FDA Approves Two New Quadrivalent Vaccines
- By BSTQ Staff
The U.S. Food and Drug Administration has approved two new quadrivalent influenza vaccines (IIV4s). In June, FDA approved Sanofi Pasteur’s new Fluzone Quadrivalent for use in children ages 6 months and older, adolescents and adults. It is the first and only IIV4 option for children as young as 6 months. The pediatric dose is available in 0.25 mL preservative-free prefilled syringes for children ages 6 months to 35 months. For individuals 36 months and older, it is available in 0.05 mL one-dose vials and 0.5 mL prefilled syringes. In clinical trials, the most common local and systemic adverse reactions were pain, erythema and swelling at the vaccination site; myalgia; malaise; headache; and fever. Some young children also experienced irritability, crying and drowsiness.
In August, FDA approved Glaxo SmithKline’s Flulaval Quadrivalent for the prevention of influenza caused by types A and B strains in adults and children ages 3 years and older. Flulaval Quadrivalent will be available in 5 mL multi-dose vials containing 10 0.5 mL doses. This is GlaxoSmithKline’s second intramuscular IIV4 approved by FDA.
These vaccines join two other available IIV4s: Fluarix Quadrivalent (GlaxoSmithKline), approved for adults and children ages 3 years and older, and FluMist (MedImmune), approved for adults and children 2 years through 49 years.
