The approval is based on absolute efficacy data from 3 influenza seasons.
The US Food and Drug Administration (FDA) has approved a cell-based quadrivalent influenza vaccine (QIVc; FLUCELVAX QUADRIVALENT) for individuals ≥2 years of age.
Granted to Seqirus, the approval expands use from previous indication of ≥4 years of age.
The approval was based on efficacy data that showed the QIVc was effective in producing a sufficient immune response against seasonal influence in pediatric patients ≥2 to <18 of age—as compared with a non-influenza agent.
The response was observed over 3 influenza seasons in the Southern Hemisphere (2017) and Northern Hemisphere (2017/18 and 2018/19).
Even more, the data represents the first absolute study efficacy study of a cell-based influenza vaccine for this population.
"Young children are at a high risk of complications from influenza, which is why annual vaccination is critical," said Gregg Sylvester, MD, Chief Medical Officer, Seqirus, in a statement.
"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,” he continued.
Flucelvax Quadrivalent will be used as a 0.5 ml intramuscular vaccine per dose just in time for the 2021/22 influenza season in the United States.
Current US Centers for Disease Control and Prevention (CDC) recommendations encourage all individuals ≥6 months of age and without contradictions annually receive their influenza shot.
Young children are at especially high risk of developing complications related to influenza. In the 2019/2020 US flu season, more than 52,000 hospitalizations occurred in children ≤18 years old—as did 434 influenza-related deaths.