2015 ACIP Immunization Schedules & Recommendations and MDPH Updates

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1 Massachusetts Department of Public Health Division of Epidemiology and Immunization 2015 ACIP Immunization Schedules & Recommendations and MDPH Updates Susan M. Lett, MD, MPH Medical Director, Immunization Program MDPH April 3, 2015

2 AGENDA 2015 ACIP Immunization Schedules LAIV Recommendations 9vHPV Recommendations Meningococcal B Vaccines Expanded Childhood Vaccine Availability MIIS Compliance Schedule MDPH

3 2015 Immunization Schedules Available at : and MDPH

4 2015 Recommended Immunization Schedules for Persons 0-18 Years MMWR 201;64:93. Pediatrics 2015;135:396 Available at: MDPH

5 2015 Childhood and Adolescent Changes: Immunization Schedule Schedule: MMR, Flu, Catch-up: Hib, pneumococcal, DT/Td/Tdap, varicella and minimum ages Footnotes: DTaP, Flu/LAIV, meningococcal, pneumococcal Job aids: Hib, pneumococcal, DTaP/DT/Td/Tdap MDPH

6 No. of Flu Doses Young Children MMR Travel MDPH

7 MDPH

8 Min. interval DTaP4 MDPH

9 LAIV Contra & Precau 1 or 2 Doses of PCV for High Risk MDPH

10 MCV4 guidance for high risk reorganized by vaccine type. 10

11 Childhood/Adolescent Catch-Up Schedule Job Aids To improve childhood and adolescent immunization schedules, CDC and partner organizations developed job aids to use with the current catch-up schedule. Aids for three vaccine groups were created Haemophilus influenzae type b (Hib) Pneumococcal conjugate (PCV13) Diphtheria, tetanus, and acellular pertussis-containing vaccines Can be found on CDC schedules webpage and scrolling to bottom MDPH

12 PCV Job Aid - Example MDPH

13 2015 Adult Immunization Available at: Schedule MMWR 2015;64:91. Annals of Internal Medicine 2015;64: MDPH

14 2015 Adult Immunization Schedule Changes from 2014 September 2014 pneumococcal vaccine recommendation Routine administration of 13-valent pneumococcal conjugate vaccine (PCV13) in series with 23-valent pneumococcal polysaccharide vaccine (PPSV23) for all (PCV13-naïve) adults aged 65 years or older August 2014 influenza vaccine contraindications and precautions for live attenuated influenza vaccine (LAIV) Move "influenza antiviral use within the last 48 hours" from precautions to contraindications Move asthma and chronic lung diseases; cardiovascular, renal, and hepatic diseases; and diabetes and other conditions from contraindications to precautions October 2014 approval by Food and Drug Administration to expand approved age for recombinant influenza vaccine (RIV) Adults aged 18 years or older (changed from 18 through 49 years) can receive RIV MDPH

15 PCV13 Routinely at 65 Years MDPH

16 16

17 Contraindications Updated information about LAIV Influenza antiviral use within the last 48 hours changed from precautions to contraindications Asthma and chronic lung diseases; cardiovascular, renal, and hepatic diseases; and diabetes and other conditions changed from contraindications to precautions MDPH

18 Born with Protection MATERNAL Tdap CAMPAIGN Researched-based campaign Targeting pregnant women & prenatal healthcare providers English and Spanish materials available. MDPH 2015

19 Changes in LAIV Recommendations in Those <8 Years of Age ACIP reviewed new data from the recent flu seasons at the meeting, including interim vaccine efficacy data from this season LAIV4 did not offer better protection than IIV in young age groups ACIP did not renew its preferential recommendation for LAIV in healthy children 2 through 8 years of age They continue to recommend that children 6 months and older get an annual influenza vaccine with no preference stated for either the nasal spray vaccine or the flu shot. ACIP will review final vaccine efficacy data in June. ACIP meeting MDPH

20 ACIP Recommendations for 9-Valent HPV Vaccine, February 2015 CDC. MMWR 2015;64:300 at: MDPH

21 9-Valent HPV Vaccine Gardasil 9 (Merck) Licensed for use in: Females 9-26 years and males 9-15 years* License application submitted to FDA in December dose schedule Includes data on females 9-26 yrs, males 9-15 yrs VLP vaccine Targets 5 additional high risk types 6, 11, 16, 18, 31, 33, 45, 52, 58 HPV VLP * ACIP has made an off-label recommendation for use in males through 26 years of age CDC. MMWR 2015;64:300 BLA Biologics License Application VLP virus like particle Package insert available at: MDPH

22 Available HPV Vaccines Bivalent (Cervarix) Quadrivalent (Gardasil) 9-valent (Gardasil 9) Manufacturer GlaxoSmithKline Merck Merck L1 VLP types 16, 18 6, 11, 16, 18 Dose of protein Producer cells 20/20 µg 20/40/40/20 µg Baculovirus infected Trichoplusia ni insect cell line Saccharomyces cerevisiae (yeast) 6, 11, 16, 18, 31, 33, 45,52, 58 30/40/60/40 µg 20 µg for others Saccharomyces cerevisiae (yeast) Adjuvant AS04: 500 µg aluminum hydroxide 50 µg 3-O-desacyl-4 - monophosphoryl lipid A AAHS: 225 µg amorphous aluminum hydroxyphosphate sulfate AAHS: 500 µg amorphous aluminum hydroxyphosphate sulfate L1 Major capsid protein ; VLP virus like particle MDPH

23 Attribution of HPV 16/18 and HPV 31/33/45/52/58, United States Data HPV-associated cancers 64% of invasive cancers attributable to HPV 16/18 65% for females and 63% for males 21,300 cases annually 10% of invasive cancers attributable to additional 5 types 14% for females and 4% for males Cervical cancer: HPV 16 or 18 account for 66% CIN2+ lesions* 50% attributable to HPV16/18 25% attributable to 5 additional types * CIN2+: cervical intraepithelial neoplasia grade 2 or worse Saraiya M., and Hariri S. presentations at Feb 2014 ACIP Meeting (% among all HPV-associated cancers) 23

24 9-valent HPV Vaccine: Currently Available and Future Data Available: Efficacy, immunogenicity, safety in females age yrs Overall 97% efficacy, similar safety profile; slightly higher injection site AEs Immunobridging adult to adolescents age 9-15 yrs >99% seroconversion; GMTs fold higher in 9-15 yr olds Co-administration with other vaccines (Menactra and Adacel) No impact on immune response or adverse events Immunogenicity and safety in males yrs, presented at October ACIP (not included in BLA) Future: Immunogenicity of 2-dose schedules* * MDPH

25 Implementation Considerations Will be a transition period. We will know more specifics about this soon. 4vHPV and 2vHPV protect against HPV types 16 and 18 which account for almost 70% of cervical and the majority of other HPV-related cancers 9vHPV include protects against and additional 10% percent of cancers Main benefit is for females Need to avoid missed opportunities and avoid vaccine waste. MDPH

26 ACIP Recommendations for HPV Vaccines ACIP did NOT express a preference for 9vHPV9 vs. 2vHPV or 4vHPV4 for females or for 9vHPV vs. 4vHPV for males. 9vHPV, 4vHPV or 2vHPV vaccines be used for the routine vaccination of females at years and for females 13 through 26 years who have not been previously vaccinated or completed the 3-dose series Either 9vHPV or 4vHPV vaccines can be used for routine vaccination of males at years and for males through 21 years* not have not previously been vaccinated or completed the 3 dose series. Either 9vHPV or 4vHPV vaccines can be used for vaccination of men who have sex with men and immunocompromised persons (including HIV infection) through 26 years* if not previously vaccinated. *off-label recommendation. CDC. MMWR 2015;64:300 MDPH

27 ACIP Recommendations for HPV Vaccines, (cont.) The 3-dose vaccination series can be started beginning at age 9 years If a provider does not know or have available the HPV product previous administered, or if in a setting transitioning to 9vHPV, any product can be used to complete the series.* If the vaccination series is interrupted, it does not need to be restarted. Need to increase HPV immunization coverage! *off-label recommendation. CDC. MMWR 2015;64:300 MDPH

28 Don t Wait: Vaccinate Providers don t realize how infrequently adolescents come for care Vast majority of HPV vaccinations occur at preventive care visits Minnesota study: 30% of years had no preventive care visits in a 4-5 year period You may not be choosing between 4vHPV and 9vHPV; but, between 4vHPV and nothing! Nordin et al. Ann. Fam. Med. Nov 2010; 8(6): MDPH

29 Future ACIP Policy Considerations HPV Vaccines The ACIP will discuss issues related to 9vHPV for persons who have completed 3 doses of 4vHPV or 2vHPV at future meeting. 2-dose vs 3-dose schedules Stay tuned. MDPH

30 9vHPV Vaccine Summary 9HPV targets 5 additional high risk types High efficacy and immunogenicity found in trials 9vHPV, 4vHPV and 2vHPV all protect against HPV types 16 and 18 which account for 66% of cervical and the majority of other HPV-related cancers Main benefit of 9vHPV is for females Could protect against an additional 15% of cervical and 25% of cervical pre-cancers in the U.S. Over all 14% of all HPV-associated cancers in females and 4% in males attributable to additional types Vaccinating every adolescent with an HPV vaccine formulation is our main goal! MDPH

31 ACIP Meets and Makes Recommendations for the Two Newly Licensed Meningococcal Serogroup B Vaccines February 26, 2015 Recommendations, not yet published in the MMWR. When they are, they will be posted on the ACIP website at: MDPH

32 CDC Presentation at ACIP Jessica MacNeil. Presentation to the Advisory Committee on Immunization Practices, October 30,2014

33 CDC Presentation at ACIP

34 Groups at Increased Risk of Meningococcal B Disease High risk medical conditions: Persistent complement component deficiencies Functional or anatomic asplenia (including sickle cell) Microbiologists Outbreaks MDPH

35 Outbreaks Meningococcal outbreaks are rare, historically causing 2-3% of US cases Five serogroup B meningococcal clusters/outbreaks occurred on college campuses during ,400 fold increased risk in students during outbreaks MDPH

36 Recent Experience with Serogroup B Disease on College Campuses Two outbreaks of serogroup B meningococcal disease on college campuses in cases at a RI with 4,5000 students Approximately 98% received 1 dose 6 cases at an OR college with 25,000 students 2 cases were epi-linked (but not close contacts) Additional sporadic cases of serogroup B meningococcal disease among college students have been reported to CDC (Adapted and updated from ACIP meeting ) MDPH

37 Meningococcal Serogroup B (MenB) Vaccines Two MenB vaccines are now licensed in the U.S. for persons 10 25* years of age: Trumenba (Pfizer) was licensed on October 29, 2014 Bexsero (Novartis) was licensed on January 23, 2015 MenB vaccines are distinct from MenACWY conjugate vaccines because they are based on immunity to proteins rather than capsular polysaccharides * ACIP has made an off-label recommendation for use in select groups >10 years. MDPH

38 FHbp: Factor H binding protein subfamily A (variant 2,3) or subfamily B (variant 1) NHBA: Neisserial heparin binding antigen NadA: Neisserial adhesin A Vaccine 30S:B87,2012 MDPH

39 Serogroup B Vaccine: MenB-FHbp (Trumenba) Trumenba Composed of two factor H binding protein (fhbp) subtypes subfamily A/V 2,3 Subfamily b/v1 3 dose series (0, 1, 6 months) Package insert: MDPH

40 Serogroup B Vaccine: MenB-4C (Bexsero) Bexsero Components: Factor H binding protein (FHbp) subfamily B/v1 Neisserial adhesion A (NadA) Neisserial heparin binding antigen (NhbA) Outer membrane vesicles (OMV) containing PorA P1.4 2 dose series (0, 1-6 months) Package insert: MDPH

41 ACIP Recommends MenB Vaccine for Persons at Increased Risk and Outbreak Control The serogroup B meningococcal ( MenB) vaccine series should be administered to persons aged 10 years* at increased risk for meningococcal disease. (Category A) This includes: Persons with persistent complement component deficiencies. 1 Persons with anatomic or functional asplenia. 2 Microbiologists routinely exposed to isolates of Neisseria meningitidis. MenB vaccine is also recommended for persons identified to be at increased risk because of a serogroup B meningococcal disease outbreak. 1 Including inherited or chronic deficiencies in C3, C5-9 properdin factor D, factor H, or taking eculizumab ( Soliris ). 2 Including sickle cell disease. Jessica MacNeil. Presentation to the Advisory Committee on Immunization Practices, February 26, 2015 * ACIP an off-label recommendation (Meeting ) MDPH

42 Interim Outbreak Recommendations for Investigational MenB Threshold for considering vaccination campaign with MenB (investigational) vaccine Population size <5,000: 2 or more case in 6 months Population size >5,000: 3 or more cases in 6 months In addition Chemoprophylaxis of close contacts Testing of isolates: molecular genotyping Determine if outbreak isolate covered by MenB vaccine(s) Comparison of isolates from outbreak Now that licensed MenB vaccines are licensed, CDC expects to be updating these guidelines later in the year. Interim guidance for Control of serogroup B meningococcal disease outbreaks in organization settings MDPH

43 ACIP MenB Vaccines Future Considerations Recommendations for MenB vaccine for use in high risk groups and outbreak control MenB expected to be published in MMWR soon. In June, the ACIP will discuss recommendations related to possible routine use in adolescents, college students or other groups; and possible permissive recommendations CDC will be issuing updated guidelines for use of MenB vaccines for outbreak control. MDPH

44 Clinicians are Key to Increase Vaccination Coverage Provide strong recommendations Do not delay vaccination Implement evidence-based strategies to improve vaccine delivery Decrease missed opportunities MDPH 2015

45 MIIS Compliance Schedule Vaccinations Across the Lifespan MDPH

46 MIIS Timeline Legislation June 2010 Regulations January 2015 Compliance Schedule March 2015 Legislation (M.G.L. Chapter 111, Section 24M) passed charging MDPH to establish an immunization registry Approved by Mass public health council and includes: Mandated System Users Registration Reporting Type of Information/Data Confidentiality Protections Duty to Inform Goal to have all mandated users registered and using the system according to the following schedule MDPH

47 Compliance Schedule 9/1/2015 Providers that do not use electronic health record systems and will enter data directly into the web interface 12/1/2015 Providers that use electronic health record technology and administer more than 1,000 doses of vaccine per year will report immunization information through electronic data exchange 6/1/2016 Providers that use electronic health record technology and administer less than 1,000 doses of vaccine per year and will report immunizations through electronic data exchange For more information or any questions: MIIS Help Desk Tel: (617) or MDPH

48 Expanded Availability of Select Vaccines for Children through 18 Years of Age For the flu season: Influenza vaccine Beginning April 1, 2015 Hepatitis A Tdap Varicella vaccines MDPH

49 Multiple Formulations of Influenza Vaccine Will be Available Formulation Size Packaging Fluzone 0.25 ml Pre-filled syringe Fluzone 0.5 ml Single-dose vial Fluzone 5.0 ml Multi-dose vial Fluarix 0.5 ml Pre-filled syringe FluMist 0.2 ml Nasal spray MDPH

50 Ordering Catch-up Doses of HepA, Tdap, and Varicella Estimate for catch up of all children through 18 years of age Take into consideration previous private purchase in your office Order a 2-month supply of catch-up doses in addition to the replacement doses you used that month Use your privately purchased doses first, and continue to seek reimbursement from insurers until private inventory is depleted For questions or consultation, please call the MDPH Vaccine Management Unit at MDPH

51 Insurance Considerations MDPH will ask insurers to continue reimbursing providers that privately purchased hepatitis A, Tdap, and varicella through September During this transition year, MDPH will ask insurers to continue reimbursing providers that privately purchased influenza vaccine through March MDPH

52 MDPH

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