Sanofi Gets a Bad Batch of H1N1 Vaccines - Pharmaceutical Executive

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Sanofi Gets a Bad Batch of H1N1 Vaccines



Looks like the conspiracy theorists boycotting the H1N1 vaccine because it was approved too quickly may have some more ammo. The Wall Street Journal, on Wednesday, reported that Sanofi-Aventis is recalling close to 800,000 does of the childrens’ version of the H1N1 vaccine due to potency problems.

According to the Center for Disease Control and Prevention (CDC), the pre-filled syringes were voluntarily recalled for non-safety–related reasons. Sanofi-Aventis discovered that a batch of the vaccine wasn’t as strong as it should have been, and notified the CDC and FDA that it will recall four lots of doses.

CDC informed the public that there are no safety concerns regarding these lots, and that the potency is only “slightly below the specified range.”

The following lots are affected:

  • 0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25): UT023DA, UT028DA, UT028CB
  • 0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70): UT030CA

No H1N1 vaccines manufactured by other companies are being recalled at this time.

In a press statement, Sanofi stated that "no action is needed other than to return unused doses. The FDA and the CDC recommend not repeating the dose for children who received vaccine from these lots because the drop in antigen content is unlikely to result in a clinically significant reduction in immune response. The CDC has stated that parents of children who received vaccine from the recalled lots do not need to take any action other than to complete the two-dose immunization series if not already completed."

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