Lessons from the Flu Vaccine Shortage

Published February 1, 2004

Every year, influenza–“the flu”–invades the U.S., striking the elderly and the ill especially hard. Every year, the Food and Drug Administration (FDA) tries to determine in advance which strain of influenza is most likely to afflict the U.S., and then recommends the particular vaccine likely to be most effective in combating that strain.

This year, a combination of errors and bad public policies resulted in a shortage of vaccine, with potentially life-threatening consequences. The shortage also prompted counterfeiters to attempt to enter the vaccine market, an invasion which, if successful, could have been deadly.

Central Planning

Government officials made at least two apparent mistakes in planning for this year’s flu season. The first was choosing to target the wrong flu virus.

The FDA committee that decides which vaccine to use was divided between those who favored a new vaccine against the Fujian strain of influenza, which would have required growing the virus in canine kidney cells and then transferring it to chicken eggs, and those who favored a vaccine that could be made using conventional methods but would provide less protection.

According to Dr. Sydney Smith, a family physician and publisher of MedPundit, the newer vaccine required a production method that “isn’t FDA-approved. In the end, the other committee members decided it was better to stick with the approved method. … That was in March. By December, the Fujian strain accounted for 75 percent of the influenza cases in the United States. And although so far it hasn’t been any deadlier than usual, it has been more widespread.”

The second mistake was by the Centers for Disease Control (CDC), which broke from past practices by recommending that everyone, regardless of age and risk status, be immunized. Dr. Smith quotes CDC Director Dr. Julie Gerberding saying, “This is the time for Americans to really step up to the plate and get vaccinated against influenza,” and Secretary of Health and Human Services (HHS) Tommy Thompson saying, “There is plenty of vaccine to meet demand.”

In fact, only 83 million doses had been produced, less than the number of seniors and persons with illnesses making them vulnerable to infection, and far less than the number of people who, frightened by the CDC and assured by HHS, lined up for vaccinations that were probably unnecessary.

Government agencies such as the CDC and HHS have institutional incentives to err on the side of being too conservative when facing risks. In this case, employees of the CDC put the risk to their own careers of approving a new method of producing vaccines that might produce negative side effects above the risk of producing a less-effective vaccine for millions of people. Staffers at HHS avoided the risk of being faulted for not taking the flu season seriously enough … by causing a run on a vaccine they knew was in short supply.

The first lesson of the vaccine shortage, then, is that putting too much authority into the hands of a few government agencies is dangerous to public safety.

Lawsuits and Liability

Only three companies in the U.S. are licensed to produce the flu vaccine: Aventis Pasteur (Fluzone), Chiron Corp. (Fluvirin), and MedImmune Inc. (the nasal spray FluMist). If more companies made the vaccines, it is unlikely the supply would have been so short, or that more doses could not have been made on short notice. Why so few?

The number of vaccine manufacturers in the U.S. has dropped from 20 to only three during the past 15 years largely as a result of lawsuits filed on behalf of supposed victims of vaccine side effects. Vaccine makers have been under nearly constant legal assault by lawyers.

Most recently, personal injury lawyers have filed lawsuits against the maker of Thimerosal, a vaccine preservative that contains mercury, claiming the compound is responsible for the recent rise in cases of autism. However, researchers have studied repeatedly the possibility of a link and have found no evidence.

According to legal expert Peter Huber, 50 to 80 percent of the cost of most vaccines is liability insurance. The risk of losing such cases, and especially the risk of losing a class-action suit that could cost the industry hundreds of millions or even billions of dollars, has persuaded many companies to leave the vaccine marketplace.

The biotechnology industry has made it clear that the threat of lawsuits is keeping it from investing in new vaccines and medicines to meet the threat of bioterrorism, such as the deliberate spread of smallpox and anthrax. In a November 2002 letter to Sen. Tom Daschle (D-South Dakota), the president of the Biotechnology Industry Organization (BIO), Carl B. Feldbaum, wrote, “Without a clear understanding of liability protection, most of our companies, particularly the smaller, innovative companies, will be unable to contract to provide preventive therapeutics or products if it means putting the future of their businesses at risk.”

The second lesson from the vaccine shortage, then, is that until lawsuit abuse is checked, drug companies will not take the necessary risks involved with producing a sufficient supply of vaccines, much less invest in finding the next generation of life-saving vaccines.

Importing Counterfeits

In late December, U.S. health officials prevented the sale of a half-million doses of an alleged flu vaccine that turned out to be, according to the New York Times, “a foreign product of unknown quality and content, not licensed for use in this country.” The bogus vaccine had been offered for sale to the Florida Health Department.

Several foreign countries manufacture flu vaccines, and U.S. officials said they were not yet sure where the counterfeit drugs were being made. Investigations into the incident are ongoing.

“The Food and Drug Administration (FDA) has received reports of potential distribution of unlicensed influenza vaccine in the United States,” the agency reported in a statement issued December 23. “The Agency is aggressively working with state health authorities and the Centers for Disease Control and Prevention (CDC) to investigate the source and quality of influenza vaccine being made available through unusual suppliers.”

“We’re concerned about people attempting to bring in unlicensed material, claiming to have licensed vaccine, from sources that are either suspect or unclear,” said Steven Masiello, director of the Office of Compliance and Biologics Quality in the FDA’s Center for Biologics Evaluation and Research. “The demand is bringing out individuals who are trying to make a quick dollar” and might also inspire criminals to make counterfeit vaccine, added Masiello.

The third and final lesson from the vaccine shortage is that ensuring the quality of the U.S. drug supply is a challenge that grows stronger every day. Importing drugs from foreign countries breaches the country’s first line of defense against counterfeit and adulterated drugs, with potentially deadly consequences.

Conrad F. Meier is managing editor of Health Care News. His email address is [email protected]. Joseph L. Bast is president of The Heartland Institute and publisher of Health Care News.