Biological Product Shortages

Hepatitis B Vaccine
Recombivax HB®

Merck & Co., Inc.

Beginning in January 2009, Merck anticipates a supply interruption in the US of the adult formulation for hepatitis B vaccine, Recombivax HB®. This includes vials, syringes and dialysis formulations. Merck states that pediatric formulations are not affected and will be sufficient to meet anticipated demand. For additional information on supply and availability, please see CDC's Current Vaccine Shortages & Delays web page .

Rubella Virus Vaccine Live
Meruvax II®

According to Merck’s web page, MERUVAX® II (Rubella Virus Vaccine Live) is no longer available for order. The Advisory Committee on Immunization Practices (ACIP) has recommended the use of combined measles-mumps-rubella vaccine (M-M-R® II - Measles, Mumps, and Rubella Virus Vaccine Live) for appropriate individuals to help protect against measles, mumps, and rubella.

Beginning in July of 2008 Merck reported shipping delays for Zostavax® (Zoster Vaccine Live). As of this posting (mid-November 2008) the product availability is unchanged with backorders of 3 to 5 weeks. More information is available on the CDC Current Vaccine Shortages and Delays web page.

Baxter Healthcare Corp

Grifols Biologicals Inc

Instituto Grifols, SA

Octapharma Pharmazeutika Produktionsges.mbH

Talecris Biotherapeutics, Inc

ZLB Behring AG

ZLB Behring LLC

The current short supply situation is due to increased order volumes in the latter part of 2007, and should improve within weeks. FDA and the manufacturer have not received reports of specific shortages at this time.

Although industry inventories are currently limited, it is possible that sufficient supplies exist at the distributor and pharmacy level.

How to obtain products for patients with urgent need:

Digibind®: Patients and healthcare providers may contact GlaxoSmithKline directly at 800-877-1158.

Your Regional Poison Control Centers may also be able to assist in locating regional supplies of Digoxin Immune Fab products (1-800-222-1222)

To report a biological product shortage, you may send an email to CBERProductshortages@cber.fda.gov. Also, during business hours, biological product manufacturers and healthcare personnel may report a real or suspected biological product shortage by calling (301) 827-6220.

Distributed by MedImmune, Inc.

Recently, MedImmune has experienced supply shortages. In order to provide product to post-operative transplant patients, MedImmune has provided ordering instructions for physicians and healthcare professionals to obtain product through designated wholesalers. For more information, call MedImmune Customer Support Network at (877) 633-4411 or look on the MedImmune web page under "Products" and click on "CytoGam®."

This action will reduce by approximately one half the expected supply of trivalent inactivated vaccine (flu shot) available in the United States for the 2004-05 influenza season. The CDC recommends vaccination priority be given to children aged 6-23 months, persons aged 2-64 years with underlying chronic medical conditions, all women who will be pregnant during the influenza season, and those over 65 years of age, as well as several other groups (see the CDC website for further information).

Production problems now appear to be resolved. On July 9, 2004, CDC in conjunction with the Advisory Committee on Immunization Practices (ACIP), the American Academy of Family Physicians, and the American Academy of Pediatrics recommended that providers administer 3 doses of vaccine. The fourth dose should still be deferred for healthy children until production and supply data demonstrate that a 4-dose schedule can be sustained. Children at high risk for severe pneumococcal disease should continue to receive the 3rd and 4th doses.