Immunization Update 2017

Transcription

1 Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Immunization Update 2017 Donna L. Weaver, RN, MN Nurse Educator Immunization Services Division Connecticut Department of Public Health October 18, 2017 Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.

2 Disclosures Donna Weaver 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 Tdap, MenB vaccines, and HPV vaccines The speaker will not discuss a vaccine not currently licensed by the FDA The use of trade names is for identification purposes only and does not imply endorsement by the ACIP or CDC

3 Disclosures The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices (ACIP): - Composed of 15 non-government 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 Next ACIP Meeting Draft Agenda -October 25-26, Votes: Zoster vaccine Mumps 2018 CH/Adol and Adult Immunization Schedules - Information and discussions HepB vaccine Influenza Shoulder injury after vaccination HPV update JE updatepcv13 update Anthrax update updateov/vaccines/acip/meetings/upcoming-dates.html

4 Overview Recent ACIP Updates General Best Practices Guidelines for Immunization HepB HPV Influenza MenACWY MenB Tdap Cholera Vaccine Updates 2vHPV and 4vHPV MenHibrix Menomune Hiberix Recombivax-HB Tenivac Menveo Resources

5 Advisory Committee on Immunization Practices (ACIP) Updates and MMWR Publications

6 Posted April 20, Timing and Spacing of Immunobiologics Contraindications and Precautions Preventing and Managing Adverse Reactions Vaccine Administration Storage and Handling of Immunobiologics Altered Immunocompetence Special Situations Vaccination Records Vaccination Programs Vaccine Information Sources 6

7 Hepatitis B Monovalent Hepatitis B vaccine should be administered within 24h of birth for medically stable infants weighing 2,000 grams born to hepatitis B surface antigen (HBsAg)-negative mothers The recommendations for vaccination of infants <2,000 grams remain unchanged Preterm infants weighing <2,000 g born to HBsAg-negative mothers should receive the first dose of vaccine 1 month after birth or at hospital discharge The recommendation for infants born to HBsAg-positive mothers or mothers whose hepatitis B status is unknown also remain unchanged

8 HPV 2-dose Schedule For persons initiating vaccination before age 15 years, the recommended immunization schedule is 2 doses of HPV vaccine at 0, 6-12 months For persons initiating vaccination at age 15 years or older, the recommended immunization schedule is 3 doses of HPV vaccine at 0, 1 2**, 6 months Immunocompromised persons*, including those with human immunodeficiency virus (HIV) infection, should receive a 3-dose series at 0, 1 2**, and 6 months, regardless of age at vaccine initiation *See MMWR December 16, 2016;65(49): , available at **ACIP off-label recommendation

9 CDC HPV 2-Dose FAQs for Clinicians

10 Recommended Composition of Influenza Vaccines for Northern Hemisphere Influenza Season It is recommended that trivalent vaccines for use in the northern hemisphere influenza season contain the following: A/Michigan/45/2015 (H1N1)pdm09-like virus [NEW] A/Hong Kong/4801/2014 (H3N2)-like virus B/Brisbane/60/2008-like virus It is recommended that quadrivalentvaccines containing two influenza B viruses contain the above three viruses and: B/Phuket/3073/

11 Influenza ACIP Recommendations Annual influenza vaccination continues to be recommendedfor persons without contraindications or precautions 6 months of age and older FluMistQuadrivalent(LAIV4) should not be used during the season due to concerns about its effectiveness against influenza A(H1N1)pdm09 viruses in the United States during the and influenza seasons

12 Afluria/Seqirus Inactivated Influenza Vaccines Season Product/Manf Presentation Age Indications Route Number of Strains 0.5 ml MFS IM 5 years and older 5.0 MDV IM: needle/syringe 18 through 64 years IM: needle/syringe or Jet injector IIV3 and IIV4 Fluad/Seqirus 0.5 ml MFS 65 years and older IM IIV3 Fluarix/GSK 0.5 ml MFS 3 years and older IM IIV4 Flublok/Protein Sciences 0.5 SDV 18 years and older IM RIV3 and RIV4 Flucelvax/Seqirus 0.5 ml MFS 4 years and older IM cciiv4 Flulaval/ID Biomedical Fluvirin/Seqirus New! Afluria is approved for children 5 years of age and older FluLaval is now approved for children 6 months of age and older 0.5 ml MFS 5.0 ml MDV 0.5 ml MFS 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 6 months and older IM IIV4 4 years and older IM IIV3 The correct dose (amount) is 0.5 ml for persons 6 months of age and older IM Fluzone High-Dose/SP 0.5 ml MFS 65 years and older IM HD-IIV3 Fluzone Intradermal/SP 0.1 ml microinjection system 18 through 64 years ID IIV4 MFS = manufacturer-filled syringe SDV = single-dose vial MDV = multidose vial IIV4

13 Pediatric Flu Vaccines for Children 6 Months of Age and Older Vaccine Doses and Schedule Product Age Dosage(amount) Schedule Fluzone 6 through35 months 0.25 ml 1 or 2 doses Schedule 36 months and older 0.5 ml 1 or2 doses FluLaval 6 monthsand older 0.5mL 1 or 2 doses Administer 2 doses, separated by at least 4 weeks Previously unvaccinated children 6 months through 8 years of age Dose (amount) based on product Either product may be used for either dose The 2-dose series can be completed with 2 doses appropriately spaced of Fluzoneor FluLaval or 1 dose of Fluzoneand 1 dose of FluLaval Administer 1 dose to: Previously vaccinated children 6 months through 8 years of age Children 9 years of age and older, regardless of immunization history

14 Influenza Vaccine During Pregnancy A published recently study showed women in early pregnancy who received two consecutive annual vaccines during and , both of which included a 2009 pandemic H1N1 component, had an increased risk of miscarriage within 28 days after receiving the second vaccine This study does not quantify the risk of miscarriage and does not prove that flu vaccine was the cause of the miscarriage Earlier studies have not found a link between flu vaccination and miscarriage There is an ongoing investigation to study this issue further

15 Influenza Vaccine During Pregnancy The Advisory Committee on Immunization Practices (ACIP), the American College of Obstetricians and Gynecologists (ACOG) and the Centers for Disease Control and Prevention (CDC) continue to recommend that pregnant women get a flu vaccine during any trimester of their pregnancy Influenza poses a danger to pregnant women and their developing babies. A flu vaccine can prevent serious illness, including hospitalization, in pregnant women

16 Shoulder Injury Related to Vaccine Administration Shoulder injury related to vaccine administration (SIRVA) was added to the Vaccine Injury Compensation Table in March 2017 Shoulder injuries related to vaccine administration are injuries to the musculoskeletal structure of the shoulder, including the ligaments, bursa, and tendons They are thought to occur as a result of the unintended injection of vaccine antigen and/or trauma from the needle going into and around the underlying bursa of the shoulder Symptoms include shoulder pain and limited mobility after the injection When administering a vaccine by intramuscular (IM) injection in the deltoid muscle, use: Proper landmarks and technique to identify the injection site The proper needle length based on the age, size of the patient and injection technique Health care personnel who administer vaccines should demonstrate their ability to properly locate the recommended injection sites and receive additional training as needed

17 Clinical Resources for Health Care Personnel You Call the Shots Influenza module Influenza Vaccine FAQs video Current influenza activity Influenza labels for storage units Fact sheet for health care providers of pregnant women Tools to Assist Satellite, Temporary, and Off-Site Vaccination Clinics

18 Influenza Vaccine Vaccine Storage, Handling, and Administration FAQs

19 Meningococcal ACWY Recommendations for HIV-infected Persons Accumulating evidence indicates that HIV infection increases the risk of invasive meningococcal disease At the June 2016 meeting ACIP voted to recommend routine MenACWYvaccination for all HIV-infected persons age 2 months and older Number of doses depends on age 2-4 doses for children younger than 2 years Persons 2 years and older should receive 2 doses separated by 8 weeks

20 Meningococcal B Vaccines* ProductName/ACIP Abbreviation Trumenba MenB-FHbp FDA Age Indications 10 through 25 years of age Dosage/Route/Schedule 3 doses 0.5 ml each IM injection 0, 1-2, and 6-month; OR 0, 6 month Bexsero MenB-4C 10 through 25 years of age 2 doses 0.5 ml each IM injection 0, 1 6 month *ACIP does not express a preference for specific MenBproduct

21 Use of 2- and 3-Dose Schedules of MenB-FHbp (Trumenba) Meningococcal Serogroup B Vaccine ACIP recommends that certain persons aged 10 years* who are at increased risk for meningococcal disease should receive MenBvaccine (Category A) 1. If MenB-FHbp (Trumenba) is used, 3 doses should be administered at 0, 1-2, 6 months. However, if the second dose of MenB-FHbpis administered at an interval of >6 months, a third dose does not need to be administered Persistent complement component deficiencies Anatomic or functional asplenia, including sickle cell disease Those who are present during outbreaks caused by serogroup B Those who have prolonged increased risk for exposure (such as microbiologists who routinely work with Neisseria meningitidis) *ACIP off-label recommendation

22 Use of 2- and 3-Dose Schedules of MenB-FHbp (Trumenba) Meningococcal Serogroup B Vaccine ACIP recommends that a MenBvaccine series may be administered to adolescents and young adults aged years to provide short-term protection against most strains of serogroup B meningococcal disease (Category B) 2. If MenB-FHbp (Trumenba) is used when given to healthy adolescents who are not at increased risk for meningococcal disease, 2 doses should be administered at 0 and 6 months. If the second dose of MenB-FHbpis administered earlier than 6 months after the first dose, then a third dose should be administered at least 4 months after the second dose

23 Tdap Update *ACIP off-label recommendation

24 Tdap in Pregnancy Infants of Tdapvaccinated mothers were born with significantly higher anti-pertussis antibodies compared to infants of unvaccinated mothers Within the weeks administration window Concentration of anti-pertussis antibodies in infant cord blood were higher when mothers were vaccinated earlier Longer exposure to vaccine allows for higher vaccine induced antibody levels produced by mother and transferred to infant The tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap) footnote for vaccination of pregnant adolescents/adults between gestational weeks has been updated to reflect a preference for vaccination earlier during this period* *ACIP off-label recommendation

25 Cholera Recommendation: One dose of CVD 103-HgR for year-old travelers from U. S. to area of active cholera transmission. No recommendation for booster doses.

26 Vaccine Updates

27 Discontinued Vaccines 2vHPV and 4vHPV vaccines MenHibrix Menomune

28 Hiberix Hiberix was first licensed in the US in August 2009 for use as a booster dose Hiberix is now FDA approved for a 3-dose infant primary vaccination series Safety and immunogenicity of Hiberix in infants is similar to ActHIB and Pentacel

29 RecombivaxHB(HepB) Merck is not currently distributing the hepatitis B vaccine: Adult formulation: Does not expect to be distributing this formulation between now and the end of 2018 Pediatric formulation will be unavailable between early August 2017 and early 2018 Merck s supply of the dialysis formulation of HepB vaccine is not affected GSK has sufficient supplies of adult and pediatric Hepatitis B vaccines to address these anticipated gap in Merck s supply Preferences for a specific presentation (i.e., vial versus syringe) may not be consistently met

30 Tenivac(Td) Vaccine Supply Tenivac vaccine (Td) has been unavailable since November 2016 Grifols, exclusive distributor for the other Td vaccine, has been supplying the US market since that time Based on higher than anticipated demand for Td vaccine, Grifolsreports that their supply of Td is constrained - Shipping delays and partial shipments may occur during August and the first half of September Sanofi anticipates distributing Tenivac vaccine (Td) in mid-august

31 Menveo(MenACWY) GSK reports potential shipping delays of Menveo (MenACWY), during late August and September Sanofi has sufficient supplies of Menactra to address potential supply gaps during this period

32 Resources

33 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

34 You Call the Shots (Several Modules Added or Updated)

35 Now Available The Pink Book, 13th Edition Supplement (2017) Supplemental information regarding: Human Papillomavirus Meningococcal Disease Pneumococcal Disease

36 CDC Vaccine and Immunization Resources Questions? CDC - Providers nipinfo@cdc.gov - Parents and patients Website Twitter Influenza Vaccine Safety

37 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)