Filling Line 'Anomaly' Extends Sanofi's DTaP Vaccine Shortage Through Mid-October

August 20, 2013 12:29 pm Matt Brown

Just weeks before previously announced summer allocation restrictions on two of its combination vaccines are set to expire, Sanofi Pasteur now has said the shortages will continue into October and will expand to include other products, as well(www.vaccineshoppe.com).

In a teleconference with representatives from the CDC and various health organizations, William Averbeck, Sanofi's vice president of U.S. marketing, said the vaccine manufacturer will be unable to meet demand for several products until mid-October. Those products are its

  • diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV-Hib: Pentacel);
  • diphtheria and tetanus toxoid and acellular pertussis vaccine adsorbed (Daptacel);
  • tetanus toxoids, reduced diphtheria and acellular pertussis vaccine adsorbed (Adacel); and
  • tuberculin purified protein derivative (Tubersol Diagnostic Antigen).
Story highlights
  • Sanofi Pasteur has announced it will extend allocation restrictions on its diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV-Hib) as well as other products.
  • DTaP vaccine manufacturer GlaxoSmithKline and Hib vaccine manufacturer Merck and Co. will help fill the supply gap.
  • According to the CDC, enough infant and adult pertussis-containing and Hib vaccine remains available to ensure that no changes to the current immunization recommendations are needed.

"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," said Averbeck. "To manage the supply, we are implementing allocations where possible, but we will stock out of multiple vaccines prior to resolution of this issue in mid-October."

Averbeck said all of the supplies currently released for distribution have passed the required tests, and no known safety issues exist.

According to Jeanne Santoli, M.D., M.P.H., deputy director of the Immunization Services Division in the CDC's National Immunization Program, DTaP vaccine manufacturer GlaxoSmithKline is prepared to fill supply gaps until Sanofi begins ramping up vaccine production again in October. The CDC also will make vaccine from its Strategic National Stockpile available to address any remaining gaps, she said.

"We will have enough of the infant and adult pertussis-containing vaccines available in the marketplace so that we will not have to make changes to the (routine vaccine recommendation schedules)," she said. "We have also spoken with (Merck and Co.) regarding its ability to make additional Hib products available, and they will be able to fill those gaps."

Santoli said that although this will be a "challenging time" because people might need to use a vaccine presentation or brand they're not accustomed to, the issue amounts to nothing more than inconvenience.

"The good news is that we are able to make up for the gaps at this point with available supply," she said.

Averbeck said the current shortfall is unrelated to the earlier challenges Sanofi has had producing Pentacel in each of the last two summers.

"We've been working to implement process improvements on Pentacel, specifically, for quite some time," he said. "The issue we are having today is an independent one -- outside those process improvements -- tied to the anomaly on the filling line. So although I can tell you we are making progress on the (Pentacel) process improvements, unfortunately, this separate issue also impacts Pentacel, as it is filled on this line."

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