1 INFLUENZA VACCINE CONSIDERATIONS 2013-2014 SEASON Karen K. O’Brien, PharmD Creighton University SPAHP September, 2013 2 Who Should Get Influenza Vaccine? • Beginning with the 2010–11 vaccination season, ACIP recommends annual vaccination for all people ages 6 months and older who do not have a contraindication to the vaccine. • Patient-specific factors influence vaccine selection 3 Persons at Risk for Medical Complications of Influenza • All children aged 6 through 59 months • All persons aged ≥50 years • Adults and children with chronic pulmonary (including asthma), • • • • • • cardiovascular (except isolated hypertension), renal, hepatic, neurological, hematologic, or metabolic disorders (including diabetes mellitus) Persons who have immunosuppression (including immunosuppression caused by medications or by HIV infection) Women who are or will be pregnant during the influenza season Children and adolescents (aged 6 months--18 years) receiving longterm aspirin therapy and who might be at risk for experiencing Reye’s syndrome after influenza virus infection Residents of nursing homes and other long-term care facilities American Indians/Alaska Natives Persons who are morbidly obese (BMI ≥40) Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 4 2013-2014 Influenza Vaccine Content • Trivalent Vaccines • A/California/7/2009 (H1N1)-like virus, A/Victoria/361/2011 (H3N2) virus, and a B/Massachusetts/2/2012-like virus • Quadrivalent vaccines • Include an additional vaccine virus, a B/Brisbane/60/2008-like virus • Type B influenza strains more problematic in pediatric population • Cause approximately same number of deaths as Type A • Encourage quadrivalent vaccine for pediatric patients Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 5 Influenza Abbreviations 2013-2014 • IIV (Inactivated Influenza Vaccine) • Replaces TIV (Trivalent Inactivated Influenza Vaccine) • IIV3: egg-based and cell culture-based trivalent inactivated influenza vaccine • IIV4: egg-based quadrivalent inactivated influenza vaccine • ccIIV3: When necessary to specifically denote a cell culture-based vaccine, the prefix “cc” is used • RIV (Recombinant Hemagglutinin Influenza Vaccine) • Available as trivalent formulation (RIV3) in 2013-2014 • LAIV (Live Attenuated Influenza Vaccine) • Available as a quadrivalent formulation (LAIV4) in 2013-2014 *IIV, LAIV & RIV denote vaccine categories *Numeric suffix indicates number of antigens in the vaccine Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 6 Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) • Indicated for healthy, nonpregnant persons aged 2 through 49 years Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 7 Quadrivalent Inactivated Influenza Vaccine (IIV4) Injection • Indicated for persons aged 6 months and older • Indicated for persons aged 3 years and older • Indicated for persons aged 3 years and older Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 8 ACIP: Vaccinating Persons with a History of Egg Allergy • Persons with a history of egg allergy who have experienced only hives after exposure to egg should receive influenza vaccine. • Avoid LAIV (little data available) • Use IIV or RIV • RIV is egg-free and may be used for persons aged 18-49 years who have no other contraindications. • IIV (egg- or cell-culture based) may also be used, with the following additional safety measures • Healthcare provider familiar with the potential manifestations of egg allergy should administer vaccine • Observe patients for at least 30 minutes for signs of a reaction after every vaccine dose Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 9 Trivalent Cell Culture-Based Inactivated Influenza Vaccine (ccIIV3) • Indicated for persons aged 18 years and older • Influenza viruses grown in mammalian cultured cells, rather than hens’ eggs • Vaccine seed strain is passaged in eggs & could contain tiny amounts of albumin Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 10 Trivalent Recombinant Hemagglutinin Influenza Vaccine (RIV3) • Indicated for persons aged 18 through 49 years • Produced with insect virus and recombinant DNA technology • Hemagglutinin is sole virus component; created by infecting insect cell cultures with a baculovirus Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 11 Adults ≥ 65 Years of Age (High Dose) • Trivalent inactivated influenza vaccine (IIV3) for IM injection • Contains 4x amount of antigen in standard dose • Rationale • Age-related weakened immune response puts older individuals at risk for severe illness • Ageing decreases immune response to vaccine • Patient Outcomes • Clinical trial data shows higher antibody levels post Fluzone HD vs. Fluzone • Study to compare ability of Fluzone HD vs. Fluzone to prevent influenza due to be completed in 2014-2015 • Neither CDC nor ACIP express a preference for Fluzone HD over another vaccine at this time Source: http://www.cdc.gov/flu/protect/vaccine/qa_fluzone.htm 12 Vaccinating Pregnant Women • Women who are or will be pregnant during influenza season should receive IIV • Live attenuated influenza vaccine (LAIV) is not recommended for use during pregnancy • Postpartum women can receive either LAIV or IIV • Pregnant and postpartum women do not need to avoid contact with persons recently vaccinated with LAIV Source: http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm#table1 13 Preservative Free/Latex Free Vaccines Preservative Free Latex Free? Route Afluria (IIV3) 0.5 mL single-dose prefilled syringe Yes IM Fluarix (IIV3) 0.5 mL single-dose prefilled syringe No IM Flucelvax (IIV3) 0.5 mL single-dose prefilled syringe No IM Fluzone (IIV3) 0.25 & 0.5 mL single-dose prefilled syringe Yes IM Fluzone ID (IIV3) 0.1 mL prefilled microinjection system Yes ID Fluzone HD (IIV3) 0.5 mL single-dose prefilled syringe Yes IM Fluarix Quadrivalent (IIV4) 0.5 mL single-dose prefilled syringe No IM Fluzone Quadrivalent (IIV4) 0.25 & 0.5 mL single-dose prefilled syringe Yes IM FluMist Quadrivalent (LAIV4) 0.2 mL prefilled intranasal Yes sprayer IN Table of Approved Influenza Vaccines for the U.S. 201314 Season. Centers for Disease Control and Prevention Website. http://www.cdc.gov/flu/protect/vaccine/vaccines.htm. And product package inserts. 14 Influenza Suspension vs. Solution • FluBlok (RIV) available as solution (0.5 mL single dose vial) • Shake vial gently prior to use (per manufacturer) • All other influenza vaccine is suspension • IIV3, ccIIV3, IIV4 or LAIV • Multi-dose vials • Single dose prefilled syringes • IM, ID • Check manufacturer package insert for specific instructions (shake vigorously, well or gently) prior to use (each use in the case of multi-dose vials) • IN LAIV • Suspension, but manufacturer does not indicate to shake prior to use