New Quadrivalent Influenza Vaccine Gets FDA Nod

Megan Brooks


June 10, 2013

The US Food and Drug Administration (FDA) today approved a 4-strain inactivated influenza virus vaccine from Sanofi Pasteur (Fluzone Quadrivalent) for use in children aged 6 months or older, adolescents, and adults.

Fluzone Quadrivalent is the "first and only" 4-strain influenza vaccine option for children as young as 6 months, Sanofi Pasteur notes in a statement.

Fluzone Quadrivalent joins 2 other quadrivalent vaccines already approved in the United States. They are Fluarix Quadrivalent (GlaxoSmithKline), approved for adults and children aged 3 years or older, and FluMist (MedImmune), approved for adults and children aged 2 years or older.

Fluzone Quadrivalent will be available in the US for the upcoming 2013-2014 influenza season in preservative-free, prefilled syringes and single-dose vials for intramuscular administration, the company said.

Until this year, seasonal influenza vaccines included only 1 B strain. Fluzone Quadrivalent vaccine includes 2 A strains and 2 B strains to help protect against influenza disease, Sanofi Pasteur notes in a statement.

"Epidemics of influenza B occur every 2 to 4 years in all age groups. Influenza B is a common cause of influenza-related morbidity and mortality in children and has been associated with pneumonia and other respiratory illnesses, nervous system disease, muscle pain and inflammation, and other complications," the company explains.

"Protection against the type B flu strain may be an especially important factor that health care providers consider when immunizing children since influenza B causes a substantial number of illnesses, hospitalizations and deaths in the pediatric population," said David Greenberg, MD, Sanofi Pasteur vice president US scientific and medical affairs.

The most common local and systemic adverse reactions seen with Fluzone Quadrivalent include pain, erythema, and swelling at the vaccination site; myalgia, malaise, headache, and fever (irritability, crying, and drowsiness in young children).

Fluzone Quadrivalent vaccine should not be administered to anyone with severe allergic reactions to any vaccine component, including egg protein, or to a previous dose of any influenza vaccine, the company said.


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