Texas Department of State Health Services

1. Texas Department of State Health Services CDC Public Health Advisors Updates December 8th 2011 www.ImmunizeTexas.com

2. ACIP Recommendations Published in MMWR Since Last Meeting 08/05/11: MCV4 use in children age 2-10 yrs and updated booster guidance. MMWR 60(30):1018-1019. 08/26/11: 2011 Influenza recommendation. MMWR 60(33);1128-1132. 10/14/11: MCV4 use in high-risk children 9-23 months. MMWR 60(40);1391-92. 10/21/11:Tdap use in pregnant women and people having close contact with infants <12 months of age. MMWR 60(41); pp-pp. 11/25/2011: Immunization of health-care personnel. MMWR Recommendations & Reports series.

3. ACIP Agenda Topics 1 – Human Papillomavirus (vote) • Routine recommendation in Males 2 – Childhood/Adolescent Schedule (vote) • ACIP review 2012 childhood and adolescent schedules proposed by the ACIP Work Group 3 – Adult Schedule (vote) • ACIP review 2012 adult schedules proposed by the ACIP Work Group

4. ACIP Agenda Topics 4 – Hepatitis B Vaccines (vote) • Recommendation for vaccination of adults with diabetes due to increased risk 5 – Meningococcal Conjugate Vaccine • Update on recommendations for infants 6 – Pneumococcal Conjugate Vaccine 13 • Update on recommendations for adults 7 – Measles, Mumps, Rubella Vaccine • Considerations of new vaccine recommendations

5. Topic 1: Human Papillomavirus • Background • Two HPV vaccines licensed (Gardasil, 2006 and Cervarix, 2009) for routine vaccination of women 11-12 and catch-up through age 26 • Gardasil was licensed for males (10/2009) and ACIP has passed a permissive recommendation for this vaccine. • The quadrivalent HPV vaccines prevents the types of HPV that causes cervical cancer in women and anal cancer and genital warts in both women and men. Gardasil (quadrivalent HPV vaccine for 6, 11,16, 18) Cervarix (bivalent HPV vaccine for 16, 18)

6. Topic 1: Human Papillomavirus • Background • Each year, estimated 15,000 HPV (16/18) related cancers in females and 7,000 (16/18) related cancers in males a • Each year, estimated 300,000 new cases of genital warts • Cervical cancers are decreasing due to screening programs and other interventions; however, other cancers, such as anal cancers in men and women and oropharyngeal cancers in males are increasing.

7. Topic 1: Human Papillomavirus • Background • Cost/Benefit • HPV vaccination in women at 12 years of age has been proven to be cost – effective • HPV vaccination in men is MOST cost beneficial when the coverage levels in women remains low • Policy Options • Recommend routine vaccination of males at 11-12 years of age • Retain permissive recommendation for males

8. Topic 1: Human Papillomavirus • CDC’s Advisory Committee on Immunization Practices (ACIP) approved the recommendations for routine vaccination of males 11 or 12 years old with 3-doses of HPV4 to protect against Human Papalloma Virus. The HPV vaccine will afford protection against certain HPV-related conditions and cancers in males, and vaccination of males with HPV may also provide indirect protection of women by reducing transmission of HPV. CDC Briefing 10/25/2011

9. Topic 1: Human Papillomavirus • ACIP Recommendation (per CDC 10/25/2011) • The new general recommendation covers boys 11 through 21. Those over 21 through 26 will continue to have a permissive recommendation. • Reasons for new recommendation: • New clinical efficacy data on prevention of cancer in males (permissive recommendation in 2009 focused mainly on genital wart prevention) • Have additional safety and cost-effectiveness data • Lack of uptake by women http://www.cdc.gov/media/releases/2011/t1025_hpv_12yroldvaccine.html

10. Topic 2: Childhood and Adolescent Schedule • 3 separate schedules • Infant (0-6) • Adolescent (7-18) • Catch-up Schedule • Infant schedule updates- • MCV 4 age indication to 9 months of age • Condensing footnotes for Rotavirus, Hib, and Pneumococcal vaccines • Updating footnotes for influenza, meningococcal, and hepatitis A vaccine

11. Topic 2: Childhood and Adolescent Schedule • Adolescent schedule updates- • MCV 4 booster dose added • HPV and MCV4 footnotes updated • Influenza, Pneumococcal, and Varicella footnotes have been condensed • Schedules will be published in February in the MMWR, Pediatrics, and in the American Family Physicians journals

12. Topic 3: Adult Schedule • Adult schedule updates- • New table for contraindications and precautions for use of adult vaccines added • Tdap/TD age indication updated (+65) and use with pregnant women • Health care personnel (HCP) vaccine updates • Zoster vaccination update (age expansion) • Pneumococcal vaccination updates (risk groups and revaccination of those after age 65) • Meningococcal vaccination updates (military and college students living in dorms)

13. Topic 4: Hepatitis B Vaccines • Prevention of hepatitis B among adults with diabetes mellitus in the US • Virus easily transmissible through blood glucose monitoring) leading to patient to patient or patient to HCP transmission. • Background • Since 1990, 24 of 28 outbreaks of hep b in long-term care facilities were focused on adults with diabetes. • More than 80% of people with diabetes monitor their blood glucose at least once per month (many on a daily basis) • Vaccine is safe in all ages and > 90% effective in adults <40

14. Topic 4: Hepatitis B Vaccines 2 Options proposed: Option 1 was chosen- • Option 1: • i. Hepatitis B vaccination should be administered to unvaccinated adults with diabetes aged <60 years • ii. Hepatitis B vaccination may be administered to unvaccinated adults with diabetes who are aged ≥60 years • a. Remarks include considering the risks of HBV, declining benefits and increasing costs for decisions to vaccinate older adults with diabetes.

15. Topic 5: Meningococcal Conjugate Vaccine Consideration for use of MCV 4 in infants • In April 2011, FDA approved MCV4-D as a 2 dose series for infants 9-23 months of age • 2 additional infant MCV4 vaccines under review by FDA • Low number of cases and deaths of meningococcal disease caused by serotypes in the vaccine (C and Y) limits support for routine recommendation. • ACIP Work Group does not support adding this vaccine to routine infant schedule (vote expected in February, 2012)

16. Topic 6: Pneumococcal Conjugate Vaccine 13- Valent (PCV 13) for Adults Consideration for PCV for adults • PCV 13 is anticipated to be licensed for use among adults 50 years of age and older in first quarter of 2012. • PCV 7 and 13 has reduced dramatically pneumococcal infections in children as well as invasive pneu. disease burden among adults through indirect effects. • ACIP working group will continue to review the literature to evaluate PCV 13 and its future use with high-risk adults.

17. Topic 7: Measles, Mumps Rubella (MMR) Vaccine • MMR update and consideration for use with children with perinatallyacquired HIV infection and all others with HIV infection • ACIP recommendations for MMR last updated in 1998 • ACIP Working Group is reviewing available data and current recommendations to propose new MMR vaccine recommendations at a future meeting • Additional considerations for vaccine recommendations for persons with HIV infection