12/19/2016

Pentacel- Diphtheria, Tetanus Toxoid, and Acellular Pertussis and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine (DTaP-IPV/Hib)

Reason for the Shortage

- Sanofi Pasteur states the reason for the shortage was manufacturing delay.[1,2]

Available Products

- Pentacel vaccine, Sanofi Pasteur, 0.5 mL single dose vial, 5 count, NDC 49281-0510-05

Estimated Resupply Dates

- Sanofi Pasteur has Pentacel vaccine readily available.[1]

Implications for Patient Care

- Pentacel is labeled for active immunization against tetanus, diphtheria, pertussis, poliomyelitis and invasive Haemophilus influenzae type B (DTap, IPV, HIB) as a 4-dose series in pediatric patients ages 6 weeks to 4 years old.[3]

Safety

- Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.[4,5]

Alternative Agents & Management

- The CDC has a guidance document available for clinicians during this shortage. Available at: http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/pentacel-delay.pdf.[6]
- There are no other combination vaccines available that include DTaP, IPV, and HIB.

References

1. Sanofi Pasteur (personal communications). January 14, February 10, March 22, April 26, June 16, July 20, September 6, October 17, November 17, and December 19, 2016
2. Sanofi Pasteur. Dear Health Care Provider Letter (December 2015). Available at: https://www.vaccineshoppe.com/mailing/VSH/2015/12allo30341/index.html. Accessed January 14, 2016.
3. Sanofi Pasteur. Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus and Haemophilus B Conjugate Vaccine) Suspension for Intramuscular Injection [product labeling]. Swiftwater, PA: Sanofi Pasteur; 2013.
4. 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 at: http://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf. Accessed January 14, 2016.
5. Department of Health and Human Services, Centers for Disease Control and Prevention. Recommended Immunization Schedule for Persons Ages 0 to 18 Years, United States 2015. Available at: http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed January 14, 2016.
6. Department of Health and Human Services, Centers for Disease Control and Prevention. Guidance for vaccinating children during the 2015-16 Pentacel manufacturing delay. Available at http://www.cdc.gov/vaccines/vac-gen/shortages/downloads/pentacel-delay.pdf. Accessed January 14, 2016.

Updated

Updated December 19, 2016 by Leslie Jensen, PharmD, Drug Information Specialist. Created January 14, 2016 by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2017, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

« Back to Drug Shortage Product Bulletins

Subscribe to AHFS Clinical Drug Information to get direct access to integrated drug shortages content, plus comprehensive and actionable drug information.