Fluzone Quadrivalent dose for infants to be reviewed by FDA

Fluzone, a quadrivalent influenza vaccine manufactured by Sanofi Pasteur, will undergo review by the FDA for a supplemental biologics license, according to a press release issued by the manufacturer.

If the review is approved, all patients with no contraindications aged 6 months and older can be administered 0.5-mL doses of the vaccine. Currently, only individuals aged 36 months and older can be administered a 0.5-mL dose. Children aged between 6 and 35 months of age have been approved for immunization using a 0.25-mL dose.

“We are dedicated to helping protect patients of all ages against the flu, which can be especially severe and life-threatening for more vulnerable age groups such as younger children,” David P. Greenberg, MD, associate vice president and regional medical head of North America at Sanofi Pasteur, said in the release. “We are one step closer to potentially offering clinicians the option to use [the] 0.5-mL dose of Fluzone Quadrivalent vaccine for all their eligible pediatric patients 6 months of age and older.”

Fluzone (quadrivalent influenza vaccine, Sanofi Pasteur) is to be reviewed by the FDA. An approved review would allow physicians to administer 0.5-mL doses of the vaccine to infants between the ages of 6 and 35 months to prevent influenza.

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The immunization is intended to protect individuals from two strains of influenza A, including H1N1, H3N2. Additionally, the vaccine may prevent two influenza B lineages, including Victoria and Yamagata.

According to the release, Sanofi Pasteur currently has phase IV data available on the immunogenicity and safety of the Fluzone, which were observed in a randomized, observed-blinded, controlled, multicenter study that included approximately 2,000 children. These data will be presented at medical meetings in late 2018.

The manufacturer noted that adverse events that may result from immunization with Fluzone may differ based on age, with erythema and swelling of the injection site occurring in children. Other systemic reactions in this age group may include myalgia, malaise and headache, which may present through irritability, abnormal crying, drowsiness, appetite loss, vomiting and fever for young children. – by Katherine Bortz