FDA approves expanded indication for Flucelvax Quadrivalent flu vaccine

The Food and Drug Administration has cleared Seqirus’ Flucelvax Quadrivalent, the company's cell-based quadrivalent influenza vaccine, for an expanded age indication for people two years of age and older.

The vaccine previously was approved for use in persons four years of age and older.

Flucelvax Quadrivalent will be available as a 0.5ml intramuscular vaccine per dose for the 2021/22 U.S. influenza season.

"Young children are at a high risk of complications from influenza, which is why annual vaccination is critical," said Gregg Sylvester, chief medical officer at Seqirus. "The absolute efficacy results for Flucelvax Quadrivalent that served as the basis for this approval indicate that the cell-based vaccine offers an important new option for children as young as two years of age."

According to the Centers for Disease Control and Prevention, the best way to prevent influenza is by receiving an annual seasonal influenza vaccine. More than 52,000 hospitalizations occurred in children aged 18 years of age and younger during the 2019/20 U.S. influenza season, and there were over 434 influenza-related deaths in this age group.

Children younger than five years of age are at high risk of developing serious flu-related complications. The CDC recommends everyone six months of age and older without contraindications receive an influenza vaccine annually.

While influenza vaccination has always offered a way to minimize the burden of disease on the healthcare system, it is more important than ever this season to minimize the burden on the healthcare system and preserve capacity for COVID-19 patients," said Dave Ross, vice president, North America Commercial Operations at Seqirus. "Especially now, we remain focused on our public health imperative to help protect as many people as possible against influenza, especially children."