Seqirus Receives FDA Approval for Cell-Based Influenza Vaccine Manufacturing Process


Seqirus is the manufacturer of Flucelvax Quadrivalent. The United States Food and Drug Administration (FDA) has approved a cell-based manufacturing process for the influenza vaccine, allowing Seqirus to double its current production levels.

The company’s annual results for 2018 show more than $ 300 million, or roughly € 259, which has been attributed to the scaling up of cellular technology that the company acquired from Novartis in 2015. Seqirus has moved on. of 3 million doses per year. in 2015 to produce 20 million doses per season last year.

Manufacturing takes place at the company’s Holly Springs, NC facility, which it acquired after taking over the cell-based influenza vaccine project from Novartis. The facility was originally built alongside the US Biomedical Advanced Research and Development Authority (BARDA).

Gordon Naylor president of Seqirus told us that the installation is what allows us to be able to produce with a scalable method, “With this FDA approval, we will go to 40 million doses. So these are really big increases in production and that’s what is so exciting here is that we’re actually on the verge of producing the vaccine in large quantities. It’s a breakthrough for us to be able to do that.

Specificity of the cellular vaccine

Since the production of vaccines for the 2017/2018 influenza season, data has become available showing that cell technology as a whole is associated with better hospital outcomes than standard influenza vaccine options.

Naylor attributed the improved results to an attribute of the cell-based vaccines, as they can be grown in cell cultures as opposed to traditional chicken eggs, making them easier to modify if the predicted strain changes.

“When the manufacturers and the World Health Organization (WHO) decide which strain to make, we all have to be very confident that that strain will grow in eggs and maybe it will be exactly the same. [strain] that exists in the world, which threatens the public, but if it does not grow in chicken eggs, it is not possible to protect the population [based upon standard manufacturing techniques], “he explained.


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