Immunization Update 2013 Across the Lifespan Andrew Kroger M.D., M.P.H. Medical Officer, Centers for Disease Control and Prevention New York State Association of County Health Officials (NYSACHO) New York Statewide Immunization Meeting March 20, 2013 National Center for Immunization & Respiratory Diseases Immunization Services Division Immunization Schedules Hib-MenCY Influenza vaccination HPV vaccine Tdap Pregnancy PCV13 Adult high-risk vaccination Storage and Handling Overview Adult immunization initiatives Adult Immunization Coverage * Citations, 1
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Hib-MenCY Vaccine HibMenCY is a combination vaccine with protection against Hib and meningococcal serogroups C/Y Licensed June 2012 as 4-dose primary series (2,4,6, 12-15 months) Expected to be available late summer 2013 October 2012 ACIP meeting Recommended for routine use only in infants at high-risk for meningococcal disease Included HibMenCY in meningococcal VFC resolution for high-risk infants HibMenCY may be used in any infant for routine Hib vaccination Hib-MenCY Vaccine Recommended for high-risk children 2 month 18 months of age High-risk = persistent complement component deficiency, functional or anatomic asplenia, or being in an outbreak of serogroup C or Y disease Can be used in circumstances where Hib vaccination is recommended (if meningococcal conjugate vaccine is NOT contraindicated Combination vaccine rule) Included in Hib VFC resolution 4
Influenza Vaccination Recommendation Annual influenza vaccination is now recommended for every person in the United States 6 months of age and older Influenza Vaccine Presentations 2012-2013 Vaccine Doseform Age Fluzone IIV (sanofi pasteur) SDS, SDV, MDV 6 months and older Fluarix IIV FluLaval IIV (GSK) SDS MDV 3 years and older 18 years and older Fluvirin IIV SDS, MDV 4 years and older Afluria IIV (CSL) SDS 9 years and older Flumist LAIV (MedImmune) Nasal spray 2-49 years (healthy, nonpregnant) 5
Influenza Vaccine Presentations 2013-2014 Name Manufacturer Age Range # Antigens Presentation Route Type/Abbrev. Afluria CSL 5 and older Trivalent Pre-Filled Syringe Multi-Dose Vial IM Inactivated IIV3 Agriflu Novartis 18 and older Trivalent Pre-Filled Syringe IM Inactivated IIV3 Fluarix GSK 3 and older Trivalent Pre-Filled Syringe IM Quadrivalent Pre-Filled Syringe IM Inactivated IIV3 Inactivated IIV4 FluBlok Protein Sciences 18-49 Trivalent Single-Dose Vial IM Flucelvax Novartis 18 and older Trivalent Pre-Filled Syringe IM FluLaval GSK 18 and older Trivalent Multi-Dose Vial IM Recombinant RIV3 Cell Culture cciiv3 Inactivated IIV3 FluMist Medimmune 2-49 Quadrivalent Pre-Filled Sprayer Intranasal (IN) Live Attenuated LAIV4 Fluvirin Novartis 4 and older Trivalent Pre-Filled Syringe Multi-dose Vial IM Inactivated IIV3 Pre-Filled Syringe Fluzone Sanofi Pasteur 6 months and older Trivalent Single-Dose Vial IM Inactivated IIV3 Multi-Dose Vial Fluzone High-Dose Sanofi Pasteur 65 and older Trivalent Pre-Filled Syringe IM Inactivated IIV3 Fluzone Intradermal Sanofi Pasteur 18-64 Trivalent Pre-Filled Microinjection System Intradermal (ID) Inactivated IIV3 Influenza Vaccine CDC s preference for choice of influenza vaccine is driven primarily by the age indication for the particular product Important for pre-booking 6
HPV Immunization Rates*, NIS-Teen, 2011 Females13-17 Years of Age HPV Vaccine U.S. NY 1 or more doses 53% 46.6% 3 dose series completion ** 70.7% 76.7% *Percentages 1 human papillomavirus vaccine, either HPV4 or HPV2 reported among females only (n=9,220) ** Percentage of females who received 3 doses among those who had at least 1 HPV dose and at least 24 weeks between the first dose and interview date. MMWR 2012; 61 (No. 34): 671-677 7
ACIP HPV Recommendations 2 products: HPV2 (Cervarix) and HPV4 (Gardasil) Approved for ages: 9 through 26 years Both products are a 3 dose series Schedule*: Administer the 2nd dose 1-2 months after dose 1 Administer the 3rd dose 6 months (24 weeks) after dose 1 and at least 12 weeks after dose 2 *Off-label recommendation. MMWR; (59)20; 626-629 Males ACIP HPV Vaccination Recommendations Routine: 11 or 12 years Catch-up: 13-21 years All 22-26 years HIV-infection Immunocompromised MSM Healthy men: 22-26 years may be vaccinated Administer HPV4 only Females Routine: 11 or 12 years Catch-up: 13-26 years Administer HPV4 or HPV2 8
HPV Vaccine and Pregnancy Pregnancy is a precaution for HPV vaccine Providers should defer vaccination during pregnancy Pregnancy testing is not recommended If a dose is given during pregnancy, no intervention is needed Strategies for Increasing HPV Vaccination Rates in Clinical Practices Recommend HPV vaccine! Include HPV vaccine when discussing other needed vaccines Integrate standard procedures supporting vaccination 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 uptake of HPV: www.cdc.gov/vaccines/teens 9
Tdap-naïve Women and Pregnancy Providers of pregnant women should recommend Tdap to their This strategy is preferred to cocooning, but if Tdap cannot be given in pregnancy it can be given in postpartum period Pregnancy and Repeat Tdap Doses Pregnant women should receive Tdap with each pregnancy Ideal time is 27-36 week gestational age 10
Risk Factors for Invasive Pneumococcal Disease Functional or anatomic asplenia Immunosuppression Renal disease CSF leak Cochlear implants Chronic Disease Cardiovascular Pulmonary (including asthma over 19 years of age) Metabolic Liver Alcoholism Cigarette smoking over 19 years of age Resident of nursing home 11
PCV13 Licensure PCV13 is approved by the Food and Drug Administration for: adults 50 years of age and older ACIP recommended use of PCV13 for high risk persons 19 years and older (June 20, 2012) Risk Factors for Invasive Pneumococcal Disease Functional or anatomic asplenia Immunosuppression Renal disease CSF leak Cochlear implants Chronic Disease Cardiovascular Pulmonary (including asthma over 19 years of age) Metabolic Liver Alcoholism Cigarette smoking over 19 years of age Resident of nursing home 12
Pneumococcal Polysaccharide Vaccine 60%-70% against invasive disease Less effective in preventing pneumococcal pneumonia First-dose Recommendation for Pneumococcal Polysaccharide Vaccine Functional or anatomic asplenia Immunosuppression Renal disease CSF leak Cochlear implants Chronic Disease Cardiovascular Pulmonary (including asthma over 19 years of age) Metabolic Liver Alcoholism Cigarette smoking over 19 years of age Resident of nursing home 13
Five-year PPSV23 Revaccination Functional or anatomic asplenia Immunosuppression Renal disease CSF leak Cochlear implants Chronic Disease Cardiovascular Pulmonary (including asthma over 19 years of age) Metabolic Liver Alcoholism Cigarette smoking over 19 years of age Resident of nursing home Pneumococcal Polysaccharide Vaccine Candidates for Revaccination Persons vaccinated at <65 years of age MMWR 1997;46(RR-8):1-24 14
Recommendations for use of PCV13 and PPSV23 in Pneumococcal Vaccine-Naïve Adults Adults 19 years and older with immunosuppression, renal disease, 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 For those that require additional doses of PPSV23, a second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 (Official Publication Pending) Recommendations for use of PCV13 in Adults Previously Vaccinated with PPSV23 Adults with immunocompromising conditions, renal disease, 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) 15
Storage Unit Recommendations CDC recommends vaccines be stored in stand-alone refrigerator and freezer units rather than combination units The refrigerator compartment of a combination unit may be used to store refrigerated vaccines and a separate freezer unit to store frozen vaccines Storage units should have Enough room to store the year s largest inventory without crowding; Sufficient room to store water bottles (refrigerator) or frozen coolant packs (freezer); Frost free or automatic defrost units are preferred Storage Unit Guidance CDC does not recommend use of a dormitory-style unit for ANY vaccine storage including temporary storage Dorm-style = freezer compartment with no exterior door or thermostat controls Increased risk of exposing vaccines to freezing temperatures NIST studies have shown there is no good vaccine storage area in a dorm-style unit 16
Updated Thermometer Recommendations CDC recommends using a calibrated, digital thermometer with a biosafe glycol-encased probe or a similar temperature buffered probe These more accurately reflect the temperature of the vaccine vial Place the probe with the vaccine in the part of the unit where recommended storage temperatures are best maintained Probes should be detachable from the digital display Additional Thermometer Guidance Calibrated thermometers should be able to provide and store data monitoring information set at programmable intervals in an active display for reading temperatures without opening the door (Data Loggers) Digital data loggers should include the following: Detachable probe; Hi/Lo alarm for out of range temperatures; Current temperature, as well as minimum and maximum temperatures; Reset button; Low battery indicator; Accuracy of +/- 1 F (0.5 C); Memory storage of at least 4,000 readings, device will not rewrite over old data and stops recording when full; User programmable logging interval (or reading rate) 17
Storage and Handling Practices Storage unit temperatures should be read and documented twice each workday The min/max temperature should be read and documented once per workday preferably in the morning Stored temperature monitoring data should be downloaded and reviewed weekly Weekly review of vaccine expiration dates and rotation of vaccine stock Adult Immunization Initiatives Affordable Care Act (2010) ACIP recommended vaccines first-dollar covered by private payers Grandfathered payers are exempt unless they make changes to their plans ERISA-exempt (self-insured) plans NOT exempt National Adult Immunization Summit May 14-16, Atlanta GA 18
New York Adult Immunization Coverage Influenza vaccine adult coverage for 2011-2012 season 37.2% Influenza vaccine adult 65 years old or older 2010-67% Pneumococcal vaccine adult 65 years old or older 2010 less than 65.5% FluViewVax, Behavioral Risk Factor Surveillance System Adult Vaccination Coverage NHIS, 2011 Compared with 2010 NHIS, modest increases only for : HPV vaccination (> 1 dose) (29.5%) -- women, 19-26 years (+8.8 percentage points) Tdap vaccination (12.5%) 19-64 years (+4.3 percentage points) Coverage for overall tetanus vaccination past 10 years unchanged Pneumococcal vaccination (62.3%) -- adults >65 years (+2.6 percentage points) Hepatitis B vaccination ( > 3 doses) (35.9%) adults, 19-49 years (+2.1 percentage points) 19
Adult Vaccination Coverage NHIS, 2011 Compared with 2010 NHIS, limited increases for : Hepatitis A vaccination ( > 2 doses) (12.5%) adults, 19-49 years (+1.8 percentage points) Pneumococcal vaccination (20.1%) -- high-risk adults, 19-64 years (+1.6 percentage points) HPV vaccination (> 1 dose) (2.1%) -- men, 19-26 years (+1.5 percentage points) Herpes zoster (shingles) vaccination (15.8%) adults, > 60 years (+1.4 percentage points) Healthy People 2020 Far below HP2020 targets of 90% for 65+ years for pneumococcal vaccine 60% for high risk 19-64 years for pneumococcal vaccine 30% for 60+ years for Zoster vaccine 20
Thank You Hotline: Email: Website: 800.CDC.INFO nipinfo@cdc.gov www.cdc.gov/vaccines 21