Preteen and teen vaccines: what to do with the recent recommendations MARK H. SAWYER UCSD SCHOOL OF MEDICINE RADY CHILDREN S HOSPITAL SAN DIEGO Continuing Education The Illinois Chapter, American Academy of Pediatrics is accredited by the Illinois State Medical Society (ISMS) to provide continuing medical education for physicians. The Illinois Chapter, American Academy of Pediatrics designates this live activity for a maximum of 1 AMA PRA Category 1 Credit(s). 2 1
Disclosures I have no financial disclosures related to this presentation 3 Objectives List the factors influencing recommendations for serogroup B meningococcal vaccines so that you can decide how to use them Describe the added benefits of HPV9 vaccine so that you can advise your patients about whether they should receive it Explain the changes in recommendations for use of influenza vaccine in eggallergic patients so that you can educate your patients Explain why we are seeing so much pertussis and why there is not a recommendation to give Tdap boosters in the general population Describe which of your teenage patients should receive PCV13 vaccine so that you are sure to immunize them 4 2
Meningococcal Disease, College Outbreaks, Meningococcal B Vaccine Meningococcal Disease Five main strains of Neisseria meningitidis (Meningococcus): A, B, C, Y, W The previously licensed meningococcal vaccines contain serogroup A, C, Y, W Serogroups B, C and Y circulate in the United States Serogroup B disease is common in young children and becoming more common in adolescents and adults Outbreaks of meningococcal type B at Princeton and UCSB in 2014; University of Oregon in 2015; Santa Clara University 2016 N. meningitidis causes overwhelming sepsis and meningitis with a high mortality rate (approx 10%) 3
Meningococcal serogroup B vaccines First serogroup B membrane protein vaccine licensed in October 2014. MenB-FHbp (Trumenba). fhbp subfamily A/v2,3; subfamily B/v1. A 3-dose vaccine Second serogroup B membrane protein vaccine licensed in January 2015. MenB-4C (Bexero). fhbp subfamily B/v1, NhbA, NadA, Por A1.4. A 2-dose vaccine. Licensed in >30 countries Use in high-risk patients recommended by ACIP in February 2015 Permissive recommendations for use in general population in June 2015 These are different vaccines from the ACWY vaccines and different from each other. They cannot be used interchangeably So we should start giving all adolescents Meningococcal B vaccine, right? It s not so simple! 4
MacNeil-ACIP October 2014; http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html MacNeil-ACIP October 2014; http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html 5
Should we immunize all adolescents to prevent a very small number of cases and deaths? MacNeil-ACIP October 2014; http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html 6
Patel-ACIP October 2014 Immunogenicity Summary Demonstrated immune response in general adolescent population 86-98% achieved protective antibody titers after 3 doses of MenB-FHbp [US adolescents and young adults] 99-100% for achieved protective antibody titers after 2 doses of MenB-4C [Chilean and UK adolescents and young adults] 73-93% [US and Polish adolescents and young adults] Data not directly comparable between the 2 vaccines Immunogenicity data not currently available in groups at increased risk Limited short-term (18-23 months) antibody persistence data available for MenB-4C Patel-ACIP October 2014 7
MenB-FHbp MenB-4C Serogroup B Meningococcal Vaccine Recommendations for High Risk A serogroup B meningococcal vaccine (MenB) series should be administered to persons aged >10 years at increased risk for meningococcal disease (Category A). This includes: Persons with persistent complement component deficiencies, including those taking eculizomab. Persons with anatomic or functional asplenia including those with sickle cell disease Microbiologists routinely exposed to isolates of Neisseria meningitides Persons identified as being at risk due to a serogroup B meningococcal outbreak MMWR, 2015;64: 608 8
MMWR, 2015;64: 608 What about everyone else? A Men B vaccine series MAY be administered to adolescents and young adults aged 16-23 years to provide SHORT-TERM protection against MOST strains of serogroup B meningococcal disease. The preferred age for Men B vaccination is 16-18 years. Macneil J, ACIP presentation June 2015 9
Meningococcal B Vaccines: Who should you give them to? 16-23 year olds who request it Those living in dormitories or other crowded conditions? Kids whose college or other institution requires it Those who smoke or drink alcohol???? Three reasons you should care about HPV vaccine HPV causes lots of cancer HPV vaccine prevents cancer We are doing a terrible job of immunizing our population with HPV vaccine to prevent cancer 10
HPV infection causes lots of cancer http://www.cdc.gov/cancer/hpv/statistics/cases.htm HPV vaccine-infection reduction since vaccine became available-females 64% reduction in prevalence of 4vHPV type infection in 14-19yo 34% reduction in 20-24 yo No reduction in >24yo populations No change in prevalence of non-vaccine serotypes Achieved with only 34% 3-dose vaccine coverage Markowitz-Pediatrics 2016:137(2): e20151968 11
Prevalence per 1000 Person-years 3/22/2016 Anogenital Wart Prevalence per 1000 person-years, US Private Insurance Enrollees, by Age, 2003-2010 Females Males 25-29 20-24 25-29 30-34 15-19 35-39 10-14 20-24 30-34 35-39 15-19 10-14 Flagg, et al. AJPH 2013 23 HPV vaccine coverage rates-united States MMWR July 31, 2015 / 64(29);784-792 12
We are part of the problem Allison MA et al. Pediatrics 2016;137(2):e20152488 HPV9 vaccine is here Previous HPV vaccines contain two (2vHPV[types 16 and 18], Cervarix) or four (4vHPV[types 6, 11, 16, 18], Gardasil) serotypes HPV serotypes 16 and 18 are in both vaccines and are the most common causes of cervical cancer HPV serotypes 6 and 11 are only in HPV4 A new vaccine with 9 HPV serotypes is now available-adds types 31, 33, 45, 52, 58 Recommended routinely beginning at 11 years of age 13
HPV Immunization Recommendations Routine immunization at age 11-12 years for all. Start using HPV9 All Females aged 13-26 years. Can complete the series with HPV9 All Males aged 13-21 years. Can complete the series with HPV9 but less benefit Men who have sex with men aged 13-26 years. Can complete the series with HPV9 but less benefit MMWR 2015; 64:300-304; CDC.gov 14
Should I revaccinate teens who have already completed an HPV vaccine series? No routine recommendation to revaccinate those who have already completed a series Lack of a recommendation is based largely on a cost-benefit assessment Focus is on just getting 3 doses into all teens No safety concerns identified with revaccination Will increase cancer prevention May not be covered by insurance MMWR 2015; 64:300-304; CDC.gov Questions You Hear about Pertussis Immunization Why are we seeing so much pertussis? Does vaccine immunity wane quickly? Does Tdap vaccine immunity wane as fast as DTaP vaccine immunity Was DTP a better vaccine than DTaP? Are circulating strains mutating (e.g., pertactin deficient strains) How are we doing with DTaP and Tdap vaccine coverage? Is Tdap vaccine safe in pregnancy? Should we be giving Tdap boosters? 30 30 15
Pertussis in California http://www.cdph.ca.gov/programs/immunize/documents/pertussisreport2-12-2015.pdf Reasons for Outbreaks of Pertussis Pertussis is very contagious People who have pertussis can be contagious for up to 3 weeks Pertussis is difficult to recognize and diagnose Even after someone begins treatment for pertussis they are contagious for up to 5 days Immunity from prior vaccination or disease wanes over time so people become susceptible again. 32 32 16
Evidence of decreased protection in adolescent immunized with acellular vaccines as infants Klein NP et al. Pediatrics, 2016;137(3):e20153326 33 Tdap Vaccine Effectiveness Koepke R, J Infect Dis 2014;210:942-53 17
Tdap Vaccine Effectiveness Klein NP et al. Pediatrics, 2016;137(3):e20153326 Prepared by County of San Diego, Health & Human Services Agency, Public Health Services, Epidemiology & Immunization Services, 9/4/14 36 18
Why Immunize at Every Pregnancy? 37 Tom Clark, CDC, ACIP presentation Feb 2013 38 19
Tdap during pregnancy works! Dabrera G, Clin Infect Dis 2015;60(3):333-7 Should we give Tdap Boosters? Tdap boosters have been considered based on waning immunity Interval between Tdap vaccines uncertain Cost-benefit is poor Growing experience in Canada, Australia, and other countries with a 10 year interval Limited experience with a 5 year interval Stay tuned. 40 40 20
Effect of Tdap boosters at 16 or 21 years of age Kamiya et al, Vaccine 2016 Feb 17. pii:s0264-410x(16)00169-9 Tdap Recommendations CDC/AAP/AAFP/ACOG/ACP Routine use at 11-12 years of age Replace Td for all ages 11-64 Special focus on adults in contact with young infants Pregnant women-primary strategy for preventing severe disease Healthcare providers Parents and siblings Grandparents (including those >64 years of age) No booster except for pregnant women 42 42 21
Influenza 2014-2015:it wasn t a very good year. 2015-2016 has been better 22
2015-2016 Interim Influenza Vaccine Effectiveness Overall=59% (44-70) Influenza A H1N1=51% (25-69) Influenza A H3N2-insufficient data Influenza B=76% (59-89) LAIV=????????????? ACIP meeting, February 2016; http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html 2016-2017 Influenza vaccine New Influenza A (H3N2) strain based on minor changes in circulating strains New Influenza B strain for the trivalent vaccine Quadrivalent vaccine contains both Influenza B strains Both trivalent and quadrivalent vaccines will be available FDA VRBPAC Meeting March 4, 2016 23
Influenza vaccine and egg allergy-stop worrying! Current manufacturing techniques have lowered the amount of ovalbumin contained in influenza vaccines to a very low amount Multiple studies have now shown that severe reactions to influenza vaccine among egg allergic individuals is exceedingly rare and no more likely than in the general population Any influenza vaccine product can be given to egg allergic individuals-including those who have had anaphylaxis to egg. Includes LAIV You should be just as prepared to treat an anaphylactic reaction to influenza vaccine as you are for any other vaccine 30 minute waiting period dropped to 15 minutes ACIP meeting, February 2016; http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html Pneumococcal conjugate vaccine (PCV13) for older children 24
Pneumococcal Vaccines POLYSACCHARIDE-PPSV23 PROTEIN CONJUGATE VACCINE- PCV13 Pneunovax Available for decades Used in high risk populations including all adults >65 years of age Immunity wanes so some groups need a repeat dose 5 years after their first PPSV23 Only limited benefit from repeated doses Prevnar 13 Induces a better immune response Began using PCV7 routinely in young children in the 1990 s PCV13 became available in 2010 Has led to reduced disease even in unimmunized populations Licensed for adults >50 years of age in 2011 49 Two populations should receive both PCV13 and PPSV23 HIGH RISK CHILDREN AND ADULTS ALL ADULTS 65 YEARS AND OLDER Immunocompromised (e.g. HIV, malignancy) Anatomic or functional asplenia Cochlear implants CSF leaks Nephrotic syndrome 25
Pneumococcal vaccine: PCV 13 for 6 through 18 year old children at increased risk Risk groups Immunocompromised (malignancy, HIV infection, asplenia, chronic renal failure) CSF leaks Cochlear implants These groups need both conjugate (PCV13-Prevnar) and polysaccharide (PPSV23-Pneumovax) Immunologic response best if PCV given prior to PPSV23 8 weeks currently recommended between vaccines PPSV recommendations have not changed Pediatrics 2014;134:1230-33 Pediatrics 2014;134:1230-33 26
Take Home Points Serogroup B meningococcal vaccine now available. Recommendations for use currently limited. New HPV9 vaccine available. Should be given to all 11-12 year old children. Limited role for reimmunizing those who have already received HPV2 or HPV4. We need to do a better job of delivering HPV vaccine to adolescents. Pertussis remains a big problem in large part due to waning vaccine immunity. Focus on immunizing pregnant women at every pregnancy Egg allergic individuals can receive any influenza vaccine safely PCV13 now indicated for high-risk older children 53 Information for Health-Care Professionals NNII (www.immunizationinfo.org) VEC (www.vaccine.chop.edu) IAC (www.immunize.org) CDC/NIP (www.cdc.gov/nip) AAP (www.aap.org) AAFP (www.aafp.org/) IVS (www.vaccinesafety.edu) Vaccine Page (www.vaccines.org) Every Child by Two (www.ecbt.org) CDPH.gov (shot for shot) PKIDS (http://www.pkids.org/) 27