FDA approves Protein Sciences’ cell-based flu vaccine for 2014
Every year influenza vaccine manufacturers must receive approval from the FDA for changes they make to the upcoming season's manufacturing process and product formulation as the influenza vaccine adapts annually.
Manon Cox, president and CEO of Protein Sciences, told BioPharma-Reporter.com that this year’s approval came much faster than last year’s for the company. The difference between the egg-based vaccines produced by other manufacturers and Protein Sciences’ vaccine is that “we only need the genetic information” to make the exact match to the existing strain of the vaccine, Cox said.
Early approval for Flublok will enable delivery on time to healthcare providers in September, she said. The strain is usually determined by the WHO (World Health Organization), and then an advisory committee for the FDA usually follows the lead, Cox said.
She added that the company has not made any manufacturing changes to its production process from last year, which was the first year the company distributed its cell-based flu vaccine. All vaccines are manufactured at the company’s plant in Meriden, Connecticut, though the company is still awaiting FDA approval for another plant in New York, which is expected to significantly increase capacity for the years to come, Cox added.
The company is hopeful the facility will be approved by the end of this year so it can use the additional capacity for next year’s vaccine, she said.
Cell-based flu vaccines are quickly becoming a new trend, and Cox said that there is concern from last year that some egg-based vaccines have had protection issues for some strain components.
In following with this trend, last month, the FDA approved Novartis’ cell-based vaccine production plant in Holly Springs, North Carolina. The plant manufactures its vaccines using Madin-Darby Canine Kidney cells, which allow for a more reliable production process, a spokeswoman told us.
