Flu Vaccine Shortage May Not Be a Real Crisis

Published January 1, 2005

There’s plenty of junk science going around when it comes to flu vaccine issues. Closer examination of the matter suggests the shortage has not one but several causes, and it may not result in any real risk to the public’s health.

Lawsuit Abuse Plays a Role

William Tucker, a senior fellow at the Discovery Institute, attributes the current shortage of flu vaccine to trial lawyers and the tort liability system. As Tucker notes in the October 25, 2004 issue of the Weekly Standard, Lederle lost a pertussis vaccine case in the sum of $1.1 million in 1980. That wiped out half of the company’s gross revenues from the pertussis vaccine for that year. And currently, the plaintiffs’ bar is trawling the Internet to find persons allegedly injured by a preservative named Thimerosal, which is used in many vaccines.

It is not clear, however, that the tort system and trial lawyers are entirely to blame for the hesitancy of drug companies to manufacture flu vaccine. A review of appellate court cases nationwide discloses almost none in which drug companies were found liable for flu vaccine injuries, other than those arising from the swine flu vaccine.

Most commonly, drug companies prevailed in these suits because their duty to the ultimate consumer includes only the duty to warn physicians of possible complications. Under the “learned intermediary” doctrine, if that warning was provided to the physician, the drug company is off the hook in a consumer case.

Federal Government’s Role

As the Lederle figure indicates, vaccine profit margins are low. Tucker points out that this situation was exacerbated by the National Childhood Vaccine Injury Act, passed by Congress in 1993. “The feds now purchase over half of all vaccines at a low fixed price and distribute them to doctors,” Tucker writes. “This has essentially finished off the private market.”

“The high risks of complex vaccine production, unpredictable consumer demand, and low profit margins, coupled with the lack of liability protection from costly lawsuits, drove many manufacturers out of the flu vaccine business during the 1990s,” noted an October 19, 2004 release by the U.S. Department of Health and Human Services press office.

“In 1994, there were five injectable influenza vaccine manufacturers: Wyeth, Evans (now part of Chiron), Connaught (now part of Aventis), Parke Davis, and Lederle,” continued the release. “Today there are two: Aventis and Chiron.” So part of the widely reported decline in the number of manufacturers was due simply to corporate mergers.

Shots Seldom Necessary, Often Ineffective

A look behind the scenes at flu vaccine production, however, indicates the benefits of getting annual flu shots have been hyped and the risks studied inadequately, all of which raises the question of whether people should bother to get flu shots at all.

The process of determining what strains of flu for which to distribute shots is immensely complicated and inexact. Each year, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meets in spring to identify the flu virus strains to be protected by the flu vaccine manufactured for that year’s fall-winter flu season. The committee consists of more than two dozen physicians and scientists from universities, medical schools, federal and state public health agencies, and consumers. The committee gathers data on flu virus strains worldwide and then identifies two or three to be targeted by the vaccine.

Some analysts call this process more of a “guess” than a science.

Among other problems is the six-month lag between the committee’s decision and the following flu season, which is necessary to allow time for manufacturing the vaccine. The array of flu strains appearing in the spring can radically change by the time the vaccine is ready in the fall. That’s what happened in 2003, when the committee voted to include the Panama flu virus in the vaccine for the 2003-04 flu season, but not to include the Fujian flu mutant virus, a more virulent but less prevalent strain at the time. That winter’s flu outbreak, however, consisted almost entirely of the Fujian strain.

Early in that outbreak, the Centers for Disease Control and Prevention (CDC) recommended even more widespread vaccination, without pointing out until much later that the vaccine then available “might not” do anything to protect the public against the prevalent flu strain. The CDC later admitted the vaccine had “no or low effectiveness against ILI (influenza-like illness).” (See Conrad Meier, “Lessons from the Flu Vaccine Shortage,” Health Care News, February 2004.)

Nevertheless, there was no true “epidemic” of Fujian flu, even in the absence of an effective vaccine. This is not necessarily surprising, because, overall, only some 28 percent of Americans receive the flu vaccination in any particular year.

This raises the obvious question of whether flu vaccines are in fact effective in preventing the flu. At the February 20, 2003, meeting of the FDA’s vaccine advisory committee, according to the official transcript, Dr. Nancy Cox of the CDC was asked about this. “There is no systematic follow-up to see, to document whether the general population who receives flu vaccine actually is infected by flu virus, because it’s an impossible task,” she said. “I mean we have 80 million doses or 70 million doses given, and it would be impossible to follow up.”

At the February 18, 2004, meeting of the vaccine advisory committee, Dr. Carolyn Bridges of the CDC cited a study of hospital workers in Denver, Colorado, intended to determine the effectiveness of the vaccine. “The conclusions from this study are that we were unable to demonstrate vaccine effectiveness against ILI,” she told the group, according to the meeting transcript. “So of the vaccinated persons, about 15 percent of them developed influenza-like illness, compared to almost 17 percent among the unvaccinated.”

Mortality Numbers Probably Exaggerated

Besides the fact that the flu vaccine was not effective, Dr. Bruce Gellin, director of the National Vaccine Program Office at the U.S. Department of Health and Human Services, told Reuters earlier this year of another problem: inaccurate data for ILI.

“The problem with influenza-like illness studies is that there are a lot of things that are influenza-like,” Gellin said. He said unless patients are tested to confirm they have influenza, they could have a range of respiratory diseases, none of which a flu vaccine could be expected to prevent.

Cox told the vaccine advisory committee last year that only about 20 percent of people presenting respiratory symptoms actually have the flu. “We really need to have a system in place year to year that tracks the efficacy of the vaccine,” Gellin said.

So what about the CDC’s widely repeated statement that 36,000 Americans die of influenza every year? CDC spokesman Curtis Allen told Insight magazine, “We don’t know exactly how many people get the flu each year because it’s not a reportable disease and most physicians don’t do the test [nasal swab] to indicate whether it’s influenza.” Allen said, “The number of reported deaths [due to complications of the influenza virus] is based on a mathematical model and not actual swabbing of the nasal cavity.”

And what about the risks of the vaccine? Currently they are unknown except as to swine flu, according to the Institute of Medicine of the National Academies of Science, which recommended this year that more risk studies be done, especially before immunization of infants and children is uniformly recommended.

“It is important to fully understand any risk for GBS [Guillain-Barré syndrome, a disorder in which the body’s immune system attacks part of the peripheral nervous system] or other neurological complication that might be associated with influenza vaccination, to ensure that it can be appropriately weighed against the sizeable burden of illness associated with influenza infection,” the institute said in its 2004 study, Immunization and Safety Review: Influenza Vaccines and Neurological Complications.

It’s something to think about while waiting in line for a flu shot during this shortage crisis.

Maureen Martin ([email protected]) is senior fellow for legal affairs at The Heartland Institute.