Next flu vaccine season off to shaky start

As this season's window of opportunity to administer the flu vaccine comes to a close, the attention of those in the supply chain -- from physicians who give the shot to the people involved in manufacturing it -- has turned to next year.

And there is already a hiccup.

Many physicians are having problems placing their pre-orders for next season's supply, an activity usually on the to-do list at this time.

"I'm very optimistic, but it does concern me," said Roger Baxter, MD, clinical leader of the flu outreach program at Kaiser Permanente in California.

At press time, neither sanofi pasteur, formerly Aventis Pasteur, which usually makes more than half the flu vaccine supply, or FFF Enterprises, a large distributor based in Temecula, Calif., was taking pre-bookings. And, although Henry Schein, another large distributor based in Melville, N.Y., was doing so, it offered no guarantee, noting that if a new round of problems were to occur, the company would use this information to direct supplies to those who need it the most.

Ultimately, the situation is the domino-effect result of the 2004-05 season, which began with an expected vaccine surplus of nearly 100 million doses that was transformed into a shortage when Chiron Corp. withdrew from the market amid contamination problems. The impact now is an unusually high level of marketplace uncertainty.

For example, it's unclear who will be making vaccine. Chiron has issued statements announcing its intent to re-enter the market, although this has yet to be OK'd by regulators. ID Biomedical, a Canadian firm, also might step into the fray -- as could others -- contingent on FDA approval.

"We don't know if Chiron will come back. There are other companies that may be in the market," said Kit-Bacon Gressit, FFF spokeswoman. "We will be able to provide product. The question is, which product?"

Most companies are returning to historical norms of taking flu vaccine orders in March, April or beyond, rather than February, and most experts do not expect the circumstances to cause significant difficulties.

"There's a lot up in the air," said Ted Epperly, MD, an American Academy of Family Physicians board of trustees member. "But it should get all sorted out by the time it needs to."

But while many of those involved in manufacturing, distributing and eventually injecting vaccine are concerned with where the shots will come from, those in public health are debating who should be getting the vaccine once it's available.

Officials long have made elderly patients a high priority, but this approach is now being challenged.

Most recently, a commentary in the Feb. 15 American Journal of Epidemiology written by a team from the Rollins School of Public Health at Emory University in Atlanta advocated vaccinating schoolchildren, who cause much of the flu's spread. The authors said vaccinating children, along with the elderly and others with medical conditions causing high risk of death from the disease, might be a more effective strategy.

The Centers for Disease Control and Prevention issued a statement that discussions are under way to determine if recommendations should be expanded, particularly if vaccine supplies are ample. Experts said this could be the future of flu vaccination strategies.

"It shouldn't be an either-or question, and we ought to be thinking of giving it to school-age kids, if we have supply," said Ronald Bangasser, MD, immediate past president of the California Medical Assn. and a member of the joint AMA and CDC National Influenza Vaccine Summit.

But some also are questioning whether the elderly get much benefit at all. A study published in the Feb. 14 Archives of Internal Medicine suggested that the impact of the vaccine on deaths of the elderly might be overstated. National Institute of Allergy and Infectious Diseases researchers analyzed data from the past 30 years related to age-specific mortality, vaccination coverage and surveillance of the dominant strains to create a mathematical model. They found there was no correlation between increasing rates of vaccination after 1980 and declining rates of death.

"Our findings indicate that the mortality benefits of influenza vaccination may be substantially less than previously thought," the authors wrote.

Public health officials and physicians alike, though, said this study in no way indicates that the elderly should stop receiving the shot.

"I'm not going to alter my practice based on one article," said Craig Czarsty, MD, a family physician from Oakville, Conn.

While the focus is turning to plans for next season, public health officials are also assessing the most recent one. According to CDC data, much of the vaccine did get to priority groups, as intended, but for some groups, it was at lower rates than in previous years.

From September to December 2004, more than 57% of children age 6 to 23 months and 43% of health care workers received the shot. Only 8% of adults not included in the ACIP recommendations received it. The vaccination rate among the elderly, however, was lower than in previous years, with only 59% of those older than 65 receiving it. In the 2003-04 season, more than 65% did so.

The AMA-CDC National Influenza Vaccine Summit will convene in May to address these issues.