“Do We Really Need Hepatitis B on the Second Day of Life?” Vaccination Mandates and Shifting Representations of Hepatitis B
Today, most newborns in the United States are vaccinated against the hepatitis B virus, usually in the first few days of life.1 The practice of vaccinating infants against hepatitis B, a blood-borne virus that attacks the liver, is a popular target for contemporary vaccine critics, who for the last decade have argued that the virus is a sexually-transmitted infection that poses little or no risk to babies. Indeed, this is how federal health officials themselves characterized the virus back in 1981 when they first approved the vaccine.
Like many twentieth-century pharmaceutical discoveries, the development of the hepatitis B vaccine was, in part, a matter of happenstance. In 1963, research physician, Baruch Blumberg, was investigating variations in susceptibility to infections among different ethnic and racial groups when he identified a protein in the blood of Australian aborigines, which he dubbed the Australia antigen. Blumberg and colleagues initially surmised that the protein was inherited, but they soon noted a correlation between Australia antigen in the blood and hepatitis B infection, then called serum hepatitis. Gradually, the researchers came to suspect that Australia antigen, which floated freely in the blood of people infected with hepatitis B, was part of the virus that caused hepatitis. In 1967, they determined that Australia antigen was, in fact, a surface protein on the virus that caused the disease; the discovery quickly led to a test to screen blood and diagnose patients. In related research, Blumberg and colleagues found that monkeys injected with highly purified Australia antigen (later renamed hepatitis B surface antigen or HBsAg) did not progress to serum hepatitis; the discovery suggested that non-infectious material could be separated from the virus itself. In 1969, the researchers patented the process for separating and purifying the antigen. The basis for the development of a vaccine, what Blumberg called “the most significant outcome” of their work, had thus been discovered.2
Over the course of the 1970s, the diagnostic test that Blumberg’s research group had developed revealed the full extent of the hepatitis B epidemic, both in the U.S. and around the world. Two distinct forms of hepatitis, A and B (formerly infectious and serum hepatitis, respectively) had been known since the 1950s, but countless cases of the latter had gone undetected, in large part because of the vague symptomatic presentation of hepatitis B infection. Infection may or may not cause acute symptoms, including debilitating fatigue, nausea, and loss of appetite, and acute symptoms may or may not be fatal. Those who do recover may or may not become chronic carriers. Carriers, in turn, may or may not become victims, decades later, of hepatitis-induced cirrhosis or liver cancer.3 Furthermore, hepatitis B’s fairly mundane acute symptoms meant that, for decades, it was routinely confused with other conditions. In the 1970s, however, armed with the newly developed diagnostic protocols, researchers identified for the first time more than 200,000 new cases in the U.S. each year, and more than 200 million carriers worldwide. Concurrent epidemiological studies also identified those at highest risk of the disease; in addition to health care workers, the list included hemophiliacs, prisoners, gay men, injection drug users, sex workers, native Alaskans, and immigrants from sub-Saharan Africa, China, and southeast Asia.4
The press also reported on the 1979 outbreak of hepatitis B among youth who shared needles to inject the recreational drug methylene deoxyamphetamine.8 Such stories began to illustrate the picture emerging from epidemiological studies for the public: that the disease posed a risk to specific subsets of the population including surgeons and drug users.
That second hepatitis B vaccine, widely available by the late 1980s, was a vastly different product from the first, blood-derived vaccine. Recombivax HB, the genetically-engineered hepatitis B vaccine approved in 1986, contained viral proteins not harvested from diseased patients in the clinical setting but rather manufactured by recombinant yeast in the lab. Before it was licensed, press reports hailed Recombivax B for its potential to prove that genetic engineering would revolutionize the pharmaceutical industry. Scientists and the reporters who quoted them called biotech vaccines “exciting and imaginative,” and referred to the hepatitis B vaccine specifically as a “pioneering product.”25 Researchers told the New York Times that biotech shots were “cutting edge weapons” that would eliminate not only hepatitis B but also AIDS and malaria.26 The business press breathlessly reported on the race between “tiny” California biotech firms to produce the world’s first genetically-engineered vaccine, and when Chiron’s Recombivax was approved, Venture magazine crowned it one of the best entrepreneurial ideas of 1986.27 The approval of Recombivax HB—the first genetically-engineered vaccine and the fifth genetically-engineered pharmaceutical to make it to market—was heralded on the front pages of the New York Times, the Los Angeles Times, the Wall Street Journal and elsewhere for ushering in what FDA commissioner, Frank Young, called a “new era in vaccine production.”28
That era was long awaited. In the 1960s, lawsuits over polio vaccine tainted with live virus had prompted half the nation’s vaccine manufacturers to pull out of the market altogether—a fact the business press repeated as they reported on the new vaccine.29 The genetically-engineered hepatitis B vaccine was enthusiastically received by investors, the pharmaceutical industry, and health professionals not only because it held the promise of a new generation of vaccines (and thus new markets), but also for its potential to address safety concerns that had damaged the industry and shaken consumer confidence. In the words of the Wall Street Journal’s editorial board, Chiron’s discovery brought an end to the days when vaccine development was “an inexact scientific art.”30 “We see no reason why our approach won’t work with virtually any infectious disease, whether it is viral, bacterial or even parasitic in nature,” one researcher told Time.31 Nodding implicitly toward past and present fears, another researcher told the magazine that genetically-engineered vaccines eliminated the “risk of actually getting herpes, hepatitis B or influenza from the injection, since the viruses themselves are not present in the formula.”32 Because the new vaccine did not contain a whole virus, it “just can’t do any damage, period,” promised FDA microbiologist Richard Daemer.33 These sentiments were echoed by FDA Commissioner Young in a press statement he made on the occasion of Recombivax’s approval. “These techniques should be…extended to any virus or parasite,” he stated. He went on to say that while the plasma-derived vaccine had never posed a risk of AIDS, the new “lab-made vaccine” should further reassure people. He also strongly urged those at high risk of hepatitis B to take advantage of this “new life-saving protection.”34
By 1999, 42 states had mandated the hepatitis B vaccine for students, and over 25,000 reports of adverse events linked to the vaccine had been reported to VAERS. Scientists asserted that the mere number of events was far from proof of causation of harm, but parents insisted the figures revealed a different truth.
In the subsequent wave of reporting on hepatitis B, media reports focused on the perspective of patients, not scientists. In 1998, the media reported on France’s decision to halt hepatitis B vaccination because of fears the shot caused neurological damage.64 Early in 1999, the television news program 20/20 aired a report on adults with impairments thought to be linked to the vaccine and an infant who died shortly after receiving the vaccine.65 In the spring of 1999, a House Committee held hearings on hepatitis B vaccine safety concerns. The hearings attempted to weigh the potential risks of the vaccine against the risks of what appeared, by this time, to be two very different diseases. To officials from the CDC and members of the American Liver Foundation and Hepatitis Foundation, hepatitis B was, primarily, a lethal disease that infected one in 20 Americans and caused 5,000 deaths each year, many of these from liver cancer. To members of Massachusetts Citizens for Vaccination Choice and Parents Requesting Open Vaccination Education, and to the doctors and parents who had witnessed blindness, deafness, seizures, and other effects in children following vaccination, hepatitis B was instead a rare, sexually-transmitted infection that threatened drug addicts and foreigners and that posed no risk to American infants from healthy families.66
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