On the surface, a nationwide tetanus and diphtheria vaccine shortage may not seem like such a big deal. How many people will step on a rusty nail this year? Doctors in states such as Wisconsin say the shortage is serious due to flooding in the state and related accidents, but in Kentucky, Oregon, Tennessee and Washington, health experts say it's not yet a problem. But the shortfall is resulting in higher prices for states and potential problems for patients.
When Wisconsin doctor Tom Saari heard about a nationwide adult tetanus and diphtheria vaccine shortage last fall, he didn't initially realize how severe it might be. Now, he says the shortage has affected his practice very significantly. "We've had to really prioritize the patients we give vaccine to and there's very little promise of getting more within the next year," Saari says.
As immunization director for a large HMO in Madison, Saari has teamed up with state officials to revise guidelines on who should receive the vaccine, known in medical lingo by the initials "Td." Recent flooding of the Mississippi River along the state's western border has not helped matters. With numerous people exposed to cuts and scratches and dirty water all at once, it's "heightened the need to conserve the vaccine in the rest of the state, since the vaccine was diverted to flood zones," Saari says.
Tetanus, also known as lockjaw, is a disease that affects the central nervous system. Most people think of tetanus as something you get when you step on a dirty nail. That's a pretty good way to look at the disease. More than half, or 64 percent, of reported tetanus cases from 1995 to 1997 were from punctures, cuts and abrasions, says the U.S. Centers for Disease Control and Prevention (CDC).
Tetanus can be fatal in humans. Developing countries report nearly 300,000 newborn deaths from the disease each year. But vaccine use in the U.S. has virtually eliminated any major threat. Infants get a different tetanus diphtheria vaccine known as DTaP up to age two and then the Td vaccine is given as a "booster," to make sure a person is still protected. Health experts also recommend the Td vaccine for people who travel to high-risk countries like sub-Saharan Africa and the Philippines and for pregnant women who have not been vaccinated within the last 10 years.
How did the shortfall occur? CDC officials initially described the shortage last November as temporary, citing low inventory from producers Wyeth-Ayerst and Aventis Pasteur. Two months later, Wyeth announced it would stop producing the vaccine altogether.
Wyeth's Douglas Petkus says the company looked over its product line at the end of 2000 and made the decision to pull out based on manufacturing concerns such as manpower. "We determined there was a sufficient number of manufacturers of the product so our exiting would not have a negative impact. We've heard there's a shortage only to the extent there's less vaccine available now than in previous years, and there's not an emergency situation that we're aware of," Petkus says.
The emergency situation remains real. As recently as May 25, CDC put out a notice in its Morbidity and Mortality Weekly Report (MMWR) that all Td boosters in adolescents and adults should be delayed until 2002. A month prior to that announcement, CDC, in conjunction with the Immigration and Naturalization Service, waived some migrant worker requirements for the vaccine.
Though Wyeth says there were "sufficient" manufacturers when officials decided to halt production, Aventis was the only other company making the vaccine at the time. An Italian-based company, Sclavo, had also made Td, but cut its U.S. production in 1993.
On top of the shortage, states are being hit hard by high prices for the vaccine from the sole producer. What cost $1.45 per dose in 1998 now costs from $6.22 to $7.61, an increase of more than 500 percent.
Aventis' Len Lavenda says the price increase is due to "economics" and a need to update manufacturing plants based on U.S. Food and Drug Administration (FDA) regulations. "We don't sit down and analyze these things on a daily basis. People have been unhappy for quite some time [with the prices] and we could only justify continuing if we raised the price," he says.
Federal officials say government-imposed price limits on vaccines like Td, dating back to 1993, were perhaps low. Still, skyrocketing price tags on the shots raise eyebrows. "Td has been around since the turn of the century... [so] you have to say why do you go up 400 percent in a two-year period? From the outside, it looks like price gouging," says Bob Snyder, public health advisor of CDC's National Immunization Program.
Some relief for the shortage is already in the works. The University of Massachusetts Biologic Laboratories has made the Td vaccine since the 1940's and produces around 500,000 doses each year for Commonwealth residents. Officials there recently agreed to step up production by one million doses to help ease the nationwide shortage. "We have no long-term contractual commitment to do this. We're delighted to use our vaccine manufacturing capacity in this way... and we're proud to do at least something," says Mark Shelton, Associate Vice Chancellor for University Relations at the U Mass Medical School.
Health care workers across the country will welcome additional vaccine, but questions remain for many on pricing strategies and the pullout of manufacturers for often-vital vaccines. In addition to Td shortages, health officials are already talking about a potential flu vaccine shortage because drug companies have stopped making the medication.
Wisconsin's Saari says it leaves him feeling very uncomfortable. "If one manufacturer drops out and you don't have anyone to pick up the slack, ... it's becoming more and more evident how tenuous this relationship is with private industry. Part of the reason is the number of vaccines offered to kids is increasing and that will compound periodic shortages, manufacturers have other lines that are more profitable and part of the fault lies too within FDA because of stringent requirements. It's not a very good way to run a railroad," he says.