fluad.comFluad Pre-Book | Seqirus US

Skip to Content Contact Us | Log in | Create Account | ABOUT SEQIRUS SCIENCE & INNOVATION PRODUCTS -- FLUAD ® FLUCELVAX ® AFLURIA ® All Products RESOURCES × There is currently an order you previously started in your shopping cart. Please either complete this order or delete it if you would like to place a different order. OK × Rollover order exists. OK Are you sure you want to leave this page If you leave now, your registration will be incomplete, and the information you have input so far will not be saved. It also means you will not be able to start orders or view important information within your portal account. Continue registration Leave and lose progress -- -- Home / Products / Fluad -- -- NOW AVAILABLE IN A QUADRIVALENT FORMULATION Adding an adjuvant makes a difference 1 FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine approved for adults Order today Reimbursed by Medicare Part B CPT code 90694 Important Safety Information See Prescribing Information See Prescribing Information Low vaccine effectiveness in adults 65+ is largely driven by 2 factors: Weakened immune system Adults 65+ experience age-related decline of the immune system and thus may be less able to mount a sufficient immune response to vaccination, leaving them more vulnerable to influenza infection and its complications. 3 Strain mismatch This occurs when circulating influenza strains do not match the World Health Organization (WHO)-selected strains contained in the vaccine. Most often, it is due to mutations from antigenic drift or egg adaptation. It can also occur when the prevalent circulating influenza strains are different from WHO-recommended vaccine strains. 4,5 Use an adjuvanted influenza vaccine to help address challenges in adults 65 years and older An adjuvant is a substance added to a vaccine to boost the immune response. 6 Adjuvants have been used in vaccines for decades. 6 Adjuvanted vaccines have been used to help prevent diseases such as shingles, pneumococcal pneumonia, hepatitis A and B, and diphtheria, tetanus, and pertussis (DTaP). 7 Adding MF59® adjuvant to an influenza vaccine is designed to strengthen, broaden, and lengthen the duration of the immune response 1,8,9 Adding MF59 adjuvant to an influenza vaccine does more than an antigen alone Antigen + MF59 adjuvant Strengthens the immune -- response by stimulating -- more immune cells to -- create more antibodies Broadens the immune response by -- creating more diverse, cross-reactive -- antibodies This may be important if there is a mismatch -- between the influenza virus strains in the -- vaccine and the circulating influenza strains. This is a conceptualization of the mechanism of action (MOA) of an MF59 adjuvanted influenza vaccine. Click to play MOA video FLUAD® QUADRIVALENT is the first-and-only adjuvanted quadrivalent seasonal influenza vaccine approved for adults Reimbursed by Medicare Part B CPT code 90694 114+ million FLUAD doses across 29 countries over the past 20 years 10 Favorable health authority recommendations 11-13 : United Kingdom . Australia . Italy Review FLUAD QUADRIVALENT FLUAD information here FLUAD QUADRIVALENT FLUAD About FLUAD QUADRIVALENT Indications and Usage FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older. This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Clinical Data FLUAD QUADRIVALENT (Influenza Vaccine, Adjuvanted) with MF59 adjuvant produces robust immune responses Compared to FLUAD, FLUAD QUADRIVALENT includes an additional B strain to help prevent disease caused by all 4 influenza strains represented in the vaccine. 2 For the non-influenza comparator vaccine, the proportion of subjects with HI titers greater than or equal to 1:40 at Day 21 were 46.7% for the A/H1N1 strain, 41.7% for A/H3N2, 21.5% for B/Yamagata and 18.4% for B/Victoria. The seroconversion rates for the non-influenza comparator vaccine were 2.1% for A/H1N1, 3.9% for A/H3N2, 3.6% for B/Yamagata and 2.1% for B/Victoria. Study 1 evaluated the immunogenicity of FLUAD QUADRIVALENT in a randomized, observer-blind, non-influenza comparator-controlled multicenter efficacy study. Adult subjects 65 years of age and older received 1 dose of either FLUAD QUADRIVALENT (N=3379) or a US-licensed non-influenza comparator vaccine (N=3382).* *Non-influenza comparator vaccine=combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, Boostrix® (GlaxoSmithKline Biologicals) HI=hemagglutinin inhibition CI=confidence interval a Success criterion: lower bound of the 95% CI for the % of subjects with HI titer ≥1:40 must be ≥60% b Seroconversion is defined as a prevaccination HI titer <1:10 and postvaccination HI titer ≥1:40 or at least a 4-fold increase in HI from prevaccination HI titer ≥1:10. Success criterion: lower bound of the 95% CI for the seroconversion rate must be ≥30% Safety Data FLUAD QUADRIVALENT has a demonstrated safety profile The safety of FLUAD QUADRIVALENT was evaluated in 2 multicenter, randomized controlled trials in 4269 adults 65+. 2 In Study 1, most common (≥10%) local and systemic adverse reactions observed within 7 days of vaccination with FLUAD QUADRIVALENT or a non-influenza comparator vaccine.* 2 N=number of subjects with solicited safety data a Solicited safety population: all subjects in the exposed population who received a study vaccine and provided postvaccination solicited safety data b Severe reactions of each type were reported in 1.1% or fewer subjects receiving FLUAD QUADRIVALENT; severe reactions of each type were also reported in the comparator group at similar percentages. Severe definitions: erythema, induration, and ecchymosis=>100 mm diameter; injection-site pain, nausea, fatigue, myalgia, arthralgia, headache, and chills=prevents daily activity; loss of appetite=not eating at all; vomiting=6 or more times in 24 hours or requires intravenous hydration; diarrhea=6 or more loose stools in 24 hours or requires intravenous hydration; fever=≥102.2°F (39°C) In Study 2, FLUAD QUADRIVALENT demonstrated a similar safety profile to that of FLUAD. 2 Solicited local and systemic adverse reactions reported were similar to those reported for Study 1. Dosing and Administration For intramuscular injection only 2 FLUAD QUADRIVALENT is supplied as a package of ten 0.5 mL prefilled needleless syringes 2 Administer FLUAD QUADRIVALENT as a single 0.5 mL intramuscular injection in adults 65 years of age and older 2 Each 0.5 mL dose of FLUAD QUADRIVALENT does not contain a preservative. The syringe, plunger, and tip cap are not made with natural rubber latex. 2 Storage and Handling Store FLUAD QUADRIVALENT at 2°C to 8°C (36°F to 46°F). Protect from light. Do not freeze. Discard if the vaccine has been frozen. Do not use after expiration date. 2 About FLUAD Indications and Usage FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older. Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available. Clinical Data FLUAD (Influenza Vaccine, Adjuvanted) with MF59 adjuvant produces a strong immune response in adults 65+ FLUAD met non-inferiority criteria for the 2 influenza A strains and the influenza B strain represented in the vaccine, compared to a non-adjuvanted, standard-dose influenza vaccine. a,14,15 Study 1 (NCT01162122) evaluated the safety an...