21 st Century Vaccine Challenges

Transcription

1 21 st Century Vaccine Challenges Presentation by Rosalyn Singleton MD, ANTHC Slides adapted from original powerpoint by: Carrie L. Byington, MD HA and Edna Benning Presidential Professor of Pediatrics University of Utah Chair, AAP Committee on Infectious Diseases September 27, 2016

2 21 st Century Challenges Reflect an Abundance of Riches

3 Challenges Number of Vaccines 15 antigens 0-18 months 18 Antigens 18 months - 18 years New Vaccines 2710 Open studies for children on ClinicalTrials.gov RSV, hmpv, parainfluenza GBS H5N1, Ebola, Zika New Approaches Vaccination of Pregnant Women to Protect Infants New Recommendations ACIP/CDC Category B recommendation Meningitis B vaccine

4 Number of Vaccines How many vaccines can be given during an office visit? All vaccines can be administered at the same visit*. There is no upper limit for the number of vaccines that can be administered during one visit. ACIP and AAP consistently recommend that all needed vaccines be administered during an office visit. Vaccination should not be deferred because multiple vaccines are needed. All live vaccines (MMR, varicella, zoster, live attenuated influenza, yellow fever, and oral typhoid) can be given at the same visit. If live vaccines are not administered during the same visit, they should be separated by 4 weeks or more. When giving several injections at a single visit, separate IM vaccines by at least 1 inch in the body of the muscle if possible to reduce the likelihood of local reactions overlapping. Here are some helpful site maps for different ages so you can record where shots were given: For infants and toddlers: pdf For adolescents: For adults: 718A.pdf For details, consult CDC's General Recommendations on Immunization at pages

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6 7 through 18 years Other resources: adolescent.html#printable

7 Adult Vaccine Schedule Vaccine Flu Tdap Recommendation Yearly for all, especially high risk. One Tdap dose for all. One dose each pregnancy, preferred weeks gestation. Td HPV4/HPV9 Pneumovax Prevnar 13 Zoster Booster every 10 years years females, years males, 3- dose series. One dose 19 years and older with high risk conditions. AK Natives yrs. One dose at 65+ years for all, preferably after Prevnar 13 (PCV13). Adults 19 years & older with immunocompromise. Adults 65 yrs and older. Adults 60 years and older. Contraindicated in immunocompromised. CDC adult schedule: Alaska pneumococcal:

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9 BMJ February 2016

10 Examples of Post- licensure Review: Number of doses needed for current vaccines 9vHPV Studies of a 2- dose schedule show comparable efficacy as 3 dose schedule, depending on age and interval Evaluation of a 2- dose schedule by FDA PCV13 Discussion about potential for a 3 dose schedule Discussion about optimal schedule for premature infants Hepatitis B Studies evaluating the need for a booster dose

11 New Vaccines Large number under development 2700 How to add new vaccines to the existing schedule Different schedules in different countries Ethical Issues around emerging infections Zika and immunization of pregnant women

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13 Epidemiology of RSV in Children oone of the most common causes of serious respiratory illness and mortality in children worldwide o>120,000 annual hospitalizations in US oalaska Native children have one of the highest hospitalization rates for RSV oillness severity related to: oage <12 weeks oabsence of breastfeeding ohistory of prematurity ounderlying heart or lung disease oimmune deficit

14 Global Childhood Mortality (<1yo) Lozano, Global Burden of Disease, Gates Foundation, Lancet 2012

15 Global estimates of severe RSV: Rate of Severe or Hospitalized RSV/1000 infants/yr Alaska Nair H et al. Global burden of RSV Lancet 2010;;375: ;; Banerji. PIDJ Cost of hospitalization for RSV in Canadian Inuit Pediatr Infect Dis 2009;;28:.

16 RSV vaccines RSV vaccines for infants not effective at an early age Adult RSV vaccines are in late clinical trials Appear to be effective Potential adult RSV uses: Pregnant women to protect their newborn infants Elderly adults Adults with high risk conditions COPD, asthma, CHF, immunocompromised

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18 Top Priorities - Immediate (Zika) 1. Develop an emerging infections response infrastructure that includes key internal & external partners. Ø Checklist for Leadership 2. Create policy that addresses the ethical considerations for vaccine & therapeutic trials that include children & pregnant women. 3. Support state & local response to emerging infections (communication, education, advocacy).

19 Pertussis U.S. 28,639 cases in 2014 Alaska 165 cases in 2014 Why do we still see outbreaks? DTaP/Tdap wane faster than DTP Easier diagnosis with PCR technology Low immunization rates Goal: Prevent disease in infants Infants are at highest risk for morbidity Misegades LK, et al. JAMA 2012;308: ; Witt MA, et al. Clin Infect Dis 2013;56: Source: Centers for Disease Control and Prevention

20 DTaP/Tdap/Td Recommendations Children under <6 years: 5 doses of DTaP at 2, 4,6, 15 months and 4 years of age. 11 Years and Older: give single dose of Tdap, followed by Td every 10 years. During each pregnancy, preferably between weeks gestation. Goals: maximize maternal antibody transfer to protects infant and prevent mother from transmitting to newborn. ACIP Recs: MMWR Feb 22, (07),

21 Maternal Tdap effectiveness, UK % uptake of maternal Tdap during outbreak Vaccine effectiveness 91% for infants <3 months Maternal Vx started Lancet,

22 Category B Vaccine Recommendation Category A recommendations are made for all persons in an age- or risk- factor- based group. Category B recommendations are made for individual clinical decision making How does the provider make recommendations? Example of the new Meningitis B recommendation

23 Meningitis B for Healthy Children The ACIP recommendation for MenB vaccine in low- risk adolescents and young adults is based on the very low incidence of serogroup B meningococcal disease in persons who are not at high risk and lack of availability of certain data that would be valuable in developing policy For these reasons, the ACIP determined that there were insufficient data to make a routine recommendation that all adolescents be vaccinated with an MenB vaccine The AAP also considered the difficulty of delivering multiple vaccine doses to adolescents, the cost of the vaccine series, and the unfavorable cost- effectiveness evaluation

24 Meningitis B Specific epidemiologic data or guidelines are not available to assist treating clinicians to determine who should receive the MenB vaccine Estimates from the CDC indicate that fewer than 60 cases of meningococcal B disease occur each year in the United States among young persons between 11 and 21 years of age Universal vaccination of the annual cohort of 4 million persons at 16 or 18 years of age would prevent an estimated maximum of 28 cases Universal vaccination of all college students is estimated to prevent, at most, 10 cases and 1 death Except during outbreaks, the available data do not suggest an increased rate of MenB disease among college students relative to non college students of the same age group.

25 What will the Framework be for Category B Recommendations? The AAP COID is considering a framework based on travel immunizations Acknowledges that not all individuals are at equal risk Providers need clear recommendations regarding who is at greatest risk Can include cost- effectiveness as well as other factors influencing completion such as number and timing of doses Allows for shared decision making with provider and patient/family

26 Summary of Challenges Number of Vaccines More vaccines, but fewer antigens than in the past New Vaccines 2710 open studies for vaccines in children. Zika vaccine development is one priority. New Approaches Vaccination of Pregnant Women to Protect Infants Highlighted potential for maternal RSV vaccines to prevent infant disease Example of Tdap in pregnant women to prevent infant pertussis New Recommendations ACIP/CDC Category B recommendation Meningitis B vaccine