The shortage of vaccines in the United States against smallpox and anthrax is hardly isolated to those once-obscure bioterrorist threats. This country suffers chronic difficulties in producing even some everyday inoculations.
The process is plagued by shortages and manufacturing snafus. Flu shots, for example, will be delayed again this year because one of the four manufacturers has stopped making the vaccine and another is experiencing plant delays.
A months-long shortage of tetanus vaccine has forced hospitals and doctors to abandon standard 10-year booster shots for adults and even to deny shots to injured patients in some remote areas. And demand for a new vaccine against such childhood maladies as meningitis has been so great that its manufacturer can't keep up.
Several other vaccines are produced by only one manufacturer and could disappear with a serious plant malfunction, a failure to meet federal standards or a decision by the producer to withdraw from the market.
The problem is that vaccine makers have little financial incentive to continue manufacturing because vaccines are relatively inexpensive. And the companies face plenty of legal liability when patients allege injury. From their perspective, plants could be better used to make blockbuster drugs.
"Let's face it, there aren't the profits in vaccines that there are in [the baldness drug] minoxidil," said Steven Block, advisor to the government on biological warfare issues and a Stanford University biophysicist.
Critics lament that the federal government has little control over the industry. Legally, the government cannot require companies to manufacture vaccines, nor can federal officials demand that companies give notice if they want to stop making one.
Dr. Steven Black, co-director of the Vaccine Study Center at Kaiser Permanente, said vaccine companies should be regulated in the same way as public utilities or banks.
If the lone maker of tetanus vaccine "decided they could make more money selling rubber ducks tomorrow, they could theoretically stop doing that and then there would be no one producing tetanus in this country," Black said. "That doesn't seem appropriate to me."
For now, doctors and patients confront some serious shortages.
Rural physicians complain that they have no tetanus vaccines for patients who suffer deep cuts or who step on scraps of metal, said Dr. Bruce Gellin, executive director of the National Network for Immunization Information. Pulmonologists, he said, have reported they couldn't get flu shots for some patients with weak immune systems.
"It's not clear that people have been harmed yet by these delays, but the fact that there are spot shortages of these vaccines--and you have to prioritize who gets it--that's a problem," Gellin said.
British Firm Making Smallpox Vaccine
With bioterrorism fears growing by the day, Health and Human Services Secretary Tommy Thompson negotiated a deal with a British company, Acambis, to produce 40 million doses of smallpox vaccine by next summer. He's also negotiating with other drug companies to expand the government's stockpile to 300 million doses.
The government had no backup supplies when Wyeth-Lederle Vaccines stopped making tetanus vaccine for adults earlier this year. Because a second company also made the tetanus vaccine, the government did not deem it necessary to keep any reserves on hand.
Aventis Pasteur, the remaining tetanus vaccine manufacture, will need several more months to increase its production.
Government officials acknowledge now that tetanus supply problems could have been prevented.
"We have to reevaluate," said Dr. Walter Orenstein, director of the National Immunization Program at the Centers for Disease Control and Prevention.
Several other vaccines are likewise made by a single company. Merck & Co. is the sole producer of measles-mumps-rubella (MMR) vaccine, as well as the chickenpox vaccine. Wyeth-Lederle is the only manufacturer of pneumococcal vaccine for children.
Neither of the two relatively new vaccines is kept in the government's stockpile.
According to recent CDC figures, the government keeps only three routine vaccines in its stockpile: 4 million doses of MMR vaccine, 3.6 million doses of polio vaccine and 150,000 doses of pediatric diphtheria-pertussis-tetanus vaccine.
Several members of Congress and the National Vaccine Advisory Committee are so concerned about the vaccine supply that they are discussing how the government can protect the public from shortages.
"The government needs to play a bigger role in assuring vaccines by stockpiling them," said Rep. Henry Waxman (D-Los Angeles), who has been actively involved in vaccine supply issues. But having a federal takeover of vaccine manufacturing "would have to be a last resort," he said.