Immunization Update 2013

1. Immunization Update 2013 Maine Pharmacy Association Fall Convention September 7, 2013 Allison Strobel, PharmD Assistant Professor Pharmacy Practice Husson University School of Pharmacy MPA Board of Directors Member

2. Disclosure • I, Allison Strobel, do not have an interest in selling a technology, program, product, and/or service • I have no conflicts of interest

3. Learning Objectives • Discriminate between the different branded influenza vaccines based on patient’s characteristics • Determine in which patient the different pneumococcal vaccines would be warranted • Identify the different travel vaccine resources • Apply principles of travel vaccines to specific patient travel plans

4. Outline • Influenza • Pneumococcal Disease • Tdap • Travel Vaccines

5. The Law – Revisited

6. LD 148 “An Act to Amend the Laws Governing Drugs and Vaccines Administered by Pharmacists” • “A pharmacist may not delegate the pharmacist’s authority to administer drugs or vaccines; except that a pharmacist licensed under this chapter who has obtained a certificate of administration pursuant to section 13832 may delegate the authority to administer adult vaccines to a pharmacy intern who is under that pharmacist’s direct supervision”

7. Influenza

8. Influenza Virus Strains1 • Influenza A virus • Moderate to severe illness • All age groups • Humans and other animals • Influenza B virus • Milder disease • Primarily affects children • Humans only • Influenza C virus • Rarely reported in humans • No epidemics

9. 2013 – 2014 Influenza Vaccine2,3 • A/California/7/2009(H1N1)-like virus • A/Texas/50/2012(H3N2)-like virus* • B/Massachusetts/2/2012-like virus* • Yamagata lineage • B/Brisbane/60/2008-like virus^ • Victoria lineage *Different than 2012-2013 vaccine ^Quadrivalentvaccine

10. Evolving Influenza virus – Antigenic Drift4 • Occurs in both type A and type B • Gradual changes to evade immune system • Mutations, substitutions, deletions • Epidemics occur in response to the changes

11. Evolving Influenza virus – Antigenic Shift4 • Occurs in type A • Sudden, major change in hemagglutinin and/or neuromidiase • Occasional change • New subtype • Little human immunity • Pandemics occur in response to this change

12. Available Influenza Vaccines *cell-cultured ^ recombinant †available in both trivalent and quadrivalent Adapted from APhA Pharmacy-Based Immunization Delivery April 2013

13. New Influenza Vaccines • Inactivated, quadrivalent vaccine containing two type A and two type B strains • Fluarix (GSK) – approved for 3 years and older • Fluzone (Sanofi Pasteur, Inc) – approved for 6 months and older • FluLaval (GSK) – approved for 18 years and older • Inactivated, trivalent vaccine produced by cell culture (mammalian cells) • Flucelvax (Novartis) – approved for 18 years and older • Inactivated, trivalent vaccine produced by recombinant technology • Flublok (Protein Sciences Corporation) – approved for 18-49 years • Live attenuated, quadrivalent vaccine containing two type A and two type B • FluMistQuadrivalent (MedImmune) – approved for 2-49 years

14. Quadrivalent vs. Trivalent: Local Side Effects5

15. Quadrivalent vs. Trivalent: Systemic Side Effects5

16. Flucelvax vs. Comparator: Local Side Effects6

17. Flucelvax vs. Comparator: Systemic Side Effects6

18. FluMistQuadrivalent vs. Trivalent – Immune Response7 • Multicenter, randomized, double-blind study assessing immunogenicity of FluMistQuadrivalent compared to FluMist Trivalent • Children and adolescents 2-17 years: 2,312 subjects • Adults 18-49 years; 1,800 subjects • The addition of the second B strain did not result in immune interference to other strains included in the vaccine

19. FluMistQuadrivalent vs. Trivalent : Side Effects in 2-17 years7

20. FluMistQuadrivalent vs. Trivalent : Side Effects in 18-49 years7

21. Fluzone Intradermal8 • Indication • Persons 18 – 64 years of age • Dose • 0.1 mL (9mcg hemagglutinin) • Similar seroprotection rate compared to IM influenza vaccine

22. Fluzone Intradermal vs. Intramuscular Adverse Events8

23. Advisory Committee on Immunization Practices – Recommendations9 • Annual vaccination of all person 6 months and older against influenza • FluMistQaudrivalent indicated for healthy persons aged 2-49 • No preference given to once brand name influenza vaccine over another • Begin to offer vaccine as soon as supply is available • Children age 6 months to 8 years should receive 2 doses if first time receiving the vaccination • All health care personal should be vaccinated

24. Intramuscular Administration • Deltoid muscle • 1 inch, 25 gauge needle

25. Intranasal Administration • 0.1 ml dose in each nostril

26. Live Attenuated Influenza Vaccine Contraindications7 • Pregnant women • Chronic medical conditions: • Lung disease (i.e. asthma, COPD) • Heart disease • Kidney or liver disease • Metabolic disease (i.e. diabetes) • Weakened immune system • Severe egg allergy

27. Question 1 Mrs. Jones is a 68 year old female who comes into your pharmacy today requesting a flu shot. She has no contraindications to receiving the vaccine today. Of the following influenza vaccines the pharmacy carries, which vaccine would be appropriate to administer to Mrs. Jones? i. Fluzone prefilled syringe ii. Fluarix (quadrivalent) prefilled syringe iii. Fluzone High-Dose iv. Flu-Mist • i, ii • ii, iii • i, ii, iii • i, ii, iii, iv

28. Question 2 Jimmy is a 9 year old boy who comes in today with his mother. Mrs. J would like to have Jimmy receive his influenza vaccine today at your pharmacy. After screening you find he has mild asthma and seasonal allergies. Which of the vaccines would be appropriate for Jimmy? • Fluzone Intradermal • Fluarix (quadrivalent) • Flu-Mist • Fluzone High-Dose

29. Pneumococcal Disease

30. Pneumovax23 – PPSV2310 • Recommended for all patients over the age of 65 • Before 65 years if patient has chronic conditions • Chronic illness (diabetes, heart disease, lung disease) • Asplenia • Immunocompromised • Cochlear implant • Smokers • Protects against 23 serotypes; 11 are unique • Improves patient outcomes if pneumococcal pneumonia develops

31. PREVNAR13 – PCV1311,12 • Indicated for children 6 weeks to 5 years and adults over 50 years • Not recommended by ACIP for routine use in adults • Main place in therapy is for immunocompromised adults • Asplenia • CSF leaks • Cochlear implants • Protects against 13 serotypes; 1 is unique

32. Dosing Schedule12 PPSV naïve patients PCV13 PPSV23 PPSV23 (PPSV23 after age 65) 8 weeks ≥5 years Prior PPSV23 vaccination ≥5 years PPSV23 PCV13 PPSV23 (PPSV23 after age 65) ≥1 year ≥8 weeks PPSV23 PPSV3 PCV13 (PPSV23 after age 65) ≥5 years ≥1 year PPSV23 PPSV23 (PPSV23 after age 65) PCV13 ≥5 years ≥1 year Adapted from APhA Pharmacy-Based Immunization Delivery April 2013

33. Advisory Committee on Immunization Practices – Recommendations12,13 • Vaccinate all people over 65 years old • Vaccinate earlier if: • 19-64 years: smoke, asthma • ≥2 years: chronic illness • If second dose is needed • Minimum of 5 years between doses • First dose given before 65th birthday • Not recommending Prevnar13 for routine use • Immunocompromised patients can receive one dose

34. Question 3 Stacy is a 55 year old female who has COPD (quit smoking 2 years ago upon diagnosis), hypertension, and hyperlipidemia. Her current medications include Spiriva, HCTZ, lisinopril, and Crestor. Which of the following immunizations would Stacy be indicated for? • PREVNAR13 • Pneumovax • Fluzone • A and C only • B and C only • All three are indicated

35. Tetanus, diphtheria, acellular pertussis

36. Tdap – Vaccine14 • Boostrix (GSK) approved for ≥10 years • Adacel (Sanofi Pasteur) approved for ages 11-64 • Replaces one tetanus booster • Timing • Administer regardless of last Td vaccine

37. What’s New?15 • October 2012 updated ACIP recommendation • Vaccinate women during each pregnancy • Third trimester preferred (after 30 weeks) • Possible adverse events • Increased injection site pain • Arthus reactions, whole arm swelling • Don’t forget about the fathers!

38. Timing and Spacing of Vaccines1 • Administer all indicated vaccines in the same visit • Individual vaccines in separate syringes injected at separate sites • Live vaccines are separated by 28 days if not administered at the same visit • Inactivated vaccines do not have a minimum interval between administration if not administered at the same visit • Vaccine Series: • Increasing the interval between doses does not weaken immune response • Decreasing the interval between doses may weaken immune response and vaccine’s protection

39. Vaccines Types1 • Live Attenuated • Intranasal influenza, herpes zoster, measles, mumps, rubella, varicella, rotavirus, oral typhoid capsules, yellow fever • Inactivated • Intramuscular influenza, pneumococcal, tetanus, diphtheria, pertussis, human papillomavirus, hepatitis A and B, meningococcal, Haemophilusinfluenzaetype B, inactivated poliovirus, rabies, intramuscular typhoid

40. Travel Vaccines16

41. Importance • Travelers can become infected while in a different country and may not develop symptoms until they return home • Introduction of pathogens into new climates can have devastating effects • Small pox introduction to North America • Syphilis introduction to Europe • Recent transmission of region specific diseases • Severe Acute Respiratory Syndrome (SARS) – 2003

42. Types of Travelers • Vacation • Business • Mission • Visiting Friends and Family

43. Travel medicine is an art of managing a person’s risk, not eliminating it

44. Available Resources • CDC’s Travelers’ Health (http://wwwnc.cdc.gov/travel/) • CDC Health Information for International Travel, The Yellow Book (http://wwwnc.cdc.gov/travel/page/yellowbook-home-2014) • International Society of Travel Medicine (http://www.istm.org/) • The American Society of Tropical Medicine and Hygiene (www.astmh.org//) • Travel Software • ShorelandTravax (http://www.shoreland.com/) • Travel+Care International (http://www.travelcare.com/en/index.cfm) • Tropimed (http://www.tropimed.com/en/index.html#&panel1-1)

45. Vaccine Preventable Disease • Typhoid • Japanese Encephalitis • Rabies • Tuberculosis* • Cholera* • Hepatitis A and B • Meningococcal Diseaseᴽ • Poliomyelitis (adult booster) • Yellow Feverᴽ *Available in other countries ᴽRequired to enter country

46. Typhoid • Life-threatening febrile illness cause by Salmonella enterica serotype Typhi • Transmitted by fecal-oral route • Consuming contaminated water or food • Incubation period of 6-30 days before gradual onset of symptoms • Fever and fatigue, headache, malaise, anorexia • Recommended for • Highest risk: Southern Asia; visiting family and friends • High risk: East/Southeast Asia, the Caribbean, Africa, Central/South America • Food and water precautions should still be followed

47. Typhoid – Vaccine Vivotif • Oral live attenuated vaccine • 4 dose series • One capsule every other day 1 hour before a meal • Restart regimen if more than 48 hours between doses • Keep refrigerated • Complete one week before exposure • Booster after 5 years • Minimum age: 6 years • Common adverse effects • Abdominal discomfort

48. Typhoid – Vaccine Typhim Vi • Capsular polysaccharide vaccine • One dose at least 2 weeks before exposure • Booster after 2 years • Minimum age: 2 years • Common adverse effects • Headache, injection site reactions

49. Japanese Encephalitis • Transmitted by infected mosquitoes • Acute encephalopathy is a classic symptom • Recommended if traveling to agricultural portions of Asia • High risk: visiting family and friends • Mosquito bite precautions • Considerations • Low overall risk of transmission • Destination and length of stay • Cost

50. Japanese Encephalitis – Vaccine • Ixiaro, JE-Vax (no longer available) • Approved for 17 years or older • 2 dose series • 0, 28 days • Complete 1 week before travel • Booster after 12 months • Common adverse effects • Injection site pain and tenderness • Fatigue, headache, influenza-like illness • Contraindicated with hypersensitivity to protamine sulfate