Bulletin
Rubella Virus Vaccine Live Injection
10 November 2009
Products Affected - Description
Meruvax II 0.5 mL single dose vials, package of 10 (NDC 00006-4673-00), Merck - discontinued
Reason for the Shortage
Merck has discontinued all of their single component vaccines of the MMR vaccine based on recommendations of the Advisory Committee on Immunization Practices and other professional organizations (see Report for additional information). Use the combination MMR vaccine whenever any of the components are clinically indicated.1
Estimated Resupply Dates
- Meruvax is discontinued and there are no other suppliers of rubella virus vaccine as a single component.1
- Supplies of M-M-R-II vaccine are not affected by this discontinuation.1
Implications for Patient Care
- Meruvax was labeled for vaccination against rubella in patients 12 months or older. 2
- Do not vaccinate pregnant women with Meruvax or M-M-R II because of the theoretical risk of congenital birth defects. The product labeling recommends encouraging patients not to become pregnant for 3 months following vaccination with M-M-R-II.2,3 The Centers for Disease Control and Prevention (CDC) vaccine information statement (VIS) and the American Academy of Pediatrics recommend encouraging patients not to become pregnant for at least 4 weeks following vaccination with M-M-R-II.4-5
Alternative Agents & Management
- The Advisory Committee on Immunization Practices (ACIP) states the three-component measles-mumps-rubella vaccine (M-M-R-II) is preferred over single component vaccines for routine immunization.6
- Postpartum women may be vaccinated with M-M-R-II. 3
- The M-M-R II vaccine is available from Merck. 1
Related Shortages
References
- Merck (personal communications). February 6 and 20, August 21, October 19, November 26, and December 3, 2007; and January 2, 4, 7, and 14, February 11, April 1, June 2 and 30, August 18, October 24, and December 1, 2008; March 5, June 1, September 1 and October 27, 2009.
- Meruvax II (Rubella Virus Vaccine Live) [product information]. West Point, PA: Merck; 2002, September.
- M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) [product information]. West Point, PA: Merck; 2006 February.
- Centers for Disease Control and Prevention. Vaccine Information Statement – MMR Vaccine (3/13/08). Accessed November 10, 2009.
- Pickering LK, Baker CJ, Kimberlin DW, Long SS. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009.
- Kroger AT, Atkinson WL, Marcuse EK, Pickering LK. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices. MMWR.2006;55(RR15):1-48.
Updated
Updated November 10, 2009 by Erin R. Fox, Pharm.D., Manager, Drug Information Service. Created February 6, 2007 by Erin R. Fox, Pharm.D., Drug Information Specialist. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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