The FDA has approved the use of Sanofi Pasteur’s 0.5-mL dose of Fluzone® Quadrivalent (influenza vaccine) for children aged 6 to 35 months old. The 0.5-mL dose, as well as the 0.25-mL dose, will be available for the upcoming 2019–2020 season for this expanded age range.
Fluzone Quadrivalent influenza vaccine is indicated for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B virus(es) in the vaccine. Approval was based on data from a phase 4 safety and immunogenicity study in approximately 2,000 children. No new safety concerns were observed and the 0.5-mL dose induced a robust immune response.
Fluzone Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine, including egg or egg products, or after a previous dose of the vaccine. Also, it should not be given to anyone who has experienced a severe allergic reaction after a previous dose of any influenza vaccine.
The most common side effects in children include pain, redness, and swelling where the shot is administered; muscle aches, fatigue, and headache. In young children, side effects include irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever.
Source: BioSpace, January 23, 2019