Hepatitis B Vaccine Recombinant and Bivalent Haemophilus influenzae type B conjugate

14 October 2009

Products Affected - Description

Recombinant hepatitis B vaccine and bivalent Haemophilus influenzae type b (Hib) conjugate vaccine (COMVAX) single-dose vials, package of 10 (NDC 00006-4898-00), Merck

Reason for the Shortage

• Merck has temporarily discontinued production of COMVAX due to sterility concerns.¹ Vaccine potency was not affected. During routine inspection of manufacturing equipment, Merck identified the potential for vaccine contamination by Bacillus cereus.
• No contamination has been found during sterility testing of vaccine lots and no resultant infections have been reported following COMVAX administration.¹

Estimated Resupply Dates

Merck cannot estimate when COMVAX will be available.¹

Implications for Patient Care

• Use individual vaccine components.
• Refer to Advisory Committee on Immunization Practices (ACIP) guidelines and Centers for Disease control and Prevention (CDC) for current immunization guidelines and vaccine availability.^2-5
• Supplies of Hib vaccine (Sanofi-Pasteur) are now sufficient to reinstate the 12 to 15 month booster dose as an on time vaccination.⁶

Safety

Ensure patients receive the adequate number of vaccinations as outlined by the Centers for Disease Control and Prevention (CDC) Recommended Immunization Schedules.^2-5

Related Shortages

• Hepatitis A Virus Vaccine Inactivated
• Hepatitis B Vaccine Recombinant
• Influenza Virus Vaccine
• Measles Virus Vaccine Live— No Longer Available
• Measles, Mumps, Rubella and Varicella Virus Vaccine Live Injection
• Meningococcal Polysaccharide Vaccine— Resolved
• Mumps Virus Vaccine Live— No Longer Available
• Rabies Vaccine— Resolved
• Rubella Virus Vaccine Live Injection— No Longer Available
• Varicella Virus Vaccine Live— Resolved
• Yellow Fever Vaccine Injection
• Zoster Vaccine Live— Resolved

1. Merck, Customer Service (personal communications). November 21 and 27, and December 3 and 11, 2001, and January 28, and February 27, April 19, May 22, August 5 and September 10, 2002; August 13, 2003, October 28, and November 4, 2003; and October 31, 2005, and January 20, March 27, May 2, September 9, 10, and 11, October 2, and December 5, 2006; February 20, and December 13, 2007; and August 18, and December 1, 2008; and February 25 and March 25, and June 22, and October 12, 2009.
2. Centers for Disease Control and Prevention (CDC). Recommended Immunization Schedules for Persons Aged 0–18 Years – United States, 2008. MMWR Morb Mortal Wkly Rep. 2008 Jan 11;57(1):Q1-Q4. Accessed January 14, 2008.
3. Immunization Action Coalition. Summary of Rules for Childhood and Adolescent Immunization, October 2007. St., Paul, MN: Merck. Accessed November 9, 2007.
4. Centers for Disease Control and Prevention (CDC). Interim recommendations for the use of Haemophilus influenzae type b (Hib) conjugate vaccines related to the recall of certain lots of Hib-containing vaccines (PedvaxHIB®) and COMVAX®). MMWR Morb Mortal Wkly Rep. 2007 Dec 19;56(Dispatch):1-2. Accessed on December 20, 2007.
5. Centers for Disease Control and Prevention. CDC Health Advisory. Invasive haemophilus influenzae type b disease in young children and importance for all young children to receive 3-dose primary series with available Hib-containing vaccine. Accessed March 25, 2009.
6. Centers for Disease Control and Prevention. Updated Recommendations for Use of Haemophilus influenzae Type b (Hib) Vaccine: Reinstatement of the Booster Dose at Ages 12—15 Months. MMWR Morb Mortal Wkly Rep. 2009 Jun 25; 58(24):673-674.

Updated

Updated October 14, 2009 by Michelle Wheeler, Pharm.D., Drug Information Specialist, Drug Information Service. Created December 11, 2001 by M. Christina Beckwith, Pharm.D., Drug Information Specialist and Erin R. Fox, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.

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