Weakened immunity: how the food and drug administration caused recent vaccine-supply problems.

• Author: Foulkes, Arthur

Since 2000 in the United States, there have been serious supply problems involving nearly all childhood vaccines recommended by the U.S. Centers for Disease Control and Prevention (CDC). (1) Such problems have occurred with other vaccines as well, including influenza vaccine. Some headlines illustrate the story:

"Vaccine Shortages Threaten Kids" (MSNBC News, September 17, 2002)

"Vaccine Shortages Frustrate Everyone" (Amednews.com [American Medical Association] March 4, 2002)

"Health Officials Warn That Flu Vaccine May Be Too Little, Too Late" (Philadelphia Inquirer, September 6, 2000)

"Flu Shot Delays Reported for Many Who Are at Risk" (New York Times, November 7, 2000)

These and other stories tell of frustrated doctors and health-care workers unable to get vaccines (Chang 2000; "Physicians Weigh In" 2002). They describe elderly patients standing in long lines at flu shot clinics or arriving at clinics only to find that supplies had run out (Borgatta 2000; Stapleton 2001). Other stories speak of "price gouging" as hard-to-find vaccines are sold for many times the usual price.

It is unclear why these difficulties happen, but many people place the blame squarely on the free market and vaccine manufacturers. "We're not distributing shoes for the prom," one doctor told the Los Angeles Times, November 4, 2000, during the flu vaccine shortage. "This is a public health issue," she said. U.S. senator Jack Reed of Rhode Island declared, "It's clear ... that we have a system that cannot guarantee an adequate supply of vaccines from year to year and is unprepared to handle a potential outbreak of routine childhood diseases." He called for several government agencies to "coordinate their oversight of manufacturers" (Reed 2002). U.S. representative Peter DeFazio of Oregon stated, "I would hope we're not making life and death decisions based on someone's ability to compete in the market." He introduced legislation that would give the secretary of the Department of Health and Human Services the authority to declare a "public health emergency" by reason of a flu vaccine shortage. The government could then "take title to such quantities of vaccine as the secretary determines to be necessary for purposes of the public health" (U.S. House 2001, emphasis added). On May 21, 2001, DeFazio told the Eugene, Oregon, Register Guard that "a market driven system for delivering vaccine doesn't work when there's a shortage or outbreak" (Christie 2001).

Did the free market really fail? Can it deliver only prom shoes and other "nonessential" goods? Is more government intervention necessary to guarantee that Americans get immunizations? In this article, I maintain that the U.S. vaccine market is far from "free" and that government intervention itself has caused the recent supply difficulties.

What Happened?

The vaccine shortages are a recent phenomenon. According to a U.S. Government Accounting Office (GAO) report, childhood vaccine supplies started to run low "in the fall of 2000 when supplies of the tetanus and diphtheria booster (Td) fell short" (U.S. GAO 2002, 8). The supply problem with influenza vaccine also emerged at that time, although the CDC had warned of it a few months earlier (U.S. CDC 2000). Over the next thirty months, nearly all of the CDC's recommended childhood vaccines were at one time or another in seriously short supply.

Seriousness of the Problem

All of the vaccine supply problems began at approximately the same time. In January 2001, just a few months after the Td and influenza vaccine shortages took hold, the vaccine known as DTaP (for diphtheria, tetanus, and pertussis) fell into short supply. Pneumococcal conjugate vaccine came next (PCV), in September 2001, followed by measles, mumps, and rubella (MMR) and chicken pox (varicella) in October 2001 (U.S. GAO 2002, 8). At the same time, shortages also occurred for the hepatitis B and haemophilus influenzae type b (Hib or meningitis) vaccines ("How to Shore Up" 2002).

State and local immunization programs felt the pinch. All fifty-two state and local programs that responded to a GAO survey reported that they "experienced shortages of two or more vaccines." Approximately two-thirds reported "shortages with five or more" of the eight vaccines. More than half reported lowering their immunization requirements for kids to attend school (U.S. GAO 2002, 11-12).

Why This Matters

One hundred years ago more than one in ten American infants died from vaccine-preventable diseases. "Since the introduction of vaccines against these diseases, incidence has dropped by 99%" ("How to Shore Up" 2002). Measles, polio, smallpox, and meningitis--all once significant dangers for children--have been virtually eliminated in the United States. Now, however, delayed and sometimes missed vaccinations are putting one hundred years of progress at risk. (2) According to the GAO, although high "vaccination rates from recent years could delay the immediate effects of deferred immunizations, ... under-immunization destabilizes population immunity and may lead to outbreaks" (U.S. GAO 2002, 13).

According to the CDC, some thirty-six thousand Americans die from flu-related illness each year. Nearly all of these deaths occur in people older than sixty-five. In 2000, the year in which the greatest difficulties in getting the flu vaccine occurred, the vaccination rate for people sixty-five or older fell to 62 percent--down five percentage points from 1999. Among people ages eighteen to sixty-four with diabetes (another group at potentially serious risk from flu), the immunization rate in 2000 was 44.3 percent--down nine percentage points from the previous year (U.S. CDC 2002b). Altogether, approximately 1 million fewer elderly people got flu shots in 2000 than did in 1999, (3) almost certainly because of the difficulty getting the vaccine during the peak demand months of October and November 2002. (4)

Tenuous Supply

Congress asked the GAO to investigate the childhood vaccine shortages. In September 2002, the GAO reported that for the most part the shortages had ended, but it warned that they might recur if disruptions, such as "a catastrophic plant fire" or product recall, took place. Many months might elapse before new vaccines could be made available (U.S. GAO 2002, 19).

The GAO also warned that vaccine supplies are vulnerable because so few companies make vaccines for the U.S. market. A single manufacturer provides five of the eight vaccines that the CDC recommends for children. With so few manufacturers, a single company's exit from the market can cause a shortage quickly (U.S. GAO 2002, 19-20). (5) The same point had been made earlier by Infectious Disease News, March 2002, when it reported, "it would take only a single manufacturer to discontinue production to lose the vaccine supply for MMR, [chicken pox], inactivated polio and [meningitis]" ("How to Shore Up").

Just four companies make virtually all childhood vaccines used in the United States.: Merck & Company (United States), Wyeth Pharmaceuticals (United States), Aventis Pasteur (France), and GlaxoSmithKline (United Kingdom). Only two companies still make injectable influenza vaccine for the U.S. market: Aventis Pasteur and Medeva Pharma (United Kingdom, known as Evans Vaccines in the United States). (6)

How the Food and Drug Administration Caused the Problem

It is no coincidence that vaccine shortages started to appear shortly after the U.S. Food and Drug Administration (FDA) launched "a new program for inspecting the biologics industry, called Team Biologics." Team Biologics was created in 1997, but it "moved to vaccines in October 1999" (U.S. GAO 2002, 15).

Prior to 1999, FDA inspections of vaccine plants "were generally shorter and involved smaller inspection teams." After Team Biologics took control, however, inspections lengthened, and inspection teams grew. Inspectors began to focus less on purely "scientific or technical issues" and more on compliance with a broader "range of issues, such as quality assurance, record keeping, equipment cleaning, personnel qualifications, and laboratory controls" (U.S. GAO 2002, 15).

Such inspections, whether prior to the introduction of Team Biologics or afterward, fall under the FDA's authority (granted in the 1962 amendments to the Food, Drug, and Cosmetic Act of 1938), known as Current Good Manufacturing Practice regulations (CGMP). These regulations are the FDA's "requirements for ensuring that biological products remain safe, pure, and potent through the entire manufacturing process" (U.S. GAO 2002, 15, emphasis added).

When the FDA strengthened its CGMP protocols, it failed to inform the vaccine industry clearly of the change. As economist David Webster stated in a 2002 interview, "FDA didn't communicate very clearly that they were changing the rules of the game. Because of that, a lot of manufacturers were sort of caught unaware."

The GAO supports this view in its 2002 report: "FDA did take steps to inform manufacturers about the program changes; however, some manufacturers reported problems related to how well the changes were communicated." The report also mentions that at least two manufacturers reported problems getting clear guidance from the FDA. It notes that in October 1999, when Team Biologics was moving into the area of vaccines, the FDA printed a "guidance manual detailing the new protocol for conducting [vaccine industry] inspection." However, this manual was intended for FDA employees and was "not made widely available--only upon request." Further, the GAO noted that although other FDA compliance manuals are available on the Internet, "the manual for licensed vaccines [was] still not available on line, well over two years after its issuance, nor [was] it included in FDA's annual comprehensive list of guidance documents published in the Federal Register" (U.S. GAO 2002, 16).

Finding the Cause of the Scarcities

It takes a little reading between the lines to discover that...