Meningococcal Update. Disclosure. Meningococal and Influenza Vaccines Update! Robert Wittler, MD Sept 12, 2014 KAAP Fall CME Meeting

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1 1 Meningococal and Influenza Vaccines Update! Robert Wittler, MD Sept 12, 2014 KAAP Fall CME Meeting 2 Disclosure Speakers Bureau: Sanofi Pasteur Vaccines and Novartis! I do not intend to discuss an unapproved/ investigative use of a commercial product/ device in my presentation. 3 Meningococcal Update Meningococcal Disease Incidence* Incidence Rate (cases per 100,000 population) 6 Male Female Age (years) *In California, Georgia, Maryland, Tennessee, Connecticut, Minnesota, and Oregon, Rosenstein NE, et al. J Infect Dis. 1999;180:

2 5 Serogroup Distribution in the US 6 Most Cases in Adolescents and Young Adults Are Potentially Vaccine-Preventable* Potentially Vaccine-Preventable % 62% Other C Number of Cases 41% % Y B 86% 70% 72% 36% < Age Group *Serogroup distribution by age group, United States, ; potentially vaccine-preventable was calculated assuming 100% efficacy using an A/C/Y/W-135 quadrivalent vaccine! 1. CDC. Active Bacterial Core Surveillance (ABCs) Report. Neisseria meningitidis ! Available at:. Meningococcal Disease Is Serious but Preventable in Adolescents and Young Adults 7 Maryland Residents Diagnosed With Invasive Meningococcal Disease, January 1, 1990 to December 31, 1999 All Ages n / Total < 15 Years n / Total Years n / Total Fatal Cases 40 / 294! (13.6%) 5 / 109! (4.6%) 16 / 71 (22.5%) Potentially Vaccine-Preventable* 193 / 257! (75.1%) 64 / 94! (68.1%) 53 / 64 (82.8%) *Serogroup information was not available for all fatal cases! P = 0.001, < 15 yrs vs yrs! P = 0.04, < 15 yrs vs yrs! 1. Harrison LH, et al. JAMA. 2001;286:694.! ACIP Recommendations for Use of Meningococcal Vaccines Update MMWR, March 22, 2013;62(RR No. 2)! In 2007 ACIP recommended vaccination for all adolescents aged years and vaccination of children aged 2-10 years at increased risk of meningococcal infection! In 2009 ACIP recommended booster dose for persons who remained at increased risk! In 2010 ACIP recommended a booster dose at age 16 years for adolescents 8

3 Vaccination Recommended 9 Persons aged 11 through 18 years! Persons aged 2 months who are at increased risk! Complement deficiencies (C5-C9, properidin, factor H, factor D)! Anatomic or functional asplenia! Persons aged 9 months traveling to, or being a resident of, countries in which meningococcal disease in hyperendemic or epidemic, particularly if contact with the local population will be prolonged! Special populations such as unvaccinated or incompletely vaccinated first-year college students living in residence halls, military recruits, or microbiologists routinely working with Neisseria meningitidis! Vaccination of persons in at-risk groups (generally age <30 years) to control outbreaks Rationale for Adolescent Booster Dose 10 Goal of the 2005 ACIP recommendation was to protect persons aged 16 through 21 years! Vaccination recommended at age 11 or 12 years! more persons have preventive-care visits at age 11 or 12 years rather than at age 14 or 15 years! strengthen the pre-adolescent vaccination platform! vaccine was expected to protect adolescents through the entire period of increased risk Rationale for Booster Dose 11 Incidence for serogroups C and Y are at historic lows! However, the peak in disease among persons aged 18 years has persisted! From to , the estimated annual number of cases of serogroups C and Y meningococcal disease decreased 75% among persons aged years and only 27% among persons aged years! Estimated 53.6% of adolescents aged years had received a dose of meningococcal vaccine Rationale for Booster Dose Vaccine effectiveness (VE) wanes! Case control study by the CDC begun Jan 2006! As of October 1, 2010, 108 case-patients and 158 controls enrolled! Vaccinated <1 year earlier, VE 95% (95th percentile CI %)! Vaccinated 1 year earlier, VE 78% (95th percentile CI 29-93%)! Vaccinated 2-5 years earlier, VE 58% (95th percentile CI %) 12

4 Rationale for Booster Dose 13 Serologic data are consistent with waning immunity! Three characteristics of conjugate vaccines important for long-term protection! circulating antibody! memory response! herd immunity Rationale for Booster Dose 14 Memory response might not be rapid enough to protect against meningococcal disease! After initial priming with a serogroup C meningococcal conjugate vaccine, a memory response was not measurable until 5-7 days later! Incubation period for meningococcal disease is usually less than 3 days! Immunization coverage not at levels to provide evidence for herd immunity! Therefore, it is felt circulating bactericidal is critical for protection Rationale for Booster Dose 15 Five studies have evaluated antibody persistence! Concluded that ~50% of persons vaccinated 5 years earlier had bactericidal antibody levels protective against meningococcal disease! Two studies evaluated response after a booster dose at 3 and 5 years after the primary vaccination! At both 3 and 5 years after the first dose, the booster dose elicited substantially higher antibody titers (2-3 times higher) Cost-effectiveness for Adolescent Vaccination Cases averted Dosage No. Range Deaths averted QALY saved No. Range No. Range Cost per QALY saves ($1000) No. Range at 11 yrs 94 (43-165) 11 (5-20) 736 ( ) 256 (84-650) at 15 yrs 115 (51-205) 14 (6-35) 850 ( ) 219 (63-600) 22 (11-40) 1442 ( ) 212 (67-535) at 11 yrs with 184 booster dose at 16 yrs (92-308) 16

5 17 Age years Vaccine Age Primary Series Booster years at age 16 years years at age years years Not needed years Not routinely recommended. May be administered as catch-up for those who have not received a dose after their 16th birthday. Not needed MenACWY-D or MenACWY-CRM 2-23 Months with High-risk Conditions Subgroup have persistent complement deficiencies! travel to or are residents of countries where meningococcal disease is hyperendemic or epidemic! are at risk during a community outbreak attributable to a vaccine serogroup Age of Primary Vaccination Booster Dose MenACWY-CRM at 2, 4, 6, and 12 mo! MenACYW-D at 9 and 12 mo! Hib-MenCY-TT at 2, 4, 6, and mo (not indicated for international travel) Person remains at risk and completed the primary series should receive additional dose of MenACWY 3 years after primary immunization; boosters should be repeated every 5 years thereafter 2-55 Years with High-risk Conditions and Not Previously Vaccinated Subgroup Primary Vaccination have persistent complement deficiencies! have functional or anatomic asplenia! have HIV, if another indication for vaccination exists 2 doses of MenACYW, 8-12 weeks apart Subgroup Primary Vaccination 19 Booster Dose Person remains at risk and completed the primary series at age:! 2 mos- 6 yrs: Should receive additional dose of MenACWY 3 years after primary immunization; boosters should be repeated every 5 years thereafter! 7 yrs: Men ACYW every 5 years after primary immunization 2-55 Years with High-risk Conditions and Not Previously Vaccinated first year college students ages 21 years living in residential housing! travel to or residents of countries where meningococcal disease is hyperendemic or epidemic! of MenACYW are at risk during a community outbreak! are microbiologists routinely exposed to isolates of Neisseria meningitidis 18 Booster Dose Person remains at risk and completed the primary series at age:! 2-6 yrs: Should receive additional dose of MenACWY 3 years after primary immunization; boosters should be repeated every 5 years thereafter! 7 yrs: Men ACYW every 5 years after primary immunization 20

6 National Immunization Survey* National 21 Kansas 100 Percent *Percent of year old adolescents who received 1 MenACWY 2013 CDC, MMWR July 25, 2014;63:625-33, MMWR Aug 30, 2013;62:685-93, MMWR Aug 31, 2012;61:671-67, MMWR Aug 26, 2011;60: , MMWR Aug 20, 2010;59: , MMWR Sept 18, 2009;58: Influenza Update 2014/2015 ACIP Recommendations 23 ACIP meeting June 25, 2014! Grohskoph AL, Olsen SJ, Sololow LZ, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP) - United States, season. MMWR 2014;63:691-7.! Annual influenza vaccination is recommended for all persons aged 6 months and older New and/or Revised Information Vaccine composition! Minor change to egg allergy language! New recommendations regarding use of LAIV and IIV for young children where either is available and appropriate! Dosing 24

7 Vaccine Strain Selection 25 For 2014/2015, recommended the same composition as for the 2013/2014 Northern Hemisphere vaccine! an A/California/7/2009 (H1N1)pdm09-like virus! an A/Texas/50/2012 (H3N2)-like virus! a B/Massachusetts/2/2012-like virus! for quadrivalent vaccines, the above viruses and a B/Brisbane/60/2008-like virus Vaccination of Persons with Severe Egg Allergy 26 Previous language! Persons who report having had reactions to egg involving such symptoms as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, particularly those that occurred immediately or within a short time after egg exposure may receive RIV3, if aged years and there are no contraindications. If RIV3 is not available or the recipient is not within the indicated age range, such persons should be referred by a physician with expertise in the management of allergic conditions for further risk assessment before receipt of vaccine. Vaccination of Persons with Severe Egg Allergy 27 New language! Persons who report having had reactions to egg involving such symptoms as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, particularly those that occurred immediately or within a short time after egg exposure may receive RIV3, if aged years and there are no contraindications. If RIV3 is not available or the recipient is not within the indicated age range, IIV should be administered by a physician with experience in the recognition and management of severe allergic conditions. Use of LAIV and IIV for Healthy Children aged 2-8 years All individuals 6 months of age should receive influenza vaccine. Influenza vaccine should not be delayed to procure a specific vaccine preparation if an appropriate one is already available.! When both LAIV and IIV are available, LAIV should be used for healthy children aged 2 through 8 years who have no contraindications or precautions.! If LAIV is not immediately available, IIV should be used. Vaccination should not be delayed in order to procure LAIV. 28

8 Persons Who Should Not Receive LAIV 29 LAIV should not be administered to! Those aged <2 years or >49 years! Those with contraindications as per the package insert! children aged 2-17 years receiving aspirin! persons who have had allergic reactions to the vaccine or its components! Pregnant women Persons Who Should Not Receive LAIV 30 Immunosuppressed persons! Persons with egg allergy! Children aged 2-4 years who have had a wheezing episode noted in the medical record within the past 12 months, or for whom parents report that a health-care provider stated that they had wheezing or asthma with the last 12 months! Persons who have taken influenza antiviral medications within the previous 48 hours Precautions for LAIV 31 Asthma in persons aged 5 years! Other chronic medical conditions conferring higher risk of complications due to influenza are precautions to use of LAIV! chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic, or metabolic disorders (including diabetes mellitus)! per package insert, safety has not been established! Persons who care for severely immunosuppressed persons who require a protective environment! or if given LAIV should avoid contact with such persons for 7 days Dose Considerations Children aged 6 months through 8 years require 2 doses of influenza vaccine administered 4 weeks apart during their first season of vaccination! Because the strains contained in the 2014/2015 vaccine are identical to those in the 2013/2014 vaccine, only one 2014/2015 dose is required for any child 6 months through 8 years who previously received of the 2013/2014 influenza vaccine 32

9 33 Dose Considerations If a child did not receive a dose of the 2013/2014 influenza vaccine or it is unknown if they received that vaccine, then the following alternate approaches for determining the necessary number of doses are acceptable 34 Dose Considerations 1. if the child received a total of at least 2 doses of seasonal influenza vaccine since July 1, 2010 they only need one dose of the 2014/2015 vaccine! 2. 2 or more doses of seasonal influenza vaccine before July 1, 2010 and 1 or more doses of monovalent 2009(H1N1) vaccine! 3. 1 or more doses of seasonal influenza vaccine before July 1, 2010 and 1 or more doses of seasonal influenza vaccine since July 1, 2010 Morbidity and Mortality Weekly Report FIGURE 1. Influenza vaccine dosing algorithm for children aged 6 months through 8 years Advisory Committee on Immunization Practices, United States, influenza season* Did the child receive at least of the seasonal influenza vaccine? Yes No/ Don t know Did the child receive a total of at least 2 doses of seasonal influenza vaccine since July 1, 2010? Yes No/ Don t know 2 doses * For simplicity, this algorithm takes into consideration only doses of seasonal influenza vaccine received since July 1, 2010, to determine the number of doses needed for the season. As an alternative approach in settings where vaccination history from before July 1, 2010, is available, if a child aged 6 months through 8 years is known to have received either 1) at least of seasonal influenza vaccine, or 2) at least two seasonal influenza vaccines during any previous season, and at least of a 2009(H1N1) containing vaccine (i.e., seasonal vaccine since or the monovalent 2009[H1N1] vaccine), then the child needs only for Using this approach, children aged 6 months through 8 years need only of vaccine for if they have received any of the following: 1) at least of seasonal influenza vaccine; or 2) 2 or more doses of seasonal influenza vaccine since July 1, 2010; or 3) 2 or more doses of seasonal influenza vaccine before July 1, 2010, and 1 or more doses of monovalent 2009(H1N1) vaccine; or 4) 1 or more doses of seasonal influenza vaccine before July 1, 2010, and 1 or more doses of seasonal influenza vaccine since July 1, Children in this age group for whom one of these conditions is not met require 2 doses for Doses should be administered at least 4 weeks apart. published studies, vaccines containing as much as 0.7 µg/0.5 ml of ovalbumin have been tolerated (27,28); however, a threshold below which no reactions would be expected is not known (27). Among IIVs for which ovalbumin content was disclosed during the through seasons, the reported maximum amounts were 1 µg/0.5 ml dose. Ovalbumin is not directly measured for Flucelvax; it is estimated by calculation from the initial content in the reference virus strains to contain less than 5x10-8 µg of total egg protein per 0.5mL dose, of which ovalbumin is a fraction (Novartis, personal communication, 2013). FluBlok is considered egg-free. However, neither Flucelvax nor FluBlok are licensed for use in children aged <18 years. ACIP recommends the following: 1. Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive influenza vaccine. Because relatively few data are available for use of LAIV in this setting, IIV or trivalent recombinant influenza vaccine (RIV3) should be used. RIV3 may be used for persons aged 18 through 49 years who have no other contraindications. However, IIV (egg- or cell-culture based) may also be used, with the following additional safety measures (Figure 2): Vaccine should be administered by a health care provider who is familiar with the potential manifestations of egg allergy; and Vaccine recipients should be observed for 30 minutes for signs of a reaction after administration of each vaccine dose. 2. Persons who report having had reactions to egg involving such symptoms as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, may receive RIV3 if they are aged 18 through 49 years and there are no other contraindications. If RIV3 is not available or the recipient is not within the indicated age range, IIV should be administered by a physician with experience in the recognition and management of severe allergic conditions (Figure 2). 3. Regardless of allergy history, all vaccines should be administered in settings in which personnel and equipment for rapid recognition and treatment of anaphylaxis are available (29). 4. Persons who are able to eat lightly cooked egg (e.g., scrambled egg) without reaction are unlikely to be allergic. Egg-allergic persons might tolerate egg in baked products (e.g., bread or cake). Tolerance to egg-containing foods does not exclude the possibility of egg allergy. Egg allergy can be confirmed by a consistent medical history of adverse reactions to eggs and egg-containing foods, plus skin and/or blood testing for immunoglobulin E directed against egg proteins (30). 5. For persons with no known history of exposure to egg, but who are suspected of being egg-allergic on the basis of previously performed allergy testing, consultation with a physician with expertise in the management of allergic conditions should be obtained before vaccination (Figure 2). Alternatively, RIV3 may be administered if the recipient is aged 18 through 49 years. 6. A previous severe allergic reaction to influenza vaccine, regardless of the component suspected of being responsible for the reaction, is a contraindication to future receipt of the vaccine. MMWR / August 15, 2014 / Vol. 63 / No. 32 Pertussis Vaccine

10 Fatal Pertussis in Infants 37 Paddock et al, Clin Infect Dis 2008;47:328-38! Refractory pulmonary hypertension! Hyperleukocytosis Infant Pertussis: Who Was the Source? Other! 25% Grandparent! 8% Sibling! 20% 38 Mother! 32% Father! 15% Bisgard KM, et al. Pediatr Infect Dis J. 2004;23(11): ACIP Meeting June Voted to recommend the routine use of Tdap vaccines in adolescents aged years in place of Td vaccines! Preferred age is years! Adolescents who have received Td but not Tdap are encouraged to receive a single dose of Tdap! ACIP Meeting Oct 2010 Uncertainty about whether someone had recently received a Td vaccine should not rule out receiving Tdap! Tdap can be administered regardless of the interval since the last tetanus or diphtheria containing vaccines 40

11 41 ACIP Meeting Oct 2010! Adults ages 65 years and older who have or who anticipate having close contact with an infant ages less than 12 months (e.g., grandparents, child-care providers, and HCP) and who have not previously received Tdap should receive a single dose of Tdap!! ACIP Meeting June 22, Use of Tdap in Pregnant Women! Women s health care providers should implement a Tdap vaccination program for pregnant women who have not previously received Tdap.! Preferably after 20 weeks gestation! If not administered during pregnancy, Tdap should be administered immediately postpartum! h#p:// 43 ACIP Oct 2012 Recommended that Tdap be given to women during every pregnancy! Optimal timing is between weeks gestation National Immunization Survey* National Kansas Percent *Percent of year old adolescents who received Tdap since age 10 CDC, MMWR July 25, 2014;63:625-33; MMWR Aug 30, 2013;62:685-93; MMWR Aug 31, 2012;61:671-67; MMWR Aug 26, 2011;60: ; MMWR Aug 20, 2010;59: ; MMWR Sept 18, 2009;58:

12 Tdap Coverage Among Adults in years 65 years Total No Infant Contact Infant contact MMWR, Feb 7, 2014;63: HPV Vaccine Coverage For Girls years Percent National Kansas HPV 2 HPV 3 HPV HPV Vaccine Coverage For Boys years National Percent Percent Vaccinated 45 Kansas HPV HPV 3 HPV 48 Questions

13 FIGURE 1. Influenza vaccine dosing algorithm for children aged 6 months through 8 years Advisory Committee on Immunization Practices, United States, influenza season* Did the child receive at least of the seasonal influenza vaccine? Yes No/ Don t know Did the child receive a total of at least 2 doses of seasonal influenza vaccine since July 1, 2010? Yes No/ Don t know 2 doses * For simplicity, this algorithm takes into consideration only doses of seasonal influenza vaccine received since July 1, 2010, to determine the number of doses needed for the season. As an alternative approach in settings where vaccination history from before July 1, 2010, is available, if a child aged 6 months through 8 years is known to have received either 1) at least of seasonal influenza vaccine, or 2) at least two seasonal influenza vaccines during any previous season, and at least of a 2009(H1N1) containing vaccine (i.e., seasonal vaccine since or the monovalent 2009[H1N1] vaccine), then the child needs only for Using this approach, children aged 6 months through 8 years need only of vaccine for if they have received any of the following: 1) at least of seasonal influenza vaccine; or 2) 2 or more doses of seasonal influenza vaccine since July 1, 2010; or 3) 2 or more doses of seasonal influenza vaccine before July 1, 2010, and 1 or more doses of monovalent 2009(H1N1) vaccine; or 4) 1 or more doses of seasonal influenza vaccine before July 1, 2010, and 1 or more doses of seasonal influenza vaccine since July 1, Children in this age group for whom one of these conditions is not met require 2 doses for Doses should be administered at least 4 weeks apart.