Having spent the past few months trying to bring standards at its Quebec City vaccine plant in line with FDA expectations, GlaxoSmithKline ($GSK) must now work to satisfy another regulator: Health Canada. The Canadian regulator sent GSK an inspection report late last week and gave the Big Pharma 30 days to come up with a plan to fix the problems faced by the facility.
The Canadian Press reports there is an overlap between the issues raised in the latest letter and the points the FDA made in its warning letter to GSK, which noted the site had long-running problems with bacterial contamination. FDA found that about one-fifth of all vaccines produced at the plant in 2014 were scrapped because of bacterial growth and problems with endotoxins when it visited in the first week of April. Health Canada will publish the findings of its June 20 inspection when it finishes writing a summary report.
While the inspectors clearly found faults with the operation, none of these are viewed as an immediate threat to the health of Canadians. As such, the regulator rated the plant as "compliant," a decision that means GSK should still be able to contribute to vaccine supplies for the coming flu season. Health Canada said GSK believes it can meet its supply commitments while fixing the plant, but there are signs Canadian authorities think there could be some disruption.
Health Canada said GSK would "adhere as closely as possible" to its original plan of shipping half of its commitment on September 15 and the rest between September 22 and the end of October. The wording doesn't rule out the possibility of delays, and the Canadian body tasked with procuring vaccines is already working on contingency plans. AstraZeneca ($AZN) and Novartis ($NVS) have both said they could step up shipments to Canada if GSK falls short of its supply commitment.
- read the Canadian Press article