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Seqirus FLUCELVAX QUADRIVALENT receives FDA approval

 

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Seqirus announced that the US Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT™(Influenza Vaccine),the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. The use of a four-strain influenza vaccine like FLUCELVAX QUADRIVALENT may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.

“As the first and only cell culture-derived seasonal influenza vaccine in the US to offer four-strain flu protection for people aged four years and older, FLUCELVAXQUADRIVALENT will provide healthcare providers and their patients with an important option to further broaden their influenza coverage,” said Gordon Naylor, President of Seqirus.1,2 “We are pleased to offer FLUCELVAX QUADRIVALENT, which is produced at our full-scale cell culture influenza vaccine manufacturing facility in North Carolina, to our valued customers during the 2016-2017 flu season.”

“Despite strong recommendations for everyone in the US six months of age and older to be vaccinated against the flu every year, fewer than half of eligible people did so in the 2014-2015 season. This includes children, the group with the highest incidence during community outbreaks,” said Dr. Gary S. Marshall, Chief of Pediatric Infectious Diseases at the University of Louisville. “Even healthy people are at risk they should be vaccinated to protect themselves and to prevent transmission to others.”

FLUCELVAX QUADRIVALENT is produced using the same full-scale cell culture manufacturing technology as its predecessor FLUCELVAX™ (Influenza Vaccine), which allows the potential for rapidly increased production of flu shots in response to outbreaks or pandemic.

FLUCELVAX QUADRIVALENT is manufactured in a state-of-the-art facility in Holly Springs, North Carolina. Development of the technology and manufacturing facility that produces FLUCELVAX QUADRIVALENT was supported by the US government to help ensure that flu shots are available when needed to help combat public health threats, such as pandemics.

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