FDA approves 0.5-mL Fluzone Quadrivalent vaccine in young children


The Food and Drug Administration has approved the 0.5-mL dosage of Fluzone Quadrivalent, an influenza vaccine, for use in children aged 6-35 months, according to Sanofi Pasteur, the vaccine’s manufacturer.

FDA icon

FDA approval was based on results of a phase 4 safety and immunogenicity study of nearly 2,000 children. Children aged 6-35 months who received one or two doses of Fluzone at 0.50 mL had a safety profile similar to that of children who received one or two doses of Fluzone at 0.25 mL. Results from the study were presented at the Pediatric Academic Societies annual meeting in April 2018.

This flu vaccine should not be given to anyone with a severe allergic reaction (anaphylaxis) to egg or egg products, according to the press release.

In children, the most common adverse events are injection site reactions, muscle aches, fatigue, and headache; in young children, irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever are common.

“Offering pediatricians the convenience of the same 0.5-mL dose option for children may help streamline immunization efforts. The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” David P. Greenberg, MD, regional medical head of Sanofi Pasteur of North America, said in the press release.

Find the full press release on the Sanofi website.

Next Article: