FDA approved Flucelvax (Novartis) for the prevention of seasonal influenza in people 18 years or older. The vaccine is the first influenza vaccine licensed in the United States produced using cultured animal cells instead of fertilized chicken eggs. This alternative production method occurs in a sterile environment, significantly reducing the risk of potential impurities. Unlike other influenza vaccines, Flucelvax does not contain preservatives such as thimerosal.
More than 200,000 people in the United States are hospitalized each year for illnesses associated with seasonal influenza infections, according to CDC, which recommends that everyone 6 months or older get a yearly influenza vaccine.
Flucelvax’s approval was based on data from a clinical trial conducted in the United States and Europe involving about 7,700 people 18 to 49 years who received either Flucelvax or a placebo. Flucelvax was 83.8% effective compared with placebo in preventing influenza. It was comparable with Agriflu (Novartis), an egg-based seasonal influenza vaccine. The most common adverse reactions were pain and erythema at the injection site, headache, fatigue, myalgia, and malaise.
The approval “represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process,” said Karen Midthun, MD, Director of FDA’s Center for Biologics Evaluation and Research, in a press release.
Flucelvax is manufactured using cell culture technology, making it easier and faster to produce for seasonal influenza or in the case of a potential pandemic. The process has been used for several decades to produce other vaccines, according to FDA.
Flucelvax is currently made in Marburg, Germany, but Novartis plans to transfer manufacturing to a high-tech facility in Holly Springs, NC. Total public/private investment in the technology and facility is more than $1 billion, according to Novartis.