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Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine

[29 September 2014]

Products Affected - Description

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine), Sanofi-Pasteur
0.5 mL, single dose vials, package of 10 (old NDC 49281-0400-10, new NDC 49281-0400-58)
 
Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine), GlaxoSmithKline
0.5 mL, single dose syringes, package of 10 (NDC 58160-0842-52)

Reason for the Shortage

  • Sanofi-Pasteur has Adacel is in short supply due to manufacturing delays. This product is also known as adult tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine.1
  • Sanofi-Pasteur is in the process of implementing new NDC numbers for vaccine products.1
  • GlaxoSmithKline has available Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Boostrix). The 1 count Boostrix syringe is no longer made.2
  • GlaxoSmithKline has Boostrix on shortage due to increased demand.2
  • Adult Tetanus and Diphtheria Toxoids Adsorbed (Td) (Tenivac, Sanofi-Pasteur) is not affected by this shortage.1

Available Products

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine), Sanofi-Pasteur
0.5 mL, single dose syringes, package of 10, old (NDC 49281-0400-15), new (NDC 49281-0400-88)
 
Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine), GlaxoSmithKline
0.5 mL, single dose vials, package of 10 (NDC 58160-0842-11)

Estimated Resupply Dates

  • Sanofi-Pasteur has Adacel vials on back order and the company cannot estimate a release date.1
  • GlaxoSmithKline has Boostrix syringes available with an expiration date of February 2015.2

Implications for Patient Care

  • Both Adacel and Boostrix are labeled for active booster immunization against tetanus, diphtheria, and pertussis infection; and are given as a single booster dose. The specific product labeling differs for the two agents.3-5
  • Adacel is labeled for booster immunization in patients 11 to 64 years.3
  • Boostrix is labeled for booster immunization in patients age 10 years and older.4
  • Tetanus and Diphtheria Toxoids Adsorbed (Tenivac) is labeled for active immunization against tetanus and diphtheria in patients 7 years and older. Tenivac may be used for the primary immunization series or for booster immunization, including post-exposure diphtheria prophylaxis and wound management for tetanus.6

Alternative Agents & Management

  • According to the ACIP, Adacel and Boostrix may be used interchangeably in adolescents between 11 and 18 years, regardless of the type of pediatric diphtheria/tetanus/pertussis vaccine used earlier in childhood.5
  • The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) recommendations for use of Tdap are summarized in Table 1.
  • To reduce the potential of disease due to individuals not being immunized, the ACIP recommends administration of Tdap without regard to the interval of previous tetanus or diphtheria-toxoid containing vaccines.5
  • If Tdap is indicated but is unavailable, the ACIP recommends the following based on the interval since the patient’s last dose of any diphtheria/tetanus vaccine (eg, DTaP, Td, DT):5
    • Administer Td if the interval is 10 years or more.
    • Temporarily defer vaccination if the patient is likely to return for follow-up and the interval is less than 10 years.
    • Consider referring the patient to another facility where Tdap is available, regardless of interval.

Related Shortages

References

  1. Sanofi-Pasteur, (personal communications). August 18, September 6 and 23, October 11 and 21, December 9, 2013; January 3, February 5, March 10 and 17, April 28 and 30, June 10, July 8 and 23, August 28, and September 29, 2014.
  2. GlaxoSmithKline, (personal communications). August 18, September 6 and 23, October 8 and 29, December 9, 2013; January 3, February 5, and March 10, April 28, May 29, June 10, July 8 and 29, August 28, and September 29, 2014. 
  3. Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed). Prescribing Information. Swiftwater, PA: Sanofi Pasteur Inc; February 2012.
  4. Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed). Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; February 2013.
  5. Broder KR, Cortese MM, Iskander JK, et al. Preventing tetanus, diphtheria, and pertussis among adolescents: Use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(RR-3):1-34.
  6. Tenivac (Tetanus Toxoid and Diphtheria Toxoid). Prescribing Information. Swiftwater, PA: Sanofi Pasteur Inc; October 2011.
  7. ACIP Childhood/Adolescent Immunization Work Group, Akinsanya-Beysolow I, Jenkins R, Meissner HC; Centers for Disease Control and Prevention (CDC).Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule for persons aged 0 through 18 years--United States, 2013. MMWR Surveill Summ. 2013 Feb 1;62 Suppl 1:2-8. PubMed PMID: 23364302.
  8. ACIP Adult Immunization Work Group, Bridges CB, Woods L, Coyne-Beasley T; Centers for Disease Control and Prevention (CDC). Advisory Committee onImmunization Practices (ACIP) recommended immunization schedule for adults aged 19 years and older--United States, 2013. MMWR Surveill Summ. 2013 Feb 1;62 Suppl 1:9-19. PubMed PMID: 23364303.
  9. Recommended Adult Immunization Schedule, by Vaccine and Age Group. United States, October 2005 – September 2006. Available online at http://www.cdc.gov/nip/recs/adult-schedule-bw.pdf. Accessed on October 5, 2006. Atlanta, GA: Centers for Disease Control and Prevention; 2006.

Updated

Updated September 29, 2014 by Megan Dryer, PharmD, Drug Information Specialist. Created October 5, 2006 by M. Christina Beckwith, PharmD, and Erin R. Fox, PharmD, Drug Information Specialists. Copyright 2014, 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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