[17 April 2013]
Products Affected - Description
Daptacel Vaccine, Sanofi Pasteur
0.5 mL single dose vial, package of 1 (NDC 49281-0286-01) - discontinued
0.5 mL single dose vial, package of 5 (NDC 49281-0286-05) - discontinued
Reason for the Shortage
- Sanofi Pasteur states the reason for the Daptacel shortage was manufacturing delay.1,2
- Sanofi Pasteur discontinued Tripedia in 2011.
Daptacel Vaccine, Sanofi Pasteur
0.5 mL single dose vial, package of 10 (NDC 49281-0286-10)
Infanrix Vaccine, GlaxoSmithKline3
0.5 mL single dose vial, package of 10 (NDC 58160-0810-11)
0.5 mL single dose syringe, package of 10 (NDC 58160-0810-52)
Estimated Resupply Dates
All presentations are currently available.
- DTaP and Tdap vaccines both contain diphtheria, tetanus toxoid, and acellular pertussis. DTaP vaccines (eg, Daptacel, Infanrix) and are recommended for use in infants and children under 7 years of age. Tdap vaccines (eg, Adacel, Boostrix) are recommended for use in adolescents and adults 10 to 64 years of age.4
- Do not substitute Tdap vaccines for DTaP vaccines.
- Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.5
Alternative Agents & Management
- Daptacel is labeled for active immunization against tetanus, diphtheria, and pertussis (DTaP) as a 5-dose series in pediatric patients ages 6 weeks to 6 years old.6
- During this shortage, clinicians should use an alternate DTaP vaccine to complete the recommended immunization schedule.5 For more information, see online Guidance document from CDC.7
- Sanofi Pasteur (personal communications). May 18, June 20, July 18, August 22, October 5, November 12, 2012; January 14, March 1, and April 1 and 17, 2013.
- Sanofi Pasteur. Supply notification letter to health care providers (April 2012). Available online. Accessed May 18, 2012.
- GlaxoSmithKline Vaccines Supply Status (updated May 9, 2012) available online.
- Wickersham RM, Novak KK, managing eds., eds. Drug Facts and Comparisons (eFacts). St. Louis, MO: Wolters Kluwer Health, Inc.; 2012.
- Centers for Disease Control and Prevention (CDC). General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practice. MMWR Morb Mortal Wkly Rep. 2011 Jan 28;60(RR02):1-60. Available online. Accessed May 18, 2012.
- Sanofi Pasteur. Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed) Suspension for Intramuscular Injection [product labeling]. Swiftwater, PA: Sanofi Pasteur; 2011.
- Department of Health and Human Services, Centers for Disease Control and Prevention. Guidance for vaccinating children during the 2012 Pentacel and Daptacel Shortage. Available online. Accessed May 18, 2012.
Updated April 17, 2013 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 18, 2012, by Jane Chandramouli, PharmD, Drug Information Specialist, Drug Information Service Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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