National Immunization Update

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National Immunization Update H. Cody Meissner, M.D. Professor of Pediatrics Tufts Medical Center Boston, MA October 18, 2018 23 rd MIAP Immunization Conference Framingham, MA

Disclaimers/Disclosure I have no financial relationship with the manufacturer(s) of any commercial product(s) discussed in this presentation I may discuss the use of vaccines in a manner not consistent with the Package Insert, but all recommendations are in accordance with recommendations from the ACIP & AAP

Today s Learning Objectives 1. The 2018 Immunization Schedule a. Review of two footnote changes a. HepB, MMR b. Considerations regarding addition of a vaccine to the schedule 2. 2018-2019 influenza season a. Present recommendations that have changed and those that have not changed 3. HPV vaccine safety data a. VAERS data after >60 million doses distributed b. Changing rates of HPV associated cancers 4. Pneumococcal vaccine a. Review the extraordinary effectiveness of Prevnar 13 b. Consider possible future changes to recommendations 5. Meningococcal vaccine a. Discuss changing epidemiology 6. Future vaccine delivery possibilities

Considerations Before a Vaccine is Licensed & Recommended Safety Efficacy Age when disease is most likely to occur Effect of age on the immune response Duration of the immune response Equity Compatibility with existing schedule Simplification of the immunization schedule Minimization of the number of doses Need for booster doses Cost-effectiveness Impact on indirect (herd) immunity Vaccine supply Vaccine acceptance by members of the public

1000 Infants Born Annually with Hepatitis B

Jeryl Lynn Hilleman with her Sister Kirsten in 1967 as a Doctor Administered the Mumps Vaccine

Mumps Viruses in US: 2015-3/2017 Genotype 2015 2016 2017* Total G 112 623 160 895 C 2 3 5 H 3 1 4 K 2 1 1 4 N 3 1 4 A 1 1 Total 128 630 164 913 **as of March 1st K: previously named K/M A:Jeryl-Lynn, vaccine (Merck) N: Leningrad-Zagreb; (SII) 10

3 rd Dose Mumps Containing Vaccine a 3 rd dose of a mumps virus containing vaccine should be administered to persons previously vaccinated with 2 doses who are identified by public health authorities as being part of a group at increased risk for acquiring mumps because of an outbreak Jan 12, 2018, MMWR 2018;67(1):33

Influenza Virus Hemagglutinin Neuraminidase

Summary of 2017-2018 Influenza Season High severity season High hospitalization rate High mortality numbers for children Which viruses circulated? Was the vaccine a good match with circulating virus? How effective was the vaccine? Overall effectiveness estimated 40% Vaccination is the best way to prevent influenza and its complications

Influenza Vaccine Options for 2018-2019 Trivalent v. Quadravalent Egg based v. cell culture v. recombinant Unadjuvanted v. adjuvanted Standard dose (3 or 4 valent) v. high dose Intramuscular v. intranasal no intradermal Inactivated v. live

Recommendations for IIV & LAIV, 2018-19 ACIP (CDC) For the 2018-19 season, providers may choose to administer any licensed, age-appropriate influenza vaccine (IIV, RIV4, or LAIV4). LAIV4 is an option for those for whom it is otherwise appropriate. COID (AAP) For the 2018-19 season, AAP recommends IIV3/4 as the primary choice for all children because LAIV4 was inferior against A/H1N1 in past seasons and efficacy is unknown for the upcoming season LAIV4 may be offered for children who would not otherwise receive an influenza vaccine

Shared Principles and Goals Influenza Prevention The CDC, AAP, AAFP (and other groups) recommendations share the same principle that influenza vaccination is an important preventive strategy. They share the same goal of increasing influenza vaccination coverage to protect as many individuals as possible. A health care provider s strong recommendation is a critical factor affecting whether or not your patient get influenza vaccine.

Number of Seasonal Influenza Doses for Children 6 Months Through 8 Years, 2018-2019 season: Has the child received 2 total doses of any trivalent or quadrivalent vaccine before July 1, 2018? Yes No/Don t know 1 Dose 2 Doses (Interval is 4 weeks)

Vaccine Recommendations That Have Not Changed For 2018-19 No preferential recommendation for one vaccine over another when more than 1 is licensed No change in groups recommended for immunization Groups at increased risk No change in dosing algorithm for children 6 m through 8 y No change in vaccine contraindications No change for persons with history of egg allergy No change in timing of influenza vaccine administration Interventions to control spread of influenza

Timing of Vaccine Administration Optimally, before onset of influenza in community Some reports suggest decrease in VE with increasing time since administration Vaccination in July, August may be associated with suboptimal protection at end of season Concern for missed opportunity Early season Recommendation: Vaccinate throughout the season because ideal time cannot be predicted because of variation each season

3 FDA Licensed Influenza Vaccines for Children 6 though 35 Months Vaccine Type Volume Age Antigen Fluzone (S/P) Fluarix (GSK) Flulaval (ID Biomed) IIV4 0.25 ml 6-35 mon 7.5 ug IIV4 0.50 ml 6 mon 15 ug IIV4 0.50 ml 6 mon 15ug

Normal Cervix Vaccine Preventable Cervical Cancer Courtesy of National Cancer Institute

Trends in Age-Adjusted Incidence of Cervical Cancer (F) & Oropharyngeal SCC (M) MMWR August 24, 2018

Adverse Events Following Distribution of >60 million doses 4vHPV, 2009-2015 Serious Adverse Event Rate/1 million doses distributed Syncope 47 Autoimmune disorder 2.7 Death 1.5 Postural orthostatic tachycardia syndrome 1.1 Guillain-Barré syndrome 0.98 Anaphylaxis 0.63 Venous thromboembolism 0.63 Complex regional pain syndrome 0.28 Arana JE. Vaccine 2018

Louis Pasteur

Infant PCV13 Administered in Schedules 4 Different Schedules 2,4,6 mon booster at 12-18 mon 3,5 mon booster at 12 mon 2,3,4 mon booster at 12 mon 2,4 mon booster at 12 mon No statistically significant difference in antibody levels after the booster dose for almost all serotypes in different schedules When herd immunity is established, four doses may not be necessary JAMA 2013;310(9):930

Meningococcal Disease Caused by Serogroup B is Extremely Rare In 2016, a total of 130 cases occurred in all ages among people in the United States Category A versus Category B 41 cases (31%) occurred in people 16 through 23 years of age NOAA notes 233 people/year stuck by lightning between 2004-2013

Microneedle Patch

Microneedle Patch Containing IIV

The End