Immunization Update 2016

Transcription

1 Immunization Update 2016 Candice L. Robinson Medical Officer Immunization Services Division New Hampshire Immunization Conference Manchester, NH March 23, 2016 Disclosures Candice Robinson is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation. The speaker will discuss the off-label use of MMR, PCV13, and MenB vaccines. The speaker will not discuss a vaccine not currently licensed by the FDA. National Center for Immunization and Respiratory Diseases Immunization Services Division Disclosures Next ACIP Meeting June 22-23, 2016 The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices (ACIP): Composed of 15 nongovernment experts in clinical medicine and public health. Provides guidance on use of vaccines and other biologic products to DHHS, CDC, and the U.S. Public Health Service. What s New? Recent ACIP Updates PCV13 & PPSV23 Intervals MenB HepB Vaccine Updates 9vHPV DTaP-IPV (Quadracel) 2016 Immunization Schedules Vaccination Coverage Rates VIS Updates Influenza Preventing Vaccine Administration Errors Immunization Events and Resources ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) UPDATES PNEUMOCOCCAL VACCINATION 1

2 Modifications to Medicare Part B Coverage of Pneumococcal Vaccinations Medicare Part B now covers full cost of 2 nd pneumococcal vaccination for Medicare enrollees, provided 2 nd pneumococcal vaccine is: Different from 1 st (e.g., first PCV13 then PPSV23) Administered no less than 11 months after the 1 st Network-MLN/MLNMattersArticles/Downloads/MM9051.pdf MENINGOCOCCCAL VACCINATION Meningococcal B Vaccines Product Name/ACIP abbreviation Trumenba MenB-FHbp Bexsero MenB-4C FDA Age Indications 10 through 25 years of age 10 through 25 years of age Dosage/Route/Schedule 3 doses 0.5 ml each IM injection 0-, 2-, and 6-month 2 doses 0.5 ml each IM injection 0, 1 6 month ACIP MenB Recommendations Certain persons aged 10 years* who are at increased risk for meningococcal disease should receive MenB vaccine. These persons include: Persons with persistent complement component deficiencies Persons with anatomic or functional asplenia** Microbiologists routinely exposed to isolates of Neisseria meningitides Persons identified as at increased risk because of a serogroup B meningococcal disease outbreak *ACIP off-label recommendation **Including sickle cell disease w 2

3 ACIP MenB Recommendations Certain other groups are included in MenACWY (MCV4)recommendations for persons at increased risk, but not in this recommendation MenB NOT currently recommended for: Children aged 2 months 9 years of age Persons who travel to or reside in countries where meningococcal disease is hyperendemic or epidemic because risk is generally not caused by serogroup B Routine use in first-year college students living in residence halls, military recruits, or all adolescents MenB for Adolescents and Young Adults A MenB vaccine series may be administered to adolescents and young adults aged years to provide shortterm protection against most strains of serogroup B meningococcal disease* The preferred age for MenB vaccination is years * Permissive recommendation (Category B) MMWR October 23, 2015 / 64(41); ACIP MenB Recommendations MenB should be administered as either a 2- dose series of MenB-4C or a 3-dose series of MenB-FHbp The same vaccine product should be used for all doses Based on available data and expert opinion, MenB-4C and MenB-FHbp may be administered concomitantly with other vaccines indicated for this age, but at a different anatomic site, if feasible No product preference to be stated HEPATITIS B Interval for Postvaccination Serologic Testing CDC recommends shortening the interval for postvaccination serologic testing (PVST) from age 9 18 months to age 9 12 months Providers should order PVST for infants born to HBsAg-positive mothers at age 9 12 months (or 1 2 months after the final dose of the vaccine series, if the series is delayed) Benefits to shortened interval: Reduced period during which nonresponders at risk for transmission from close contacts with HBV infection Enables prompt revaccination if indicated Increase adherence with recommendations for timely testing Reduces possibility for misclassification and unnecessary revaccination Vaccine Updates 3

4 HPV Vaccines Bivalent 2vHPV (Cervarix) Quadrivalent 4vHPV (Gardasil) L1 VLP types 16, 18 6, 11, 16, 18, 9-Valent 9vHPV (Gardasil9) 6, 11, 16, 18, 31, 33, 45,52, 58 Manufacturer GSK Merck Merck FDA Indications Females (9-25 yrs): Cervical precancer and cancer Males: Not approved for use in males Females (9-26 yrs): Anal, cervical, vaginal, and vulvar precancer and cancer; genital warts Males (9-26 yrs): Anal precancer and cancer; genital warts Females (9-26 yrs): Anal, cervical, vaginal, and vulvar precancer and cancer; genital warts Males (9-26 yrs): Anal precancer and cancer; genital warts DTaP-IPV Quadracel Manufacturer: sanofi pasteur FDA approved for use in children who received Pentacel or Daptacel: 4 through 6 years of age, 5th dose in the diphtheria, tetanus, pertussis (DTaP) vaccination series, and 4th or 5th dose in the inactivated poliovirus (IPV) vaccination series IMMUNIZATION SCHEDULES

5 4 weeks if first dose of DTaP/DT was administered before the 1 st birthday. Hepatitis B (HepB) vaccine. (Minimum age: birth) Routine vaccination: At birth: Administer monovalent HepB vaccine to all newborns before hospital discharge. For infants born to hepatitis B surface antigen (HBsAg)- positive mothers, administer HepB vaccine and 0.5 ml of hepatitis B immune globulin (HBIG) within 12 hours of birth. These infants should be tested for HBsAg and antibody to HBsAg (anti-hbs) at age 9 through 18 months (preferably at the next well-child visit) or 1 to 2 months after completion of the HepB series if the series was delayed; CDC recently recommended testing occur at age 9 through 12 months; see 6 months (as final dose) if first dose of DTaP/DT or Tdap/Td was administered at or after the 1 st birthday. Diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine. (Minimum age: 6 weeks. Exception: DTaP-IPV [Kinrix, Quadracel]: 4 years) Routine vaccination: Administer a 5-dose series of DTaP vaccine at ages 2, 4, 6, 15 through 18 months, and 4 through 6 years. The fourth dose may be administered as early as age 12 months, provided at least 6 months have elapsed since the third dose. Inadvertent doses of DTaP vaccine: - If the fourth dose of DTaP was administered at least 4 months, but less than 6 months, after the third dose of DTaP, it need not be repeated. Inactivated poliovirus vaccine (IPV). (Minimum age: 6 weeks) (cont d) Catch-up vaccination: In the first 6 months of life, minimum age and minimum intervals are only recommended if the person is at risk for imminent exposure to circulating poliovirus (i.e., travel to a polioendemic region or during an outbreak). If 4 or more doses are administered before age 4 years, an additional dose should be administered at age 4 through 6 years and at least 6 months after the previous dose. A fourth dose is not necessary if the third dose was administered at age 4 years or older and at least 6 months after the previous dose. If both OPV and IPV were administered as part of a series, a total of 4 doses should be administered, regardless of the child s current age. If only OPV were administered, and all doses were given prior to 4 years of age, one dose of IPV should be given at 4 years or older, at least 4 weeks after the last OPV dose. IPV is not routinely recommended for U.S. residents aged 18 years or older. For other catch-up guidance, see Figure 2. 5

6 11. Meningococcal vaccines. (Minimum age: 6 weeks for Hib- MenCY [MenHibrix], 9 months for MenACWY-D [Menactra], 2 months for MenACWY-CRM [Menveo], 10 years for serogroup B meningococcal [MenB] vaccines: MenB-4C [Bexsero] and MenB-FHbp [Trumenba]) Routine vaccination: Administer a single dose of Menactra or Menveo vaccine at age 11 through 12 years, with a booster dose at age 16 years. Adolescents aged 11 through 18 years with human immunodeficiency virus (HIV ) infection should receive a 2- dose primary series of Menactra or Menveo with at least 8 weeks between doses. For children aged 2 months through 18 years with high-risk conditions, see below. Catch-up vaccination: Administer Menactra or Menveo vaccine at age 13 through 18 years if not previously vaccinated. If the first dose is administered at age 13 through 15 years, a booster dose should be administered at age 16 through 18 years with a minimum interval of at least 8 weeks between doses. If the first dose is administered at age 16 years or older, a booster dose is not needed. For other catch-up guidance, see Figure 2. Clinical Discretion Young adults aged years (preferred age range is 16 through18 years) may be vaccinated with either a 2-dose series of Bexsero or a 3-dose series of Trumenba vaccine to provide short-term protection against most strains of serogroup B meningococcal disease. The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses. Meningococcal B vaccines: 1. Bexsero or Trumenba o Persons 10 years or older who have not received a complete series: Administer either a 2 -dose series of Bexsero, at least 1 month apart or a 3- dose series of Trumenba, with the second dose at least 2 months after the first and the third dose at least 6 months after the first. The two MenB vaccines are not interchangeable; the same vaccine product must be used for all doses. Children with persistent complement component deficiency (includes persons with inherited or chronic deficiencies in C3, C5-9, properidin, factor D, factor H, or taking eculizumab (Soliris ): Meningococcal conjugate ACWY vaccines: 1. Menveo o Children who initiate vaccination at 8 weeks through 6 months: Administer doses at 2, 4, 6, and 12 months of age. o Unvaccinated children 7 through 23 months: Administer 2 doses, with the second dose at least 12 weeks after the first dose AND after the first birthday. o Children 24 months and older who have not received a complete series: Administer 2 primary doses at least 8 weeks apart. 2. MenHibrix o Children 6 weeks through 18 months: Administer doses at 2, 4, 6, and 12 through 15 months of age. o If the first dose of MenHibrix is given at or after 12 months of age, a total of 2 doses should be given at least 8 weeks apart to ensure protection against serogroups C and Y meningococcal disease.. 3. Menactra o Children 9 through 23 months: Administer 2 primary doses at least 12 weeks apart. o Children 24 months and older who have not received a complete series: Administer 2 primary doses at least 8 weeks apart. Catch-up Guidance Job Aids 13. Human papillomavirus (HPV) vaccines. (Minimum age: 9 years for 2vHPV [Cervarix], 4vHPV and 9vHPV [Gardasil and Gardasil 9]) Routine vaccination: Administer a 3-dose series of HPV vaccine on a schedule of 0, 1-2, and 6 months to all adolescents aged 11 through 12 years. 9vHPV, 4vHPV or 2vHPV may be used for females; and only 9vHPV or 4vHPV may be used for males. The vaccine series may be started at age 9 years. Administer the second dose 1 to 2 months after the first dose (minimum interval of 4 weeks); administer the third dose 16 weeks after the second dose (minimum interval of 12 weeks) and 24 weeks after the first dose. Administer HPV vaccination beginning at age 9 years to children and youth with any history of sexual abuse or assault who have not initiated or completed the 3-dose series. Catch-up vaccination: Administer the vaccine series to females (either 2vHPV or 4vHPV or 9vHPV) and males (4vHPV or 9vHPV) at age 13 through 18 years if not previously vaccinated. Use recommended routine dosing intervals (see Routine vaccination above) for vaccine series catch-up. Catch-up Guidance Job Aids Catch-up Guidance Job Aids 6

7 Catch-up Guidance Job Aids IMMUNIZATION COVERAGE RATES Estimated Vaccine Coverage Among Children Aged Months, NIS 2014 State/Area Vaccine Series* 4:3:1:3:3:1:4 United States 71.6% New Hampshire 80.4% Estimated percentage of children enrolled in kindergarten who have been exempted from receiving one or more vaccines, by state United States, school year New Hampshire (Total = 357) Medical Nonmedical Any exemption Religious Philosophic = 0.2% 331 N/A 2.8% 2.9% US 39.7 GA 47.1 *Includes >4 doses DTaP/DT/DTP, > 3 doses polio, > 1 dose MMR, full series Hib, > 3 doses Hep B, dose > 1 varicella, and > 4 doses PCV. MMWR 2015; 64(33): MMWR 2015; 64(33):

8 Estimated Vaccination Coverage among Adolescents Aged Years, NIS-Teen, United States, Estimated Vaccination Coverage among Adolescents Aged Years, NIS-Teen, United States, 2014 Percent Source: MMWR. 2014;63; Year Revised APD definition * 1 Tdap 1 MenACWY 1 HPV (F) 1 HPV (M) 3 HPV (F) 2 MenACWY** 3 HPV (M) Vaccine United States New Hampshire >1 Tdap 89.8% 95.5% >1 HPV (F) 60.0% 71.0% >3 HPV (F) 39.7% 50.1% >1 HPV (M) 41.7% 56.1% >3HPV (M) 21.6% 33.0% >1 MenACWY 79.3% 90.6% MMWR 64(29); * APD = Adequate provider data; ** 2 doses MenACWY among adolescents aged 17 years Influenza Vaccination Coverage Among U.S. Adults: , , and Seasons 8

9 Improving Adult Coverage Rates Reduce client costs Vaccinate during home visits Use client reminder/recall systems Recommend and offer the vaccine Use standing orders and provider reminders, Expand access in non-traditional settings (e.g., pharmacies and the workplace) VACCINE INFORMATION STATEMENTS UPDATE 9

10 Updated VISs VIS RV PCV13 PPSV23 Hib 9vHPV MenB Influenza IIV & LAIV Multiple Provider Information Stay Current Sign up for VIS alerts Import the current VISs to your website Seasonal Influenza Update SEASONAL INFLUENZA UPDATE Flu activity continues to increase in the U.S., but for the week ending March 5 th, NH has experienced minimal influenza-like-illness (ILI) activity Influenza A (H1N1) viruses most common in recent weeks Overall vaccine effectiveness (VE) 59%: VE was 51 percent against the influenza A (H1N1) viruses responsible for most flu illness this season; VE was 76 percent against all influenza B viruses; and VE was 79 percent against the B/Yamagata lineage of B viruses Seasonal Influenza Update It is likely flu activity will continue for several more weeks Vaccination now, can still offer protection against flu this season While flu vaccine is the best way to prevent flu, flu antiviral drugs can treat flu illness Patients suspected of having influenza who are at high-risk or who are very sick should receive influenza antiviral drugs promptly without waiting for confirmatory testing

11 PREVENTING VACCINE ADMINISTRATION ERRORS Don t let this happen! Prosecutor reviewing cases of kids getting wrong medicines... (Salem County, NJ 07/06/15) 1,900 doses of flu vaccine spoil in hospital s faulty fridge (West Allis, WI; 11/3/04) Kaiser mishandles flu vaccine (Fresno, CA; 12/15/04) Storage errors cause thousands to be vaccinated again (Knoxville, TN; 1/21/05) U.S. doctor accused of giving last year s flu vaccine (Bellingham, WA; 11/6/04) Frozen vaccine could cost state more than $30,000 (Arkansas; 11/19/04) Vaccine Administration Errors Vaccination Error reports comprised 6-15% of all reports to VAERS in recent years The number and percentage of vaccination error reports have increased in VAERS during the period from (10; 0.07% of all annual reports to a peak of 4324;15% in 2013) Three-fourths of vaccination error reports have no reported adverse health event However, errors can affect cost, convenience, effectiveness, and confidence in vaccine and providers CDC unpublished data Top 3 Vaccine Administration Errors 1. Inappropriate schedule errors (wrong age, timing between doses) (5,947; 27%) Most common vaccines involved Quadrivalent human papillomavirus HPV4 (1,516) Rotavirus vaccine (880) 2. Storage errors (4,983, 23%) Expired vaccine administered (2,746) Seasonal live attenuated influenza (LAIV) (978; 36%) Incorrect storage of vaccine (2,202) Vaccines kept outside of proper storage temp, (too cold ) CDC unpublished data Top 3 Vaccine Administration Errors 3. Wrong vaccine administered (3,372; 15%) Common Wrong Vaccine Mix-ups* Varicella with Herpes zoster Diphtheria, tetanus and pertussis (DTaP) Trivalent inactivated influenza vaccines (IIV3) with with Tetanus, diphtheria and pertussis (Tdap) Another IIV3 of different age indications Pneumococcal conjugate with Pneumococcal polysaccharide Hepatitis A with Hepatitis B Vaccine mix ups can be either combination (e.g. varicella vaccine instead of herpes zoster vaccine or herpes zoster vaccine instead of varicella vaccine). CDC unpublished data S&H and Administration Best Practices Store vaccines according to manufacturer guidelines Adhere to Rights of Medication Administration Involve staff in selection of products to be used in your facility Provide ongoing staff training and education Keep current reference materials available for staff 11

12 S&H and Administration Best Practices Only administer vaccines you have prepared and triple checked Use standardized ACIP vaccine abbreviations Consider using standing orders Establish an environment that values reporting and investigating errors as part of risk management and quality improvement Vaccine Administration Resources What if a Vaccine Error Occurs? Inform the patient/parent of the error Determine the status of the patient Explain any needed next steps Make sure you know how to correct the error Contact your local health department, vaccine manufacturer, or nipinfo@cdc.gov for guidance Record the vaccine as it was given on the vaccine administration record and in immunization information system (NMSIIS) Reporting Vaccination Errors to Vaccine Adverse Event Reporting System (VAERS) VAERS accepts all reports VAERS encourages reports of clinically significant adverse health events Providers are encouraged to report vaccination errors without health events if they believe the error may pose a safety risk Upcoming Immunization Events National Infant Immunization Week April 16-23, th National Immunization Conference (NIC) It Takes a Community September 13-15, 2016 Hilton Hotel in Atlanta, GA

13 CDC Resources for Staff Education Competency-based education for staff is critical Multiple education products available free through the CDC website: Immunization courses (webcasts and online self-study) Netconferences You Call the Shots self-study modules Continuing education credits available You Call the Shots (Several Modules Added or Updated Now Available The Pink Book (course textbook), 13th Edition (2015) CDC Vaccine and Immunization Resources Questions? CDC Providers Parents and patients Website Twitter Influenza Vaccine Safety Additional Resources State Immunization Program And local public health immunization programs, too! Immunization Action Coalition Vaccine Education Center American Academy of Pediatrics (AAP) National Foundation for Infectious Diseases (NFID) Acknowledgments Ms. Beth Hibbs, RN, MPH Ms. Ginger Redmon, BS Ms. JoEllen Wolicki, RN, BSN Ms. Donna Weaver, RN, Dr. Andrew Kroger, MD, MPH Dr. Raymond Strikas, MD, MPH 13

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