GlaxoSmithKline's N1 Bird Flu Vaccine Gets FDA Approval

(RTTNews) - The U.S. Food and Drug Administration or FDA, Friday said it approved GlaxoSmithKline Plc's (GSK, GSK.L), first adjuvanted Influenza A (H5N1) Virus Monovalent Vaccine, for the prevention of H5N1 influenza. The vaccine is not intended for commercial use, and has been purchased by the U.S. Department of Health and Human Services from its maker, ID Biomedical Corporation of Quebec, an unit of GlaxoSmithKline Biologicals. This purchase would add the vaccine within the National Stockpile for distribution by public health officials if needed.

The vaccine is for use in people aged 18 and older, who are at increased risk of exposure to the H5N1 influenza virus, better known as avian or bird flu. H5N1 is an influenza virus with pandemic potential because it continues to infect wild birds with occasional outbreaks of influenza disease in poultry populations, and most humans have no immunity to it. According to the World Health Organization, when people do become infected with H5N1, about 60 percent die.

The vaccine is made using an egg-based manufacturing process, and the adjuvant is a substance used into some vaccines to boost the immune response of the vaccinated individual. The vaccine is administered through a intramuscular injection in two doses within a span of 21 days. A multi-center study was conducted to evaluate the safety of the vaccine by administering it to 3,400 adults 18 years and above, in comparison with 1,100 adults who received placebo. To study about the vaccine, the immune response was evaluated in about 2,000 of the vaccinated adults.

The manufacturer will join with the FDA and other U.S. governmental agencies on plans to collect additional safety and effectiveness data through U.S. government-sponsored studies of the vaccine, in the event that it is used during an H5N1 influenza virus pandemic.