Health Canada Approves GSK's Action Plan On Quebec Plant
Health Canada has given GlaxoSmithKline the green light to begin its plan to address contamination issues at its flu vaccine production plant at Ste. Foy in Quebec, Canada.
Health Canada acknowledged that the company has responded to the inspections and has implemented corrective measures. Health Canada stated in an email, “We have completed the evaluation of GSK's action plan of its Ste. Foy facility, ID Biomedical. GSK's proposed approach and the timelines proposed have been deemed acceptable by Health Canada. We will monitor the progress of the implementation of the corrective action plan and conduct regular testing on lots of vaccine prior to their release onto the Canadian market.”
The department also noted that issues with vaccine production plants are not uncommon due to their complex nature and high safety standards. Health Canada conducts an inspection of the plant every two years.
The company has been experiencing problems with the plant since spring after inspections from both the U.S. Food and Drug Administration (FDA) and Health Canada came up with a number of observations. The FDA also issued a warning letter to the company particularly mentioning concerns about bacterial contamination at the plant.
GSK said it is addressing the problems and does not anticipate a delay or shortage in its scheduled vaccine distribution for this year’s flu season. The company has an ongoing $425.9 million contract to produce pandemic flu vaccines for Canadians for the next ten years.
The company also does not foresee any issues meeting demand in the U.S. Indeed, in the U.S., two lots of flu vaccines from the Ste. Foy plant have been released by the FDA for distribution, showing that the company is on track to answer the country’s upcoming demand.
The company has also set its sights on contributing a vaccine candidate to the current fight against the Ebola outbreak. GSK is currently preparing to begin clinical trials of an investigational vaccine against Ebola virus, which it is developing with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in response to the disease outbreak in Africa. While it’s unclear when this trial will commence, the NIAID suggested that the trial could be launched as early as 2014,” Reuters says.