CSL’s flu vaccine scores FDA approval
pharmafile | May 24, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | CSL, FDA, Vaccine, flu, four strain, four-strain, influenza, influenza a, influenza b, seqirus
Seqirus, a division of CSL, has announced that the US Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent (influenza vaccine), which is the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older.
The vaccine offers protection against the two influenza A viruses and two B viruses recommended by the World Health Organisation (WHO) and the FDA for the current influenza season. With this vaccine covering the four most common strains of influenza, Seqirus hopes to reduce the burden of influenza upon health systems across the US.
It is estimated that around 200,000 people are hospitalised due to flu complications each year. The Centers for Disease Control and Prevention encourages annual vaccination for all individuals aged six months and older.
This new vaccine is produced using the same full-scale cell culture manufacturing technology as its predecessor Flucelvax, which offers the potential for rapidly increased manufacturing capabilities in cases of outbreak or pandemic. The US government has supported the technology at Seqirus’s North Carolina facility to ensure that flu shots are available if such a crisis were to occur.
Gordon Naylor, president of Seqirus, says: “As the first and only cell culture-derived influenza vaccine in the US to offer four-strain flu protection for people aged four years and older, Flucelvax Quadrivalent will provide healthcare providers and their patients with an important option to further broaden their influenza coverage.
“We are pleased to offer Flucelvax Quadrivalent, which is produced at our full-scale cell culture vaccine manufacturing facility in North Carolina, to our valued customers during the 2016-17 flu season.”
Orexo has announced that its New Drug Application (NDA) for OX124 has been accepted for …
Arcturus Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan …
Alladapt Immunotherapeutics has announced that ADP101 has received Fast Track Designation from the US Food …