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

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Immunization Update

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

    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. 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

    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

    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

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

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

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

    9. 2012 ACIP Adult Immunization Schedule, Age-Based Recommendations

    10. 2012 ACIP Adult Immunization Schedule, Medical, Occupational and Behavior-Based Recommendations

    11. 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).

    12. MCV4 Recommendations • New footnotes: • For children ages 9 through 23 months • With persistent complement componentdeficiency, • 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.

    13. 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.

    14. 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 MMWR 2011;60(No.40):1391-2

    15. 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.

    16. 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 MMWR 2009;58(No. 37):1042-3

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

    18. 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.

    19. 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.

    20. 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)

    21. 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 *off-label recommendation. MMWR 2009;58(No. 37):1042-3

    22. 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

    23. 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

    24. 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

    25. 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)

    26. Proposed 2012-2013 Algorithm for Children 6 Mos. Through 8 yrs. Has the child ever received influenza vaccine? No/Don’t know 2 doses* Yes Did the child receive a total of 2 or more doses of seasonal influenza vaccine since July 1, 2010? No/Don’t know 2 doses*† • *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. Yes 1 dose

    27. Seasonal Influenza Vaccination Coverage by Race/Ethnicity: 2008-09 -- 2010-11 Seasons, BRFSS and NIS 1. BRFSS estimates, (19 states for children; 43 states plus DC for adults) online at: and CDC, unpublished 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

    28. 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

    29. Human Cases of H3N2v – comparison of 2011 and 2012, as of September 7, 2012Updated weekly at* *16 hospitalizations, 1 death reported

    30. Pertussis - United States, 1940-2010

    31. Pertussis - United States, 1980-2010

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

    33. ± Includes one case with unknown age 1 Vitek CR et al. Pediatr Infect Dis J 2003; 22(7):628-34. 2 National Notifiable Diseases Surveillance System, CDC, *Provisional 2010 data Reported Pertussis-related Deaths by Age Groups, U.S., 1980-2010*

    34. Tdap • Reduces the risk of pertussis by 60% - 80% • Both products currently approved for one lifetime dose • 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 Wei SC et al. Clin Infect Dis 2010;51:315-21

    35. New Tdap Recommendations for Adolescents • 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

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

    37. 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 • 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

    38. Tdap and Pregnancy

    39. 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 MMWR 2011;60(No. 41):1424-6 (October 21)

    40. 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 MMWR 2011;60(41):1424-6 (October 21)

    41. #1 Question about Td and Tdap since 2005: What is the interval between Td and Tdap?

    42. Td to Tdap Interval Adolescent 2006 Adult 2006

    43. 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

    44. Pneumococcal Vaccine(ppsv23 and PCV13)

    45. 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

    46. 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

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

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

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