The Evolving World of Adult Vaccines :: New Indications ::

1. The Evolving World of Adult Vaccines :: New Indications :: Jessica L. MacLeod, APRN Adult & Gerontology Nurse Practitioner (AGNP) VT Immunization Conference October 28, 2011

2. “When meditating over a disease, I never think of finding a remedy for it, but, instead, a means of prevention.” Louis Pasteur

3. Learning Objectives • Increase confidence around current changes to adult immunizations. • Understand importance of adult immunizations. • Summarize 2011-2012 Adult Vaccine Updates. • Identify three recent immunization recommendations made by Advisory Committee on Immunization Practices (ACIP). • Describe two emerging immunization issues. • Locate resources that support up-to-date immunization practice.

4. 2011-2012 Vaccine Updates • Influenza • Tdap • Zoster • HPV • Meningococcal Conjugate

5. Why adult vaccinations? • Immunity wanes over time. • As we age, we become more susceptible to serious diseases caused by common infections, such as shingles, flu & pneumonia. This results in otherwise preventable morbidity & mortality. • Considerable vaccine-preventable morbidity • Excess hospitalization • Diminished quality of life (post-herpetic neuralgia) • Missed work • Medical complications

6. Why adult vaccinations? Adult deaths from vaccine preventable diseases = 60,000 This is 200-fold greater mortality compared with children (300 children died). From: IOM, Calling the Shots: Immunization Finance Policies and Practices, 2000.

7. Influenza • Rates of infection are highest among persons age 65 and older (and children). • Influenza deaths associated with an annual average of 23,600 deaths from 1976 thru 2007 and approximately 226,000 hospitalizations from 1979 thru 2001. • H1N1 in 2009 was the cause of the first influenza pandemic since 1968; included in 2011-2012 vaccine. • In US, influenza A (H3N2)=predominant virus 2010/2011 season. • Two Types: Trivalent Inactivated Vaccine (TIV), Live Attenuated Influenza Vaccine (LAIV). • Thimerosal preservative (only in multidose vials); thought to be safe. • 2010-2011 season introduced: • Fluzone High-Dose TIV (65+). Contains 4 times as much hemagglutinin as the standard formulation of Fluzone for adults. ACIP has NOT stated a preference for this high-dose Fluzone. • May 2011: • FluzoneIntradermalapproved (18-64 yo). The intradermal is pre-filled syringe; use deltoid NOT the volar surface of the forearm as is done with TB vaccine. Increased side effects compared with IM vaccine, but resolve in 3-7 days. No preference from ACIP. • LAIV or Flumist; approved for ages 2-49 yo who are not pregnant or immunocompromised; single dose.

8. Influenza, continued • Optimal time to vaccinate? • Since 1970s >80% affected in Jan/Feb; “peak season.” • Offer as soon as vaccine is available; during routine OVs and hospitalizations/ER visits. • Continue to offer in December especially to health-care workers and those at high-risk of complications. • Continue to vaccinate through March per ACIP. • One dose per season (changing vaccine components and bioavailability of vaccine >1 year). • Do vaccinate women who are pregnant with TIV (LAIV contraindicated). • Should HCWs be vaccinated & why? • Often implicated in introducing influenza to patient settings, such as ICU, LTC facilities, internal medicine offices.

9. Contraindications & Precautions Guide to Vaccine Contraindications & Precautions: www.cdc.gov/vaccines/recs/vac-admin/downloads/contraindications-guide-508.pdf

10. Algorithm: Evaluation of an Egg Allergy Preceding Influenza Vaccination Yes Administer vaccine per usual protocol Can the person eat lightly cooked (e.g., scrambled egg) without reaction? No Yes Administer TIV (Inactivated) Observe for reaction for at least 30 minutes after vaccination After eating eggs or egg-containing foods, does the person experience ONLY hives? No Refer to a provider with expertise in management of allergic conditions for further evaluation • Does the person experience other symptoms such as: • Cardiovascular changes (e.g., hypertension) • Gastrointestinal (e.g., nausea/vomiting) • Reaction requiring epinephrine • Reaction requiring emergency medical attention Yes www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb11/06-5-flu-vac-egg.pdf

11. Tetanus, Diphtheria & Pertussis (Tdap) • Vaccine has been available since 1940s. • Outbreaks of pertussis continue to occur, despite high vaccination rates. • In 2004 & 2005, >25,000 cases. Increased in 2010 and has been increasing since 1990s. • ACIP contends this is due to vaccine immunity waning from last dose. • Adults with pertussis are a source of infection for others, notably infants. • 195,000 world deaths in 2008. • 17,000 cases in US in 2009; >40% in adults & adolescents.

12. Tetanus, Diphtheria & Pertussis (Tdap), cont • Two Types: Boostrix & Adacel. • Adacel only FDA-approved up through 64 yo. • Either brand may be used, even though Adacel is off-label. • Updated schedule for Tdap for adults: ACIP recommends that adults 19-64 yo who didn’t receive Tdap before or whose vaccination history is unknown, receive a one-time dose of Tdap to replace the next 10-year Td booster. • In July 2011, FDA expanded age indications to include persons age 65+, meaning all adults 19+ should received a Tdap once in their lifetime. • Also added is the recommendation to administer Tdap regardless of interval since the most recent Td-containing vaccine. • Special Populations; Pregnant women & HCWs: • Tdap ok during 3rd trimester of pregnancy if no prior Tdap. Also, use Tdap if preggo woman needs booster. • Any woman considering becoming pregnant should be immunized with Tdap. This is to protect young infants through passive immunity in infants too young to received pertussis immunization. • HCWs should get Tdap as soon as possible.

13. Herpes Zoster / Shingles • Caused by a reactivation of a latent varicella zoster virus infection; very painful blistering rash that can result in significant morbidity (blindness). • Associated with normal aging & anything that causes immunosuppression. • Estimated lifetime risk of developing zoster is 32%; increases the older we get. • Estimated approx 1 million cases/year in US • Approx 50% are >60yo • As of 2009, only 10% of adults received vaccine, according to the National Health Interview Survey • Most common complication is post-herpetic neuralgia.

14. Herpes Zoster / Shingles, continued • Vaccine is called Zostavax; administered subcutaneously in single dose. • Live vaccine; containing a weakened varicella zoster virus in an amount approximately 14 times greater than in standard varicella vaccine. • Since 2006, the ACIP/CDC recommends to vaccinate all people > 60yo regardless of history of shingles. • March 2011: • FDA expanded indication to include persons 50-59 yo (based on ZEST clinical trial). • The ACIP declined to recommend this after reviewing the literature—due to evaluation of disease burden, limited vaccine supply, and associated cost of Zostavax. • Risk of Zoster and associated complications increases after age 50, but incidence of Zoster in 70 yo is twice that in persons 50-59 yo. So, ACIP wanted to protect the most vulnerable population of people. • Studies currently in progress to examine the need for more than 1 dose of Zostavax; research shows the vaccine works for a minimum of 4 years, but unknown for how much longer.

15. Herpes Zoster / Shingles, continued • Screening for a h/ovaricella disease is not recommended; you can assume the person had chicken pox even if they did not have it. Born prior to 1980 means they had it. • It is not necessary to draw titers/serologic testing. • It is necessary to screen for contraindications, which should be done with all live viruses. • Give with precaution when using with anti-virals. • Refer to ACIP general recommendations for further details on precautions & contraindications. • In June 2011, Merck (manufacture of Zostavax) revised product information & recommended to space out Zostavax & Pneumovax by 4 weeks between administration. • A clinical trial showed reduced efficacy of Zostavax when given simultaneously with Pneumonia vaccine. Another study of 14,000 patients, did not demonstrate this inefficacy. • Thus, CDC has not changed its recommendation and both Zoster & Pneumonia vaccines may be administered at the same visit if indicated.

16. Human Papilloma virus (HPV) • Most common sexually transmitted virus in US with more than 50% of sexually active women & men infected at some point in their lives (~ 20 million currently). • Two types: HPV2 (Cervarix) & HPV4 (Gardasil) • HPV4 • 3-injection vaccine recommended for girls/women & boys/men aged 11-26 (can start as young as 9yo). In the past CDC did not recommend routine vaccination in boys/men. • Covers types 6, 11, 16, 18. • Guards against genital cancers (cervical, vaginal, vulvar, & anal cancers), genital warts, and precancers. • Goal is to immunize prior to HPV exposure. • If vaccine schedule is interrupted, the series does not need to start over. • Ok with lactating women, people HPV+ or h/o genital warts. • Not recommended for pregnant women.

17. Human Papilloma virus (HPV) • How common are HPV-related health problems in men? • About 1% of sexually active men in the U.S. have genital warts at any one time. • Each year in the U.S. there are about 400 men who get HPV-associated penile cancer. • 1,500 men who get HPV-associated anal cancer. • 5,600 men who get HPV-associated  oropharyngeal cancers (cancers of the back of throat including base of tongue and tonsils).

18. Human Papilloma virus (HPV), continued In the media on Tuesday, 10/25/2011, All Things Considered, NPR News.

19. Meningococal Conjugate • ACIP has made several new recommendations in past 2 years. • Respiratory transmission; most common transmission late winter/early spring. • 2,000-3,000 new cases each year, declining to 850 in 2010—might this be due to vaccine? Unclear. • Two available: Meningococcal Polysaccharide Vaccine (MPSVQ) and Meningococcal Conjugate (MCV4) (Menactra & Menveo) • Approved for 9m-55yo, Menactra • Approved 2-55yo, Menveo • Since 2011: • The ACIP recommends a booster dose, for up to 18 yo, single. First dose age 11-12 with booster dose at 16 yo. No booster is needed if person gets first dose 16yo+. • Give a 2-dose series to adults with functional or physical asplenia, persistent complement component deficiencies, as well as adults living with HIV with additional risk factor(s), travelers to high-risk locations of Neisseriameningitidis and certain microbiologists.

20. From: http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm

21. From: healthvermont.gov/hc/imm/documents/vaccine_vt_adult_schedule.pdf

22. Case Study 1

23. Case Study 2

24. Case Study 2, continued

25. Resources Updated from 2006.

26. Resources, cont. • CDC “Vaccine Information Statements” or “VISs” • www.cdc.gov/vaccines/pubs/vis/ • It is the law to offer these to your patients. • Can get email updates!

27. Resources, cont. • CDC “You call the Shots” • www.cdc.gov/vaccines/ed/youcalltheshots.htm • Also, the CDC Info Contact Center is available 24/7 to patients, families, and providers: • 800-CDC-INFO

28. Resources, cont. State of VT Website: healthvermont.gov/hc/imm/provider.aspx

29. Questions & Answers Thank you for joining me today! Jessica L. MacLeod, APRN jessicam@nchcvt.org