The state's health director says she routinely faces shortages of many vaccination drugs.

BY: ANN S. KIM Staff Writer

While the flu shot shortage took many Mainers by surprise, the state's top health official has dealt with vaccine shortfalls many times before.

"In my eight and a half years on this job, I'd say 80 percent of the time, we've been faced with moderate to severe shortages of one vaccine or another," said Dr. Dora Anne Mills, director of the state Bureau of Health. "It's hard for me to think of a time when we've not been challenged by a vaccine shortage."

Mills is among the public health officials who want the federal government to do more to ensure adequate supplies. Market forces cannot ensure a supply to meet usual demand and any unforeseen surges due to an outbreak, she said.

The United States will be short about 45 million doses of flu vaccine this year because of problems at the plant of one of the manufacturers, Chiron Corp. Aventis Pasteur, the other manufacturer of injectable vaccine for the U.S. market, is expected to make about 58 million doses. A third company, MedImmune, is expected to make about 3 million doses of FluMist, a new nasal spray vaccine for healthy 5- to 49-year-olds.

There are now five manufacturers of the vaccines recommended in the United States. That's down from more than 25 makers 30 years ago, according to an August 2003 report released by the Institute of Medicine, a private nonprofit group that advises the government on health. The report recommended that the government require insurers to cover vaccinations while providing subsidies or reimbursements and vouchers for the uninsured.

Experts say low prices, stringent regulation of the manufacture of biological products and difficulty predicting demand make the vaccine market unappealing. The pharmaceutical industry also cites product liability lawsuits that drove out many companies in the late 1970s and early 1980s.

It's common now for a couple of manufacturers or even just one maker to be the sole supplier of a particular vaccine.

Government contracts are one way to boost prices and attract manufacturers, said Frank Sloan, who led the committee that produced the IOM report. He is the director of Duke University's Center for Health Policy, Law and Management.

"They'd tell you what they'd be willing to sell them for . . . you sort of entertain a request for proposals, just like you would be bidding for bombers, Army uniforms," said Sloan, an economist. "We shouldn't be surprised they operate on the profit motive."

Health and Human Services Secretary Tommy Thompson wants to use grants to promote less-risky cell-based methods for producing flu vaccine, said Bill Pierce, a spokesman for the department. The process now uses eggs to grow the viruses for the vaccine, which can be expensive and time-consuming.

Another possible remedy is assuring makers a market for a certain number of doses. Although use of flu shots has grown thanks to public health campaigns, it remains difficult for manufacturers to predict demand for a given season. Makers also must contend with the fact that vaccine can only be used in the season for which it was manufactured.

"In the last year we were in the business, we had to throw out 8 million doses," representing 40 percent of vaccine manufactured, said Doug Petkus, a spokesman for Wyeth, which stopped producing injectable vaccine after the 2002-2003 season. Petkus said the company destroyed about $50 million worth of inventory in the last couple of years it made the vaccine.

Wyeth is still in the vaccine business. It introduced Prevnar in 1999 as the first vaccine for infants to prevent pneumococcal diseases such as bacterial meningitis and blood infection. That vaccine, administered in a four-dose series, costs about $65 a dose, Petkus said, compared to about $5 a dose for flu vaccine in 2002.

Prevnar was subject to shortages earlier this year. The U.S. Centers for Disease Control recommended deferring later doses in the series for about seven months until supplies reached adequate levels, said Curtis Allen, a CDC spokesman.

Since 2001, there have been shortages of six vaccines recommended for children under 2 years of age, he said.

Members of Maine's congressional delegation say they are looking at ways to improve the country's vaccine supply when Congress goes back in session next month.

Republican Sen. Susan Collins is part of a group that will examine vaccine policy, including how to bring more makers to the market and improve research into creating vaccine.

Democratic Rep. Tom Allen said he wants to investigate how the shortage occurred through the House Energy and Commerce Committee, to determine what policy changes may be necessary.

Sen. Olympia Snowe said she has already urged the Food and Drug Administration to promptly review the applications of potential vaccine manufacturers.

Staff Writer Ann Kim can be contacted at 791-6383 or at:

akim@pressherald.com