Novartis won FDA approval Tuesday for Flucelvax®, the first cell-culture-derived seasonal flu vaccine to be approved in the U.S. The vaccine was approved for adults 18 years old and older.
Flucelvax is produced using cell culture manufacturing technology, enabling rapid production within weeks for a pandemic or other public health needs. The technology, used for decades in other FDA-approved vaccines, is an alternative method to traditional egg-based production that uses mammalian cells rather than chicken eggs to grow virus strains. Flucelvax does not contain preservatives such as thimerosal, or antibiotics.
Flucelvax will be produced in Holly Springs, NC, at the first facility of its kind in the U.S. once it is ready for full-scale commercial production. The facility will also allow for enhanced domestic pandemic preparedness.
Novartis and the U.S. Biomedical Advanced Research and Development Authority (BARDA) have collectively spent more than $1 billion on both the technology and the manufacturing facility.
FDA based its approval on data from clinical trials that found Flucelvax to be well tolerated, with an efficacy of 83.8% against antigenically matched strains compared to placebo. During the 2007-2008 influenza season, a total of 11,404 patients – all adults aged 18 to 49 -- received Flucelvax, Agriflu® or placebo in a multinational, randomized, observer-blinded, placebo-controlled trial.
According to an FDA statement, use of Flucelvax in people older than 49 was supported by antibody responses in about 1,700 adults which showed it to be comparable to Agriflu, an egg-based seasonal flu vaccine also approved for adults 18 years and older.
In a separate safety evaluation, about 6,700 individuals received Flucelvax in controlled clinical studies. Injection site and general reactions to Flucelvax were typical of those seen with current influenza vaccines. Pain, redness, and soreness at the injection site, and headache and fatigue were the most common reactions.