BETHESDA, MD 21 November 2012—FDA on November 20 announced the licensing of the nation's first seasonal influenza virus vaccine produced in a cell culture system instead of the traditional egg-based technology.
Flucelvax, made by Novartis Vaccines, is an inactivated vaccine derived from virus propagated in a continuous cell line of canine kidney cell origin.
for Flucelvax states that the vaccine is indicated for use in people 18 years of age or older.
The federal government has supported Novartis and other manufacturers in the development of cell-based influenza vaccines as part of the nation's pandemic response and planning activities. Supposed advantages of cell-based influenza vaccines over traditional ones include the ability to grow candidate vaccine virus strains without first adapting them to egg culture and the potential for speeding large-scale production.
In addition, continuous cell culture lines can be frozen for later use in vaccine production, but chicken eggs for vaccine production need to be farmed year-round in special facilities to ensure a continuous supply.
The recommended dosage of Flucelvax is 0.5 mL administered as an intramuscular injection, preferably in the deltoid of the upper arm. The syringe should be vigorously shaken before administration to ensure an even suspension of the vaccine.
In clinical trials, Flucelvax induced a serologic response that was similar to that of Agriflu, an egg-based seasonal influenza virus vaccine made by Novartis.
The most common adverse events reported by Flucelvax recipients were injection-site reactions, headache, fever, myalgia, and malaise.
The vaccine will be supplied in cartons of 10 syringes, each containing a single 5-mL, preservative-free, antimicrobial-free dose. The syringe caps may contain latex.
No needles are supplied with the vaccine.
Flucelvax should be stored at 2–8 °C until use. Do not administer the vaccine if it has been frozen.
Flucelvax will be produced at Novartis's 475,000 square-foot manufacturing facility in Holly Springs, North Carolina. According to Novartis, the manufacturing facility will eventually have the capacity to produce 50 million doses of trivalent seasonal influenza vaccine each year.