On November 20, 2012, the FDA announced its approval of Flucelvax, a vaccine for the prevention of seasonal influenza in individuals aged 18 and older. The virus used in Flucelvax is grown in cultured animal cells derived from mammals rather than from fertilized chicken eggs. This cultured cell technology has been used in other vaccines in the United States for many years, but Flucelvax is the first influenza vaccine manufactured with cultured cells.
According to the agency, the advantages of using cultured animal cells include the ability to maintain an adequate supply of readily available, pretested cells, so that large quantities of the vaccine may be developed and manufactured quickly when it is needed in the event of a pandemic.
The vaccine was tested in a randomized clinical trial in the United States and Europe, using about 7,700 subjects between the ages of 18 and 49. Because Flucelvax was found comparable to Agriflu, used for older adults, it has also been approved for individuals age 50 or over.