Flu season accentuates vaccine industry's woes

NEW YORK — It's no comfort to people scrambling to find a flu vaccine to learn that last year Aventis Pasteur ended up discarding 5 million extra doses of the 43 million it produced.

This year, the drugmaker again produced 43 million doses — 35 percent more than were ordered — and yet it still sold out.

It isn't supposed to be this way. The flu vaccine business is supposed to be predictable: Customers place orders so manufacturers know how much to produce and they don't lose money throwing away unwanted product.

But it seldom is that easy. Over the past few years there have been shortages of several vaccines, either caused as in this case by a severe flu season or in other instances by a manufacturer ending production.

Every time there is a vaccine shortage, doctors lament how public health is dependent on for-profit companies. That reliance is considered especially problematic for vaccines, since drugs help individuals but vaccines protect the public.

Part of the problem is that low profit margins, complex manufacturing and a challenging regulatory environment have driven vaccine makers from the business. Thirty years ago, there were 25 vaccine makers. Now there are five.

"There are a whole array of barriers keeping companies from the business," said Dr. William Schaffner, chairman of the department of preventive medicine at Vanderbilt University Medical Center and a member of the National Vaccine Advisory Committee, which reports to the department of Health and Human Services.

"And there are no simple solutions," Schaffner added.

Vaccine production is a difficult business because immunizations are made from live viruses or bacteria, which are tricker to work with than the chemicals used to make most drugs. Vaccines have low profit margins and don't offer the same repeat business as drugs.

The risk of litigation also is higher. Unlike drugs, vaccines are given to healthy people. So while a cancer patient may be willing to endure severe side effects from a drug, the same doesn't hold true for someone getting a flu vaccine.

"The safety challenges in this industry are extraordinary," Schaffner said.