10/12/2016. Disclosures. Immunization Update Disclosures

Transcription

1 Immunization Update 2016 JoEllen Wolicki, BSN, RN Nurse Educator Immunization Services Division 2016 Professional Immunization Seminar Erie, Pennsylvania October 20, 2016 National Center for Immunization and Respiratory Diseases Immunization Services Division Disclosures JoEllen Wolicki is a federal government employee with no financial interest in or conflict with the manufacturer of any product named in this presentation The speaker will discuss the off-label use of LAIV, PCV13, and MenB vaccines The speaker will not discuss a vaccine not currently licensed by the FDA Disclosures Next ACIP Meeting October 19-20, 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 1

2 2016 IMMUNIZATION SCHEDULES Download the App Download the App 2

3 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% Pennsylvania 78.6 Philadelphia 76.2 Rest of the state 79.0 *Includes > 4 doses DTaP/DT/DTP, > 3 doses polio, > 1 dose MMR, full series Hib, > 3 doses HepB, > 1 dose varicella, and > 4 doses PCV. MMWR 2015;64(33): Estimated Vaccine Coverage among Adolescents Aged Years, NIS-Teen, United States, Tdap 1 HPV (F) 1 HPV (M) 3 HPV (F) 2 MenACWY** 3 HPV (M) MMWR.2016;64(33): * APD = Adequate provider data; ** 2 doses MenACWY among adolescents aged 17 years 3

4 VACCINE INFORMATION STATEMENT (VIS) UPDATES Influenza Vaccine Information Statement (VIS) Flu VISs are no longer updated every year Current edition is dated 8/7/2015 Use the inactivated flu VIS for: Trivalent Quadrivalent Recombinant Cell culture Intradermal High-dose Recently Updated VISs HepA HepB MenB Polio 4

5 What Do You Think? Vaccine information statements are only required to be given to parents/patients for the first dose in the series not subsequent doses. True False ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) UPDATES INFLUENZA VACCINATION 5

6 Influenza Season Influenza A (H1N1) viruses predominated overall Circulating viruses similar to vaccine strains Relatively mild moderate season overall Later season than most: Activity peaked in early March High rates of disease among younger adults 85 reported influenza-associated pediatric deaths What Has Changed for Flu Season? Recommended viruses for trivalent vaccine formulation include: A/California/7/2009 (H1N1)pdm09-like virus A/Hong Kong/4801/2014 (H3N2)-like virus B/Phuket/3073/2013-like virus (B/Yamagata lineage) Quadrivalent vaccine includes the same 3 strains as trivalent vaccine plus: B/Brisbane/60/2008-like virus (Victoria lineage) New Inactivated Vaccines for Fluad (Seqirus) Adjuvanted trivalent influenza vaccine Age indications: Persons 65 years of age and older Storage: 2 C - 8 C (36 F - 46 F), protect from light Administration: 0.5 ml by intramuscular (IM) injection Flucelvax Quadrivalent (Seqirus) Replaces trivalent Flucelvax for season Age indications: 4 years of age and older Storage: 2 C - 8 C (36 F - 46 F), protect from light Administration: 0.5 ml by intramuscular (IM) injection Fluad PI: Flucelvax PI: 6

7 Inactivated Influenza Vaccines Season Product/Manf Presentation Age Indications Route ACIP Abbreviation Quadrivalentinactivated influenza vaccines Fluarix/GSK 0.5 ml MFS 3 years and older IM IIV4 Flulaval/ID Biomedical 0.5 ml MFS 3 years and older IM IIV4 5.0 ml MDV Fluzone/SP 0.25 ml MFS 6 months and older 0.5 ml MFS 0.5 ml SDV 3 years and older 5.0 ml MDV 6 months and older Fluzone Intradermal/SP 0.1 ml microinjection system 18 through 64 years ID IIV4 Flucelvax/Seqirus 0.5 ml MFS 4 years and older IM cciiv4 Trivalent inactivated influenza vaccine Afluria/Seqirus 0.5 ml MFS 9 years and older IM 5.0 MDV 9 years and older IM: needle/syringe 18 through 64 years IM: Jet injector Fluvirin/Seqirus 0.5 ml MFS 5.0 ml MDV 4 years and older IM IIV3 Fluad/Seqirus 0.5 ml MFS 65 years and older IM IIV3 Fluzone High-Dose/SP 0.5 ml MFS 65 years and older IM IIV3 Flublok/Protein Sciences 0.5 SDV 18 years and older RIV3 MFS = manufacturer-filled syringe SDV = single-dose vial MDV = multidose vial IM IIV4 IIV3 ACIP Influenza Recommendations ACIP recommendations were published in the MMWR on August 26, 2016 Annual influenza vaccination continues to be recommended for persons without contraindications or precautions 6 months of age and older Principal changes: LAIV4 is not recommended during the season Updated egg allergy recommendations MMWR 2016;65(5):1 54 ACIP Recommendations LAIV LAIV is not recommended for use in the influenza season In light of low effectiveness against influenza A(H1N1)pdm09 in the United States during the and seasons, for the season, ACIP makes the interim recommendation that LAIV4 should not be used. Because LAIV4 is still a licensed vaccine that might be available and that some providers might elect to use, for informational purposes, reference is made to previous recommendations for its use MMWR 2016;65(5):1 54 7

8 ACIP Recommendations LAIV Data analysis from 3 observational studies of LAIV4 vaccine effectiveness for the season revealed low effectiveness against influenza A(H1N1)pdm09 among children 2 through 17 years During season (A[H1N1]pdm09 viruses were predominant) data from the U.S. Influenza Vaccine Effectiveness Network showed no significant vaccine effectiveness among children aged 2 through 17 years for LAIV4 for all influenza A and B viruses combined Estimated effectiveness of IIV against these viruses among children aged 2 through 17 years was significant across all three studies Following review of this information in June 2016, ACIP made the interim recommendation that LAIV4 should not be used for the influenza season MMWR 2016;65(5):1 54 Influenza Vaccines and Egg Sensitivity Most influenza vaccine available for the season will be produced in hen s eggs Ovalbumin concentrations up to 1.4 mcg per ml In clinical studies of egg-allergic persons, IIV was tolerated without serious reactions Flucelvax not manufactured in egg (MDCK cells), but consists of strains isolated in eggs (amount of ovalbumin 50 femtograms [10-15] gm) FluBlok not manufactured in eggs MMWR 2016;65(5):1 54 Severe Allergic Reaction to Egg and Influenza Vaccine ACIP no longer recommends a 30-minute postvaccination observation period for persons with an egg allergy Persons with a history of a severe allergic reaction to eggs (i.e., any symptom other than hives) Vaccines should be administered in settings where personnel and equipment are available for rapid recognition and treatment of anaphylaxis Vaccine administration should be supervised by HCP who are able to recognize and manage severe allergic conditions MMWR 2016;65(5):1 54 8

9 Inactivated Influenza Vaccine Schedule Group Age Dose # of Doses 6-35 mos 0.25 ml 1 or yrs 0.50 ml 1 or 2 9 yrs and older 0.50 ml 1 Seasonal Influenza Vaccination Schedule Administer 2 doses of influenza vaccine at least 4 weeks apart to: Children aged 6 months through 8 years who have never been vaccinated against influenza or with an unknown vaccination history Children who have not received at least 2 doses of seasonal influenza vaccine* before July 1, 2016 Administer 1 dose of influenza vaccine to: Persons 9 years of age and older, regardless of immunization history. Children 6 months through 8 years who have received at least 2 doses of seasonal influenza vaccine* before July 1, 2016 *LAIV or inactivated, trivalent or quadrivalent vaccine MMWR 2016;65(5):1 54 What Do You Think? Tariq is receiving flu vaccine for the first time this fall. He has received 1 dose 6 weeks ago. He turned 9 years old yesterday. Does he need a second dose of flu vaccine? Yes No 9

10 PNEUMOCOCCAL VACCINATION Characteristic Pneumococcal Vaccines 23-valent Pneumococcal Polysaccharide Vaccine (PPSV23) 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Components Purified polysaccharide Purified polysaccharide covalently bound to carrier protein Ages 2 years and older 6 weeks and older* Number of serotypes Route Subcut or IM injection IM Injection *ACIP off-label recommendation MMWR (40): Administering Pneumococcal Vaccines to Adults Administer PCV13 before PPSV23 whenever possible PCV13 and PPSV23 should not be administered during the same clinic visit Either vaccine may be administered with other vaccines Adult PCV13 schedule: Administer 1 dose to eligible adults who have no history of PCV13 vaccine If PCV13 was administered before age 65, no additional doses are indicated at 65 years of age and older Adult PPSV23 schedule: No more than 2 doses of PPSV23 are recommended before age 65 and 1 dose after Separate doses of PPSV23 by at least 5 years Prior doses count and do not need to be repeated MMWR 2015;64(34):

11 Pneumococcal Vaccination and Adults PCV13 and PPSV23 adult vaccination recommendations are divided between 2 age groups. Persons who are: 19 through 64 years of age 65 years of age and older Immunization recommendations for persons 19 through 64 years of age are based on risk, including those at: High risk Higher risk Highest risk MMWR 2015;64(34): High Risk for IPD Adults 19 through 64 years of age at high risk for IPD include: Persons with chronic conditions, including: Pulmonary disease (including asthma) Cardiac disease (excluding hypertension) Liver disease (including cirrhosis) Diabetes Alcoholism Smokers Residents of a long-term care facility Administer 1 dose of PPSV23 PPSV23 PCV13 MMWR 2015;64(34): Higher Risk for IPD Adults 19 through 64 years of age at higher risk for IPD, including those with: CSF leak Cochlear implant Administer PCV13 followed by PPSV23 vaccine PCV13 8 weeks apart PPSV23 MMWR 2015;64(34):

12 Highest Risk for IPD Adults 19 through 64 years of age at highest risk for IPD, including those who: Are immunocompromised (including HIV infection) Have chronic renal failure or nephrotic syndrome Have asplenia Administer PCV13 and 2 doses of PPSV23 PCV13 8 weeks PPSV23 5 years PPSV23 MMWR 2015;64(34): Persons Age 65 Years and Older No history of pneumococcal vaccine PCV13 1 year* PPSV23 Immunization history of PPSV23 at age 65 or older PPSV23 1 year PCV13 *8 weeks if at higher or highest risk MMWR 2015;64(34): Persons Age 65 Years and Older Received PPSV23 before age 65 years PPSV23 before 65 years 1 year PCV13 1 year* PPSV23 Separate doses of PPSV23 by at least 5 years *8 weeks if at higher or highest risk MMWR 2015;64(34):

13 CDC Pneumococcal Vaccine Timing Immunization Action Coalition Pneumococcal Recommendations MDH Pneumococcal Vaccination Pocket Guide MENINGOCOCCAL B VACCINATION Meningococcal B Vaccines Product Name/ACIP Abbreviation Trumenba MenB-FHbp FDA Age Indications Dosage/Route/Schedule 10 through 25 years of age 3 doses 0.5 ml each IM injection 0, 2, and 6 months Bexsero MenB-4C 10 through 25 years of age 2 doses 0.5 ml each IM injection 0, 1 6 months 13

14 ACIP MenB Recommendations Certain persons aged 10 years* and older who are at increased risk for meningococcal disease should receive MenB vaccine, including: Persons with persistent complement component deficiencies. Persons with anatomic or functional asplenia** Microbiologists routinely exposed to isolates of Neisseria meningitidis Persons identified as at increased risk because of a serogroup B meningococcal disease outbreak *ACIP off-label recommendation **Including sickle cell disease ACIP MenB Recommendations Certain other groups are included in MenACWY (MCV4) recommendations for persons at increased risk, but not in this recommendation MenB is NOT currently recommended for: Children aged 2 months through 9 years of age even if in an at-risk group 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 short-term protection against most strains of serogroup B meningococcal disease* The preferred age for routine vaccination with MenB vaccine is years *Permissive recommendation (Category B) MMWR 2015;64(41):

15 ACIP MenB Recommendations MenB should be administered as either a complete series of MenB-4C (Bexsero) or MenB-FHbp (Trumenba) 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 at the same time as other vaccines indicated for this age Always use a different anatomic site ACIP does not express a product preference HUMAN PAPILLOMAVIRUS (HPV) VACCINATION HPV Infection Most females and males will be infected with at least one type of mucosal HPV at some point in their lives Estimated 79 million Americans currently infected 14 million new infections/year in the U.S. HPV infection is most common during the teens and early 20s Most people will never know that they have been infected Jemal A, et al. J Natl Cancer Inst 2013;105:

16 Adolescent HPV Coverage, 2015 U.S. Penn Female 1 HPV 62.8% 62.2% Female 3 HPV 41.9% 47.8% Male 1 HPV 49.8% 55.9% Male 3 HPV 28.1% 38.3% MMWR.2016;64(33): Human Papillomavirus Vaccines 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 Contraindications FDA Indications Hypersensitivity to latex* Females (9-26 yrs): Cervical precancer and cancer Males: Not approved for use in males * May be present in tip of manufacturer-filled syringes Hypersensitivity to yeast Females (9-26 yrs): Anal, cervical, vaginal, and vulvar precancer and cancer; genital warts Males (9-26 yrs): Anal precancer and cancer; genital warts Hypersensitivity to yeast Females (9-26 yrs): Anal, cervical, vaginal, and vulvar precancer and cancer; genital warts Males (9-26 yrs): Anal precancer and cancer; genital warts Updated ACIP HPV Recommendations Vaccinate males and females at years* Catch up those previously unvaccinated or missing doses: Females age 13 through 26 years Males age 13 through 21 years High-risk males age 22 through 26 years Men who have sex with men and immunocompromised men (including HIV-infected men) Use: 2vHPV, 4vHPV, or 9vHPV** for females 4vHPV or 9vHPV** for males *Vaccination series can be started at 9 years of age **9vHPV is the only product available through Vaccines For Children program 5/2/2016 MMWR 2015;64:

17 10/12/2016 Updated ACIP Recommendations Interchangeability* If immunization providers do not know or do not have available the HPV vaccine product previously administered, or are in settings transitioning to 9vHPV, for protection against HPV 16 and 18: Females: Use any HPV vaccine product to continue or complete the series Males: Use 4vHPV or 9vHPV* to continue or complete the series *ACIP off-label recommendation MMWR 2015;64(29): What Do You Think? Parents rate the importance of HPV vaccine as high as other vaccines for children and adolescents. True False 17

18 Clinicians Underestimate the Value Parents Place on HPV Vaccine Healy C, et al. Parent and provider perspectives on immunization: Are providers overestimating parental concerns? Vaccine.2014;32: VACCINE STORAGE AND HANDLING UPDATE Updated Vaccine Storage and Handling Toolkit Recommendations and best practices for: Managing vaccine inventory Storing and preparing vaccine Monitoring vaccine temperature Using and maintaining storage unit and temperature monitoring equipment Preparing for emergency storage, handling, and transport situations Developing standard operating procedures for routine and emergency vaccine management and staff training 18

19 Recommended Storage Unit Temperature Range The 2016 Vaccine Storage and Handling Toolkit reflects an adjustment in CDC s guidance on the Fahrenheit temperature range for storing refrigerated vaccines New recommended Fahrenheit temperature range is 36 F 46 F (previously 35 F 46 F) Celsius temperature range (2 C 8 C) remains unchanged Temperature ranges are as stated in all manufacturer package inserts for routinely recommended vaccines FAQ document at mp-change-qa.pdf VACCINE ADMINISTRATION ERRORS Common Vaccine Administration Errors 1. Inappropriate schedule errors (wrong age, timing between doses) Most common vaccines involved: Quadrivalent human papillomavirus (HPV4) Rotavirus vaccine 2. Storage errors Expired vaccine administered Incorrect storage of vaccine Vaccines kept outside of proper storage temperature too cold!! 3. Wrong vaccine administered Varicella instead of zoster DTaP instead of Tdap CDC unpublished data 19

20 Strategies to Prevent Errors Make the easy thing to do the right thing to do! Establish an environment that values reporting and investigating errors as part of risk management and quality improvement Take immediate action and isolate vaccine(s) exposed to improper temperatures Check expiration dates weekly and promptly remove expired vaccines from the storage unit Color code and label vaccines in storage bins with indications such as type, age, and gender (if applicable) Store some vaccines on separate shelves, if possible: Pediatric and adult formulations of the same vaccine Sound-alike and look-alike vaccines Use standing orders Immunization Action Coalition has standing orders templates What if a Vaccination Error Occurs? Inform the patient/parent of the error Determine the status of the patient Explain any needed next steps Know how to correct the error Contact your local health department, vaccine manufacturer, or nipinfo@cdc.gov for guidance Not all errors require revaccination Record the vaccine as it was given on the medical administration record Contact the immunization information system for additional information as needed Reporting Vaccination Errors to 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 20

21 IMMUNIZATION RESOURCES CDC Resources for Staff Education Competency-based education for staff is critical Multiple education products available free through the CDC website: Immunization courses You Call the Shots self-study modules Netconferences Continuing education is available Epidemiology and Prevention of Vaccine-Preventable Diseases Webinars Provide information about vaccine-preventable diseases and the vaccines that prevent them Archived presentations Free continuing education available For more information: Course text available online view, print, or download Bound copies may be purchased. 21

22 Vaccine Administration Vaccine Storage and Handling CDC Injection Safety web page CDC Vaccine Administration web page CDC Vaccine Storage and Handling web page CDC Immunization Apps for Health Care Personnel Vaccine Schedules app.html Influenza information Morbidity and Mortality Weekly Report (MMWR) Travel Well Vaccine and Immunization Resources Questions? CDC Providers Parents and patients CDC website Twitter for health care personnel Influenza Vaccine Safety State Immunization Programs 22