AMA-CDC summit leads quest to restore trust in flu shot system

Atlanta -- Eric B. Einstein, MD, an internist from Georgetown, Conn., is trying to craft an influenza vaccine ordering strategy. Should he place his order for 1,500 doses with one company? Should he hedge his bets and split it between two or more? Or should he give up on it completely?

"This has been a major distraction and headache for months between the time spent trying to arrange delivery and explaining things to patients," he said. "I've honestly toyed with not offering it. I'd hate to do that."

Dr. Einstein's situation is an example of one of the many challenges facing those working to stabilize the influenza vaccine supply.

The 2005-06 season has been characterized by high expectations and predictions from public health officials that supplies would be ample. In reality, many physicians did not receive many doses, if they received any at all. Chiron Corp., most often the source of shots for many doctors' offices, did not produce as much vaccine as expected, and what it did produce was shipped late. This difficulty came on the heels of several rough seasons. Thus, although belief in the flu vaccine as a vital medical service is high, confidence in the system that gets vaccines to those who need it is not.

This issue is one of many that had stakeholders at last month's National Influenza Vaccine Summit worried about the future participation of various players, especially physicians, in the distribution chain.

"There's a concern that the challenges in terms of supply and distribution are generating a lack of trust among the physician community as well as the public," said AMA Chair-elect Cecil B. Wilson, MD. "They expect a flu shot to be there, and it's not."

These concerns are particularly high, considering that the capacity to produce vaccine is expected to grow. According to presentations at the summit, organized annually since 2001 by the AMA and the Centers for Disease Control and Prevention, the United States potentially could have more than 100 million doses next season and even more in following years.

"We have lots of reasons to be optimistic," said CDC Director Julie L. Gerberding, MD, MPH.

Sanofi Pasteur is expected to produce at least 50 million doses; Chiron Corp., about 40 million; and GlaxoSmithKline, more than 20 million. Medimmune is slated to make 3 million to 4 million doses of the nasal version. The total, then, would far exceed any previous season.

But experts worry that a lack of confidence in the distribution chain might put a damper on demand, which could lead to supplies going unused. This scenario, in turn, could lead to manufacturers scaling back. About 84 million doses were manufactured for this past season, although it is unclear how many will be left over.

A rebuilding process

In order to buttress the hope of such production increases, summit participants called for steps to rebuild trust in the vaccine supply system. Many say the key is communication.

"We should put more emphasis on managing the expectations of those who are going to deliver vaccine, because you can't really manage the vaccine supply," said Jeffrey S. Duchin, MD, chief of communicable disease control, epidemiology and immunization with the Seattle and King County Public Health Dept.

Representatives from Chiron, for instance, offered an apology. "Half of the production cycle was taken up by Chiron basically getting its act together," said Peter A. Galiano, vice president of U.S. sales for the company. "But Chiron should have done a better job of communication."

The summit participants also recognized the need for a national organization, possibly the CDC, to issue a statement about exactly what went wrong with this past season and address misconceptions about vaccine haves and have-nots.

Complaints were rampant that commercial settings such as grocery stores had plenty of vaccine, while physicians' offices had none. But according to data presented at the summit, big-box flu vaccine providers had problems of their own, with only about a third receiving more than 80% of their total order and only 10% of total vaccine supplies ending up in the hands of large-scale immunizers. Another message was that these data should be disseminated more widely.

"We need to make sure that people understand all this stuff that we now know," said William Schaffner, MD, a spokesman for the National Foundation for Infectious Diseases.

Despite the fact that supply glitches existed across the board, there is increasing acknowledgement that physicians, particularly in small or solo practices, might have had the most trouble.

To address this situation, medical organizations are increasingly calling for consideration to be given to the development of some kind of preseason stockpile or a purchasing co-operative for small-practice physicians.

These approaches are very controversial. Critics say a preseason stockpile would be disastrous if vaccine were in short supply and the flu season began early but the only available doses were being held back. A purchasing co-operative also would not make much of a difference if the order were placed with a manufacturer that ended up having problems.

Still, Rhode Island already has such a purchasing co-operative. The American Academy of Family Physicians is considering one for its members. The AMA suggests establishing a pre-order period specifically for those who want to buy small amounts of vaccine. The Association also seeks that the CDC develop a preseason stockpile for medical practices that don't get their vaccine orders.

"Despite sincere efforts, physicians have continued to experience problems getting vaccine, particularly physicians in small office practices," said AMA President J. Edward Hill, MD.