passive surveillance), preliminary (Feb 9, 2017); state reports to CDC (outbreaks) Mumps Summary Use of the mumps vaccine reduced disease levels ~99% versus pre vaccine era in the United States Since 2006, mumps outbreaks have occurred in highly 2 dose vaccinated Current 2 dose schedule is sufficient for mumps control in the general population Intense exposure settings and waning immunity appear to be risk factors for secondary vaccine failure The benefit of a 3 rd MMR dose still needs to be assessed The Advisory Committee on Immunization Practices (ACIP) has established a Mumps Working Group

Pertussis Trends Pertussis cases have steadily increased in recent decades More than 20,000 cases per year in recent years: 20,762 cases in 2015 32,971 cases in 2014 28,639 cases in 2013 48,277 cases in 2012 580 cases in Arizona in 2015 For U.S. infants under 1 year old: 2,709 cases in 2015 3 deaths in 2015 Sources: https://www.cdc.gov/pertussis/surv reporting/cases by year.html https://www.cdc.gov/pertussis/surv reporting.html Pertussis Summary It s Complicated! Pertussis incidence has increased since 1980s Resurgence of childhood disease despite high DTaP coverage Young infants at risk Excellent initial vaccine effectiveness Moderate and immediate waning of immunity Re emergence of adolescent disease Tdap effectiveness about 70% 1, 2, duration of protection unknown Tdap boost in DTaP recipients may wane more quickly 3 Switch to acellular pertussis vaccines is changing epidemiology Waning immunity driving disease incidence Contribution of pertactin deficient strains 1 Clin Infect Dis. 2010 Aug 1;51(3):315 21. 2 Ped Infect Dis J 2009;28(2):152 153. 3 CDC. MMWR 2012;61(28);517 522. Low Maternal Vaccination Rates Coverage of recommended vaccines for pregnant women remains low leaving a number of pregnant women and their infants at risk for complications from vaccine preventable diseases Only 50.3% of women received influenza vaccination before or during pregnancy in 2014 2015 a Only 41.7% of pregnant women received Tdap vaccination from 2007 2013 b a Ding H. MMWR Morb Mortal Wkly Rep. 2015. b Kharbanda EO. Vaccine. 2016.

Vaccines for Preteens and Teens Adolescent Vaccination Coverage United States, 2006-2014 Impact of the Immunization Schedule Impact of 7 valent Pneumococcal Conjugate Vaccine on Rate of Invasive Pneumococcal Disease, United States <5y >65y Pilishvili T et al. J Infect Dis 2010;201:32

Rates of Serogroup C, Y, and W Meningococcal Disease in the United States Year Rate per 100,000 (95% confidence intervals) 11 19 year olds 20 year olds 2004 and 2005 0.27 (0.17, 0.39) 0.17 (0.14, 0.21) 2006 and 2007 0.31 (0.21, 0.45) 0.23 (0.19, 0.28) 2008 and 2009 0.15 (0.08, 0.26) 0.23 (0.19 0.27) 2012 and 2013 0.07 (0.03, 0.12) 0.14 (0.12 0.17) Decreasing incidence in 11 19 year olds Cohn AC et al. MMWR 2013;62 (RR02):1 22 Number of HPV Attributable Cancers Averted over 100 Years of 9 Valent HPV Vaccination Program Total US population Number of HPV attributable cancers averted 1,800,000 1,600,000 1,400,000 1,200,000 1,000,000 800,000 600,000 400,000 200,000 2014 coverage (Females 39.7%, Males 21.6%) Higher male and female coverage (80%) 709,000 1.27 million 1.23 million 1.56 million 0 HPV cancers averted total (excluding herd immunity) HPV cancers averted total Estimates calculated using published model (Chesson et al, Hum Vaccin Immunother 2016), with modified coverage assumptions. Coverage levels shown (39.7%, 21.6%, and 80%) refer to coverage among ages 13 17. For females, the annual probability of vaccination in the current coverage scenario was modeled as 20.9% for age 12, 8.9% for ages 13 to 18, and 0.89% for ages 19 to 26. For males, these values were 10.5%, 4.4%, and 0.44% (through age 21), respectively. In the 80% coverage scenario, the annual probability of vaccination was 73.8% for age 12, 8.9% for ages 13 to 18, and 0.89% for those 19 and older (through age 21 for men and age 26 for women). Childhood Immunization Provides Big Savings CDC estimates that vaccination of children born between 1994 and 2016 will: Prevent 381 million illnesses Prevent 24.5 million hospitalizations Help avoid 855,000 early deaths Save nearly $360 billion in direct costs and $1.65 trillion in total society costs Updated data from previous article: Benefits from Immunization During the Vaccines for Children Program Era United States, 1994 2013. MMWR. 25 April 2014

www.cdc.gov/vaccines/acip Thank you! Amanda Cohn, MD Executive Secretary, Advisory Committee on Immunization Practices National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention acohn@cdc.gov For more information, contact CDC 1 800 CDC INFO (232 4636) TTY: 1 888 232 6348 www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.