ACIP: rabies vaccine, IG supplies will be 'less than ideal'.

ATLANTA -- Supplies of human rabies biologicals for pre- or postexposure prophylaxis in the United States are "manageable, but are expected to be less than ideal" over the next few years, Charles E. Rupprecht, V.M.D., said at the winter meeting of the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

The CDC, along with the Food and Drug Administration and industry, "continue to work together towards productive solutions to this problem," said Dr. Rupprecht, chief of the CDC's rabies program.

Since the winter meeting, ACIP has formed an ad hoc working group to address the problem.

The group is currently discussing strategies for maximizing the current supplies and devising algorithms for how to prioritize the vaccine and immune globulin in the event of an actual shortage, CDC spokeswoman Abbigail Tumpey said in an interview.

At the same time, the CDC also is working on public education messages about when rabies vaccination is necessary and when it isn't. "Many scenarios, such as merely seeing a rabid animal, being in the same room, petting, etc., are notconsidered grounds for prophylaxis.... This is an emerging area where we're overvaccinating those not at risk," Dr. Rupprecht noted in his presentation at the meeting.

There are currently two human rabies vaccines and two rabies immunoglobulins (IGs) on the U.S. market. The vaccines are the human diploid cell vaccine Imovax (Sanofi-Pasteur) and the purified chick embryo cell RabAvert (Novartis AG). The IG products are IG Imogam Rabies-HT (Sanofi-Pasteur) and HyperRAB S/D (Talecris Biotherapeutics).

The Novartis RabAvert supply currently is limited and is thus being distributed for postexposure prophylaxis only and not for routine vaccination of high-risk occupational groups.

The company filed a biologics license application supplement with the FDA in December 2007 for upgrading their rabies vaccine manufacturing facilities, and it is not certain when it will be back to full supply, said Rajiv De Silva, president of Novartis Vaccines in the United States.

Sanofi-Pasteur has stepped in to fill the gap as much as possible but can only supply a limited portion of the U.S. rabies vaccine market, said Philip H. Hosbach, vice president of immunization policy and government relations at Sanofi-Pasteur US.

Mr. Hosbach estimated that the company could supply half of the U.S. market for the next 2 years before having increased vaccine production capacity and availability, possibly in late 2009.

Meanwhile, the overall supply of IG--which is administered along with vaccine as postexposure prophylaxis--is limited because of human plasma shortages.

In addition, Talecris has recently issued a statement saying that the 2-mL pre-filled syringe of HyperRAB "does not address all dosing situations" and providing guidance on how the product should be used (www.talecris.com / us / talecris-ushyperrab.htm).

Information about rabies and its management is available online at www. cdc.gov/rabies.

BY MIRIAM E. TUCKER

Senior Writer