Getting a jump on flu season, GlaxoSmithKline announced last week that it is making available approximately 35 million doses of Fluarix and FluLaval combined, an increase of about 10 million doses over last year. The Centers for Disease Control and Prevention recommends that three out of every four Americans receive a flu shot each year.
GSK is a relatively new player in the influenza-vaccination market in the United States, having entered it in 2004. But the company has invested nearly $2 billion to expand its flu-vaccine manufacturing capacity and increase production of its antiviral drug Relenza.
It is estimated that 130 million could receive a flu vaccination this year, based on the number of doses available from all vaccine manufacturers. The World Health Organization identifies influenza strains each February. According to GSK, both Fluarix and FluLaval are the same in that they protect against the same strain of the flu, but the main difference is the delivery method (Fluarix has a tip-lock, pre-filled syringe).
Unlike most drugmakers, flu-vaccine manufacturers aren't concerned with generics entering the market: Because flu strains mutate every year, there is always room for new vaccines. "It's not like other diseases, where the vaccination protects against several strains," explained Jeff McLaughlin, spokesperson for GlaxoSmithKline. "Every year, WHO identifies a new strain, and pharma companies essentially have to start from scratch and begin creating a flu vaccination and filing for a biological licensing agreement."
GSK says it's committed to raising awareness of the importance of a flu vaccination. "How many disease categories are there where 75 percent of the population should be protecting themselves annually?" McLaughlin said. "The flu season is finite, it starts in September and goes through April. It's a short amount of time for a large amount of people to get a vaccination."
In related news, GSK is still tight-lipped about its H5N1 flu vaccine, which was approved for development in Europe. The manufacturer told Pharm Exec that it's undertaking a Phase I North American trial for the vaccine, but wouldn't reveal any more details.