Problems with a new manufacturing process at the GlaxoSmithKline ($GSK) influenza vaccine plant in Canada caused some of the issues raised by regulators there, and so the U.K. drugmaker is reverting to its earlier process to get product to the market for the upcoming flu season.
A report by Health Canada found 10 issues but none of them create substantial health risks. "Given the size of the facility and complexity of the production process, this number of observations is considered acceptable. None of the observations were critical (risk 1)," the report said.
But GSK's efforts to fix some of the issues did not resolve them. To make sure it can meet Canada's vaccination needs for the impending flu season, Health Canada said the company will go back to the "former process which had been in place … and had been used to safely produce vaccine for several years."
The drugmaker has contracts to make more than half of the flu vaccines in the country for the 2014-2015 season. Health Canada has given the drugmaker until Aug. 4 to come up with a plan of action for the plant in Ste-Foy, Quebec, operated by its ID Biomedical unit.
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.
- here's the report
As Glaxo begins 2014-15 flu vaccine shipments, manufacturing questions linger
Health Canada gives GSK 30 days to show how it will fix its vaccine plant
FDA finds contamination issues at GSK vax plant