GlaxoSmithKline ($GSK) has begun shipping its flu vaccine for the coming season after facing a string of issues last year that included receiving a warning letter for a flu vax plant and culminated with it pulling about 1.7 million doses of a vaccine from the market just a couple of months ago. But the British drugmaker says it is ready for this year, and expects to ship up to 38 million doses of two flu vaccines, both formulated to protect against four strains of the virus.
That is a huge boost in quadrivalent doses, nearly double what it shipped last year, after the company decided to ditch its trivalent jab this year and manufacture 100% quadrivalent vaccines because of customer demand. It said it has begun shipping its Flurix Quadrivalent and "Pending additional FDA lot releases," GSK expects to begin shipping Flulaval Quadrivalent in August.
GSK in April recalled 1.7 million doses of last season's Flulaval Quadrivalent in prefilled syringes because there were questions about whether the vaccine was retaining its potency. The vaccines were manufactured at a plant that ran into a series of manufacturing issues last year--including an FDA warning letter. The syringes were filled at a plant in Belgium. GSK said at the time that the potency questions were not tied to the manufacturing process at the plant in Canada.
The company had to reduce the amount of vaccine it shipped last year after a series of manufacturing problems at its Quebec City plant. The FDA issued a warning letter in June in which it raised concerns about bacterial contamination. After GSK's efforts to get on top of the problems came up short, it resorted to a manufacturing process it had used in the past. But then it had to temporarily suspend production to investigate "irregular results" in quality-control monitoring.
As it turned out, the past season's flu vaccines posted one of the worst efficacy rates in recent memory. That was been blamed on the fact that the viral strains the vaccines contained did not closely match the ones that ended up circulating.
- here's the GSK release