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Vaccine industry needs a shot in the arm to prevent further shortages, says MED prof

By Brian Fitzgerald

Bioterrorist threats have caused the media to focus on the shortage in the United States of vaccines to prevent and treat anthrax and smallpox. But this country has serious difficulties in producing enough of even such everyday inoculations as diphtheria, tetanus, and whooping cough, according to Jerome Klein, a MED professor of pediatrics.

He says that the vaccine production process is plagued by manufacturing problems. Influenza shots, for example, were unavailable for a time last year because one of the four companies producing the vaccine stopped making it and another experienced delays in culturing one of the strains. "We will have continued problems with the vaccines' supply unless we develop strategies to consider how to respond," says Klein, a member of the National Vaccine Advisory Committee (NVAC).

Klein will speak about the crisis at a NVAC conference on February 11 and 12 in Washington, D.C., entitled Strengthening the Vaccine Supply. It will include officials from the federal Department of Health and Human Services, health-care providers, and representatives from vaccine manufacturers. The NVAC plans to identify potential strategies to address the vaccine supply problem and make recommendations to Health and Human Services Secretary Tommy G. Thompson.

Klein says that there are several reasons for the shortage. Some vaccine makers have stopped production suddenly to focus on more profitable products or have interrupted distribution to change their manufacturing methods -- with no stockpile to meet the continuing demand. This has resulted in little or no vaccine in many areas for some diseases, including tetanus. "There used to be four tetanus vaccine manufacturers," says Klein. "Now there is one."

Tetanus, which typically infects the body through a deep wound, can be fatal if not treated. However, because of the shortage, some hospitals and physicians have resorted to rationing the tetanus vaccine, abandoning the required 10-year booster shots for adults. The tetanus vaccine shortage began last year when Wyeth-Lederle Vaccines, one of only two tetanus vaccine manufacturers, discontinued sales of tetanus-related vaccines, while the other company, Aventis Pasteur, suffered a temporary decrease in inventory. Because the government had no backup supplies, it had to wait several months for Aventis Pasteur to step up its production.

Other vaccines are made by a single company: the measles-mumps-rubella vaccine (MMR), as well as the chicken pox vaccine, is made by Merck and Company. Wyeth-Lederle is the sole manufacturer of pneumococcal vaccine, whose brand name is Prevnar. Last year delays in the delivery of Prevnar resulted in shortages because demand exceeded the company's expectations. The NVAC fears that a serious plant malfunction in one of these companies could create a situation where the vaccines could disappear. The government has stockpiles of only three routine vaccines: 4 million doses of the MMR vaccine, 3.6 million doses of polio vaccine, and 150,000 doses of pediatric diphtheria-pertussis-tetanus vaccine.

"It's clear that manufacturers of some vaccines dropped out of the market because there wasn't sufficient profit to stay in," says Klein. Others left the vaccine business because of liability concerns: with large-scale vaccination programs, some patients become sick from the vaccines, and a few die. Some pharmaceutical companies have chosen to focus on vaccines for more specialized conditions, such as Alzheimer's disease, AIDS, and cancer. Blockbuster drugs can enable companies to turn large profits, whereas everyday vaccines are relatively inexpensive, and hence, less profitable.

There are also other factors. "Over the years, the government has increased the stringency of regulations for manufacturing processes," says Klein, "so a number of manufacturers who had aging plants found themselves with a product that was entirely safe, but with new regulations that would force them to spend millions of dollars to upgrade their manufacturing processes, or abandon old plants and build entirely new ones."

Some critics say that the federal government should have more control over the industry, arguing that drug companies should be regulated in the same way as public utilities or banks. Others suggest greater financial incentives for companies to manufacture vaccines. Mass vaccination programs are typically developed under government or World Health Organization contracts that offer modest profit margins.

"The manufacturers publicize their reasons for dropping out, but if it were financially to their advantage to stay in, they would," says Klein.

At the NVAC meeting next month, Klein hopes to develop "a menu of options that will respond to the issue of shortages and propose them to the secretary of health and human services so they subsequently can be reviewed for possible legislation."

Why has the crisis been allowed to come this far? "Vaccines are somewhat taken for granted, as is much of preventive medicine," says Klein. "If you prevent something and it doesn't happen, people don't realize what the seriousness of the situation would have been if it had occurred. It's like insurance. Some people figure that if you don't get in a car crash, the insurance is wasted."

Klein sees a positive side to the media focus on anthrax and smallpox. "Media interest is episodic," he says. "They get interested when there's a problem, and I think that the anthrax and smallpox issues have reignited public interest in vaccines. They're at the forefront again."

18 January 2002
Boston University
Office of University Relations