December 12, 2012
FDA Approves Seasonal Flu Vaccine Not Made in Fertilized Chicken EggsWashington, D.C.—For the first time, the FDA has approved a seasonal flu vaccine produced by using cultured animal cells instead of fertilized chicken eggs.
The drug, Flucelvax, is approved to prevent seasonal influenza in people ages 18 years and older.
While the manufacturing process for Flucelvax, manufactured by Novartis Vaccines and Diagnostics GmbH, Marburg, Germany, is similar to other flu vaccines, virus strains included in the vaccine are grown in animal cells of mammalian origin instead of in eggs. That technology has been in use for several decades to produce other vaccines licensed in the United States.
“Today’s 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 the FDA’s Center for Biologics Evaluation and Research.
The use of cell culture technology has several advantages, including the ability to maintain an adequate supply of readily available, previously tested and characterized cells for use in vaccine production and the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic, according to the FDA.
In a randomized controlled clinical study conducted in the United States and Europe to evaluate Flucelvax, 7,700 people ages 18 to 49 years received either
Flucelvax or a placebo. Flucelvax was shown to be 83.8% effective in preventing influenza when compared to placebo.
Flucelvax use in those older than 49 is supported by antibody responses in about
1,700 adults, comparable to Agriflu, an egg-based seasonal influenza vaccine approved by FDA for use in adults.
In a safety evaluation of about 6,700 individuals who received Flucelvax in controlled clinical studies, injection site and general reactions were typical of those seen with current influenza vaccines. The most common reactions were pain, redness and soreness at the injection site, as well as headache and fatigue.
“The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the U.S,” said Andrin Oswald, division head, Novartis Vaccines and Diagnostics. “Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way.”
Novartis has partnered with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority, in development of the cell-culture manufacturing technology and construction of a state-of-the-art facility in Holly Springs, NC, the first of its kind in the United States. Flucelvax will be produced in Holly Springs when the facility is ready for full-scale commercial production.
|U.S. Pharmacist Social Connect