Fluad Approved for Flu Vaccination for Older Adults
November 24, 2015 – The U.S. Food and Drug Administration (FDA) approved Fluad, an inactivated trivalent influenza virus vaccine. Fluad is manufactured by Seqirus. Trivalent vaccines protect against two strains of type A influenza virus and one strain of type B. Fluad is indicated for individuals age 65 years and older. This population typically has the highest numbers of flu-related complications, hospitalizations and deaths. Fluad is the first vaccine approved in the U.S. that includes an adjuvant to boost the body’s immune response. Fluad will be supplied in single-dose, pre-filled syringes with 0.5mL of vaccine to be administered as one intramuscular (IM) injection into the upper arm. A launch date and pricing for Fluad have not yet been released. Sanofi-Pasteur’s Fluzone High-Dose (influenza vaccine) is the only other flu vaccine specifically designed for immunizing individuals who are 65 years old or older.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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