1. Avoiding Missed Opportunities Elaine Rosenblatt NP Clinical Professor UW WI-Madison November 8, 2006

2. Objectives Understand the indications for the new vaccines available for adults Learn how to appropriately administer the new vaccines Identify the controversies surrounding some of the new vaccines No financial disclosures

3. Cases 1. College woman born in 1982 who comes to your clinic for an employment physical exam. She will be working in a health care facility. You need to assess for: __Td/Tdap __Hepatitis B __HPV __Influenza __Measles __Meningococcal __Mumps __Pneumococcal __Rubella __Varicella __Zoster

4. Cases 1. 65 yo man with no history of shingles in your office for a health assessment. You need to assess for: __Td/Tdap __Hepatitis B __HPV __Influenza __Measles __Meningococcal __Mumps __Pneumococcal __Rubella __Varicella __Zoster

5. Cases 1. 70 yo with a history of herpetic neuralgia. Establishing care with you. Reports an allergy to eggs. You need to assess for: __Td/Tdap __Hepatitis B __HPV __Influenza __Measles __Meningococcal __Mumps __Pneumococcal __Rubella __Varicella __Zoster

6. Tetanus, Diphtheria and Acellular Pertussis Vaccine (Tdap) Main focus: adolescents ages 11-12 Adult version approved for ages 11-64 A one time booster or can be used one time in a primary series Preferably 5 years (minimum 2 years) since last booster Side effects: similar to Td

7. INFLUENZA: Recommendations 50 years of age and older Chronic diseases (pulmonary, cardiac, DM, immune problems, cancer, renal, blood disorders) Pregnancy: all trimesters Health care workers Caretakers of the elderly/frail Children ages 6-59 months and close contacts

8. Influenza recommendations cont. Those living in chronic care facilities Anyone with a condition that can compromise respiratory function, the handling of secretions or increased risk for aspiration Those wishing to reduce likelihood of illness Best to give between October and November but can give during the influenza season (typically December through March)

9. Influenza—Nasal Spray FluMist Approved June 17, 2003 by FDA Live attenuated vaccine for influenza A and B viruses For healthy children and adults age 5-49 years 87% efficacy in reducing influenza among children in study In healthy adults it was effective in reducing severe illness with fever and URI problems which may be caused by influenza

10. FluMist, continued Can start to give in August Keep in freezer, thaw just before using Kids up to age 9 need 2 doses No needles Increased cost—about $10.00 more per dose than inactivated vaccine HMO’s not covering at this time as injection is a good and more cost effective alternative that covers a larger population

11. FluMist, continued Do not give to patients who are immunosuppressed or in contact with Safety in patients with moderate to severe asthma and other reactive airway diseases has not been established Do not administer to patients with therapies including aspirin, a history of Guillain-Barre syndrome, chronic diseases, allergies to eggs or those who are pregnant. Most common adverse events: nasal congestion, runny nose, sore throat, cough.

12. Meningococcal Vaccine For international travel to endemic areas, damaged spleen or asplenia, terminal complement component deficiency, and college students (especially freshmen who live in dorms) WisAct 61 2003 “Requiring college students be informed about meningococcal disease and hepatitis B and to require colleges to maintain certain records about the vaccination of students” Advise students to seek health care after potential exposures, whether vaccinated or not

13. Meningococcal Meningitis Vaccine Highly efficacious and well tolerated. The new conjugated vaccine has longer immunity Effective 10 days after vaccination Menomune: polysaccharide: age 2 and older.5 ml SC in arm. Booster dose at 3-5 years Good for 35 days once reconstituted Menactra (MCV4): conjugated: preferred vaccine ages 11-55.5 ml IM in deltoid. Booster not yet determined

14. Controversies with Conjugated Vaccine (Menactra) Shortage in 2006 Guillain-Barre Syndrome –As of September 2006 seventeen cases –Remains unclear if this is rate is higher than in adolescent population –CDC and AAP continue to recommend routine vaccination of at risk populations with conjugated vaccine –Contraindicated if history of GBS –Additional information cdc.gov or http://aapredbook.aappublications.org/news

15. Quadrivalent Human Papillomavirus Vaccine: Gardasil Prevention of: – Cervical cancer, genital warts, and the precancerous lesions, cervical adenocarcinoma in situ, cervical intraepithelial neoplasia (CIN) grades 1, 2 and 3 – Vulvar intraepithelial neoplasia grades 2 and 3 – Vaginal intraepithelial neoplasia grades 2 and 3.

16. HPV Of the 40 types of HPV, 18 are considered to be strongly associated with cervical cancer (“high- risk” types). Twelve HPV types classified as “low-risk” for the development of cervical cancer cause anogenital warts and mild degrees of cervical dysplasia. Most HPV infections clear spontaneously within 1-2 years Persistent infections are associated with precancerous lesions of the cervix. About 70% of cases of cervical cancer are caused by the HPV subtypes 16 and 18 Vaccine comprised of high-risk HPV types 16 and 18 and the low-risk types 6 and 11.

17. HPV Vaccine Age Range: 9-26 0.5 mL intramuscularly for three doses given at 0, 2 and 6 months. Monitor for injection site pain and inflammation, and for signs of hypersensitivity. The UWHC cost for a single 0.5-mL syringe is $116.29. The AWP is $149.69. Three doses at UWHC would cost approximately $350.00, plus procedure charges. Need for booster dose still being studied, but most recent data suggest immunity extends beyond 4 years for both vaccines

18. Vaccine Efficacy 90% decrease, in patients receiving vaccine compared to placebo*, for –Incidence of persistent HPV infection with the vaccine types. –Incidence of disease associated with the vaccine compared to placebo. Women still need to follow current recommendations for screening for cervical cancer. *Combined incidence of 0.7 per 100 woman-years at risk vs. 6.7 per 100 women-years, respectively; p<0.0001.

19. ACIP Recommendations for HPV Girls ages 11 and 12 years old. Catch-up vaccination for girls and young women ages 13-26 years. Vaccination can start at age 9 at clinician’s discretion. The vaccine is recommended in girls and women who have already been infected with HPV in order to prevent infection with other types of HPV included in the vaccine. Need to continue regular pap smear testing

20. Controversial Issues with HPV Vaccine Concern from some parental groups that giving vaccine gives the girls ‘permission’ to have sex Expense ACIP recommends giving with other age-appropriate vaccines (Td, meningococcal, hepatitis B), but what about MMR, which is a live vaccine Parents more likely to accept HPV vaccination if they believe that the vaccine is safe and effective, if the provider recommends it and if they know how severe HPV-related disease can be Use as opportunity to reinforce safe-sex messages

21. Herpes Zoster Vaccine (Zostavax) Indicated for immunocompetent adults 60 years of age or older with no history of shingles, who have had chickenpox. Live attenuated vaccine; avoid if immunosuppressed Reactions at injection site mild; can develop varicella-like rash at injection site Contraindicated if history of anaphylactic reaction to gelatin, neomycin or other components of the vaccine

22. Herpes Zoster Vaccine Single subcutaneous dose (0.65 mL) Costs about $150.00 plus injection fee Store frozen and administer immediately after reconstitution to minimize loss of potency Need for booster remains unclear

23. Shingles Prevention Study Outcomes studied: incidence of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in individuals age 60 and older Median follow-up 3.1 years Effective in preventing HZ 51% overall (64% in patients 60-69 and 38% in those 70 and older) Reduced severity and duration of pain and discomfort caused by Herpes Zoster by 61% Efficacy in preventing PHN 67%, regardless of age

24. Cost Effectiveness of a Vaccine to Prevent Herpes Zoster and Post-herpetic Neuralgia in Older Adults by Hornberger and Robertus “Vaccination would be more cost-effective in “younger” older adults (age 60-64 years) than in “older” older adults (age ≥ 70). Longer life expectancy and a higher level of vaccine efficacy offset a lower risk for herpes zoster in the younger group.”

25. Controversies Herpes Zoster Vaccine Go outside FDA licensure to broader age group (50 and up) Use in persons with history of shingles Medicare coverage not decided Need for a booster dose

26. Other New Recommendations Mumps vaccine –2 doses a minimum of 1 month apart for kids and high risk adults, eg healthcare workers

27. Websites www.cdc.gov/nip Centers for Disease Control and Prevention National Immunization Program www.vaccineinformation.org Immunization Action Coalition www.immunize.org

28. “ A vaccine not given is 100% ineffective!”