FDA approves Flucelvax Quadrivalent

The FDA recently approved Flucelvax Quadrivalent — the first seasonal influenza vaccine to be cell-derived and to protect against the four major strains of influenza A and B — for patients aged 4 years and older, according to its manufacturer.

“Flucelvax Quadrivalent will provide health care providers and their patients with an important option to further broaden their influenza coverage,” Gordon Naylor, president of Seqirus, said in a press release. “We are pleased to offer Flucelvax Quadrivalent … to our valued customers during the 2016-2017 flu season.”

Previously, influenza vaccines protected against two strains of influenza A virus and one strain of influenza B virus, the release said. Since 1985, two strains of B virus have dominated the influenza season. To protect against these B strains, Seqirus produced Flucelvax Quadrivalent, an inactivated vaccine, that provides protection against the two A strains and two B viruses recommended by the FDA and WHO for the upcoming influenza season.

To create Flucelvax Quadrivalent, Seqirus researchers added an extra B strain to Flucelvax, the company’s trivalent, cell-derived vaccine, according to the release. In studies of participants aged 18 to 49 years, Flucelvax was 69.5% effective against all circulating strains. When compared with the other strains in the trivalent vaccine, Flucelvax Quadrivalent created a stronger antibody response for the added B strain and was well-tolerated, according to the release. The company said the efficacy and safety data for Flucelvax was relevant to Flucelvax Quadrivalent because the vaccines are manufactured similarly and share overlapping compostions. The most common adverse reaction (≥ 10%) was injection site pain (range, 21.6%, patients aged older than 65 years; to 58%, patients aged 9 to 17 years).

According to the release, the cell-culture manufacturing technology allows for rapidly increased production of influenza shots by not relying on eggs. Instead, the vaccine is produced in sterile bioreactors. In doing so, Seqirus said it can produce enough doses of vaccine in response to an unforeseen pandemic.