Flu vaccine worries fade; focus shifts to future

With the influenza vaccine supply in good shape and the delivery system ready, long-term concerns are now on the public health horizon.

By Victoria Stagg Elliott, amednews staff. Aug. 12, 2002.

Public health officials and providers of flu vaccine are cautiously optimistic about the level of preparedness for the upcoming influenza season.

Between 92 million and 97 million doses of vaccine, more than ever before, are expected. Many of the distribution problems of recent years appear to be fading into history, and the public health focus is shifting from the short-term goal of ending shortages and delays to the long-term goal of getting many more people vaccinated. For example, manufacturers have promised to expand supply over the next few years to meet the Healthy People 2010 goal of vaccinating 150 million people.

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Topic: Vaccine supply

"Things continue to look good," said Dennis J. O'Mara, associate director for adult immunization at the Centers for Disease Control and Prevention National Immunization Program.

But in the background, quiet worries persist -- questions of "what if" -- in regard to possible production instabilities or changes, including the departure of one of the three remaining flu vaccine manufacturers from the market.

A record 92 million plus doses of flu vaccine are expected this year.

Such an exit would be a public health worst-case scenario, though not one that any of the manufacturers have signaled to be in their plans.

Still, several of the recent vaccine shortages have been caused by companies abruptly ceasing production -- sometimes leaving only one company behind to ramp up production to pick up the slack. Therefore, this possibility cannot be left out of future contingency planning.

"We should not be dependent on only one or two manufacturers," said Tony Sun, MD, chief medical director of Louisiana Healthcare Review. "Monopoly is a concern."

Why worry?

The 2000-2001 flu vaccine season, the first year of trouble, was in part caused by one company leaving the market.

A host of other factors, including Food and Drug Administration compliance issues at another company's manufacturing facility and the challenges of a slow-growing strain, combined to make for chaos. Last season was better, but far from perfect.

But the fact that so few companies are involved in vaccine production has led experts to contemplate the impact of one company leaving the market.

The FDA is reviewing an inhaled flu vaccine.

"The loss of any one of the three companies would be a tremendous setback for our efforts to improve vaccine coverage," said O'Mara.

It could cause more turmoil, depending on the timing of the announcement and also depending on which company decided to exit.

Consider current expectations for the upcoming flu season. The disappearance of Aventis Pasteur, the company providing the majority of the vaccine supply in 2002-2003 with a promised 45 million doses, could be catastrophic. The loss of Evans Vaccines, which will manufacture 27 million doses -- although not all are intended for the U.S. market -- or Wyeth Pharmaceuticals, which has not released their numbers for this year, would also be significant, although less so because they provide less of the total.

"If one of the smaller ones dropped out, the situation would not be as dire," said David L. Webster, PhD, president of the Webster Consulting Group in Bethlehem, Pa. "There's more of a cushion than there was in the past two years."

And for now, no company has indicated any such intent.

But the concerns remain because of the hard lessons learned in the past and the resulting awareness that the vaccine supply cannot be taken for granted.

Those involved in the vaccine delivery system say that this time around, if a company ceased production, it might not have the same negative impact as in past years.

Sudden departures are less likely because public health officials and others involved in vaccine issues are paying much closer attention to related issues.

"Having had the experience of the past two years, we at CDC and all the stakeholders are in better position to be responsive than we were before," said O'Mara. "But it will depend on the circumstances."

A system now more fit

Communication lines are more open because of several meetings over the past couple years to tackle shortage issues.

Vaccine manufacturers have made gentlemen's agreements to alert relevant government agencies if for any reason there are problems or a decision is made to cease production. The agreements are nonbinding. But, because the general public is much more aware of the situation, it could turn into a public relations nightmare if a company's sudden withdrawal were to cause a shortage.

"Manufacturers are much more willing to share supply information with the CDC," said Dr. Webster. "And, in essence, they're sharing it with each other through the CDC. That helps a great deal with their planning."

The pharmaceutical companies involved say that with enough notice and if there are no production troubles such as a slow-growing strain, they could make up the slack. Even with late notice, they could extend production so that there would be enough vaccine, albeit late in the season.

And although most consider the small number of companies producing vaccines to be a major factor in the instability of the supply, there is the possibility that having one or two strong producers may be better than a half-dozen marginal ones.

"Maybe it's more efficient to have two companies with very, very large production systems," said Howard Weinblatt, MD, medical director of Integrated Health Associates in Ann Arbor, Mich. He is also a member of the state's vaccine advisory committee.

Improving the science

There is also a wild card in the mix. FluMist, an inhaled vaccine that will be marketed by Wyeth once it is approved, is currently being reviewed by the FDA.

In July, the agency said there was sufficient evidence that it was effective but that more safety data were needed. The vaccine is, however, intended for healthy people, and it is unknown if it will take some pressure off the injectable supply.

It may have no impact whatsoever, but experts say that improving the science behind the flu vaccine is the way to go in attempting to buttress the supply.

Unlike other vaccines, influenza vaccines change annually and cannot be stockpiled from year to year. This factor also makes the manufacturing process trickier.

What many would like to see is a vaccine that does not have to be reformulated each season.

"We're going to know more about the virus, and we're [going] to be able to develop different types of vaccine that might be more generic," said Bennett Lorber, MD, chair of infectious disease at Temple University in Philadelphia. "You'd be able to make large amounts of vaccine which would be effective across the board."

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Fewer doctors are willing to give it a shot

The small town of Madisonville, Texas, has only three full-time physicians, but only two of them will be administering flu vaccine this season.

"One person is just not going to do it," said Andrew Eisenberg, MD, a local family physician. "That physician is under the impression that it's just going to cost too much to give it. It will really limit access in an entire county."

Dr. Eisenberg plans to give flu shots this coming season but, like many physicians across the country, he is finding that fewer doctors are willing to do so. Past hassles with supply and reimbursement levels that have not kept up with price increases have led many to make the decision to stop.

"How can you keep administering vaccine if you lose money with every dose?" asked Howard Weinblatt, MD, medical director of Integrated Health Associates in Ann Arbor, Mich.

Many physicians are warning that public health gains and doctors' role in administering flu vaccine are in jeopardy. In order to address this, the American Medical Association passed a resolution at its Annual Meeting asking for increased Medicare reimbursement for flu vaccine.