FDA approves quadrivalent flu vaccine process at Holly Springs facility

HOLLY SPRINGS–The U.S. Food and Drug Administration (FDA) has approved the latest Seqirus cell-based Flucelvax Quadrivalent flu manufacturing process at its Holly Springs manufacturing facility.

Massachusetts-based Seqirus says the approval will enable it to more than double production levels. When Seqirus tool over the cell-based influenza vaccine program, the Holly Springs plant produced about 3 million doses annually. Last year, the company made technical improvements that boosted production to around 20 million doses per season.

The Flucelvax Quadrivalent vaccine targets four strains of flu rather than just the three of conventional vaccines. The North Carolina Biotechnology Center sponsors free shots of the advanced vaccine at the beginning of each flu season.

In the 2017/2018 flu season, U.S. health agencies compared the effectiveness of the technology with other types of licensed flu vaccines. The data presented by the FDA showed that the cell-based vaccines were associated with better hospital outcomes than standard options. The company said increased availability of its vaccine in future seasons will provide additional opportunities to study their effectiveness.

The company said the FDA approval of its latest innovations will lead to the biggest change in output yet, with more gains expected in the future.

The Holly Springs facility was built in partnership with the U.S. Biomedical Advanced Research and Development Agency (BARDA) to help combat influenza threats.

“Since acquiring this promising technology three years ago, we have been able to transition Flucelvax from pilot scale to the most widely available cell-based influenza vaccine,” said Gordon Naylor, Seqirus president, in a statement. “The approval of our next generation process will enable us to meet increasing demand for this innovative vaccine in the U.S. market as well as support its launch in Europe next season.”

Conventional flu vaccines are incubated in eggs and cannot be produced as quickly as cell-based vaccines.

BARDA Director Rick Bright said in a statement that “Making the right vaccine available quickly can translate into more lives saved. Increasing the speed and efficiency of producing influenza vaccines has game-changing implications for our nation’s health security. This type of progress clearly show the difference public-private partnerships can make.”