GlaxoSmithKline ($GSK) is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.
According to a summary report from the regulatory body, Glaxo will need to inform it 90 days before restarting manufacturing activities for the pair of shots. Health Canada said the advance warning would allow it to take any further actions it deemed necessary at the troubled plant.
In a statement emailed to FierceVaccines, GSK spokeswoman Michelle Smolenaars Hunter said the company is "fully committed to working with regulators" and has no objection to the proposed amendment.
Glaxo has promised a formal response by Aug. 4 to Health Canada's objections at the facility, 7 of which the agency identified as major. Last month, an FDA warning letter raised concerns over bacterial contamination problems that had forced the pharma giant to toss more than 20% of the lots it had produced there this year.
But despite the heat it's taking from regulators, the company has said supply won't be affected. As the report notes, in order to help ensure it hits Canadian supply requirements for this season's flu vaccine, Glaxo reverted to an older manufacturing process that had proven itself safe in the past.
In addition to a contract to produce 53% of seasonal flu vaccines for its home country, the facility is also on tap to provide 23 million of 28 million jabs it will supply the U.S. market with this year.
- read the summary report
Special Reports: The top 5 vaccine makers by 2013 revenue - GlaxoSmithKline | Top 5 Vaccine Companies by Revenue - 2012 - GlaxoSmithKline | Major FDA vaccine approvals of 2012 - Fluarix Quadrivalent - FluLaval