Immunization Update 2015 JoEllen Wolicki BSN, RN Immunization Services Division National Center for Immunization and Respiratory Diseases Tennessee Annual Spring Immunization Review April 2015 National Center for Immunization & Respiratory Diseases Immunization Services Division Disclosures JoEllen Wolicki is a federal government employee with no financial interest or conflict with the manufacturer of any product named in the following presentations The off-label use of MMR, HPV, and PCV13 vaccines will be discussed Vaccines not currently licensed by the FDA will not be discussed Disclosures Upcoming ACIP Meetings June 24-25 October 21-22 www.cdc.gov/vaccines/recs/acip/ The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices (ACIP) Composed of 15 nongovernment experts in clinical medicine and public health Provides guidance on use of vaccines and other biologic products to DHHS, CDC, and the U.S. Public Health Service 1
What s New? 2015 Immunization Schedules Updated Vaccine Information Statements Immunization Rates Measles ACIP Recommendations Human Papillomavirus Pneumococcal Influenza Meningococcal New Vaccines and Products MenB DTaP-IPV Immunization Resources 2015 Childhood Immunization Schedule Updates MMWR publication in February 2015 Contains website links to schedules - actual schedules not included Updated guidance for: MMR vaccination for infants 6 11 months of age if they will travel or live abroad Meningococcal conjugate vaccine recommendations for use of MenACWY, and Hib-MenCY in children aged 2 months and older with certain high-risk conditions Pneumococcal vaccination for children with high-risk conditions Haemophilus influenzae type b (Hib) conjugate vaccine, pneumococcal conjugate vaccine, tetanus, diphtheria, acellular pertussis (Tdap), and varicella vaccine catch-up schedules were updated to provide more clarity MMWR 2015;64(No.4) February 6, 2015 www.cdc.gov/mmwr/pdf/wk/mm6404.pdf 2
4/29/2015 www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html www.cdc.gov/vaccines/schedules/hcp/imz/catchup.html There is a Schedule App?!! Catch-up Guidance Job Aids www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html 3
UPDATED VACCINE INFORMATION STATEMENTS (VISS) Updated VISs Multi-Vaccines RV Hib Tdap Td www.cdc.gov/vaccines/hcp/vis/index.html Stay Current Sign up for e-mail alerts when VISs are updated Import the current VISs to your website www.cdc.gov/vaccines/hcp/vis/current-vis.html 4
IMMUNIZATION COVERAGE RATES Estimated Coverage of Vaccines among Children Aged 19-35 Months, NIS 2013 State/Area Vaccine Series* 4:3:1:4:3:1:4 United States 70.4% Tennessee 68.5% *Includes >4 doses DTaP/DT/DTP, > 3 doses polio, > 1 dose MMR, full series of Hib, > 3 doses HepB, > 1 dose varicella, and > 4 doses PCV MMWR 2014; 62(36): 733-40 www.cdc.gov/vaccines/imz-managers/coverage/nis/child/tables/13/tab02_antigen_iap_2013.pdf National Estimated Vaccination Coverage Levels among Adolescents 13-17 Years, National Immunization Survey-Teen, 2006-2013 US 57.3 TN 48.9 US 86.0 TN 80.0 US 77.8 TN 67.8 US 37.6 TN 35.9 US 34.6 TN 28.9 US 13.9 TN N/A MMWR. 2014;63(29);625-33 5
Estimated Percentage of Kindergarten Children who Have Been Exempted from Receiving One or More Vaccines, 2013-14 School Year MMWR 2014; 63(41): 913-920 MEASLES 2015 Measles Cases 2015 www.cdc.gov/measles/cases-outbreaks.html 6
www.cdc.gov/measles/cases-outbreaks.html www.cdc.gov/measles/importation-infographic.html What Can You Do? Ensure all patients (and HCP!) are up-todate on MMR vaccine Ask about planned international travel during healthcare encounters CDC urges HCP to consider measles when evaluating patients with fever and rash Ask about recent international travel history and travel to domestic venues frequented by international travelers 7
Keep Your Guard Up! Promptly isolate patients with suspected measles to avoid disease transmission and immediately report the suspect case to the health department For more information, including guidelines for patient evaluation, diagnosis, and management, visit: http://www.cdc.gov/measles/hcp/ MMWR 2013;62(RR-4) MMR Vaccination Recommendations* Routine recommendations: Pediatric: Dose 1 at 12-15 months; Dose 2 at 4-6 years of age Adults: College and other students and healthcare personnel need 2 appropriately spaced doses and all other adults need 1 dose International travel: Infants 6 through 11 months should receive 1 dose of MMR Previously vaccinated children 1 through 3 years can receive a second dose of MMR at least 4 weeks after the first dose Persons 4 years of age and older should receive 2 doses separated by at least 4 weeks *Without evidence of immunity MMWR 2013;62(RR-4) Evidence of Measles Immunity Evidence of measles immunity: 2 appropriately spaced and documented doses of MMR vaccine Laboratory evidence of immunity, or Laboratory confirmation of disease No additional doses are indicated or recommended even for HCP No serologic testing is recommended MMWR 2013;62(RR-4) 8
ACIP IMMUNIZATION RECOMMENDATIONS FOR SPECIFIC VACCINES HUMAN PAPILLOMAVIRUS (HPV) VACCINATION http://www.cdc.gov/vaccines/pubs/acip-list.htm#hpv Available HPV Vaccines Bivalent (Cervarix) Quadrivalent (Gardasil) L1 VLP types 16, 18 6, 11, 16, 18 9-Valent (Gardasil9) 6, 11, 16, 18, 31, 33, 45,52, 58 Manufacturer GSK Merck Merck Indications Females: Cervical precancer and cancer Males: Not approved for use in males Females: Anal, cervical, vaginal, and vulvar precancer and cancer; Genital warts Males: Anal precancer and cancer; Genital warts Females: Anal, cervical, vaginal, and vulvar precancer and cancer; Genital warts Males: Anal precancer and cancer; Genital warts L1, major capsid protein; VLP, virus like particle 27 9
Estimated Number of HPV-attributable Cancer Cases per Year, United States http://www.cdc.gov/cancer/hpv/statistics/cases.htm Cancer Estimated Percentages of Cancers Attributed to HPV in the U.S. HPV attributable % (95% CI) HPV 16/18 attributable % (95% CI) HPV 31/33/45/52/58 attributable % (95% CI) Cervical 91 (88-92) 66 (63-69) 15 (12-17) Vaginal 75 (63-84) 55 (43-67) 18 (11-30) Vulvar 69 (62-75) 49 (41-56) 14 (10-20) Penile 63 (52-73) 48 (37-59) 9 (4-17) Anal Male Female Oropharyngeal Male Female 89 (77-95) 92 (85-96) 72 (68-76) 63 (55-71) 79 (66-88) 80 (70-87) 63 (59-68) 51 (43-59) 4 (1-13) 11 (6-19) 4 (3-7) 9 (6-15) Adaptead from Saraiya, presented at Anal Intraepithelial Neoplasia Society Conference, March 13 15, 2015, Atlanta, GA. 29 Summary: Attribution of HPV 16/18 and HPV 31/33/45/52/58, United States HPV-associated cancers ~33,000 per year 64% of cancers attributable to HPV 16/18 66% of cervical cancer Other cancers: range, 48% penile -80% anal 10% of cancers attributable to additional 5 types 15% of cervical cancer Other cancers: range, 4% oropharyngeal -18% vaginal Differences by sex: 14% for females; 4% for males CIN2 lesions ~50% attributable to HPV 16/18 ~25% attributable to 5 additional types >CIN, cervical intraepithelial neoplasia grade 2 or worse % among all HPV-associated cancers MMWR 2015;64:300-4 MMWR RR 2014; 63:1-30 Hariri et al. CEBP 2015 30 10
Updated ACIP Recommendations All HPV vaccines (2vHPV, 4vHPV, and 9vHPV) protect against HPV 16 and 18, which cause about 66% of cervical cancers and the majority of other HPVattributable cancers in the U.S. 9vHPV targets 5 additional cancer causing types, which account for about 15% of cervical cancers 4vHPV and 9vHPV also protect against HPV 6 and 11, which cause genital warts MMWR 2015;64:300-4 Updated ACIP Recommendations Routine vaccination at age 11 or 12 years Vaccination recommended through age 26 for females and through age 21 for males not previously vaccinated Vaccination recommended for men who have sex with men and immunocompromised men (including persons HIV-infected) through age 26 Females: Administer 2vHPV, 9vHPV or 4vHPV (as long as this formulation is available) Males: Administer 9vHPV or 4vHPV (as long as this formulation is available) MMWR 2015;64:300-4 32 Updated ACIP Recommendations Interchangeability* If vaccination providers do not know or do not have available the HPV vaccine product previously administered, or are in settings transitioning to 9vHPV, for protection against HPV 16 and 18: Females: any HPV vaccine product may be used to continue or complete the series Males: 4vHPV or 9vHPV may be used to continue or complete the series for males *ACIP off-label recommendation MMWR 2015;64(29):300-4 33 11
Updated ACIP Recommendations Administration Administer in a 3-dose schedule* Dose #2: Administer at least 1 to 2 months after the first dose Dose #3: Administer at least: 12 weeks after dose 2 AND 24 weeks after dose 1 If the vaccination schedule is interrupted, the series does not need to be restarted IM injection *ACIP off-label recommendation MMWR 2015;64(29):300-4 Updated ACIP Recommendations HPV Vaccination During Pregnancy No change in recommendations HPV vaccine not recommended for use in pregnancy Information on vaccine in pregnancy registries updated A new vaccine in pregnancy registry has been established for 9vHPV. Exposure during pregnancy can be reported to the respective manufacturer Patients and healthcare providers can report an exposure to HPV vaccine during pregnancy to the Vaccine Adverse Event Reporting System (VAERS) Registries for 4vHPV and 2vHPV have been closed with concurrence from FDA www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm434787.htm 9vHPV Vaccination for Persons who Completed an HPV Vaccination Series The manufacturer did not seek an indication for 9vHPV vaccination for persons who previously completed an HPV vaccination series A study of 9vHPV in prior 4vHPV vaccinees was conducted Due to time limitations (abbreviated ACIP meeting), this was not discussed; will be discussed at a future ACIP meeting 36 12
PNEUMOCOCCAL VACCINATION AND CHILDREN AT INCREASED RISK www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/mening.html ACIP Recommendations for PCV13 Pediatric All children 2 through 59 months of age should complete the series appropriate for age A single supplemental dose of PCV13 is recommended for children who have received a complete age-appropriate series of PCV7: Healthy children 14 through 59 months Children 14 through 71 months with an underlying medical condition (including those who have already received a dose of PPSV) MMWR 2010;59 (RR-11) Children Ages 2 through 18 Years with a High-risk Condition Age Condition Vaccination History 2 through 5 years 6 through 18 years* Immunocompetent Immunocompromised Immunocompetent Cochlear implant CSF leak Immunocompromised Functional or anatomic asplenia, including sickle cell disease Chronic renal failure and nephrotic syndrome HIV infection and other immunocompromising conditions *Off-label recommendation: ACIP vote, February 20, 2013 MMWR 2010;59 (RR-11) None or fewer than 3 doses No history of PCV13 PCV13 Schedule 2 doses at least 8 weeks apart 1 dose 13
Pneumococcal Polysaccharide Vaccine Recommendations Persons in environments or settings with increased risk Persons 2 years and older who are Immunocompromised or Asplenic- functional or anatomic Immunocompetent with certain chronic illnesses or conditions PPSV23 High-risk Conditions Immunocompetent children Chronic heart disease * Chronic lung disease Diabetes mellitus Cerebrospinal fluid leaks Cochlear implant Children with functional or anatomic asplenia including sickle cell disease and other hemoglobinopathies Children with immunocompromising conditions HIV infection Chronic renal failure and nephrotic syndrome Diseases associated with treatment with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin disease, or solid organ transplantation Congenital immunodeficiency * Particularly cyanotic congenital heart disease and cardiac failure. Including asthma if treated with high-dose oral corticosteroid therapy Includes B- (humoral) or T-lymphocyte deficiency; complement deficiencies, particularly C1, C2, C3, and C4 deficiency; and phagocytic disorders (excluding chronic granulomatous disease) MMWR 2010; 59: (RR-11) ACIP Recommendations for PCV13 and PPSV23 Immunocompetent Children at Increased Risk At/after age 65 PCV13* + PPSV23 + PPSV23 At least 8 weeks apart and age 2 * Age-appropriate PCV13 series 14
Pneumococcal Polysaccharide Vaccine Revaccination Routine revaccination of immunocompetent persons is not recommended Revaccination recommended for persons 2 through 64 years of age who are at highest risk of serious pneumococcal infection Single revaccination dose at least 5 years after the first dose, before age 65 MMWR 2010;59(No.34):1102-5 Pneumococcal Polysaccharide Vaccine Candidates for Revaccination Persons 2 years or older with: Functional or anatomic asplenia (including sickle cell disease) Immunosuppression (including HIV infection) Solid organ transplant Chronic renal failure Nephrotic syndrome MMWR 2010;59(No.34):1102-5 and 2010;59(RR-11) ACIP Recommendations for PCV13 and PPSV23 Immunocompromised Children At/after age 65 PCV13* + PPSV23 + PPSV23 + PPSV23 At least 8 weeks apart and age 2 At least 5 years * Age-appropriate PCV13 series 15
www.immunize.org/catg.d/p2016.pdf Seasonal Influenza 16
2014-15 Influenza Vaccine Recall Certain presentations of quadrivalent influenza vaccine (IIV4) are being recalled because the antigen content has declined below the stability specification limit There are no safety concerns related to the recalled vaccines and re-immunization is not necessary Recalled vaccines includes: SP: 3 lots of Fluzone quadrivalent influenza vaccine in multidose vials ONLY This vaccine was available through the VFC program Contact your VFC point of contact GSK: Quadrivalent Flulaval in manufacturer-filled syringes ONLY This vaccine was not available through the VFC program Contact the vaccine manufacturer 17
Influenza Vaccine Strains 2015-16 2 new vaccine strains for 2015-16 season Trivalent vaccine will contain: A/California/7/2009 (H1N1)pdm09-like virus A/Switzerland/9715293/2013 (H3N2)-like virus B/Phuket/3073/2013-like virus Quadrivalent vaccine contains the above 3 strains plus: B/Brisbane/60/2008-like virus Influenza Vaccines for 2015-16 Inactivated (IIV) Age indications vary by product, formulation, and presentation Trivalent (IIV3): Intramuscular or intradermal injection or jet injector Quadrivalent (IIV4): Intramuscular injection Live, attenuated vaccine (LAIV4) 2 years and older, healthy, not pregnant Intranasal Quadrivalent MENINGOCOCCAL VACCINATION www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/mening.html 18
Incidence Declines Observed in All Serogroups, United States, 1993-2012 B C Y W Rate per 100,000 0.6 0.5 0.4 0.3 0.2 0.1 0 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 Year ABCs cases from 1993-2012 estimated to the U.S. population with 18% correction for under reporting 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Incidence by Serogroup* and Age Group, United States, NNDSS, 2005-2012 Incidence per 100,000 2.5 2 1.5 1 0.5 0 <1 year 1-4 years Serogroup B 5-10 years Serogroup A, C, W, Y 11-14 years 15-18 years 19-22 years Age group (years) 23-26 years 27-64 years 65+ years *NNDSS data with additional serogroup data from ABCs and state health departments. Unknown serogroup excluded (23%). 50-60% of Disease in Children Under 5 Years is Due to Serogroup B *Other includes serogroups W-135, nongroupables, other, and unknown ABCs cases from 1993-2009 and estimated to the U.S. population with 18% correction for under reporting 19
Vaccination of High-risk Groups Vaccination is recommended for persons 2 months of age and older who are at increased risk for meningococcal disease, including: Functional or anatomic asplenia Persistent complement component deficiency Travelers to high-risk areas Certain lab workers For use in meningococcal outbreaks caused by vaccine serogroups Comparing Meningococcal Conjugate Vaccines Brand Name Serogroups Ages ACIP Abbrev Route Meningococcal Conjugate Meningococcal Conjugate and Haemophilus influenzae type b Menactra Menveo Menhibrix A, C, Y, and W C and Y 9 months through 55 years* 2 months through 55 years* MenACWY or MCV4 6 weeks through 18 months Intramuscular injection (IM) Hib-MenCY *Off-label ACIP recommendation persons 56 years of age and older Meningococcal Vaccination for High-risk Children 2 through 23 Months Vaccine Menactra MenHibrix Menveo MMWR. 2013;62(3) Indicated for: Complement deficiencies Outbreaks Travel Complement deficiencies Asplenia Outbreaks Complement deficiencies Asplenia Outbreaks Travel Not Indicated for: Primary Vaccination Booster Doses Asplenia 9, 12 months 3 years after 1 0 series, then every 5 years Travel Booster dose 2, 4, 6, and 12-15 months 2, 4, 6, and 12 months 3 years after 1 0 series, then every 5 years (using Menactra or Menveo) 3 years after 1 0 series, then every 5 years 20
Vaccination for High-risk Persons Administer 2 doses of MCV4 to previously unvaccinated high-risk persons 2 years of age and older with: Persistent complement deficiencies Functional or anatomic asplenia Administer 1 dose of MCV4 to: Certain travelers Persons present during outbreaks Lab personnel routinely working with Neisseria meningitidis Residents of countries where disease is hyperendemic or epidemic MMWR. 2013;62(3) Meningococcal Booster Vaccination for those at Continued Risk Persons who remain at increased risk and completed the primary dose or series: 2 months 6 years: Should receive additional dose of either MCV4 3 years after primary immunization; boosters should be repeated every 5 years thereafter 7 years and older: Should receive additional dose of either MCV4 5 years after primary immunization; boosters should be repeated every 5 years thereafter *ACIP off-label recommendation www.immunize.org/catg.d/p2018.pdf 21
NEWLY LICENSED VACCINES Meningococcal B Vaccines Product Name Trumenba (Pfizer) Bexsero (Novartis) FDA Age Indications Dosage/Route/Schedule 10 through 25 years of age 10 through 25 years of age Three 0.5 ml doses IM injection 0-, 2-, and 6-month Two 0.5 ml doses IM injection 0, 1 6 month February 2015 meeting: ACIP voted to recommend meningococcal B vaccine to certain high-risk persons 10 years of age and older. Immunization recommendations will be published in the MMWR. Recorded proceedings at www.cdc.gov/vaccines/acip/meetings/meetings-info.html Quadracel Combination vaccine containing DTaP and IPV Manufacturer: sanofi pasteur FDA approved for use in children who received Pentacel or Daptacel 4 through 6 years of age Fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and Fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series 22
On the Horizon Hexavalent vaccine Manufacturers: Sanofi pastuer and Merck DTaP + IPV + Hib + HepB 3 dose series: 2, 4 and 6 month of age Biologics Licensure Application (BLA) accepted by FDA for review October 2014 Licensure expected by Fall 2015 IMMUNIZATION RESOURCES CDC Vaccines and Immunization Resources Questions? Email CDC Providers Parents and patients Website nipinfo@cdc.gov ww.cdc.gov/cdcinfo ww.cdc.gov/vaccines Influenza www.cdc.gov/flu Vaccine Safety ww.cdc.gov/vaccinesafety 23
Additional Resources State of Tennessee Immunization Program https://health.state.tn.us/ceds/immunization.htm And local public health immunization programs, too! Immunization Action Coalition Vaccine Education Center www.immunize.org www.chop.edu American Academy of Pediatrics (AAP) National Foundation for Infectious Diseases (NFID) www.aap.org/immunize www.nfid.org Act as if what you do makes a difference. It does. William James Act as if what you do makes a difference. It does. William James 24
High-dose Influenza A recent study found that a high-dose IIV3 provided significantly more protection than the standard dose IIV3 in people 65 years of age and older Additional findings: a significant reduction in influenza-related hospital admissions for those receiving high-dose IIV3 compared to those receiving standard dose IIV3 ACIP currently does not express a preference for high-dose IIV3 Comparative effectiveness of high-dose versus standard dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using Medicare data: a retrospective cohort analysis Lancet Infect Dis 2015 Feb 6. pii: S1473-3099(14)71087-4. 25