[19 June 2013]
Products Affected - Description
Diphtheria, Tetanus Toxoid, and Acellular Pertussis Vaccine (DTaP)
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
0.5 mL single dose vial, package of 10 (NDC 49281-0286-10)
Reason for the Shortage
- Sanofi Pasteur states the reason for the Daptacel shortage is a manufacturing delay.1,2
- Sanofi Pasteur discontinued Tripedia in 2011.
Available Products
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
- Sanofi Pasteur has Daptacel on allocation.
Safety
- 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
Related Shortages
References
- Sanofi Pasteur (personal communications). May 18, June 20, July 18, August 22, October 5, and November 12, 2012; and January 14, March 1, April 1 and 17, and June 18, 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
Updated June 19, 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.
Disclaimer
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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