Needle Facts: Immunization Update 2017

Transcription

1

2 Needle Facts: Immunization Update 2017 Miranda Wilhelm, Pharm.D. Clinical Associate Professor Southern Illinois University Edwardsville (SIUE) School of Pharmacy

3 Disclosure and Conflict of Interest Miranda Wilhelm reports she is a Speaker s Bureau Member for Merck Vaccines

4 Pharmacist Objectives At the conclusion of this program, the pharmacist will be able to: 1. Discuss the new 2017 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations 2. Review influenza vaccine considerations in preparation for the season 3. Evaluate a patient s immunization history to determine vaccine recommendations based on the appropriate immunization schedule

5 Technician Objectives At the conclusion of this program, the technician will be able to: 1. Discuss the new 2017 Advisory Committee on Immunization Practices (ACIP) recommendations regarding adult and pediatric immunizations 2. Review influenza vaccine considerations in preparation for the season 3. Evaluate a patient s immunization history to determine vaccine recommendations based on the appropriate immunization schedule

6 Pre-Test Question #1 Which of the following patients is a candidate for a 2- dose series of HPV vaccine? a. 11 year old male who already received the first dose b. 16 year old female who has not received any doses c. 20 year old male receiving chemotherapy/radiation d. 28 year old female who is not sexually active

7 Pre-Test Question #2 Which of the following vaccines is currently available? a. Cervarix b. Gardasil 9 c. Menhibrix d. Menomune

8 Pre-Test Question #3 Which of the following patients is considered immunocompromised and is contraindicated to receive live vaccines? a. 5 year old female with otitis media taking amoxicillin BID x 10 days b. 19 year old male with cochlear implants attending college for the first time this fall c. 30 year old male taking prednisone 10 mg PO daily x 10 days d. 45 year old female with psoriasis using Enbrel 50 mg SQ weekly

9 Pre-Test Question #4 Which influenza vaccine contains an adjuvant and is indicated for patients 65 years of age? a. Fluzone Intradermal b. Fluad c. Flucelvax d. Flublok

10 Summary ACIP Recommendations 2016 Recommendations for Use of Meningococcal Conjugate Vaccines in HIV-Infected Persons Advisory Committee on Immunization Practices (ACIP), 2016 Use of a 2-Dose Schedule for Human Papillomavirus Vaccination Updated Recommendations of the Advisory Committee on Immunization Practices

11 Summary ACIP Recommendations 2017 General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices Recommendations of the Advisory Committee on Immunization Practices for Use of Cholera Vaccine Updated Recommendations for Use of MenB- FHbp Serogroup B (Trumenba) Meningococcal Vaccine

12 Meningococcal Conjugate in HIV-Infected Persons MMWR, November 4, 2016;65(43); What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation All HIV-infected persons aged 2 months should routinely receive age appropriate meningococcal conjugate vaccine Age appropriate booster doses should also be administered

13 MMWR, November 4, 2016, 65(43); Recommended Schedule and Interval

14 Update on Vaccine Availability MenHibrix (Hib-MenCY) October 2016, GSK announced discontinuation Menomune (MPSV4) February 2017, Sanofi Pasteur announced discontinuation Current lots will expire in June or September 2017 No meningococcal polysaccharide vaccines will be licensed for patients 56 years of age or older Travelers will need to use Menactra or Menveo instead HPV Vaccine Availability, United States. CDC Website. Available at: Accessed 6/28/17. Sanofi Pasteur Statement on the Discontinuation of Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined. Sanofi Pasteur Website. Available at: Accessed 6/28/17. Clinical Update Menomune discontinuation. CDC Website. Available at: Accessed 6/28/17.

15 2-Dose HPV vaccine MMWR, December 16, 2016;65(49); What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation Persons initiating HPV vaccination at ages 9 through 14 years, except immunocompromised persons, receive 2 doses Persons initiating HPV vaccination at ages 15 through 26 years, and immunocompromised persons ages 9 to 26 years receive 3 doses

16 MMWR, December 16, 2016, 65(49); Recommended Schedule and Doses

17 GRADE Evidence for 2-Dose HPV Outcome Number of Subjects (number of studies) Comparison groups Results Immunogenicity (seroconversions to 9vHPV types) Immunogenicity (GMTs for 9vHPV types) 1102 (1) Girls and boys 2 doses and Girls and boys 3 doses and Women 3 doses 560 (1) Girls 2 doses versus Women 3 doses 559 (1) Boys 2 doses versus Women 3 doses 555 (1) Girls and boys 2 doses versus Women 3 doses 97.9% seropositive at 1 month post last dose in all groups in the per-protocol population Non-inferiority criteria met for all 9vHPV types at 1 month post last dose Non-inferiority criteria for all 9vHPV types at 1 month post last dose Non-inferiority criteria met for all 9vHPV types at 1 month post last dose Grading of Recommendations Assessment, Development and Evaluation (GRADE) of a 2-dose schedule for human papillomavirus (HPV) vaccination. CDC website. Available at: Last updated December 15, Accessed April 24, 2017.

18 Best Practice Guidance CDC Website 4/20/17 What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation 13 updates are included in this document Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. CDC website. Available at Accessed June 1, 2017.

19 Best Practice Guidance New information on simultaneous vaccination and febrile seizures Enhancement of definition of a precaution to include any condition that might confuse diagnostic accuracy Confirmation that if a patient is not acutely moderately or severely ill, vaccination during hospitalization is best practice More descriptive characterization of anaphylactic allergy Incorporation of protocols for management of anaphylactic allergy Allowances for alternate route (SQ) for hepatitis A vaccination Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. CDC website. Available at Accessed June 1, 2017.

20 Best Practice Guidance An age cutoff of 12 years through 17 years of age for validating a dose of intradermal influenza vaccine Deletion of much of the content from storage and handling Incorporation of Infectious Diseases Society of America guidance on vaccination of persons with altered immunocompetence Timing of intramuscular administration in patients with bleeding disorders Updated data on vaccination record policy Additional impacts of the Affordable Care Act on adult vaccination Updated programmatic contact information on source material for vaccine information Kroger AT, Duchin J, Vazquez M. General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. CDC website. Available at Accessed June 1, 2017.

21 Definition of High- and Low-Level Immunosuppression High-Level Receiving cancer chemotherapy Within 2 months after solid organ transplantation HIV infection with CD4 count < 200 cells/mm 3 for adults Receiving daily corticosteroid therapy with a dose of 20 mg of prednisone for 14 days Receiving certain biologic immune modulators (TNFα tumor necrosis factoralpha blocker) Low-Level Asymptomatic HIVinfected patients with a CD4 count cells/mm 3 for adults Receiving a lower daily dose of corticosteroid therapy for 14 days or alternate-day therapy Receiving methotrexate (MTX) 0.4 mg/kg/week, azathioprine 3 mg/kg/day or 6- mercaptopurine 1.5 mg/kg/day Clin Infect Dis 2014 Feb; 58(3):e

22 Recommendations for Timing of Vaccination Before Immunosuppression Vaccines should be administered prior to planned immunosuppression if feasible Live vaccines should be administered 4 weeks prior to immunosuppression and should be avoided within 2 weeks of initiation of immunosuppression Inactivated vaccines should be administered 2 weeks prior to immunosuppression After Immunosuppression Low-Level 1 month High-Level 3 months unless otherwise stated Live vaccines follow before immunosuppression recommendations Inactivated vaccines may consider administration as recommended by CDC depending on type of immunosuppression Clin Infect Dis 2014 Feb; 58(3):e

23 Cholera Vaccine MMWR, May 12, 2017;66(18); What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation Safe food and water precautions, proper sanitation and personal hygiene measures should be followed Vaxchora (Cholera, Vaccine, Live, Oral) is recommended for adult travelers (18-64 years) from the US to an area with endemic or epidemic cholera Booster doses are not recommended at this time

24 Meningococcal Vaccine (Trumenba) MMWR, May 19, 2017;66(19); What is currently recommended? Why are the recommendations being modified now? What are the new recommendations? Recommendation Persons at increased risk for meningococcal disease or during a serogroup B outbreak, should receive 3 doses of Trumenba (MenB-FHbp) Healthy adolescents, should receive 2 doses of Trumenba (MenB-FHbp) Recommendations regarding Bexsero (MenB- 4C) are unchanged

25 MMWR, May 19, 2017, 66(19); MenB Antibody Titers

26 MMWR, May 19, 2017, 66(19); Persistence of Antibody Response

27 Schedule for Birth to 18 Years by Age Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. CDC website. Available at Accessed June 1, 2017.

28 Schedule for Birth to 18 Years by Medical or Other Indication Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. CDC website. Available at Accessed June 1, 2017.

29 Schedule for Adults (19 Years +) by Age Recommended Immunization Schedule for Adults Aged 19 Years or Older. CDC website. Available at Accessed June 1, 2017.

30 Schedule for Adults (19 Years +) by Medical or Other Indication Recommended Immunization Schedule for Adults Aged 19 Years or Older. CDC website. Available at Accessed June 1, 2017.

31 Vaccine News New Zoster Vaccine New Bandage

32 Old vs New (Phase 3) Herpes Zoster Vaccine Zostavax 51% effective against herpes zoster disease 67% effective against postherpetic neuralgia Shingrix 97.2% effective against herpes zoster disease in patients 50 years and older 89.9% effective against herpes zoster disease in patients 70 years and older 88.8% effective against postherpetic neuralgia Adjuvanted, inactivated two-dose series vaccine

33 Inject-Safe TM Barrier Bandage Inject-Safe TM barrier Bandage Web site. Available at: Accessed 8/10/17.

34 Influenza Influenza season is October to May and commonly peaks in January to February Annual influenza vaccination is recommended for all persons 6 months of age and older

35 MMWR, August 26, 2016; 65(5): Influenza Algorithm for Children 6 months through 8 years

36 Inactivated Influenza Vaccine (IIV) Quadrivalent inactivated influenza vaccine (IIV4) Trivalent inactivated influenza vaccine (IIV3) Cell cultured inactivated influenza vaccine (cciiv4) Adjuvanted inactivated influenza vaccine (aiiv3) Recombinant hemagglutinin Influenza Vaccine (RIV) Live-attenuated Influenza Vaccine (LAIV) Quadrivalent live-attenuated influenza vaccine (LAIV4)

37 ACIP Votes Down Use of LAIV June 21, 2017 ACIP Meeting Awaiting further data (anticipated October 2017) Poor or lower efficacy of LAIV4 for children 2 to 17 years from vaccine effectiveness (VE) for LAIV4 was 3% For H1N1 vaccine effectiveness (VE) for LAIV was -21% vaccine effectiveness (VE) for IIV was 63% ACIP Says No to LAIV for Flu Season. AAFP Web site. Available at: Accessed 7/26/17.. ACIP votes down use of LAIV for flu season. CDC Website. Available at: Accessed June 1, 2017

38 Recommended Influenza Vaccine Composition A/Michigan/45/2015 (H1N1)pdm09-like virus A/Hong Kong/4801/2014 (H3N2)-like virus B/Brisbane/60/2008-like virus Additional strain for quadrivalent vaccines B/Phuket/3073/2013-like virus Recommended composition of influenza virus vaccines for use in the northern hemisphere influenza season. World Health Organization Website. Available at:. Accessed 4/19/17.

39 Vaccine Inactivated Influenza Vaccine (IIV3) Afluria Fluvirin Fluzone High-Dose Inactivated Influenza Vaccine IIV4) Fluarix Quadrivalent Flulaval Quadrivalent Fluzone Quadrivalent Fluzone Intradermal Quadrivalent Seasonal Influenza Vaccines Inactivated Influenza Vaccine Cell-Cultured (cciiv4) Flucelvax Quadrivalent Adjuvanted Inactivated Influenza Vaccine (aiiv3) Fluad Recombinant Influenza Vaccine (RIV3) Flublok Live Attenuated Influenza Vaccine (LAIV4) FluMist Quadrivalent MMWR, August 26, 2016; 65(5): Approved Age Indication 9 years needle/syringe years jet injector 4 years 65 years 3 years 3 years 6 months 18 to 64 years 4 years 65 years 18 years 2 to 49 years (healthy, not pregnant)

40

41

42

43

44

45 Case 1 NS is a 15 year old male presenting to the community pharmacy. His mom recently saw something on the HPV vaccine on a morning talk show and realized they missed his appointment. What is the first question that you should ask NS about immunizations?

46 NS s Profile and Immunization Record Profile Multiple vitamin 1 PO daily Amoxicillin 500 mg 1 PO BID x 10 days (August 2017) Immunization Record Up-to-date at 5 year old well child visit

47 Screening Question Response 1. Is the child sick today? No 2. Does the child have allergies to medications, foods, a vaccine component, or latex? No 3. Has the child had a serious reaction to a vaccine in the past? No 4. Has the child had a health problem with lung, heart, kidney or metabolic disease (e.g., diabetes), asthma, or a blood disorder? Is he/she on long-term aspirin therapy? 5. If the child to be vaccinated is 2 through 4 years of age, has a healthcare provider told you that the child had wheezing or asthma in the past 12 months? 6. If your child is a baby, have you ever been told he or she has had intussusception? N/A 7. Has the child, a sibling, or a parent had a seizure; has the child had brain or other nervous system problems? 8. Does the child or family member have cancer, leukemia, HIV/AIDS, or any other immune system problems? 9. In the past 3 months, has the child taken medications that affect the immune system such as prednisone, other steroids, or anticancer drugs; drugs for the treatment or rheumatoid arthritis, Crohn s disease, or psoriasis; or had radiation treatments? 10. In the past year, has the child received a transfusion of blood or blood products, or been given immune (gamma) globulin or a antiviral drug? 11. Is the child/teen pregnant or is there a chance she could become pregnant during the next month? 12. Has the child received vaccinations in the past 4 weeks? No What vaccinations are recommended for NS? No N/A No No No No N/A

48 Schedule for Persons Aged 0 Through 18 Years

49 How Many Doses of HPV? Administer a 3-dose series of HPV vaccine on a schedule of 0, 6-12 months to all adolescents aged 11 or 12 years. The vaccination series can start at age 9 years. Administer HPV vaccine to all adolescents through age 18 years who were not previously adequately vaccinated. The number of recommended doses is based on age at administration of the first dose. For persons initiating vaccination before age 15, 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. A vaccine dose administered at a shorter interval should be readministered at the recommended interval.

50 Case 1 Summary Inactivated influenza vaccine (IIV3/IIV4) Meningococcal conjugate vaccine (MCV4) Tetanus-diphtheria-acellular pertussis vaccine (Tdap) Human papillomavirus vaccine (9vHPV)

51 Case 2 AW, a 65 year old female, presents to the community pharmacy for an annual influenza vaccine. What is the first question that you should ask AW about immunizations?

52 AW s Profile and Immunization Record Profile Humira (adalimumab) 40 mg SQ QOW Alendronate 70 mg 1 PO weekly Levothyroxine 100 mcg 1 PO daily Multiple vitamin 1 PO daily Immunization Record Influenza yearly x 20 years Unsure of childhood immunizations

53 Screening Question Response 1. Are you sick today? No 2. Do you have allergies to medications, foods, a vaccine component, or latex? No 3. Have you ever had a serious reaction after receiving a vaccination? No 4. Do you have a long-term health problem with heart disease, lung disease, asthma, kidney disease, metabolic disease (e.g., diabetes), anemia or other blood disorder? 5. Do you have cancer, leukemia, HIV/AIDS, or any other immune system problem? No 6. In the past 3 months, have you taken medications that affect the immune system such as prednisone, other steroids, or anticancer drugs; drugs for the treatment or rheumatoid arthritis, Crohn s disease, or psoriasis; or have you had radiation treatments? 7. Have you had a seizure or a brain or other nervous system problem? No 8. In the past year, have you received a transfusion of blood or blood products, or been given immune (gamma) globulin or a antiviral drug? 9. For women: Are you pregnant or is there a chance she could become pregnant during the next month? 10. Have you received any vaccinations in the past 4 weeks? No What vaccinations are recommended for AW? No Yes No No

54 Schedule for Adults by Age and Medical / Other Indications

55 Case 2 Summary Inactivated influenza vaccine (IIV3/IIV4) Tetanus-diphtheria-acellular pertussis vaccine (Tdap) Pneumococcal 13-valent conjugate vaccine (PCV13) 8 weeks later Pneumococcal 23-valent polysaccharide vaccine (PPSV23)

56 Post Test Question #1 Which of the following patients is a candidate for a 2- dose series of HPV? a. 11 year old male who already received the first dose b. 16 year old female who has not received any doses c. 20 year old male receiving chemotherapy/radiation d. 28 year old female who is not sexually active

57 Post Test Question #2 Which of the following vaccines is currently available? a. Cervarix b. Gardasil 9 c. Menhibrix d. Menomune

58 Post Test Question #3 Which of the following patients is considered immunocompromised and is contraindicated to receive live vaccines? a. 5 year old female with otitis media taking Amoxicillin BID x 10 days b. 19 year old male with cochlear implants attending college for the first time this fall c. 30 year old male taking Prednisone 10 mg PO daily x 10 days d. 45 year old female with psoriasis using Enbrel 50 mg SQ weekly

59 Post Test Question #4 Which influenza vaccine contains an adjuvant and is indicated for patients 65 years of age? a. Fluzone Intradermal b. Fluad c. Flucelvax d. Flublok

60 Summary All HIV-infected persons aged 2 months should routinely receive age appropriate meningococcal conjugate vaccine and booster doses Persons initiating HPV vaccination at ages 9 through 14 years, except immunocompromised persons, should receive 2 doses at 0 and 6-12 months The CDC recently updated and published the General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices. Influenza vaccine should be administered before the onset of influenza activity in the community and by October, if possible. Balance vaccine protection with avoiding missed opportunities Fluad is a new adjuvanted influenza vaccine

61 Resources & References Immunization Action Coalition Advisory Committee on Immunization Practices Centers for Disease Control and Prevention Vaccines and Immunizations General Best Practice Guidelines for Immunization: Best Practices Guidance of the Advisory Committee on Immunization Practices

62 Needle Facts: Immunization Update 2017 Miranda Wilhelm, Pharm.D. Clinical Associate Professor Southern Illinois University Edwardsville (SIUE) School of Pharmacy