Industry incentives may help ensure flu vaccine supply

OB/GYN News, Nov 15, 2004 by Mary Ellen Schneider

With the United States facing an influenza vaccine shortage this season, vaccine experts are calling for long-term solutions to ensure adequate supplies in the future.

"It's such a fragile supply system and such an unpredictable demand that any little thing can throw it out of orbit," commented Gregory Poland, M.D., who is the director of the Mayo Vaccine Research Group at the Mayo Clinic, Rochester, Minn.

This season, health officials in the United States had expected to have about 100 million doses of the flu vaccine on hand, but manufacturing problems at one company's facility has blocked access to almost half of the expected doses and left only one manufacturer to produce the vaccine.

As U.S. health officials urge health care providers to channel vaccines only to those individuals who are at the greatest risk of developing complications from the flu--mainly young children and the elderly--experts are examining why manufacturers are reluctant to make vaccines and how to entice more companies into the field.

Manufacturers are leaving the market because they don't see it as profitable, Julie Gerberding, M.D., who is the director of the Centers for Disease Control and Prevention, said at a recent press conference on this year's flu vaccine shortage.

Companies are also reluctant to take on the complex process of making these vaccines, she said.

"These are biologics and we use them for healthy people so the risks are very high," Dr. Gerberding said. "Anytime you're offering something to someone who is a completely healthy person, the balance between risks and benefits looms large."

And vaccine makers face especially high hurdles in the United States, she said, because there are additional requirements on the manufacturing process to ensure safety.

The major issue in ensuring an adequate supply of influenza vaccine is attracting and sustaining private sector involvement, said Dr. Poland, who is also a member of the CDC's Advisory Committee on Immunization Practices.

"Right now it's not economically worth-while," Dr. Poland said.

In addition, most companies that manufacture vaccines do so "at risk"; that is, they have no guarantee of how much they will sell, said William Schaffner, M.D., who is the chair of the department of preventive medicine at Vanderbilt University in Nashville, Tenn.

In many seasons, there is leftover vaccine supply and the companies take that as a loss.

This is compounded by the enhanced regulation of Good Manufacturing Practices by the Food and Drug Administration, and increasing costs for producing vaccines and making manufacturing improvements, Dr. Schaffner said.

One possible solution is for the government to assume some of the risk, Dr. Schaffner said, by offering to purchase a certain amount of vaccine leftover at the end of the season.

The country also needs to create a national program aimed at adult vaccination, he said. There is already a national infancy and childhood vaccination program that utilizes a combination of public and private payment to expand coverage.

The creation of a national adult immunization program would not only bring prevention to the adult population but would also create a larger vaccine market for companies, Dr. Schaffner said.

The government should also consider expanding the patent protections on manufacturing platform technology so that vaccine makers have more time to recoup their investment costs, according to Dr. Poland.

Improved technology could help cut down on potential manufacturing problems, Dr. Poland added, and the government could help pay for some of those development costs.

If private manufacturers can't be encouraged to enter the market, the government will have to take cover control of vaccine production, Dr. Poland said.

"Flu vaccine is a must have," he commented.

But putting the government in control of vaccine manufacturing isn't a good idea, said Louis Z. Cooper, M.D., a pediatrician and member of the steering committee of the National Network for Immunization Information. Government control of vaccine making would result in a loss of the flexibility and experience that vaccine makers bring to the table, he said.

Instead, the government should work collaboratively with other countries to bring vaccines into the United States, Dr. Cooper said.

The Bush administration has been pushing for additional funding to increase and stabilize the egg supply for vaccine making, and to modernize vaccine manufacturing through cell culture, according to Bill Pierce, who is a spokesman for the Department of Health and Human Services.

Congress gave the administration about $50 million in fiscal year 2004 toward that effort and will likely appropriate at least that much for fiscal year 2005, Mr. Pierce said.

In the meantime, Congress is pushing for changes to help solve this year's shortage and make improvements for the future.

Sen. John Reed (D-R.I.) and Sen. Hillary Clinton (D-N.Y.) have introduced legislation (S. 2968) that would require the HHS secretary to seek purchase of additional stocks of vaccine from Europe, Canada, or Japan, a move that has been approved by the regulatory agencies of those lands.