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

Last Updated: December 19, 2016
Status: Resolved

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.

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