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 tetanus-toxoid, 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  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  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  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 guidance no longer recommends Hib vaccination of previously unvaccinated adults with HIV infection because their risk for Hib infection is low.

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 6–12 months after transplant regardless of prior Hib vaccination.

Comparing Meningococcal Vaccines Meningococcal Polysaccharide (Menomune) Meningococcal Conjugate Meningococcal Conjugate & Haemophilus influenzae type b (Menactra)(Menveo) Ages2 years and older 9 months through 55 years 2 months through 55 years 6 weeks through 18 months AbbrevMPSV4MCV4 or MenACWY Hib-MenCY RouteSubcutaneous (Subcut.) Intramuscular (IM) *ACIP off-label recommendation

Routine MCV4 Vaccination for Persons 11 through 21 Years of Age Age Group Primary VaccinationBooster Dose* years years years 1 dose 1 dose if not vaccinated previously Not routinely recommended but 1 dose may be administered as catch-up vaccination for those who have not received a dose after their 16th birthday 1 dose recommended if first dose administered before 16th birthday *ACIP off-label recommendation

Meningococcal Vaccination for Infants 2 through 18 months of Age at Increased Risk *ACIP off-label recommendation Risk GroupPrimary Vaccination Persistent complement deficiencies Functional or anatomic asplenia, including sickle cell Risk during a community outbreak attributable to a vaccine serogroup 4 doses of Hib-MenCY at 2, 4, 6, and 12–15 months *If later travel to an area where A and W-135 protection are needed, administer an age- appropriate MCV4 dose prior to travel

Meningococcal Vaccination for Children 9 through 23 months of Age at Increased Risk *ACIP off-label recommendation Risk GroupPrimary Vaccination 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 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 series

*ACIP off-label recommendation Risk GroupPrimary Vaccination Persistent complement deficiencies Functional or anatomic asplenia, including sickle cell HIV+, if another indication for vaccination exists 2 doses of MCV4, 8 to 12 weeks apart *If Menactra is used, it should be administered at least 4 weeks after completion of all PCV doses Meningococcal Vaccination for Persons 2 through 55 Years of Age at Increased Risk and Not Previously Vaccinated

*ACIP off-label recommendation Risk GroupPrimary Vaccination First year college students 21 yrs of age or younger living in residential housing Travel to or resident of countries where meningococcal disease is hyper endemic or endemic Risk during a community outbreak attributable to a vaccine serogroup Microbiologists routinely exposed to isolates of Neisseria meningitidis 1 dose of MCV4 *If Menactra is used, it should be administered at least 4 weeks after completion of all PCV doses.

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-naïve 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

HUMAN PAPILLOMAVIRUS VACCINES (HPV)

Comparing HPV Vaccines HPV4 (Gardasil)HPV2 (Cervarix) Types6, 11, 16, 1816, 18 Recommendations for Females Routine: yrs Catch-up: yrs Routine: yrs Catch-up: 13-26* yrs Recommendations for Males Routine: yrs Catch-up: yrs Immunocompromised: yrs MSM: yrs HIV positive: years Do not administer to males Schedule0, 1-2*, 6 mos RouteIntramuscular (IM) *ACIP off-label recommendation

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: NIS-Teen, 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

Oropharynx Average Number of New HPV-Associated Cancers by Sex, in the United States, n=3039 n=2317 n=3084 n=11279 n=9312 n=1687 n=1003 Jemal A et al. J Natl Cancer Inst 2013;105: n=694

HPV-Associated Oropharyngeal Cancers Prevalence increased from 16.3% ( ) to 71.7% ( ) Population-level incidence of HPV-positive cancers increased by 225% while HPV-negative 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 years Catch-up ages years for males; for females Permissive use ages 9-10 years for both males and females; 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 haven’t 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 haven’t 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 haven’t 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 clinician’s 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 – WHO’s Global Advisory Committee on Vaccine Safety 3 – Institute of Medicine’s report on adverse effects and vaccines, Vaccine Adverse Events Reporting System, 2 Vaccine Safety Datalink,

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-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

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 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 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  manufacturer’s vaccine-specific guidelines  evidence-based safe injection practices on CDC's Injection Safety Information for Providers webpage

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 staff’s 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 CDC-INFO Websitewww.cdc.gov/infowww.cdc.gov/info Website: