1st Flu Vaccine From Cell Culture Wins FDA Nod

SILVER SPRING, Md. -- A seasonal influenza vaccine produced in cell culture, rather than chicken eggs, has been approved by the FDA for people 18 and older.
To be sold with the brand name Flucelvax, the Novartis product is the first approved flu vaccine to be manufactured this way, the FDA said.

Cell-culture-based manufacturing is expected to shave weeks off the necessary start-up time to produce new vaccine formulations compared with the conventional method using chicken eggs.

In a placebo-controlled clinical trial conducted during the 2007-2008 flu season in the U.S., Finland, and Poland, the vaccine showed efficacy of 83.8% in preventing infection -- similar to a conventional flu vaccine -- among adults 18 to 49 years old.

A separate study in individuals 65 and older also demonstrated efficacy comparable with a conventional product.
Adverse events with Flucelvax were also similar in type and frequency to regular flu vaccines.

The product's approval is especially important because it represents the culmination of U.S. government efforts to encourage production of cell-culture-derived flu vaccines, as preparation for a possible future pandemic, the FDA said.

Other types of vaccines are currently manufactured in cell culture, the FDA noted.

The government partnered with Novartis to build a $1-billion manufacturing facility in Holly Springs, N.C., to produce the vaccine. However, it is not yet ready for full-scale commercial production, the company said in a statement.

Neither the FDA nor Novartis indicated when Flucelvax would be generally available.