USFDA APPROVES INFLUENZA VACCINE FROM SEQIRUS

HIGHLIGHTS

  • USFDA has approved the expanded age indication of cell-based Quadrivalent influenza vaccine for people aged two years and above.
  • The vaccine has been developed by Seqirus.

The United States Food & Drug Administration (USFDA) has approved an influenza vaccine called FLUCELVAX QUADRIVALENT which has been developed by Seqirus. Seqirus is a global leader in developing influenza prevention solutions.

FLUCELVAX QUADRIVALENT is a cell-based Quadrivalent Influenza Vaccine (QIVc) for an expanded age indication for people aged two years or above. Earlier, FLUCELVAX QUADRIVALENT was approved for use by USFDA in persons aged four years or above. FLUCELVAX QUADRIVALENT is going to be available as a 0.5 milli-liter (ml) intramuscular (IM) vaccine per dose for the 2021-22 U.S. influenza season.

The expanded age indication of this vaccine is based on absolute efficacy data which indicates that highlighted the efficiency as well as ability of FLUCELVAX QUADRIVALENT to produce a sufficient immune response against influenza in children and adolescents between 2 to 18 years of age over three influenza seasons in the Southern Hemisphere (2017) and Northern Hemisphere (2017-18 and 2018-19) Hemispheres.

Gregg Sylvester, the Managing Director (MD) and Chief Medical Officer (CMO) at Seqirus said that young children were at a high risk of complications from influenza. Hence, the annual vaccination was critical. The absolute efficacy results for FLUCELVAX QUADRIVALENT served as the basis for this approval. The approval indicated that the cell-based vaccine offered a new option and an important one, for children as young as two years of age.

Centers for Disease Control and Prevention (CDC) said that the best way to prevent influenza was by receiving an annual seasonal influenza vaccine.

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