Re: Farmas USA
Flu Vaccine vs NVAX
A GSK spokesperson said in an emailed statement Wednesday that the company is "fully committed to working with regulators to ensure we adhere to the requirements of all Good Manufacturing Practices." It also said that the agency had given it a "compliant rating" and that it was "making progress on their concerns."
But meeting Health Canada's concerns are only part of the difficulty the facility faces because Health Canada went in for a look only after problems were initially identified in a warning letter the FDA sent the facility in June.
FDA inspectors questioned the quality of the new FluLaval vaccine and its intermediates. It said that of 20 lots manufactured this year, 21% had to be rejected because of bacterial growth and problems with "endotoxin excursions." It also said that in April 2013, contamination was the cause of 80% of rejected eggs. In August 2013, the agency approved FluLaval Quadrivalent, which protects against four flu strains. The fact that GSK appeared to be struggling led the agency to ask for a meeting with senior management, "given the potential contributions of FluLaval to the public health."
GSK is slated to provide between 28 million and 33 million doses of four-strain and three-strain flu shots to the U.S. market for the 2014-2015 season. It said last week that it had begun shipping the first doses of Fluarix Quadrivalent, which make up part of that commitment. That vaccine is manufactured at a plant in Dresden, Germany.
