HEALTH & SCIENCE

Federal role in vaccine production debated

A think tank ponders what it would take to have an adequate supply of both existing and new vaccines on hand to forestall a bioterrorist attack.

By Susan J. Landers, AMNews staff. July 29, 2002. Additional information

Washington -- There are specific public policy changes that could supply the incentives needed to encourage manufacturers to boost vaccine production and develop the new pharmaceuticals that would be required in the event of a bioterrorist attack.

For instance, Christine Grant, vice president for vaccine developer Aventis Pasteur, urged the Centers for Medicare & Medicaid Services to reconsider a decision made this year to reduce reimbursements to physicians for administering vaccines.

CMS implemented the reductions despite the widely held belief that vaccines are cost-effective and already yield less revenue than the most popular cholesterol-lowering statin, said Grant. Her comments were part of a recent panel discussion, "Vaccine Development and Biodefense: How Does Public Policy Affect Research and Development?" The session was hosted by the Washington, D.C.-based think tank, American Enterprise Institute.

Meanwhile, there is interest among some within Congress to take on these challenges. A bill introduced by Sen. Joseph Lieberman (D, Conn.), for example, would provide a number of incentives such as tax credits and patent and liability protections, said Chuck Ludlam, counsel in Lieberman's office. He also participated in the AEI discussion.

The incentives would spur production of the diagnostics, drugs and vaccines necessary to combat a bioterrorist attack, Ludlam said.

What are the options?

Vaccine developers are in the spotlight these days. Widely publicized shortages of vaccines put them at center stage, and the threat of a bioterrorist attack with anthrax, smallpox or any of a number of lethal diseases keeps them there.

But, while allowing that Aventis would welcome some government assistance, Grant drew the line at a government-controlled program. "Regardless of ownership, it won't speed up the science or attract the talent," said Grant, who was New Jersey's commissioner of health and senior services from 1999 to 2001.

Last fall the Institute of Medicine resurrected the concept of a national vaccine authority.

"Evidence for the inability of the private sector to meet the country's needs for vaccines has accumulated substantially since the 1993 report," said the IOM's 20-member council in a statement in November 2001.

The council also favored the creation of a GoCo -- a government-owned, contractor-operated national vaccine facility.

However, both the GoCo and a national vaccine authority "are of questionable value," said Grant, adding, "I know they dampen enthusiasm for new entrants."

The IOM council noted that there are only four major vaccine manufacturers in the world today and only two in the United States. There were four times that many just 20 years ago.

Today there are many small companies backed by venture capital that are working on new vaccines. However, high costs of testing and manufacturing prevents most products from making it to market.

High liability costs also prevent more manufacturers from entering the field, said Grant. "I think you'll find that manufacturers are more than willing to produce limited-use vaccines, but they need reasonable financial incentives and predictable long-term contracts," she said.

Agency role

Financial disincentives do exist for vaccine manufacturers, as they do for most public health preventive measures, which seem to generate low prices and an uncertain market, agreed Jesse Goodman, MD, MPH, deputy director of the Food and Drug Administration's Center for Biologics Evaluation and Research.

In addition, "Because they are being given to healthy people [vaccine manufacturers face] higher safety expectations," said Dr. Goodman.

The vaccine safety concerns of several consumer groups should also not be ignored, he said, as they tend to foster broader mistrust of government and to escalate liability issues.

There is a continuing need for consistent and objective protection of public safety that is especially important when a sense of urgency within the government and in academia can generate the loss of some objectivity, Dr. Goodman warned.

"Bioterrorism isn't a disease of predictable epidemiology," he said. For example, "You start out with an anthrax vaccine thinking it's just for a group of special forces, then you immunize the troops, then you immunize the entire U.S. population. Somebody needs to check the safety and effectiveness ... in these different settings."

For its part in encouraging vaccine development, the FDA is instituting a policy of "early and frequent consultations" with product developers as a way to improve the quality of lab studies, clinical studies and the manufacturing process, said Dr. Goodman.

The policy is especially important for inexperienced product developers, he said. "It reduces the chance of misunderstandings and the likelihood of unwelcome surprises."

What the FDA can't do to promote vaccine development is provide money, require that a company manufacture a product, assume the burden of product development or reveal trade secrets, said Dr. Goodman.

But the FDA can encourage and perform research that promotes product development, improves regulation and supports the science base, he said. "The end result should be increased confidence in resulting products and the reduced likelihood of serious adverse events," he said.

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Copyright 2002 American Medical Association. All rights reserved.