GlaxoSmithKline (GSK) Reports Flu Vaccine Recall

April 16, 2015 – GlaxoSmithKline (GSK) has notified CDC and FDA that it is recalling remaining doses of its 2014-2015 FLULAVAL® QUADRIVALENT Thimerosal-free Pre-Filled Syringes (PFS) flu vaccine. This recall does not affect FLULAVAL QUADRIVALENT Multi Dose Vials (MDV), FLULAVAL [trivalent] MDV or any other GSK vaccines. GSK voluntarily initiated this recall because of the potential that FLULAVAL pre-filled syringes may have reduced effectiveness due to a decrease in potency detected through routine testing. The vaccine’s potency fell below a pre-specified limit prior to the expiration of the vaccine. According to GSK, the potency issue only affects FLULAVAL pre-filled syringe vaccine doses administered in early January 2015 or later. 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.

FLULAVAL® QUADRIVALENT PFS is a quadrivalent flu vaccine that protects against four influenza (flu) viruses: two influenza A viruses and two influenza B viruses. The issue involves slightly reduced potency (less than 5 percent below the minimum specification) in the two influenza B viruses contained in the 2014-2015 FLULAVAL® QUADRIVALENT Thimerosal-free Pre-Filled Syringes (PFS) vaccine. This means the vaccine no longer meets the manufacturer’s specifications for potency for these particular viruses. The potency of the remaining two influenza A viruses in the vaccine was within pre-specified limits. Potency (or strength) of a vaccine is determined by the measurement of the concentration of the active ingredient (also called antigen) in the vaccine. Reduced potency does not necessarily mean people vaccinated with this vaccine received reduced benefit, although it is a possibility.

Given that flu activity in the United States is declining at this time, CDC does not recommend revaccination for people who received the recalled FLULAVAL pre-filled syringes vaccine. However, people vaccinated with the vaccine in early January 2015 or later who wish to be revaccinated should talk to their doctor.

People who received the vaccine in early January 2015 or later, and who are planning to travel to the Southern Hemisphere (where flu season is just beginning) 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 has sent customers who purchased FLULAVAL® QUADRIVALENT PFS directions for returning any unused vaccine from these lots. Thirteen lots of vaccine are affected by the recall and include: 2B472 /379MY /42N4L / 5AZ7H / 9A3ZM / ZS95Z / A2PK7 / AR57J / DR4GF / YF5DT / F45C5 / T3J4S / XP4J2.

Further questions should be directed to FDA and GSK.

• FDA has posted a recall notice on its website.
• GSK has posted a recall letter [32 KB, 2 pages] on its website.
• GSK has indicated that individuals with additional questions can call the GSK Response Center at 1-888-825-5249, Monday – Friday, 8:30 a.m. – 5:30 p.m. EST.