Abstract

For the 2013–14 influenza season, health care providers will have more vaccine choices than ever before, including the first quadrivalent formulations. But that doesn’t mean you’ll have an abundance of products in your pharmacy. “Because of limited supplies, determining which flu vaccine to use will depend on availability,” said Stephan Foster, PharmD, FAPhA, Professor and Vice Chair, University of Tennessee College of Pharmacy, and APhA liaison to the CDC Advisory Committee on Immunization Practices (ACIP). Sanofi Pasteur’s new quadrivalent formulation of Fluzone, for example, sold out 24 hours after the vaccine’s availability was announced, Foster told Pharmacy Today.■The new quadrivalent vaccines contain antigens for two A strains and two B strains.■Healthy, nonpregnant patients aged 2 to 49 years can receive FluMist Quadrivalent, a live, attenuated nasal spray.■Fluzone High-Dose, a trivalent with four times as much antigen as regular influenza vaccine, is the first and only vaccine designed specifically for older adults. ■The new quadrivalent vaccines contain antigens for two A strains and two B strains.■Healthy, nonpregnant patients aged 2 to 49 years can receive FluMist Quadrivalent, a live, attenuated nasal spray.■Fluzone High-Dose, a trivalent with four times as much antigen as regular influenza vaccine, is the first and only vaccine designed specifically for older adults. All of the 2013–14 influenza vaccines contain antigens for the following three strains:■A/California/7/2009 (H1N1) pdm09-like virus■A(H3N2) virus antigenically like the cell-propagated prototype virus A/Victoria/361/2011■B/Massachusetts/2/2012-like virus The quadrivalents—Fluarix Quadrivalent (GlaxoSmithKline), Fluzone Quadrivalent (Sanofi Pasteur), and Flu-Mist Quadrivalent (MedImmune)—also contain B/Brisbane/60/2008-like-virus antigen. Table 1 on the next page summarizes available influenza vaccines for the 2013–14 season. Not all of these flu vaccines are right for everyone, however. For most healthy adults younger than 65 years, any of the inactivated influenza vaccines listed in the table can be used. Healthy, nonpregnant patients aged 2 years to 49 years can receive FluMist Quadrivalent, a live, attenuated nasal spray influenza vaccine that replaces the trivalent formulation used in the previous flu season.Table 1Influenza vaccines: United States, 2013–14 influenza seasonManufacturer (with estimated doses)Trade nameAvailable productaAge indicationRouteMerck/CSL Biotherapies (10 millon, half of which are prefilled syringes)Afluria (IIV3)Prefilled syringes≥9 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Multidose vials≥9 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.GlaxoSmithKline (22–24 million, 10 million of which are IIV4)Fluarix (IIV3)Prefilled syringes≥3 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Fluarix Quadrivalent (IIV4)Prefilled syringes≥3 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.FluLaval (IIV3)Multidose vials≥18 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Novartis (30 million)Flucelvax (ccIIV3)Prefilled syringes≥18 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Fluvirin (IIV3)Prefilled syringes≥4 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Multidose vials≥4 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Sanofi Pasteur (50 million)Fluzone (IIV3)Prefilled syringes, 0.25 mL6–35 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Prefilled syringes≥36 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Single-dose vials, 0.5 mL≥36 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Multidose vials≥6 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Fluzone Intradermal (IIV3)cTrivalent inactivated vaccine, intradermal: A 0.1-mL dose contains μg of each vaccine antigen (27 μg total). “Trivalent inactivated vaccine, high-dose: A 0.5-mL dose contains 60 μg of each vaccine antigen (180 μg total).Prefilled microinjection system, 0.1 mL18–64 yI.D.Fluzone High-Dose (IIV3)dPrefilled syringes≥65 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Fluzone Quadrivalent (IIV4)Prefilled syringes, 0.25 mL6–35 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Prefilled syringes≥36 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Single-dose vials, 0.5 mL≥36 moI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.Protein Sciences (250,000)FluBlok (RIV3)Single-dose vials, 0.5 mL18–49 yI.M.bFor adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.MedImmune (13–15 million)FluMist Quadrivalent (LAIV4)eFluMist is shipped refrigerated and stored in the refrigerator at 35°F-46°F (2°C-8°C) after arrival in the vaccination clinic. The dose is 0.2 mL divided equally between each nostril.Prefilled intranasal sprayer, 0.2 mL2–49 yfIndicated for healthy, nonpregnant individuals aged 2–49 years. People who care for severely immunosuppressed individuals who require a protective environment should not receive FluMist given the theoretical risk of transmission of the live, attenuated vaccine virus.I.N.Abbreviations used: ccIIV3, cell culture–based inactivated influenza vaccine, trivalent; I.D., intradermal; IIV, inactivated influenza vaccine; IIV3,1IV, trivalent; IIV4, IIV, quadrivalent; I.M., intramuscular; I.N., intranasal; LAIV4, live, attenuated influenza vaccine, quadrivalent; RIV3, recombinant influenza vaccine, trivalent. aPrefilled syringes contain 0.5 mL unless otherwise noted. Multidose vials contain 5 mL.Source: Centers for Disease Control and Prevention. www.cdc.gov/flu/professionals/acip/2013-interim-recommendations.htm. Accessed July 24, 2013.b For adults and older children, the recommended site of intramuscular administration is the deltoid muscle. The preferred site for infants and young children is the anterolateral aspect of the thigh. Specific guidance regarding site and needle length for intramuscular administration can be found in ACIP’s General Recommandations on Immunization.c Trivalent inactivated vaccine, intradermal: A 0.1-mL dose contains μg of each vaccine antigen (27 μg total). “Trivalent inactivated vaccine, high-dose: A 0.5-mL dose contains 60 μg of each vaccine antigen (180 μg total).e FluMist is shipped refrigerated and stored in the refrigerator at 35°F-46°F (2°C-8°C) after arrival in the vaccination clinic. The dose is 0.2 mL divided equally between each nostril.f Indicated for healthy, nonpregnant individuals aged 2–49 years. People who care for severely immunosuppressed individuals who require a protective environment should not receive FluMist given the theoretical risk of transmission of the live, attenuated vaccine virus. Open table in a new tab Abbreviations used: ccIIV3, cell culture–based inactivated influenza vaccine, trivalent; I.D., intradermal; IIV, inactivated influenza vaccine; IIV3,1IV, trivalent; IIV4, IIV, quadrivalent; I.M., intramuscular; I.N., intranasal; LAIV4, live, attenuated influenza vaccine, quadrivalent; RIV3, recombinant influenza vaccine, trivalent. aPrefilled syringes contain 0.5 mL unless otherwise noted. Multidose vials contain 5 mL. Source: Centers for Disease Control and Prevention. www.cdc.gov/flu/professionals/acip/2013-interim-recommendations.htm. Accessed July 24, 2013. For patients 65 years or older, there’s an alternative: Fluzone High-Dose (Sanofi Pasteur), a trivalent formulation with four times as much antigen as regular influenza vaccine. It is the first and only vaccine designed specifically for older adults. Adults aged 18 years to 49 years with serious egg allergies have a new option in FluBlok (Protein Sciences), a trivalent product made using recombinant processes. If FluBlok supplies run out, the cell culture–derived trivalent Flucelvax may be used instead, according to Foster, because it contains only a miniscule amount of egg protein. FDA has not licensed Flucelvax for use with patients who have egg allergies, however, since the seed virus was grown in eggs, Foster said. CDC does not recommend influenza vaccine for children younger than 6 months. For older infants and children, options include Fluzone and Fluzone Quadrivalent, including a lower dosage licensed for children aged 6 months to 35 months. Children 3 years and older can also receive Fluarix or Fluarix Quadrivalent. FluMist is a good option for children 2 years and older when injections need to be avoided; however, children ages 2 years through 4 years who have asthma or recurrent wheezing or who have had a wheezing episode in the past 12 months should not receive this product. Before giving FluMist to children in this age group, ask parents or caregivers: “In the past 12 months, has a health care provider ever told you that your child had wheezing or asthma?”CDC has recommended that health care providers begin vaccinating as many patients as possible as soon as influenza vaccine is available and continue vaccinating through the rest of the flu season or until all vaccine has been distributed. CDC has recommended that health care providers begin vaccinating as many patients as possible as soon as influenza vaccine is available and continue vaccinating through the rest of the flu season or until all vaccine has been distributed. Although Afluria (CSL Limited) is indicated for ages 5 years and older, ACIP recommended not using this vaccine for children 6 months through 8 years because of increased risk of febrile reactions noted in this age group. Providers may use Afluria if no other age-appropriate, inactivated vaccine is available for children 5 years through 8 years old with a medical condition that increases their risk of complications from influenza. Patients should not receive the flu vaccine if they’ve had Guillain-Barré syndrome within 6 weeks of a previous influenza vaccination (precaution), if they have a significant fever at the time of vaccination (until symptoms have disappeared), or if they’ve had a severe hypersensitivity reaction to previous flu vaccines. CDC recommended that health care providers begin vaccinating as many patients as possible as soon as influenza vaccine is available and continue vaccinating through the rest of the flu season or until all vaccine has been distributed. Providers should review FDA-approved prescribing information for the most updated vaccine information, stated ACIP. The committee will publish an expanded influenza vaccination recommendation statement before the 2013–14 influenza season begins. Senior Assistant Editor, Pharmacy Today

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