Soaring Prices Curb Availability of Tetanus Vaccine

The state has been able to purchase and distribute just a third of its normal supply of tetanus/diphtheria vaccine--used mainly for unvaccinated schoolchildren--because the manufacturer has quadrupled the price.

As a result, counties have been forced to either dramatically cut their immunization programs or purchase the extra vaccine at great cost, officials said Monday.

“If we’re not able to give it to those children who require it, we could possibly be building up a susceptible population,” said John Dunajsky, assistant immunization branch chief for the state Department of Health Services.

“There has been very little tetanus among children in schools since laws were passed [requiring immunization]. But if this continues, there is the possibility of building up a population of kids who aren’t protected.”

The problem is compounded by a severe nationwide shortage of the vaccine, which is now produced by only one company, Aventis Pasteur of Swiftwater, Pa., the American arm of the French firm Aventis SA.

Aventis Pasteur says it was forced to raise prices in 2000--affecting vaccines earmarked for use this year--because the vaccine was underpriced and the company had spent millions to modernize its manufacturing plants.

California, which typically purchases about 210,000 doses of the vaccine each year and distributes them to county health departments, was able to buy just 70,025 doses for use in late 2000 and early 2001, said Natalie Smith, immunization branch chief of the state health department.

Counties generally use the vaccines to immunize schoolchildren who did not receive them as infants, as well as youths and adults who have been exposed to tetanus or need booster shots. The vaccine is different from the one administered to infants; there is only a slight shortage of that vaccine, which protects against diphtheria, pertussis and tetanus.

Because the state has cut back so severely on its purchases of the vaccine, Smith and her staff are allowing counties to use it for children only.

To make matters worse, the federal government, which until 1999 purchased the vaccine at discounted rates and then resold it to states, no longer does so. Officials say the price has risen so high that it outstrips a federal limit on prices that the Centers for Disease Control and Prevention are allowed to pay for immunizations.

“We used to have a stockpile” of the tetanus/diphtheria vaccine,” said Robert Snyder, who is in charge of purchasing vaccines for the CDC’s National Immunization Program. “But that changed when I could no longer buy it.”

Now, Snyder said, immunization programs in all 50 states are suffering.

California, with its large populations of uninsured residents and immigrants who may not have been immunized as children, has been hit the hardest, he said.

The shortage and price hikes have affected private doctors and hospitals as well. They too have begun rationing the vaccine.

Aventis Pasteur has given priority in distribution to emergency rooms, to be used for people who have been exposed to tetanus and are not immunized, and to doctors who use it for the same reason. Booster shots for adults--unless they have been injured and possibly exposed to tetanus--are generally not offered.

In Los Angeles County, health officials expect to receive just 38,000 doses of the vaccine from the state, down from 98,000 doses in a typical year.

The county, which plans to buy the remainder on the private market, is shielded from the price increase this year only because of an old contract. Next year, however, such a purchase would cost $462,000.

In Orange County, officials expect to receive just 2,000 to 3,000 doses from the state, down from a typical year’s supply of up to 10,000 doses, said Dr. Gerald Wagner, medical director of the county’s immunization program. The county plans to purchase the rest, which will cost about $50,000.

Aventis Pasteur hiked the price of a 10-dose vial of the vaccine from $14.50 in 1999 to $60.40 in 2000, and then to $62.21 this year, not including a federal excise tax of $15 on every 10-dose batch.

The company attributed its price increases to a need to modernize its facilities, and said the vaccine was so severely underpriced that revenues didn’t cover costs.

But the decision was made when the company controlled 60% of the market for the vaccine, according to the CDC, and faced just one competitor, Wyeth Lederle, which has since stopped making it.

Snyder, Smith and other public health officials have wondered aloud whether Aventis Pasteur’s strong position in the marketplace was behind the decision to raise prices, but Aventis Pasteur insists that was not the case.

“These decisions were made in late 1999, long before we knew Wyeth Lederle was pulling out,” said Aventis Pasteur spokesman Len Lavenda. “It wasn’t until sometime in 2000 that we realized they were having difficulties.”

When Wyeth did finally decide to stop making the vaccine, Lavenda said, Aventis Pasteur found itself faced with making enough for the entire U.S. market. Because it takes nearly a full year to grow the bacterial cultures used in the vaccine, production fell way behind, he said.