CDC Presentation

CDC Presentation

Immunization Update 2014 Andrew Kroger M.D., M.P.H. Centers for Disease Control and Prevention Finger Lakes Area Immunization Coalition 2014 Regional Immunization Conference May 20, 2014 National Center for Immunization & Respiratory Diseases Immunization Services Division Disclosures No financial conflict or interest with the manufacturer of any product named during this presentation.

I will present recommendations for tetanustoxoid, diphtheria-toxoid, acellular pertussis (Tdap) vaccine, human papillomavirus vaccine (HPV) , and influenza vaccines in an off-label manner Overview 2014 Immunization schedule Hib recommendations MCV4 recommendations HPV vaccine

Pneumococcal vaccine recommendations Storage and handling Vaccine administration * Citations, Take Out Your Cell Phone You will have the opportunity to text answers to questions! Please note: message and data rates may apply Impact of Haemophilus influenzae

type b disease Formerly the leading cause of bacterial meningitis among children younger than 5 years of age Approximately 1 in 200 children developed invasive Hib disease Almost all infections among children younger than 5 years

Uptick in disease among adults in Utah from 1998-2008 121 cases persons 65 years of age and older 51% of cases 66% of Hib-related deaths increase also in nontypeable Hib strains and in serotype f increases have also been noted in Illinois, Alaska, and Spain Reasons may include: changes in the organism greater numbers of high-risk people

waning immunity to the organism Updates to Hib Footnotes High-risk Hib vaccine for young children 12-15 months of age Vaccinate with 2 doses if unvaccinated or only 1 dose prior to 12 months of age, for Ig deficiency, complement deficiency, anatomic/functional asplenia, chemotherapy recipients and HIV infection 15-59 months of age Vaccinate with 2 doses if unvaccinated or only 1 dose prior to 12 months of age, for Ig deficiency, complement deficiency, anatomic/functional asplenia, chemotherapy recipients and HIV infection Vaccinate with 1 dose if no primary series/booster or no doses after 14 months of age, for those undergoing

elective splenectomy vaccine to be given 14 days before splenectomy Updates to Hib Footnotes High-risk Hib vaccine for older children/adults 5 years to 18 years Vaccinate with 1 dose if no primary series/booster or no doses after 14 months of age, for those with anatomic/functional asplenia, chemotherapy recipients and HIV infection Adults 1 dose of Hib vaccine should be administered to persons who have functional or anatomic asplenia, sickle cell disease, or are undergoing elective splenectomy, if they have not previously

received Hib vaccine. Hib vaccination 14 or more days before splenectomy is suggested. For Hib vaccine guidance recommended that Hib vaccination of persons infected with human immunodeficiency (HIV) be considered, but updated Hib Recommendations Hematopoeitic Cell Transplant Recipients Recipients of hematopoietic stem cell transplant (Adults who have had a successful hematopoietic stem cell transplant are recommended to receive a 3-dose series of Hib vaccine 612 months after transplant regardless of prior Hib vaccination.

Comparing Meningococcal Vaccines Meningococca Meningococcal l Conjugate Polysaccharid (Menactra) (Menveo) e (Menomune) Ages 2 years and older Meningococcal Conjugate

& Haemophilus influenzae type b 9 months 2 months 6 weeks through 55 through through 18 years 55 years months Abbre MPSV4 MCV4 or Hib-MenCY v MenACWY

Route Subcutaneous Intramuscular (Subcut.) (IM) Routine MCV4 Vaccination for Persons 11 through 21 Years of Age Age Group Primary Vaccination 11-12 years 1 dose 13-18 years

1 dose if not vaccinated previously 19-21 years Not routinely recommended but 1 dose may be administered as catchup vaccination for those who have not received a dose after their 16th birthday *ACIP off-label recommendation Booster Dose* 1 dose recommended if

first dose administered before 16th birthday Meningococcal Vaccination for Infants 2 through 18 months of Age at Increased Risk Risk Group Persistent complement deficiencies Functional or anatomic asplenia, including sickle cell Primary Vaccination 4 doses of Hib-MenCY at 2, 4, 6, and 1215 months

*If later travel to an area where A and W-135 protection are needed, Risk during a community administer an ageoutbreak attributable to a appropriate MCV4 dose vaccine serogroup prior to travel *ACIP off-label recommendation Meningococcal Vaccination for Children 9 through 23 months of Age at Increased Risk Risk Group Persistent complement deficiencies Travel to or resident of

countries where meningococcal disease is hyperendemic or endemic Risk during a community outbreak attributable to a vaccine serogroup *ACIP off-label recommendation Primary Vaccination 2 doses of MCV4, 12 weeks apart *8 weeks apart if needed for travel **Because of high risk for IPD, children with functional or anatomic

asplenia should not be immunized with Menactra before 2 years of age to avoid interference with the immune response to PCV Meningococcal Vaccination for Persons 2 through 55 Years of Age at Increased Risk and Not Previously Vaccinated Risk Group Primary Vaccination Persistent complement deficiencies

2 doses of MCV4, 8 to 12 weeks apart Functional or anatomic asplenia, including sickle cell *If Menactra is used, it should be administered at least 4 weeks after completion of all PCV doses HIV+, if another indication for vaccination exists *ACIP off-label recommendation Meningococcal Vaccination for Persons 2

through 55 Years of Age at Increased Risk and Not Previously Vaccinated Risk Group Primary Vaccination First year college students 21 1 dose of MCV4 yrs of age or younger living in *If Menactra is used, it residential housing should be administered at Travel to or resident of least 4 weeks after countries where completion of all PCV meningococcal disease is doses.

hyper endemic or endemic Risk during a community outbreak attributable to a vaccine serogroup Microbiologists routinely *ACIP off-label exposed torecommendation isolates of Neisseria meningitidis Meningococcal Vaccination of High-Risk Persons 56 Years of Age and Older MPSV4 is only licensed vaccine for persons in this age

group MPSV4 is preferred for meningococcal vaccine-nave persons aged 56 years and older who anticipate requiring a single dose of meningococcal vaccine (e.g., travelers and persons at risk as a result of a community outbreak For persons now aged 56 years of age and older who were vaccinated previously with MCV4 and are recommended for revaccination or for whom multiple doses are anticipated (e.g., persons with asplenia and microbiologists), MCV4* is preferred *ACIP off-label recommendation

http://www.cdc.gov/mmwr/PDF/rr/rr6202.pdf HUMAN PAPILLOMAVIRUS VACCINES (HPV) http://www.cdc.gov/vaccines/pubs/ACIP-list.htm#hpv Comparing HPV Vaccines Types HPV4 (Gardasil) HPV2 (Cervarix) 6, 11, 16, 18 16, 18

Recommendations for Females Routine: 11-12 yrs Catch-up: 13-26 yrs Routine: 11-12 yrs Catch-up: 13-26* yrs Recommendations for Males Routine: 11-12 yrs Catch-up: 13-21 yrs Immunocompromised: 11-26 yrs MSM: 11-26 yrs HIV positive: 11-26

years Do not administer to males Schedule Route *ACIP off-label recommendation 0, 1-2*, 6 mos Intramuscular (IM) HPV Series Completion Significant number of girls who began the HPV series do not receive all three doses

Related factors include parents understanding vaccine not needed (19.1%); vaccine not recommended (14.2%); vaccine safety concerns (13.1%); lack of knowledge about the vaccine or the disease (12.6%); daughter is not sexually active (10.1%) MMWR 2013; 62 (No. 29) July 26, 2013

Actual and Potentially Achievable Vaccination Coverage if Missed Opportunities Were Eliminated: NISTeen, 2011 Healthy People 2020 Objectives HPV-1 coverage is among females only. Source: NIS Teen 2011; Slide courtesy Shannon Stokley (CDC/NCIRD/ISD) Missed Opportunities 84.0% of HPV-unvaccinated girls have had a missed opportunity in 2012 If these girls had received the HPV vaccine

during visits when another vaccine was given, coverage with at least 1 dose of HPV could be 92.6% MMWR 2013; 62 (No. 29) July 26, 2013 Average Number of New HPV-Associated Cancers by Sex, in the United States, 2005-2009 n=694 n=3039 n=1003 n=2317 n=1687

n=3084 Oropharynx n=9312 n=11279 Jemal A et al. J Natl Cancer Inst 2013;105:175-201 HPV-Associated Oropharyngeal Cancers Prevalence increased from 16.3% (198489) to 71.7% (2000-04) Population-level incidence of HPV-positive cancers increased by 225% while HPVnegative cancers declined by 50% If trends continue, the annual number of HPV-positive oropharyngeal cancers is expected to surpass the annual number of cervical cancers by the year 2020

Chaturvedi, 2011, J Clin Oncol- data from SEER ACIP Recommendation and AAP Guidelines for HPV Vaccine Routine HPV vaccination recommended for both males and females ages 11-12 years Catch-up ages 13-21 years for males; 13-26 for females Permissive use ages 9-10 years for both males and females; 22-26 for males Recommendation for Females Either bivalent HPV vaccine (Cervarix) or quadrivalent HPV vaccine (Gardasil) recommended for girls at age 11 or 12 years for prevention of cervical cancer and

precancer Also for girls 13 through 26 who havent started or completed series Only quadrivalent HPV vaccine (Gardasil) also for prevention of vaginal, vulvar, and anal cancers, as well as genital warts. Recommendation for Males Quadrivalent HPV vaccine (Gardasil) recommended for boys at age 11 or 12 years for prevention of anal cancer and genital warts Also for boys 13 through 21 who havent started or completed series Young men, 22 through 26 years of age, may get the vaccine Teen boys and young men through age 26 who identify as gay or bisexual and havent started or completed series should be vaccinated

HPV Vaccination Schedule Recommended schedule is 0, 1-2, 6 months Following the recommended schedule is preferred Minimum intervals 4 weeks between doses 1 and 2* 12 weeks between doses 2 and 3 24 weeks between doses 1 and 3

The vaccination series can be started as young as 9 years of age at the clinicians discretion * Off-label ACIP recommendation- HPV4 only HPV Vaccine Safety The most common adverse events reported were considered mild For serious adverse events reported, no unusual pattern or clustering that would suggest that the events were caused by the HPV vaccine These findings are similar to the safety reviews of MCV4 and Tdap vaccines 57 million doses of HPV vaccine distributed in US since 2006

HPV Vaccine Safety Data Sources Post-licensure safety data (VAERS)1 Post-licensure observational comparative studies (VSD)2 Ongoing monitoring by CDC and FDA Post-licensure commitments from manufacturers Vaccine in pregnancy registries Long term follow-up in Nordic countries Official reviews WHOs Global Advisory Committee on Vaccine Safety 3 Institute of Medicines report on adverse effects and vaccines, 2011 4 Vaccine Adverse Events Reporting System, http://vaers.hhs.gov/index Vaccine Safety Datalink, http://www.cdc.gov/vaccinesafety/Activities/VSD.html 3 http://www.who.int/vaccine_safety/Jun_2009/en/

4http://www.iom.edu/Reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx 1 2 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 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) Adult Recommendations for PCV13

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

Adult Recommendations for PCV13 Functional or anatomic asplenia Immunosuppression Renal disease CSF leak Cochlear implants Pneumococcal Polysaccharide Vaccine (PPSV23) 60%-70% against invasive

disease Less effective in preventing pneumococcal pneumonia Adult Recommendations for PPSV23

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 Five-year Revaccination PPSV23

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 Five-year Revaccination PPSV23 Functional or anatomic asplenia Immunosuppression Renal disease Pneumococcal Polysaccharide Vaccine

Candidates for Revaccination Persons vaccinated at <65 years of age MMWR 1997;46(RR-8):1-24 Recommendations for use of PCV13 and PPSV23 in Pneumococcal Vaccine-Nave Adults Adults 19 years and older with immunosuppression, renal disease, functional or anatomic asplenia, CSF leak, or a cochlear implant who are vaccine nave, 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 Recommendations for use of PCV13 in Adults Previously Vaccinated with PPSV23 Adults with immunocompromising conditions, functional or anatomic asplenia, renal disease, 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 Storage and Handling 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 years largest inventory without crowding; Sufficient room to store water bottles (refrigerator) or frozen coolant packs (freezer); Frost free or automatic defrost units are preferred www.cdc.gov/vaccines/recs/storage/toolkit/default.htm 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 Vaccine Administration Errors Vaccine Error Any preventable

event that may cause or lead to inappropriate use of a vaccine or cause patient harm No one wants to make an error Vaccine Administration Key to ensuring vaccination is as safe and effective as possible Incorporate professional standards for medication administration manufacturers vaccine-specific guidelines

http://www.immunize.org/packageinserts/ evidence-based safe injection practices on CDC's Injection Safety Information for Providers webpage http:// Staff Training and Education All personnel who administer vaccines (permanent and temporary) should receive comprehensive, competency based training before administering vaccines Providers need to validate staffs knowledge and skills with a skills checklist Integrate training into new staff orientation annual education requirements

when vaccine administration recommendations are updated or when new vaccines are added Thank You Email: DC-INFO Website [email protected] www.cdc.gov/info Website: cdc.gov/vaccines

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