Haemophilus B Conjugate Vaccine Shortage

• • GlaxoSmithKline relaunched Hiberix in August 2016.[1]
  • Sanofi Pasteur had ActHIB in short supply due to the shortage of other combination vaccines (eg, Pentacel).[2,3]
  • Merck has Pedvax HIB (Haemophilus b meningococcal protein conjugate vaccine) available.[4]

• • ActHIB intramuscular powder for solution, Sanofi Pasteur, 10 mcg, single dose vial, 5 count, NDC 49281-0545-05
  • Hiberix intramuscular powder for solution, GlaxoSmithKline, 10 mcg, single dose vial, 10 count, NDC 58160-0818-11
  • PedvaxHIB intramuscular solution for injection, Merck, 7.5 mcg, 0.5 mL single dose vial, 10 count, NDC 00006-4897-00

Estimated Resupply Dates

• • All presentations are currently available.

Implications for Patient Care

• • ActHIB is labeled for primary and booster immunization against infection with H. influenzae type B as a 4-dose series in pediatric patients ages 2 months to 5 years.[5]
  • Hiberix is labeled for primary and booster immunization against infection with H. influenzae type B in patients ages 6 weeks to 4 years of age.[6]
  • PedvaxHIB is labeled for primary and booster immunization against infection with H. influenzae type B in patients 2 to 71 months of age.[7]

Safety

• • Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.[8,9]

Alternative Agents & Management

• • The CDC has a guidance document available for clinicians during this shortage. Available at: https://www.cdc.gov/vaccines/hcp/clinical-resources/downloads/pentacel-delay.pdf.[10]

References

• 1. GlaxoSmithKline (personal communications). January 14, February 3, March 7, April 26, June 7, July 22, August 1, September 6, November 16, and December 13, 2016.
  2. Sanofi Pasteur (personal communications). January 14, February 3, March 7, April 26, May 26, July 20, August 24, September 6, November 16, and December 12, 2016.
  3. 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.
  4. Merck (personal communications and website). January 25, March 7, April 26, May 26, July 22, August 3, September 6, November 17, and December 12, 2016.
  5. Sanofi Pasteur. ActHIB Haemophilus b Conjugate Vaccine (Tetanus toxoid conjugate) Solution for Intramuscular Injection [product labeling]. Swiftwater, PA: Sanofi Pasteur; 2015.
  6. GlaxoSmithKline. Hiberix Haemophilus b Conjugate Vaccine (Tetanus toxoid conjugate) Solution for Intramuscular Injection [product labeling]. Research Triangle Park, NC: GlaxoSmithKline, January 2016.
  7. Merck & Company. Liquid PedvaxHIB Haemophilus b Conjugate Vaccine (Meningococcal protein conjugate) Injection [product labeling]. Whitehouse Station, NJ: Merck & Company; December 2010.
  8. 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.
  9. 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.
  10. 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.