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CDC Notice

Expect Shipment Delays for Some Hepatitis A Vaccine Products

By News Staff
8/3/2007

Merck & Co. has notified the CDC that the company currently reports backorders, with associated shipment delays, for both the pediatric and adult formulations of its hepatitis A vaccine, inactivated. At this time, however, CDC officials are not calling for any related changes in hepatitis A immunization recommendations.

Clinical Practice
Merck reports expected delays of as much as six to seven weeks in shipping backorders of the vaccine, sold as VAQTA. Details about availability of these Merck products after September are unknown, but a statement from the CDC promises updates as soon as more information becomes available.

No changes are planned in the current recommendations for use of hepatitis A vaccine, say CDC officials. All recommendations developed by the CDC's Advisory Committee on Immunization Practices for use of this vaccine, including those for post-exposure prophylaxis, should be followed.

The other U.S. manufacturer of hepatitis A vaccine, GlaxoSmithKline, or GSK, reports it has initiated plans to boost production of its pediatric and adult hepatitis A vaccine formulations, sold as Havrix -- as well as its adult hepatitis A/hepatitis B combination vaccine, Twinrix -- but it is not yet clear how much additional vaccine GSK will provide.

Regardless, the CDC statement notes, "The overall U.S. hepatitis A vaccine supply is expected to be adequate to fully vaccinate all persons who are recommended to receive hepatitis A vaccine, including all children at age 1 year (i.e., 12-23 months), as well as older children in areas with existing hepatitis A vaccination programs and persons at increased risk for hepatitis A."

Comprehensive immunization recommendations are available from the CDC Web site. (30-page PDF file; About PDFs)

Physicians who receive hepatitis A vaccine from Merck -- whether through a direct purchase account or via a distributor -- may wish to consult their manufacturer or distributor representatives to discuss options for obtaining vaccine in a timely fashion. Merck encourages health professionals with existing orders of the vaccine to address questions to the company's order management center at (800) 637-2579.

Information about this and other vaccine shortages is available by linking to the CDC through the AAFP Web site.

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