[04 November 2013]
Products Affected - Description
Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine), Sanofi-Pasteur
0.5 mL, single dose syringes, package of 10 (NDC 49281-0400-15)
0.5 mL, single dose vials, package of 10 (NDC 49281-0400-10)
Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine), GlaxoSmithKline
0.5 mL, single dose syringes, package of 1 (NDC 58160-0842-32) - discontinued
0.5 mL, single dose syringes, package of 10 (NDC 58160-0842-52)
0.5 mL, single dose vials, package of 10 (NDC 58160-0842-11)
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
- GlaxoSmithKline has available Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Boostrix). The 1 count Boostrix syringe is no longer made.2
- Adult Tetanus and Diphtheria Toxoids Adsorbed (Td) (Tenivac, Sanofi-Pasteur) is not affected by this shortage.1
There is insufficient supply for usual ordering.
Estimated Resupply Dates
- Sanofi-Pasteur has Adacel vials available on allocation. Adacel syringes are on back order and the company estimates a release date of mid-December 2013.1
- GlaxoSmithKline’s Boostrix is available for ordering but has shipping delays. The typical shipping delay is approximately 5 days.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.
- Sanofi-Pasteur, (personal communications). August 18, September 6 and 23, and October 11 and 21, 2013.
- GlaxoSmithKline, (personal communications). August 18, September 6 and 23, and October 8 and 29, 2013.
- Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed). Prescribing Information. Swiftwater, PA: Sanofi Pasteur Inc; February 2012.
- Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed). Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; February 2013.
- 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.
- Tenivac (Tetanus Toxoid and Diphtheria Toxoid). Prescribing Information. Swiftwater, PA: Sanofi Pasteur Inc; October 2011.
- 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.
- 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.
- 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 November 4, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created October 5, 2006 by M. Christina Beckwith, PharmD, and Erin R. Fox, PharmD, Drug Information Specialists. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.
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