The US Food and Drug Administration has given the green light to Novartis' Flucelvax, the first seasonal influenza vaccine produced using cultured animal cells, instead of fertilised chicken eggs.
The approval is based on data from a study involving 7,700 people aged 18 to 49 years who received either Flucelvax or placebo. The results showed that Flucelvax was 83.8% effective in preventing influenza when compared to placebo and its use in people older than 49 is supported by antibody responses in about 1,700 adults. The FDA said this showed Flucelvax to be comparable to Agriflu, an egg-based flu vaccine.
The agency noted that the manufacturing process for Flucelvax is similar to the egg-based production method. However, it also says that the advantages of cell culture technology "include the ability to maintain an adequate supply of readily available, previously-tested and characterised 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".
Cell-culture technology is already used in vaccines for polio, rubella and hepatitis and also those distributed during the H1N1 pandemic. Novartis notes that production occurs in a closed, sterile, controlled environment, which significantly reduces the risk of potential impurities, adding that Flucelvax does not contain any preservatives, such as thimerosal, or antibiotics.
Andrin Oswald, head of the Novartis vaccines and diagnostics unit, said the approval "is an important milestone for our influenza franchise and brings an innovative vaccine to the USA". He added that "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 US Department of Health and Human Services to develop the cell-culture manufacturing technology, as well as for construction of a state-of-the-art facility in Holly Springs, North Carolina. Total public/private investment is more than $1 billion, the Swiss major said.