The potency issue, according to the company, the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) only affects Flulaval pre-filled syringe vaccine doses that were given in early January 2015 or later.
A CDC statement said, “Doses of this vaccine administered through the end of 2014 did not fall below specified potency limits. The reduced potency of the GSK Flulaval pre-filled syringes vaccine does not pose a safety concern for people who received it.”
This particular type of vaccine is designed to protect against four common strains of the flu. About 1.7 million doses of the vaccine are affected. Two of the strains are for Type A flu and two are for Type B flu. Older flu vaccines generally only protected against three strains, two Type A and one Type B.
“The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern,” said company spokeswoman Anna Padula in a statement. According to the company, more than 99 percent of the vaccines were distributed in 2014, which was before indications the flu vaccine began to lose potency.
Because spring in the U.S. is at the lower end of the risk period for influenza, the CDC is not recommending revaccination for individuals who received the recalled vaccine. But, people who received the vaccine in early January or later who do want to be revaccinated, the CDC suggests they contact their physician. However, in the Southern Hemisphere, flu season is just starting.
If people who have not received the vaccine or did receive it in January or later who are traveling to the Southern Hemisphere, the CDC says they “may wish to speak to their doctor about flu treatment or prevention options, including the possibility of being re-vaccinated with another 2014-2015 flu vaccine. However, because a new flu vaccine has been formulated for use in the Southern Hemisphere, vaccination with a Northern Hemisphere flu vaccine approved for use in the United States might provide suboptimal protection against flu viruses expected to circulate in the Southern Hemisphere in the coming months.”
GSK indicates that it initiated the recall after company tests showed the vaccine’s potency against the B strains could fall below the standards for minimum effectiveness.
Seven companies manufacture flu vaccines for use in the U.S. They are GSK, bioCSL, ID Biomedical Corp, a subsidiary of GSK, MedImmune, Novartis, Protein Sciences Corp and Sanofi.
April 20, 2015
By Mark Terry, BioSpace.com Breaking News Staff