Do not use after expiration date. FLUAD also contains MF59C.1 adjuvant (MF59FLUAD is prepared by combining the three virus antigens with the MF59C.1 adjuvant.
Do not freeze. It is used as active immunisation in the elderly (of 65 years of age and over), particularly in people with an increased risk of associated complications. 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.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. FLUAD does not contain a preservative. anaphylaxis) to any component of the vaccine, including egg protein If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks. FLUAD is approved for use in persons 65 years of age and older.
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(Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine. The safety analysis set included 3545 FLUAD recipients and 3537 AGRIFLU (Influenza Vaccine) recipients. 36 0 obj
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Flu is caused mainly by two types of influenza virus, known as influenza A and B. If you are a consumer or patient please visit FLUAD is standardized according to United States Public Health Service requirements and each 0.5 mL dose is formulated to contain 15 mcg of hemagglutinin (HA) from each of the following three influenza strains recommended for the 2020-2021 influenza season; A/Victoria/2454/2019 IVR-207 (an A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like virus), A/Hong Kong/2671/2019 IVR-208 (an A/Hong Kong/2671/2019 (H3N2)-like virus) and B/Victoria/705/2018 BVR-11 (a B/Washington/02/2019-like virus). Global surveillance of influenza identifies yearly antigenic variants. Download this reference guide of the Seqirus portfolio of products for the 20/21 flu season. The primary immunogenicity analyses were conducted on all vaccinated subjects with a blood sample collected at Day 22 (N=3,225-3,227 [91%] and 3,256- 3,259 [92%] in the FLUAD and AGRIFLU groups, respectively). 0000004723 00000 n
The history of MF59® adjuvant: a phoenix that arose from the ashes. Each of these circulate as different strains, which change over time. 1. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by 0000003888 00000 n
(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 not approved for use in persons < 65 years of age. 0000017721 00000 n
(1) This indication is approved under accelerated approval based on the immune response elicited by FLUAD.
FLUAD is approved for use in persons 65 years of age and older.
The enrolled subject population in Study 1 was 65 to 97 years of age (mean 72 years) and 64% were female. Seqirus, a global leader in influenza prevention, today announced that its adjuvanted quadrivalent influenza vaccine (aQIV) - launching as FLUAD® TETRA - has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending the approval of the marketing authorisation application (MAA) for use in people aged … Solicited adverse reactions were assessed in a multicenter, observer-blind, randomized controlled study (Study 1) conducted in the United States, Colombia, Panama and the Philippines.
Within each treatment group, 53% were Asian, 28% were Caucasian, 18% were Hispanic, 1% were Black, and fewer than 1% each were Native American/Alaskan, Pacific Islander/Hawaiian, or Other.
The most common (≥ 10%) local (injection site) adverse reactions observed in clinical studies were injection site pain (25%) and tenderness (21%). The safety and effectiveness of FLUAD in the pediatric population have not been established. Holly Springs, NC: Seqirus Inc; 2020. 0000002401 00000 n
Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD. 0000015073 00000 n
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