The FDA has approved Flucelvax, the first seasonal vaccine licenced in the USA made with the use of cultured animal cells, instead of fertilized chicken eggs.
The FDA (Food and Drug Administration) has approved Flucelvax to protect patients aged at least 18 years from seasonal flu.
Flucelvax’s manufacturing process is similar to that used in egg-based manufacturing. However, when using cultured animal cells, the virus strains are grown in those cells of mammalian origin, rather than in eggs.
According to the vaccine’s makers, Novartis Vaccines and Diagnostics, Flucelvax’s production occurs in a closed, sterile, controlled environment, which considerably reduces the risk of potential impurities. Flucelvax has no preservatives, such as thimerosal, or antibiotics.
The FDA informed in a communiqué that cell culture technology has been used successfully for several decades in other approved vaccinations.
Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said:
“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.”
Andrin Oswald, Division Head, Novartis Vaccines and Diagnostics, said:
“The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the US. Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way.”
Cell culture technology is an alternative way of manufacturing vaccines. Cell culture technology’s main advantage is that it is easier to produce required supplies of vaccines rapidly, compared to egg-based vaccines. With cell culture technology, it is possible to maintain a plentiful supply of readily available, already tested and characterized cells for use in the manufacturing of vaccinations.
In cases of a pandemic, cell culture technology is better at providing adequate supplies quickly.
The FDA reviewed a randomized, controlled clinical study which had been carried out in Europe and the USA. It involved approximately 7,700 people aged from 18 to 49 years – they were administered either Flucelvax or a placebo.
When compared to a placebo, Flucelvax was 83.8% effective in preventing flu. A study involving patients aged more than 49 years showed good antibody responses (similar to Agriflu) in approximately 1,700 people. Agriflu is an egg-based seasonal flu vaccine which the FDA had approved for patients aged at least 18 years.
About 6,700 people were involved in the vaccine’s safety evaluation in a controlled clinical trial. The researchers informed that general reactions and injection site reactions to Flucelvax were similar to those seen in current flu vaccines. The most common reactions included fatigue, headache, and soreness at the injection site.
The best way to prevent seasonal influenza is to be vaccinated every year, the FDA informed. The CDC (Centers for Disease Control and Prevention) recommends that everybody aged at least 6 months should receive the flu vaccine annually.
Written by Christian Nordqvist