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Seqirus secures FDA approval for next generation cell-based influenza vaccine manufacturing process

Seqirus, a global leader in influenza vaccine innovation, today announced FDA approval of its next generation cell-based manufacturing process at Holly Springs, North Carolina. The approval will enable Seqirus to more than double current production levels of FLUCELVAX® QUADRIVALENT for supply in the 2019/20 influenza season.


The approval came as Seqirus announced its FY18 earnings, which showed the company has delivered on its commitment to reach profitability just three years after it was created.1 The results represent more than US$300 million turnaround, which has largely been driven by the successful scale up of the cell-based technology acquired from Novartis in 2015.

At the time Seqirus took over the cell-based influenza vaccine program, the Holly Springs facility produced around 3 million doses annually. Last year the company announced that it had boosted production to around 20 million doses of FLUCELVAX®QUADRIVALENT per season by making technical improvements to the current process. This latest innovation will lead to the biggest step change in output yet, with more gains expected in the future.

Volumes of cell-based influenza vaccines supplied during the 2017/18 season enabled US health agencies for the first time to compare the effectiveness of this technology with all other types of licensed influenza vaccines.2 This real world data, presented by the FDA, showed cell-based technology to be associated with better hospital outcomes than standard influenza vaccine options.2 Seqirus has worked with scientific partners to generate additional real-world effectiveness data from the 2017/18 winter, which it expects to release later this year. Increased availability of cell-based vaccines in future seasons will provide further opportunities to study their effectiveness.

The Holly Springs facility was built in partnership with the US Biomedical Advanced Research and Development Authority (BARDA) to help combat influenza threats.3 The public-private partnership is the first in the world to establish cell-based technology as a highly scalable method of production, and may ultimately lead to the transformation of the global influenza vaccine market as we know it today.4

"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. "The approval of our next generation process will enable us to meet increasing demand for this innovative vaccine in the US market as well as support its launch in Europe next season."

"Influenza is a very serious public health threat and Seqirus is committed to working on the front line with partners to advance new vaccine technologies. We acknowledge BARDA for its vision in supporting the development of cell-based technology and are proud to partner with the US Government to make such a significant contribution to the future of influenza vaccination."

"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 shows the difference that public-private partnerships can make," said BARDA Director, Dr. Rick Bright.

About Seqirus

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 20,000 people with operations in more than 60 countries.

Seqirus was established on 31 July 2015 following CSL’s acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. As the second largest influenza vaccine provider in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

Seqirus operates state-of-the-art production facilities in the US, the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies, as well as a proprietary adjuvant. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.


1. CSL Limited. CSL press announcement. CSL Delivers a Full Year Net Profit of $1.7 billion. Accessed August 2018.   
2. Centers for Disease Control and Prevention (CDC). Advisory Committee on Immunization Practices (ACIP) Presentation Slides: June 2018 Meeting. Accessed August 2018. 
3. This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I. 
4. US Department of Health & Human Services (HHS). First U.S. cell-based flu vaccine plant set for dedication; Facility's ability to produce cell-based pandemic flu vaccine marks historic change. HHS news release. Accessed August 2018.

SOURCE Seqirus

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