June 01, 2009


 Some restrictions on human-use rabies vaccine lifted

Posted May 16, 2009

Federal authorities announced removal of limitations on one brand of pre-exposure rabies vaccine that had been imposed in spring 2008 because of tight supplies.

An early April announcement from the Centers for Disease Control and Prevention stated that Novartis Vaccines, one of the nation's two human-use rabies vaccine suppliers, had doses available for pre-exposure use. Novartis and Sanofi Pasteur both supply vaccines for postexposure use, but Sanofi's vaccine is available only following evaluations from state or local health departments.

Both vaccines were restricted to postexposure use starting in May 2008, with exceptions for people who were at the greatest risk, such as veterinarians, wildlife biologists, and laboratory workers.

Information provided by Sanofi Pasteur indicates the company started renovations to its rabies vaccine production facility in June 2007 to maintain compliance with U.S. and French regulations. The facility is scheduled to be operational this year.

Sanofi Pasteur had produced its vaccine on the basis of historical demand prior to the start of renovations, but Novartis was unable to produce projected quantities of its vaccine, according to the CDC.

Dr. Charles Rupprecht, chief of the Centers for Disease Control and Prevention's rabies program, said demand remains a volatile issue for vaccines as regions can experience unusually high numbers of rabies exposures.

"We hope that things will...start to improve, given that Novartis is back in this month with no restrictions, and we trust that the preparations that Sanofi has made toward their new production capability will continue on schedule so we will have both manufacturers back in the national vaccine supply situation as it was prior to the limitations experienced during 2007," Dr. Rupprecht said.

Market conditions, regulatory oversight, and the availability of human rabies immune globulin can also affect the dynamics of production of these products for rabies prevention, he said.

"There are a variety of things both in nature and from an industrial standpoint that are going to affect the availability of biologics," Dr. Rupprecht said.

Domestic animals continue to serve as a firewall for human exposures to rabies, and Dr. Rupprecht hopes people do not neglect vaccinations for pets. Unless local laws require yearly vaccinations, he recommends vaccinating pets with three- or four-year biologics.

"We clearly feel that the vaccination buffer provided by veterinary care and biologics to dogs and cats as a whole has a large impact on the number of individuals that would require prophylaxis," Dr. Rupprecht said.

Dr. Rupprecht also expressed praise for veterinarians who vaccinate not only pets, but also horses, livestock, and other animals at risk of contact with wildlife.

"Those animals that come in frequent contact with the public—such as at fairs, petting zoos, etc.—these are the animals that we sometimes forget but obviously are at risk and create a huge important buffer against potential mass exposures," Dr. Rupprecht said.

The CDC's national working group suggested last year creating a stockpile of rabies vaccine to avert supply limitations if a true shortage manifested, Dr. Rupprecht said. The proposal is under discussion at the CDC, he said.