Sanofi delays return of vaccines after testing 'anomaly'

Sanofi's ($SNY) vaccine manufacturing plants have had a rocky 18 months, with warning letters, recalls and shortages marring 2012. Next month was supposed to be a milestone in efforts to resume full supply of all vaccines, but now a testing anomaly has caused further delays.

The problem this time relates to a filling line at the plant that manufactures two combination vaccines, Daptacel and Pentacel. Sanofi began limiting orders of the vaccines--which protect against diphtheria, tetanus, pertussis (DTaP), polio and Haemophilus influenzae type B--in April 2012. Three months ago, Sanofi pencilled in the start of September for a return to full production, but it is now set to miss this target.

As well as delaying the return of Daptacel and Pentacel to mid-October, Sanofi is now struggling to meet demand for another two products, the Adacel vaccine and Tubersol diagnostic antigen. Both were affected by the same problem that delayed the return of Daptacel and Pentacel, AAFP News Now reports. "This delay resulted from an anomaly identified during a routine test procedure of one of our filling lines, and, since a repeat test is now required, all products from that line are delayed," Sanofi's vice president of U.S. marketing, William Averbeck, said during a teleconference with the Centers for Disease Control and Prevention (CDC) and various health organizations.

While Sanofi resolves the delay--which is unrelated to process improvements it is making at the plant--GlaxoSmithKline ($GSK) and Merck ($MRK) will cover the shortfall in supply with their rival vaccines. CDC will also dip into the Strategic National Stockpile to ensure that enough doses are available.

- read the AAFP article
- here's Sanofi's notice (PDF)