May 13, 2015
No Need to Revaccinate Those Receiving Recalled Flu Vaccine

Atlanta—The CDC is not recommending revaccination for people receiving flu shots from vaccine lots recalled by the manufacturer because of reduced potency.

Sanofi Pasteur recently notified the CDC and the FDA that it is recalling three lots of its Fluzone Quadrivalent flu vaccine supplied in multidose vials. The lot numbers included in this recall are UI196AA, UI190AC, and UI190AD.

Other lots of Fluzone Quadrivalent vaccine in multidose vials or any other presentations of Sanofi Pasteur’s Fluzone vaccines are not affected by the recall.

The recall was voluntarily initiated because potency in the lots fell below a prespecified limit prior to the expiration of the vaccine, according to the CDC. Potency standards for flu vaccines were established by the FDA in part because a vaccine could provide less than optimal effectiveness if it fails to meet a prespecified potency limit.

“Because of declining flu activity at this time, CDC is not recommending revaccination for people who received the recalled vaccine,” according to an agency press release which also emphasized that the reduced potency vaccines pose no safety concern for the people who received them.

The CDC cautions, however, that people who received the recalled vaccine and are planning to travel to the Southern Hemisphere, where flu season is just beginning, should speak to their physicians about prevention and treatment options, including being vaccinated when they arrive at their destination.

“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,” the CDC noted. “People traveling to the Southern Hemisphere for an extended period of time may wish to consider getting vaccinated with a flu vaccine formulated for the Southern Hemisphere. Southern Hemisphere vaccines are not licensed for use in the United States.”

Fluzone Quadrivalent was designed to protect against four influenza viruses: an influenza A (H1N1) virus, an influenza A (H3N2) virus, and two influenza B viruses (one of the Victoria lineage and one of the Yamagata lineage).

The recall involves reduced potency in the influenza A (H3N2) and influenza B (Victoria lineage) virus components in the three recalled lots. The potency of the remaining influenza A (H1N1) and B Yamagata virus components of this vaccine was within prespecified limits.

“Reduced potency does not necessarily mean people vaccinated with this vaccine received reduced benefit, but CDC cannot rule out the possibility,” according to the press release.

Customers who purchased vaccine from any of the recalled lots have received instructions from Sanofi Pasteur to not use the remaining vaccine. The manufacturer also has provided directions for returning unused doses.

Here is additional information on the recalled lots:

Lot Number:         Expiration Date:    Carton NDCa:      Vial NDC:          Presentation:
UI196AA                30JUN15                 49281-621-15       49281-621-78   10-dose vials
UI196AC                30JUN15                 49281-621-15       49281-621-78   10-dose vials UI196AD                30JUN15                 49281-621-15       49281-621-78   10-dose vials

U.S. Pharmacist Social Connect