Disclosures The recommendations to be discussed are primarily those - PDF document

CHAMPS 2011 Immunization Update Teleconference August 10, 2011 Disclosures • The recommendations to be discussed are primarily those of the Advisory Committee on Immunization Practices 2011 Immunization Update (ACIP) Teleconference – composed of 15 experts in clinical medicine and public health who are di i d bli h lth h August 10, 2011 not government employees – provides guidance on the use of vaccines and other biologic products William Atkinson, MD, MPH to the Department of Health and National Center for Immunization and Human Resources, CDC, and the U.S. Respiratory Diseases Public Health Service www.cdc.gov/vaccines/recs/acip/ This information is valid as of August 3, 2011 1 3 Disclosures What’s New in Immunization • New influenza vaccine and • William Atkinson is a federal government recommendations employee with no financial interest or conflict with the manufacturer of any • Expansion of meningococcal product named in this presentation conjugate vaccine recommendations • The speaker will discuss the off-label use Th k ill di th ff l b l • Tdap vaccine for pregnant women, of meningococcal conjugate and Tdap children 7-9 years and persons 65 vaccines years and older • The speaker will not discuss a vaccine not • Zoster vaccine for persons 50-59 currently licensed by the FDA years of age 2 4 1

CHAMPS 2011 Immunization Update Teleconference August 10, 2011 Influenza Vaccination Timing of Influenza Recommendation Vaccination • Immunization providers should begin offering vaccine as soon as it becomes available in the office • Annual influenza vaccination • Providers should offer vaccine during is recommended for every y routine healthcare visits or during routine healthcare visits or during person in the United States 6 hospitalizations whenever vaccine is available months of age and older • Continue to vaccinate throughout influenza season (December through March) especially to healthcare personnel and those at high risk of complications MMWR 2010;59(RR-8) MMWR 2010;59(RR-8) 5 7 Rationale: Recommendation to Vaccinate Influenza Vaccine Components All Persons 6 Months of Age or Older 2011-2012 • Morbidity and mortality occurs in all age • Same 3 influenza strains as the 2010-2011 groups, including among adults 19-49 years seasonal vaccine of age – A/California/7/2009 (H1N1)-like • Some persons who have influenza complications – A/Perth/16/2009 (H3N2)-like – have no previously identified risk factors – B/Brisbane/60/2008-like – have risk factors but are unaware that • A dose of 2011-2012 vaccine is they should be vaccinated, or recommended regardless of whether the – might be at risk due to newly identified person received 2010-2011 vaccine risk factors (e.g., morbid obesity) • Both inactivated and live attenuated • Simplicity vaccines will be available MMWR 2010;59(RR-8) 6 8 2

CHAMPS 2011 Immunization Update Teleconference August 10, 2011 Influenza Vaccine Presentations Fluzone High-Dose 2011-2012 Vaccine Doseform Age • Contains 4 X amount of influenza antigen than regular Fluzone Fluzone TIV SDS, SDV, 6 months and older (sanofi pasteur) MDV • Approved only for persons 65 years and Fluarix TIV SDS 3 years and older older FluLaval TIV MDV 18 years and older (GSK) (GSK) • Produced higher antibody levels; slightly Fluvirin TIV SDS, MDV 4 years and older higher local reactions Agriflu TIV SDS 18 years and older • Studies underway to assess clinical (Novartis) effectiveness Afluria TIV SDS 9 years and older (CSL) • No preference stated by ACIP for HD or Flumist LAIV Nasal spray 2-49 years (healthy, regular influenza vaccination (MedImmune) nonpregnant) SDS=single dose syringe; SDV=single dose vial; MDV=multidose vial MMWR 2010;59(No. 16):485-6 9 11 Fluzone TIV Formulations Fluzone Intradermal Formulation (age) HA per dose • Licensed by FDA in May 2011 • Adult (>36 mos) 45 mcg/0.5 mL • Approved only for persons 18 through 64 years of age • Pediatric (6-35 mos) 22.5 mcg/0.25 mL • High dose (>65 yrs) g ( y ) 180 mcg/0.5 mL g • Dose is 0.1 mL administered in the Dose is 0.1 mL administered in the deltoid area by a specially designed • Intradermal (18-64 yrs) 27 mcg/0.1 mL microneedle and injector system in the deltoid (not the forearm) • Formulated to contain more HA (27 mcg) than a 0.1 mL dose of regular Fluzone formulation (9 mcg) 10 12 3

CHAMPS 2011 Immunization Update Teleconference August 10, 2011 Reported Pertussis-related Deaths by Age Pertussis - United States, 1980-2010* Groups, U.S., 1980-2010* 30000 Age-Group 1980-1989 1 1990-1999 1 2000-2010 2 0-1 month 38 68 170 25000 2-3 month 11 16 28 20000 4-5 month 5 5 2 ses 6-11 month 7 4 1 15000 Ca 1-4 years 13 2 3 10000 5-10 years 1 6 3 11-18 years 0 0 3 5000 >18 years 1 2 11 0 Total 77 ± 103 221 1980 1985 1990 1995 2000 2005 2010 ± I ncludes one case w ith unknow n age 1 Vitek CR et al. Pediatr I nfect Dis J 2 0 0 3 ; 2 2 ( 7 ) :6 28-34. *2010 provisional data 2 National Notifiable Diseases Surveillance System , CDC, * Provisional 2 0 1 0 13 15 data Reported Pertussis Incidence by Tdap Age Group - 1990-2010* 100 • Tdap reduces the risk of pertussis by 60% - 80% nce rate 80 <1 yr • Both Tdap products currently approved 00,000) 1-6 yrs for ONE lifetime dose 7-10 yrs 60 11-19 • Tdap approved ages Td d (per 1 Incide 20+ yrs 40 – 10 through 64 years for Boostrix – 11 through 64 years for Adacel 20 • Tdap not approved by the Food and Drug 0 Administration for children 7 years 1990 1995 2000 2005 2010* through 9 years or adults 65 years or older Year Wei SC et al. Clin Infect Dis 2010;51:315-21 SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplem ental Pertussis Surveillance 14 16 System . * 2 0 1 0 data are provisional 4

CHAMPS 2011 Immunization Update Teleconference August 10, 2011 New Tdap Recommendations Tdap Recommendations for Adolescents and Adults for Adults* • All adolescents should preferably receive • Adults 65 years of age and older who Tdap at the 11 to 12 year-old preventive have or who anticipate having close healthcare visit contact with an infant younger than • Persons 11 through 18 years of age who 12 months of age and who have not have not received Tdap should receive a have not received Tdap should receive a previously received Tdap should previously received Tdap should dose receive a single dose of Tdap • All adults, especially healthcare personnel • Other adults 65 years of age and and those with close contact with infants, older may receive a dose of Tdap should receive Tdap if they have not previously received a dose MMWR 2011; 60 (No. 1):13-5 *off-label recommendation. MMWR 2011; 60 (No. 1):13-5 17 19 New Tdap Recommendations Tdap and Pregnancy for Adolescents • Infants are most likely to be hospitalized or • Persons 7 through 10 years of age who die from pertussis are not fully immunized against pertussis (including those never vaccinated or with • If a woman receives Tdap before or during unknown pertussis vaccination status) pregnancy, her passive immunity might should receive a single dose of Tdap* g p help protect the newborn from pertussis help protect the newborn from pertussis • “Not fully immunized” • There are few safety data for pregnant women given Tdap – fewer than 4 doses of DTaP • There are concerns by some experts that – 4 doses of DTaP and last dose was prior the passive pertussis antibody could to age 4 years interfere with the infant’s response to DTaP *off-label recommendation. MMWR 2011; 60 (No. 1):13-5 18 20 5

CHAMPS 2011 Immunization Update Teleconference August 10, 2011 Tdap Recommendations for Meningococcal Vaccines Pregnant Women* • Meningococcal polysaccharide • Any woman who might become pregnant is encouraged to receive a single dose of vaccine Tdap – first licensed in 1974 • Tdap is preferred over Td during pregnancy – limited indications limited indications if no prior Tdap dose if no prior Tdap dose • Meningococcal conjugate vaccines • Vaccinate during third trimester or late in second trimester (after 20 weeks gestation) – First licensed in 2005 • Alternatively, administer Tdap immediately – only vaccine recommended for postpartum routine use among civilians *Recommendations approved by ACIP in June 2011; not yet published 21 23 Menactra MCV4 Vaccine Td-Tdap Interval Recommendation* • Tdap can be administered regardless of • Quadrivalent polysaccharide vaccine the interval since the last tetanus and (A, C, Y, W-135) conjugated to diphtheria containing vaccine diphtheria toxoid • Approved for a single dose among pp g g • ACIP concluded that while longer intervals g persons 9 months* through 55 years between Td and Tdap vaccination could of age decrease the occurrence of local reactions, the benefits of protection • FDA approval based on serologic against pertussis outweigh the potential non-inferiority compared to risk for adverse events meningococcal polysaccharide vaccine *off-label recommendation. MMWR 2011; 60 (No. 1):13-5 *as of April 22, 2011 22 24 6