DTaP Vaccine Supplies Will Be Limited for Summer 2013

Although No Change in Immunization Recommendations, CDC Offers Guidance During Shortage

May 22, 2013 02:45 pm Matt Brown

For the second consecutive summer, the CDC has issued guidance(www.cdc.gov) on immunizing children during an ongoing shortage of certain combination vaccines.

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According to a notice on the CDC website(www.cdc.gov), Sanofi Pasteur's diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTaP-IPV-Hib), marketed as Pentacel, as well as its diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed, marketed as Daptacel, are expected to remain in short supply throughout summer 2013.

Michael Szumera, director of U.S. communications/public relations for Sanofi Pasteur, said the company will resume distributing Pentacel in limited quantities the week of June 3, but allocation restrictions on the vaccine will remain in place throughout the summer.

"Sanofi Pasteur has made significant progress in the manufacturing of Pentacel vaccine and fully anticipates beginning the process of lifting Pentacel vaccine allocations in early September," Szumera told AAFP News Now. "Daptacel vaccine is currently under customer level allocations to help responsibly manage inventory following the recent supply announcement from another manufacturer," he added, referring to GlaxoSmithKline (GSK).

The shortage, which began in April 2012, also will affect supplies of GSK's diphtheria and tetanus toxoids and acellular pertussis absorbed, hepatitis B (HepB recombinant) and inactivated poliovirus vaccine, marketed as Pediarix. During last year's shortage, GSK was able to fill the gap created by Sanofi Pasteur's vaccine shortage, but will be hard-pressed to do so again this year.

"GSK has taken steps to meet this increased demand, but will not be able to supply (Pediarix) at the same rate over the next four-six months before Pentacel is available without restrictions, which is currently anticipated to occur in September 2013," the CDC said in its notice.

Therefore, said the agency in its guidance document, "Practices using these vaccines may need to find alternatives during the shortage. Single-component DTaP, IPV, HepB, and Hib vaccines and other age-appropriate licensed combination vaccines are available to complete series begun with Pentacel or Pediarix. Currently, there is a sufficient supply of these products to meet the anticipated demand."

Overall, said the CDC, physicians and other health care professionals are encouraged to follow Advisory Committee on Immunization Practices recommendations when changing vaccine products and use the same brand of vaccine for all doses of a vaccination series when feasible.

During the shortage, however, or when the brand previously used is unknown, other brands may be administered. For example, a child who began the series with Pentacel and then received single-component products at one or more subsequent visits may be given Pediarix in lieu of DTaP, IPV and HepB when all three vaccines are indicated.

"If different brands of a vaccine require different numbers of doses, use the higher number when mixing brands," the CDC said in its guidance, which also includes a reminder that with the exception of GSK's single-component Hib vaccine (Hiberix), which is licensed only for use as a booster in the Hib series, other Hib vaccines are interchangeable.

The agency has provided a quick reference table(www.cdc.gov) detailing which alternative vaccines may be given during the shortage and when.

Physicians who participate in the CDC's Vaccines for Children program(www.cdc.gov) may wish to contact their state and/or local immunization program for guidance about ordering vaccine.