1. Immunization Update Allegheny County PA Immunization Coaliton (ACIC) Monroeville, PA October 4, 2012 Allegheny County PA Immunization Coaliton (ACIC) Monroeville, PA October 4, 2012 Andrew Kroger, MD, MPH National Center for Immunization and Respiratory Diseases Andrew Kroger, MD, MPH National Center for Immunization and Respiratory Diseases

2. 2 Andrew Kroger is a federal government employee with no financial interest or conflict with the manufacturer of any product named in this presentation The speaker will discuss the off-label use of meningococcal and pneumococcal conjugate and Tdap vaccines The speaker will not discuss a vaccine not currently licensed by the FDA Disclosures

3. 3 General Presentation Objectives After the presentation the listener should be able to –Schedule patients for all routinely recommended vaccines per the Advisory Committee on Immunization Practices recommendations, –Administer newly recommended vaccines to the appropriate priority groups, and –Predict new vaccines on the horizon After the presentation the listener should be able to –Schedule patients for all routinely recommended vaccines per the Advisory Committee on Immunization Practices recommendations, –Administer newly recommended vaccines to the appropriate priority groups, and –Predict new vaccines on the horizon

4. 4 Overview Updates to the 2012 Harmonized Child/Adolescent Schedule Updates to the 2012 Adult Schedule New infant meningococcal vaccine recommendations 2012-2013 influenza vaccine recommendations New Tdap recommendations –Adults older than 65 years New highest-risk Pneumococcal PCV13 Recommendations Human Papillomavirus Vaccine (HPV) Recommendations –Females and males –Strategies to increase coverage New vaccines, new recommendations Updates to the 2012 Harmonized Child/Adolescent Schedule Updates to the 2012 Adult Schedule New infant meningococcal vaccine recommendations 2012-2013 influenza vaccine recommendations New Tdap recommendations –Adults older than 65 years New highest-risk Pneumococcal PCV13 Recommendations Human Papillomavirus Vaccine (HPV) Recommendations –Females and males –Strategies to increase coverage New vaccines, new recommendations

5. 5 2012 Childhood Schedules Basic layout of the schedules is unchanged Three schedules –0 through 6 years –7 through 18 years –“Catch-up”  4 months through 6 years  7 through 18 years Each schedule has separate footnotes Basic layout of the schedules is unchanged Three schedules –0 through 6 years –7 through 18 years –“Catch-up”  4 months through 6 years  7 through 18 years Each schedule has separate footnotes

6. 6

7. 7 Proposed Changes to Figure 2. Recommended Immunization Schedule for Persons Aged 7 Through 18 Years

8. 8 Changes to the 2012 “Catch-up” Schedule

9. 9 Proposed Changes to the 2012 “Catch-up” Schedule

10. 10 2012 ACIP Adult Immunization Schedule, Age-Based Recommendations

11. 11 2012 ACIP Adult Immunization Schedule, Medical, Occupational and Behavior-Based Recommendations

12. 12 Changes to the Meningococcal Recommendations New Child/Adolescent schedule footnote heading: Meningococcal conjugate vaccines, quadrivalent (MCV4). Minimum age 9 months for Menactra (MCV4-D), 2 years for Menveo (MCV4-CRM). New Child/Adolescent schedule footnote heading: Meningococcal conjugate vaccines, quadrivalent (MCV4). Minimum age 9 months for Menactra (MCV4-D), 2 years for Menveo (MCV4-CRM).

13. 13 MCV4 Recommendations New footnotes: –For children ages 9 through 23 months  With persistent complement component deficiency,  Who are residents of or travelers to countries with hyperendemic or epidemic disease and  Who are present during outbreaks caused by a vaccine serogroup,  administer 2 primary doses of MCV4-D ideally at 9 months and 12 months old or at least 8 weeks apart. New footnotes: –For children ages 9 through 23 months  With persistent complement component deficiency,  Who are residents of or travelers to countries with hyperendemic or epidemic disease and  Who are present during outbreaks caused by a vaccine serogroup,  administer 2 primary doses of MCV4-D ideally at 9 months and 12 months old or at least 8 weeks apart.

14. 14 New MCV4 Recommendations New Child/Adolescent schedule footnotes: –For children 24 months and older with  persistent complement component deficiency who have not been previously vaccinated or  anatomic/functional asplenia,  administer 2 primary doses of either MCV4 at least 8 weeks apart, and 1 dose every 5 years thereafter. New Child/Adolescent schedule footnotes: –For children 24 months and older with  persistent complement component deficiency who have not been previously vaccinated or  anatomic/functional asplenia,  administer 2 primary doses of either MCV4 at least 8 weeks apart, and 1 dose every 5 years thereafter.

15. 15 Meningococcal Vaccination of Children with Asplenia Data suggest a reduction in response to PCV13 if given at the same visit as Menactra brand MCV4 Asplenic persons are at very high risk of invasive pneumococcal disease The minimum age for meningococcal vaccination of children with asplenia (including those with sickle cell disease) remains 2 years Separate PCV13 and Menactra by at least 4 weeks Data suggest a reduction in response to PCV13 if given at the same visit as Menactra brand MCV4 Asplenic persons are at very high risk of invasive pneumococcal disease The minimum age for meningococcal vaccination of children with asplenia (including those with sickle cell disease) remains 2 years Separate PCV13 and Menactra by at least 4 weeks MMWR 2011;60(No.40):1391-2

16. 16 New Spacing Recommendation: MCV4-D and PCV13 –For children with anatomic/functional asplenia, if MCV4-D (Menactra) is used, administer MCV4-D (Menactra) at a minimum age of 2 years old and at least 4 weeks after completion of all PCV doses. –See MMWR 2011;60(03);72-76 and VFC Resolution No.6/11-1 and MMWR 2011; 60(40);1391-1392 for further guidance, including revaccination guidelines. –For children with anatomic/functional asplenia, if MCV4-D (Menactra) is used, administer MCV4-D (Menactra) at a minimum age of 2 years old and at least 4 weeks after completion of all PCV doses. –See MMWR 2011;60(03);72-76 and VFC Resolution No.6/11-1 and MMWR 2011; 60(40);1391-1392 for further guidance, including revaccination guidelines.

17. 17 Meningococcal Conjugate (MCV4) Revaccination In its 2005 recommendations for MCV, ACIP made no recommendation about revaccination pending the availability of additional data Serologic data are now available from the manufacturer that show significant decline in antibody 3-5 years after vaccination although few “breakthrough” cases have been reported In its 2005 recommendations for MCV, ACIP made no recommendation about revaccination pending the availability of additional data Serologic data are now available from the manufacturer that show significant decline in antibody 3-5 years after vaccination although few “breakthrough” cases have been reported MMWR 2009;58(No. 37):1042-3

18. 18 Rates of Meningococcal Disease (C and Y) by Age, 1999-2008 Active Bacterial Core surveillance (ABCs), 1998-2008 Option 1 Dose at 11-12 yrs and booster at 16 yrs Option 1 Dose at 11-12 yrs and booster at 16 yrs Option 2 Single dose at 16 yrs Option 2 Single dose at 16 yrs

19. 19 Routine Adolescent MCV4 Recommendation 3.Meningococcal conjugate vaccines, quadrivalent (MCV4). –Administer MCV4 at age 11 through 12 years with a booster dose at age 16 years. –Administer MCV4 at age 13 through 18 years if not previously vaccinated. 3.Meningococcal conjugate vaccines, quadrivalent (MCV4). –Administer MCV4 at age 11 through 12 years with a booster dose at age 16 years. –Administer MCV4 at age 13 through 18 years if not previously vaccinated.

20. 20 Adolescent MCV4 Minimum Intervals and Number of Doses –If the first dose is administered at age 13 through 15 years, a booster dose should be administered at age 16 through 18 years with a minimum interval of at least 8 weeks from the preceding dose. –If the first dose is administered at 16 years or older, a booster dose is not needed. –If the first dose is administered at age 13 through 15 years, a booster dose should be administered at age 16 through 18 years with a minimum interval of at least 8 weeks from the preceding dose. –If the first dose is administered at 16 years or older, a booster dose is not needed.

21. 21 New MCV4 Adolescent Vaccination Recommendations The minimum interval between doses is 8 weeks A booster dose is not recommended for healthy persons if the first dose is administered at 16-21 years of age A booster dose is not recommended for healthy persons 22 years or older even if the first dose is administered at 11-15 years of age The booster dose should always be MCV4 (not MPSV4)

22. 22 MCV Revaccination Recommendations Other high-risk persons recommended for revaccination –microbiologists with prolonged exposure to Neisseria meningitidis –frequent travelers to or persons living in areas with high rates of meningococcal disease Revaccinate every 5 years* as long as the person remains at increased risk –MCV for persons 2 through 55 years of age –MPSV for persons 56 years and older Other high-risk persons recommended for revaccination –microbiologists with prolonged exposure to Neisseria meningitidis –frequent travelers to or persons living in areas with high rates of meningococcal disease Revaccinate every 5 years* as long as the person remains at increased risk –MCV for persons 2 through 55 years of age –MPSV for persons 56 years and older *off-label recommendation. MMWR 2009;58(No. 37):1042-3

23. 23 Influenza Introduction  Influenza viruses cause yearly epidemics and sporadic pandemics  Influenza illnesses occur in all age groups  Highest illness rates in young children  Severe illness, hospitalizations and deaths disproportionately affect very young, elderly, pregnant women and persons with certain medical conditions  E.g. asthma, diabetes, heart disease, neurologic conditions, chronic renal and liver disease, immune compromised conditions  Average of 226,000 hospitalizations per year  About 60% among people 65 years and older  From 3,000 – 49,000 influenza-related deaths per year  About 90% among people 64 years and older  Influenza viruses cause yearly epidemics and sporadic pandemics  Influenza illnesses occur in all age groups  Highest illness rates in young children  Severe illness, hospitalizations and deaths disproportionately affect very young, elderly, pregnant women and persons with certain medical conditions  E.g. asthma, diabetes, heart disease, neurologic conditions, chronic renal and liver disease, immune compromised conditions  Average of 226,000 hospitalizations per year  About 60% among people 65 years and older  From 3,000 – 49,000 influenza-related deaths per year  About 90% among people 64 years and older

24. 24 Influenza Vaccine Recommendation Everyone six months of age older should be vaccinated as soon as the 2012-2013 vaccine is available, even if they got vaccinated last season –protection declines over the course of a year after vaccination –a flu shot last year may not protect this season Everyone six months of age older should be vaccinated as soon as the 2012-2013 vaccine is available, even if they got vaccinated last season –protection declines over the course of a year after vaccination –a flu shot last year may not protect this season

25. 25 Persons at Increased Risk of Complications of Influenza Children 6 months through 4 years of age Persons 50 years of age and older Persons 6 months of age and older with underlying medical conditions, particularly cardiovascular, pulmonary, and metabolic conditions Immunosuppressed Children 6 months through 4 years of age Persons 50 years of age and older Persons 6 months of age and older with underlying medical conditions, particularly cardiovascular, pulmonary, and metabolic conditions Immunosuppressed

26. 26 Persons at Increased Risk of Complications of Influenza Children 6 months through 18 years receiving long-term aspirin therapy Residents of long-term care facilities American Indians/Alaska Natives Morbidly obese (BMI 40 or higher) Children 6 months through 18 years receiving long-term aspirin therapy Residents of long-term care facilities American Indians/Alaska Natives Morbidly obese (BMI 40 or higher)

27. 27 Proposed 2012-2013 Algorithm for Children 6 Mos. Through 8 yrs. 2 doses* No/Don’t know Yes Has the child ever received influenza vaccine? Did the child receive a total of 2 or more doses of seasonal influenza vaccine since July 1, 2010? Yes No/Don’t know 2 doses*† 1 dose * Doses should be administered at least 4 weeks apart. † For simplicity, this algorithm takes into consideration only doses of seasonal influenza vaccine received since July 1, 2010. As an alternative approach in settings where vaccination history from prior to July 1, 2010 is available, children 6 months through 8 years of age need only 1 dose of vaccine in 2013-2013 if they have received any of the following: 2 or more doses of seasonal influenza vaccine since July 1, 2010 or; 2 or more doses of seasonal influenza vaccine before July 1, 1010 and 1 or more doses of monovalent 2009 H1N1 vaccine or; 1 or more doses of seasonal influenza vaccine before July 1, 2010 and 1 or more doses of seasonal influenza vaccine since July 1, 2010 Children for whom one of these conditions is not met require 2 doses in 2012-2013.

28. 28 1. BRFSS estimates, (19 states for children; 43 states plus DC for adults) online at: http://www.cdc.gov/mmwr/PDF/wk/mm5839.pdf and CDC, unpublished http://www.cdc.gov/mmwr/PDF/wk/mm5839.pdf 2. BRFSS and NHFS estimates, 2009-10; BRFSS and NIS estimates, 2010-11, both years for 50 states plus DC for children, 43 states plus DC for adults. In press, MMWR, June 10, 2011 Seasonal Influenza Vaccination Coverage by Race/Ethnicity: 2008-09 -- 2010-11 Seasons, BRFSS and NIS

29. 29 H3N2v – Swine to Human Transmission of Variant influenza A Virus  Transmission of influenza viruses between humans and pigs known to occur  Since July 2012, increase reporting and identification of human infections with H3N2v  Children most susceptible to this virus  Virus is combination of 2009 H1N1 and swine-origin H3N2 strain  Nearly all cases associated with exposure to live pigs at state or county fairs  No risk of influenza in eating pork or pork products  Pigs, like people, have illness that ranges from no symptoms to cough, fever, and runny nose  Seasonal influenza vaccine unlikely to provide protection  Situation being closely monitored  Transmission of influenza viruses between humans and pigs known to occur  Since July 2012, increase reporting and identification of human infections with H3N2v  Children most susceptible to this virus  Virus is combination of 2009 H1N1 and swine-origin H3N2 strain  Nearly all cases associated with exposure to live pigs at state or county fairs  No risk of influenza in eating pork or pork products  Pigs, like people, have illness that ranges from no symptoms to cough, fever, and runny nose  Seasonal influenza vaccine unlikely to provide protection  Situation being closely monitored

30. 30 Human Cases of H3N2v – comparison of 2011 and 2012, as of September 7, 2012 Updated weekly at www.cdc.gov/flu* States Reporting H3N2v Cases Cases in 2011 Cases in 2012 Hawaii 1 Illinois 4 Indiana2138 Iowa3 Maine2 Maryland 12 Michigan 5 Minnesota 2 Ohio 102 Pennsylvania3 11 Utah 1* West Virginia2 3 Wisconsin 18 Total12297 *16 hospitalizations, 1 death reported

31. 31 Pertussis - United States, 1940-2010

32. 32 Pertussis - United States, 1980-2010

33. 33 Reported Pertussis Incidence by Age Group - 1990-2010* SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System. *2010 data are provisional

34. 34 Reported Pertussis-related Deaths by Age Groups, U.S., 1980-2010* Age-Group1980-1989 1 1990-1999 1 2000-2010 2 0-3 month4984198 4-5 month552 6-11 month741 1-4 years1323 5-10 years163 11-18 years003 >18 years1211 Total77 ± 103221 1 Vitek CR et al. Pediatr Infect Dis J 2003; 22(7):628-34. 2 National Notifiable Diseases Surveillance System, CDC, *Provisional 2010 data ± Includes one case with unknown age

35. 35 Tdap Reduces the risk of pertussis by 60% - 80% Reduces the risk of pertussis by 60% - 80% Both products currently approved for one lifetime dose Both products currently approved for one lifetime dose Tdap approved ages Tdap approved ages –10 years and older for Boostrix –11 through 64 years for Adacel Neither brand of Tdap is approved by the FDA for children 7 years through 9 years and Adacel is not approved for adults 65 years or older Neither brand of Tdap is approved by the FDA for children 7 years through 9 years and Adacel is not approved for adults 65 years or older Reduces the risk of pertussis by 60% - 80% Reduces the risk of pertussis by 60% - 80% Both products currently approved for one lifetime dose Both products currently approved for one lifetime dose Tdap approved ages Tdap approved ages –10 years and older for Boostrix –11 through 64 years for Adacel Neither brand of Tdap is approved by the FDA for children 7 years through 9 years and Adacel is not approved for adults 65 years or older Neither brand of Tdap is approved by the FDA for children 7 years through 9 years and Adacel is not approved for adults 65 years or older Wei SC et al. Clin Infect Dis 2010;51:315-21

36. 36 Children 7 through 10 years of age who are not fully immunized against pertussis (including those never vaccinated or with unknown pertussis vaccination status) should receive a single dose of Tdap* Either brand may be used If Tdap is given at this age a second dose at 11-12 years is not needed Children 7 through 10 years of age who are not fully immunized against pertussis (including those never vaccinated or with unknown pertussis vaccination status) should receive a single dose of Tdap* Either brand may be used If Tdap is given at this age a second dose at 11-12 years is not needed *off-label recommendation. MMWR 2011; 60 (No. 1):13-5 New Tdap Recommendations for Adolescents

37. 37 “Not fully immunized” –fewer than 4 doses of DTaP, or –4 doses of DTaP and last dose was prior to age 4 years MMWR 2011; 60 (No. 1):13-5 New Tdap Recommendations for Adolescents

38. 38 New Tdap Recommendations for Adults* Adults 65 years of age and older who have or who anticipate having close contact with an infant younger than 12 months of age and who have not previously received Tdap should receive a single dose of either brand of Tdap Adults 65 years of age and older who have or who anticipate having close contact with an infant younger than 12 months of age and who have not previously received Tdap should receive a single dose of either brand of Tdap Other adults 65 years of age and older may receive a dose of either brand of Tdap Other adults 65 years of age and older may receive a dose of either brand of Tdap Adults 65 years of age and older who have or who anticipate having close contact with an infant younger than 12 months of age and who have not previously received Tdap should receive a single dose of either brand of Tdap Adults 65 years of age and older who have or who anticipate having close contact with an infant younger than 12 months of age and who have not previously received Tdap should receive a single dose of either brand of Tdap Other adults 65 years of age and older may receive a dose of either brand of Tdap Other adults 65 years of age and older may receive a dose of either brand of Tdap *Off-label recommendation. MMWR 2011; 60 (No. 1):13-5

39. 39 Tdap and Pregnancy

40. 40 Tdap and Pregnancy Infants are most likely to be hospitalized or die from pertussis If a woman receives Tdap before or during pregnancy, her passive immunity might help protect the newborn from pertussis There are few safety data for pregnant women given Tdap There are concerns by some experts that the passive pertussis antibody could interfere with the infant’s response to DTaP Infants are most likely to be hospitalized or die from pertussis If a woman receives Tdap before or during pregnancy, her passive immunity might help protect the newborn from pertussis There are few safety data for pregnant women given Tdap There are concerns by some experts that the passive pertussis antibody could interfere with the infant’s response to DTaP MMWR 2011;60(No. 41):1424-6 (October 21)

41. 41 Tdap Recommendations for Pregnant Women Any woman who might become pregnant is encouraged to receive a single dose of Tdap Tdap should be administered to pregnant women who have not received a dose Vaccinate during third trimester or late in second trimester (after 20 weeks gestation) Alternatively, administer Tdap immediately postpartum Any woman who might become pregnant is encouraged to receive a single dose of Tdap Tdap should be administered to pregnant women who have not received a dose Vaccinate during third trimester or late in second trimester (after 20 weeks gestation) Alternatively, administer Tdap immediately postpartum MMWR 2011;60(41):1424-6 (October 21)

42. 42 #1 Question about Td and Tdap since 2005: What is the interval between Td and Tdap?

43. 43 Td to Tdap Interval Adolescent 2006 Adult 2006

44. 44 Td-Tdap Interval Recommendation* Tdap can be administered regardless of the interval since the last tetanus and diphtheria containing vaccine ACIP concluded that while longer intervals between Td and Tdap vaccination could decrease the occurrence of local reactions, the benefits of protection against pertussis outweigh the potential risk for adverse events *Off-label recommendation. MMWR 2011; 60 (No. 1):13-5

45. 45 PNEUMOCOCCAL VACCINE (PPSV23 AND PCV13)

46. 46 Pneumococcal Polysaccharide Vaccine (PPSV23) Recommendations (1) Previously unvaccinated adults 65 years and older Persons 65 years or older who received PPSV23 for any reason prior to age 65 years* Persons 19 years and older with –cigarette smoking –asthma *at least 5 years after previous dose MMWR 2010;59(No.34):1102-5

47. 47 Pneumococcal Polysaccharide Vaccine (PPSV23) Recommendations (2) Persons 19 years and older with normal immune systems who have chronic illness –Chronic heart disease (excluding HTN) –Chronic lung disease –diabetes –alcoholism –CSF leak –Chronic liver disease, including cirrhosis –cochlear implant Persons with functional or anatomic asplenia MMWR 2010;59(No.34):1102-5

48. 48 Pneumococcal Polysaccharide Vaccine (PPSV23) Recommendations (3) Persons 19 years and older who are immunocompromised –Congenital or acquired immunodeficiencies –HIV infection –Chronic renal failure –Nephrotic syndrome –Leukemias –Lymphomas –Hodgkin disease –Generalized malignancy –Solid organ transplantation –Multiple myeloma –Diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids or radiation therapy Persons 19 years and older who are immunocompromised –Congenital or acquired immunodeficiencies –HIV infection –Chronic renal failure –Nephrotic syndrome –Leukemias –Lymphomas –Hodgkin disease –Generalized malignancy –Solid organ transplantation –Multiple myeloma –Diseases requiring treatment with immunosuppressive drugs, including long-term systemic corticosteroids or radiation therapy MMWR 2010;59(No.34):1102-5

49. 49 MMWR 2010;59(No.34):1102-5

50. 50 Pneumococcal Polysaccharide Vaccine Revaccination For most persons for whom PPSV23 is indicated, ACIP does not recommend routine revaccination. Revaccination recommended for persons 19 through 64 years of age who are at highest risk of serious pneumococcal infection For most persons for whom PPSV23 is indicated, ACIP does not recommend routine revaccination. Revaccination recommended for persons 19 through 64 years of age who are at highest risk of serious pneumococcal infection MMWR 2010;59(No.34):1102-5

51. 51 PPSV23 Recommendations for Adults at Highest Risk of Invasive Pneumococcal Disease (IPD) Adults ages 19 through 64 years with the following conditions should receive two doses of PPSV23 separated by at least 5 years –functional or anatomic asplenia –Immunocompromised persons, including those immunocompromised secondary to disease and/or immunosuppressive drugs or therapy Adults ages 19 through 64 years with the following conditions should receive two doses of PPSV23 separated by at least 5 years –functional or anatomic asplenia –Immunocompromised persons, including those immunocompromised secondary to disease and/or immunosuppressive drugs or therapy

52. 52 PPSV23 Revaccination Persons who received one or two doses of PPSV23 before age 65 years for any indication should receive another dose at age 65 or older if at least 5 years have passed since previous dose Those who receive their first dose of PPSV23 at or after age 65 do not need any additional doses Persons who received one or two doses of PPSV23 before age 65 years for any indication should receive another dose at age 65 or older if at least 5 years have passed since previous dose Those who receive their first dose of PPSV23 at or after age 65 do not need any additional doses

53. 53 PCV13 USE IN ADULTS

54. 54 PCV13 Licensure PCV13 is approved by the Food and Drug Administration for: –children 6 weeks through 71 months of age –adults 50 years of age and older ACIP recommended use of PCV13 for immunocompromised persons 19 years and older (June 20, 2012) PCV13 is approved by the Food and Drug Administration for: –children 6 weeks through 71 months of age –adults 50 years of age and older ACIP recommended use of PCV13 for immunocompromised persons 19 years and older (June 20, 2012)

55. 55 Pneumococcal Conjugate Vaccine (PCV13) for Adults On December 30, 2011, PCV13 (Prevnar13, Pfizer) was approved for use among adults 50 years of age and older FDA approved expanded age indication through the Accelerated Approval Pathway On December 30, 2011, PCV13 (Prevnar13, Pfizer) was approved for use among adults 50 years of age and older FDA approved expanded age indication through the Accelerated Approval Pathway

56. 56 Pneumococcal Conjugate Vaccine (PCV13) for Adults Immunogenicity of PCV13 was found to be non-inferior to PPSV23 Indication for use of PCV13 –prevention of pneumococcal disease, including pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes in PCV13 Immunogenicity of PCV13 was found to be non-inferior to PPSV23 Indication for use of PCV13 –prevention of pneumococcal disease, including pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes in PCV13

57. 57 Summary of Feb 2012 ACIP Deliberations: PCV13 for Adults ACIP deferred universal recommendation for all adults pending the further collection of data Efficacy of PCV13 against pneumonia (CAPITA trial, results in 2013) Indirect (herd) effects of PCV13 use in children ACIP deferred universal recommendation for all adults pending the further collection of data Efficacy of PCV13 against pneumonia (CAPITA trial, results in 2013) Indirect (herd) effects of PCV13 use in children

58. 58 PCV13 use for Some Adults Voted on at June 2012 ACIP meeting For adults with: –immunocompromising conditions –Functional or anatomical asplenia –Cochlear implants –CSF leaks (Official Publication Pending) Voted on at June 2012 ACIP meeting For adults with: –immunocompromising conditions –Functional or anatomical asplenia –Cochlear implants –CSF leaks (Official Publication Pending)

59. 59 ACIP Recommendations June 2012 PCV13 for Immunocompromised Adults Extremely high burden of disease among immunocompromised adults Benefits outweigh any risks for use of PCV13 in some adults Indirect effects of PCV13 use in children not likely to eliminate IPD due to PCV13 serotypes in adults PCV13 use alone may not provide adequate coverage of serotypes causing disease in adults Combined use of PCV13 and PPSV23 more effective than either vaccine alone (Official Publication Pending) Extremely high burden of disease among immunocompromised adults Benefits outweigh any risks for use of PCV13 in some adults Indirect effects of PCV13 use in children not likely to eliminate IPD due to PCV13 serotypes in adults PCV13 use alone may not provide adequate coverage of serotypes causing disease in adults Combined use of PCV13 and PPSV23 more effective than either vaccine alone (Official Publication Pending)

60. 60 Incidence of IPD in adults aged 18--64 years with selected underlying conditions, United States, 2009 3-7 fold increased risk 20 fold increased risk Active Bacterial Core Surveillance, 2009. Unpublished data

61. 61 PCV13 Use in Some Adults  PCV13 dose is recommended to be given before PPSV23, whenever possible  Recommendations for those persons needing a 2 nd dose of PPSV and a dose at age 65 years or older remain unchanged from earlier (2010) recommendations  PCV13 dose is recommended to be given before PPSV23, whenever possible  Recommendations for those persons needing a 2 nd dose of PPSV and a dose at age 65 years or older remain unchanged from earlier (2010) recommendations

62. 62 Recommendations for use of PCV13 and PPSV23 in Pneumococcal Vaccine-Naïve Adults Adults 19 through 64 years of age with immunocompromising conditions, functional or anatomic asplenia, CSF leak, or a cochlear implant who are vaccine naïve, should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later Recommendations for 2 nd dose of PPSV23 and a dose at age 65 years or older remain unchanged from earlier (2010) recommendations For those that require additional doses of PPSV, a second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 Adults 19 through 64 years of age with immunocompromising conditions, functional or anatomic asplenia, CSF leak, or a cochlear implant who are vaccine naïve, should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later Recommendations for 2 nd dose of PPSV23 and a dose at age 65 years or older remain unchanged from earlier (2010) recommendations For those that require additional doses of PPSV, a second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 (Official Publication Pending)

63. 63 Recommendations for use of PCV13 in Adults Previously Vaccinated with PPSV23 Adults with immunocompromising conditions, functional or anatomic asplenia, CSF leak, or a cochlear implant previously vaccinated with PPSV23 should receive PCV13 one or more years after the last PPSV23 dose For those that require additional doses of PPSV23, the first dose should be administered no sooner than 8 weeks after PCV13 and at least 5 years after the most recent dose of PPSV23 Adults with immunocompromising conditions, functional or anatomic asplenia, CSF leak, or a cochlear implant previously vaccinated with PPSV23 should receive PCV13 one or more years after the last PPSV23 dose For those that require additional doses of PPSV23, the first dose should be administered no sooner than 8 weeks after PCV13 and at least 5 years after the most recent dose of PPSV23 (Official Publication Pending)

64. 64 HPV Vaccine Recommendations  ACIP recommends routine vaccination of adolescents at 11 or 12 years of age  HPV4 for males  HPV4 or HPV2 for females  May be administered as young as 9 years of age  ACIP recommends routine vaccination of adolescents at 11 or 12 years of age  HPV4 for males  HPV4 or HPV2 for females  May be administered as young as 9 years of age MMWR 2010;59(No. 20):626-9

65. 65 HPV Vaccine Recommendations  Females:  Administer to females ages 13 through 26 years if not previously vaccinated  Males:  Administer 13 through 21 years of age if not previously vaccinated  HPV4 may be administered to males 22 through 26 years of age  Females:  Administer to females ages 13 through 26 years if not previously vaccinated  Males:  Administer 13 through 21 years of age if not previously vaccinated  HPV4 may be administered to males 22 through 26 years of age

66. 66 HPV Vaccine- Ensuring Protection

67. 67 Human Papillomavirus (HPV) Most common sexually transmitted pathogen in males and females in U.S. –Approximately 20 million people currently infected 1 –Another 6 million new infections annually 1 –At least 50% of sexually active males and females will contract an HPV infection at some time in their lives 1 Highest prevalence in sexually active adolescents and young adults –First infection occurs soon after onset of sexual activity 2 Most common sexually transmitted pathogen in males and females in U.S. –Approximately 20 million people currently infected 1 –Another 6 million new infections annually 1 –At least 50% of sexually active males and females will contract an HPV infection at some time in their lives 1 Highest prevalence in sexually active adolescents and young adults –First infection occurs soon after onset of sexual activity 2 1 CDC http://www.cdc.gov/std/hpv/stdfact-hpv.htmhttp://www.cdc.gov/std/hpv/stdfact-hpv.htm 2 Winer RL, et al. AmJ Epidemiol. 2003; 157:218-226 2 Partridge JM. J Infect Dis. 2007:196:1128-1136

68. 68 ACIP HPV Recommendations Females Routine: 11 or 12 years Catch-up: 13 through 26 years Administer HPV4 or HPV2 Females Routine: 11 or 12 years Catch-up: 13 through 26 years Administer HPV4 or HPV2 Males Routine: 11 or 12 years Catch-up: 13 through 21 years, 21 through 26 years who have sex with men or are immunocompromised Healthy men 22 through 26 years may be vaccinated Administer HPV4 only 2 vaccines: HPV2 (Cervarix) and HPV4 (Gardasil) Both vaccines are a 3-dose series Schedule: Administer 2 nd dose 1-2 months after dose 1 Administer 3 rd dose 6 months (24 weeks) after dose 1 and at least 12 weeks after dose 2

69. 69 Tdap, MenACWY, and HPV vaccination estimates among adolescents, 13-17 years, NIS-Teen, United States, 2007-2011 * Tetanus toxoid, diphtheria toxoid, acellular pertussis vaccine since age 10 † Meningococcal conjugate vaccine § Among Females **Among Males

70. 70

71. 71 HPV Vaccination Coverage Low teenage uptake compared to meningococcal and Tdap vaccines HPV vaccine uptake has stalled –53% of teen girls began HPV vaccine series –Almost 30% who receive first dose do not complete vaccine series –Only ~35% of all girls 13 through 17 years complete the 3-dose series Low teenage uptake compared to meningococcal and Tdap vaccines HPV vaccine uptake has stalled –53% of teen girls began HPV vaccine series –Almost 30% who receive first dose do not complete vaccine series –Only ~35% of all girls 13 through 17 years complete the 3-dose series National Immunization Survey (Teen) MMWR 2012; 61:671-7

72. 72 Strategies for Increasing HPV Vaccination Rates in Clinical Practices Recommend HPV vaccine! –Include HPV vaccine when discussing other needed vaccines Integrate standard procedures –Assess for needed vaccines at every clinical encounter –Immunize at every opportunity –Standing orders Reminder and recall AFIX: assessment, feedback, incentive, and eXchange NEW! HEDIS measure (Jan 2012) –Proportion of 13 year old girls who have not received 3 doses Tools for improving HPV vaccine uptake at www.cdc.gov/vaccines/teens Recommend HPV vaccine! –Include HPV vaccine when discussing other needed vaccines Integrate standard procedures –Assess for needed vaccines at every clinical encounter –Immunize at every opportunity –Standing orders Reminder and recall AFIX: assessment, feedback, incentive, and eXchange NEW! HEDIS measure (Jan 2012) –Proportion of 13 year old girls who have not received 3 doses Tools for improving HPV vaccine uptake at www.cdc.gov/vaccines/teens

73. 73 Predictions are difficult, particularly when they involve the future. - Yogi Berra

74. 74 New Vaccines, New Recommendations Additional combination vaccines Meningococcal vaccination of infants More than 1 dose of Tdap PCV13 vaccination of adults Additional combination vaccines Meningococcal vaccination of infants More than 1 dose of Tdap PCV13 vaccination of adults

75. 75 CDC Vaccines and Immunization Contact Information Telephone 800.CDC.INFO (for patients and parents) Email nipinfo@cdc.gov (for providers) Website www.cdc.gov/vaccines/ Vaccine Safety www.cdc.gov/vaccinesafety/