Cell-Based Influenza Vaccine Flucelvax Tetra Approved by EC

Seqirus cell-based flu shot Flucelvax approved by the European Commission

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The European Commission (EC) has issued marketing approval for Flucelvax Tetra, a cell-based quadrivalent influenza vaccine (QIVc), for people over the age of 9 years old. 

The EC’s decision on Flucelvax Tetra was made “on the basis of immunogenicity and safety” compared to a cell-based trivalent vaccine. 

‘Cell-based’ refers to how the flu vaccine is made. 

Most inactivated influenza vaccines are produced by growing influenza viruses in eggs. The influenza viruses used in the cell-based vaccine are grown in cultured cells of mammalian origin instead of in hens’ eggs. 

At the Canadian Immunisation Conference during December 2018, the producer of Flucelvax Tetra, Seqirus, presented data based on 1.3 million medical records, which suggested that this cell-based flu vaccine was 36.2 percent more effective at preventing influenza-like illness in patients older than 4 years of age, reported Pharmafile.   

This means cell-based vaccines may offer a closer match and potentially improved protection compared to standard egg-based options during ‘some’ flu seasons. 

A previous study published in December 2018 supports this EC approval.   

Russell Basser MD, SVP of research and development, Seqirus, explained in a press release, “This real-world study, along with other emerging evidence, indicates that cell-based influenza vaccines may result in better influenza-related outcomes when compared to standard egg-based vaccine options in some seasons, particularly those seasons characterized by egg-adapted changes.” 

The US Centers for Disease Control and Prevention (CDC) says the influenza virus is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. 

Recommended:

To reduce the risk of serious outcomes, the CDC encourages annual flu vaccinations for all individuals aged 6 months and older. 

This CDC recommendation includes pregnant women. 

If you have flu vaccine questions, it's best to speak with your doctor, nurse or pharmacist, says the CDC.

There are various flu vaccines available for the 2018-19 season. The CDC Vaccine Price List provides the private sector prices for general information.

Flu vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

Seqirus produces cell-based influenza vaccines at its Holly Springs facility in North Carolina in the U.S. The facility was purpose-built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to combat pandemic influenza threats.