Tight supplies crimp human rabies vaccine

Nothing becomes dearer than a medicine in short supply. Whether it's preventive antibiotics during the anthrax-letter attacks seven years ago or periodic seasonal shortages of flu shots, medical shortages can impose systems of rationing that Americans usually tolerate only in wartime or with hot Christmas toys.

And increasingly, patients find themselves in the clutches of a world market supplied by just a handful of companies making something people literally can't live without. That's what has happened this year with human rabies vaccines.

Two companies, Novartis and Sanofi Pasteur, make vaccines that are licensed for use in people exposed to rabies in the United States. Except, since mid-2007, Sanofi hasn't been making any, and Novartis encountered production problems that ran afoul of the U.S. Food and Drug Administration, suspending shipments for several months.

Sanofi officials thought they had stockpiled plenty of their vaccine before they started renovating their production facility in France. They planned on resuming operations next summer or fall.

Along with the supply problems, demand also increased worldwide with new outbreaks of the virus reported in domestic and wild animals. Rabies affects the central nervous system and usually produces symptoms within a few weeks after infection from an animal bite. Fatigue, headaches and fever are followed by seizures, hallucinations and paralysis. Untreated, it is almost always fatal.

While an estimated 40,000 to 50,000 people in the United States are potentially exposed to rabies each year, only a few Americans die from the infections each year. Worldwide, health officials estimate that 40,000 to 70,000 people die from rabies annually.

Why the difference? Most Americans vaccinate their pets against rabies. And most of us who get an animal bite from wildlife or an unfamiliar pet seek medical attention. Dogs are seldom vaccinated in less developed countries, and many people who are bitten by an animal can't or don't seek medical care until it's too late.

Public-health officials say that 80 percent to 90 percent of human exposure to rabies in this country comes from wild animals, particularly from bats, along with skunks, raccoons and feral dogs and cats.

In recent years, U.S. doctors have tended to err on the side of vaccinating rather than not vaccinating when people come in with bites or even exposure to saliva from an animal behaving erratically. A few celebrated cases of people dying after apparent bat exposure may be one factor, along with concern over medical liability. So even though the series of shots can be painful and costly - $1,000 or more - unless a bite turned out to be from an insect or a bird (critters that don't transmit rabies), patients got the shots.

A person who is exposed and has never been vaccinated should get five doses of rabies serum - the first as quickly as possible and the rest at intervals over 28 days. They should also receive a dose of an antibody that provides immediate, but temporary, protection.

But this summer and fall around most of the country doctors are being forced to be choosier about who gets vaccinated for rabies. Precautionary shots for veterinarians, animal trainers, biologists and others who handle animals have not been available, in most cases, at all this year.

And state and local health departments, along with the federal Centers for Disease Control and Prevention, are warning people to take extra precautions around wildlife and strange domestic animals to avoid bites.

Although the specifics vary, doctors treating bite victims have to consult with a public-health official, either by phone or via a faxed form, to determine if rabies-prevention shots are warranted. The official will then give the doctor a code number, which must be used to order the doses from Novartis or Sanofi.

Dr. Charles Rupprecht, the veterinarian who heads the CDC's rabies program, says that despite the restrictions, "no one who really needs rabies vaccine is going without." Rabies exposure for humans typically subsides in most of the country during the winter - fewer animals moving about and fewer humans outside to interact with them - so demand for vaccine should go down.

But until Sanofi's plant re-opens next year, and Novartis starts up a new German vaccine plant with greater capacity in 2011, it's a good time to make sure your pets' rabies shots are up to date and to keep them, and you, away from wildlife.