The first vaccine against hepatitis B, Heptavax-B (Merck Sharp & Dolme), was licensed and approved by the U.S. Food and Drug Administration (FDA) in November 1981,(1) It consisted of antigen from human serum collected from several intravenous drug addicts and homosexual men.(2-3) When the vaccine became available in 1982, the Advisory Committee on Immunization Practices (ACIP) recommended it for individuals who were at risk of contracting hepatitis B because of their lifestyle or employment. The target population included intravenous drug users, male homosexuals, individuals with multiple sexual partners, newborns of hepatitis B-positive mothers, and health care workers and patients exposed to blood and blood products.(4)
Concerns about the safety of using human serum in vaccines, due to potential contamination with human viruses, led to the introduction of a second hepatitis B vaccine by Merck Sharp & Dolme, Recombivax-HB, in 1986.(5) This new type of vaccine, known as a recombinant vaccine, was the first vaccine created through genetic engineering. To develop this recombinant hepatitis B vaccine, the HBV protein envelope gene was inserted into yeast cells, eliminating the risk of viral contamination from using human serum to produce the vaccine.(6)
Between 1982 and 1991, hepatitis B vaccine was recommended for individuals considered to be at moderate or high risk of developing hepatitis B. These populations included health care workers exposed to blood and blood products, staff and patients in institutions for the developmentally retarded, staff and patients in hemodialysis units, infants born to hepatitis B-positive mothers, intravenous drug users, homosexual men, and heterosexual men with multiple sexual partners.(7-8)
While hepatitis B vaccine uptake was slow but progressing among health care workers, institutional workers and residents, and those administering and receiving hemodialysis, by 1987 the rate of use among intravenous drug users, male homosexuals, or individuals with multiple sexual partners had not improved much.(9)
By 1989, a second recombinant hepatitis B vaccine, Engerix-B (SmithKlineBeecham), was approved for use in the United States.(10) However, even though two vaccine manufacturers had produced two new hepatitis B vaccines that were authorized by the FDA for use in children and adults, the vaccine was not being used.
In 1990, officials at the U.S. Centers for Disease Control and Prevention (CDC) expressed concern that targeting high-risk populations was an ineffective strategy because high-risk populations did not understand the risk of hepatitis B or the need for the vaccine; the cost of the vaccine was a barrier to those who could not afford it; and there was no infrastructure with personnel to reach high-risk populations and adequately identify and vaccinate those most at risk. Additionally, vaccine education programs for intravenous drug users “failed to motivate them to receive three doses of vaccine.”(11)
While acknowledging that “sources of infection for most cases include intravenous drug abuse (28%), heterosexual contact with an infected person or multiple partners (22%), and homosexual activity (9%),” CDC officials also stated that “between 25% and 50% of children infected before age 5 years become carriers, whereas only 6% to 10% of acutely infected adults become carriers.”
For this reason, in 1990, the CDC recommended developing a global strategy to administer the hepatitis B vaccine to all children, “before they engage in behaviors or occupations that put them at risk for infection.”(12)
In 1991, the Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended that all newborns be given the first dose of hepatitis B vaccine at birth, before being discharged from the hospital nursery. This recommendation was also supported by the American Academy of Pediatrics' (AAP) Committee on Infectious Diseases, despite little knowledge about an individual infant's immune and neurological health at birth.(13)
Prior to the 1991 ACIP recommendations, the media published articles portraying hepatitis B as a deadly disease that was sweeping the United States. News sources reported that hepatitis B was spreading rapidly and that everyone was at risk of infection because over 1,5 million people in the United States had the disease.(14)
These CDC-generated media reports used statistics about hepatitis B disease that were not grounded in documented facts, yet they are still used today to promote mass vaccination against hepatitis B. Most of the inflated disease statistics were generated by statements from CDC officials. In the 1991 ACIP recommendations calling for mass vaccination with the hepatitis B vaccine, published in the Morbidity and Mortality Weekly Report (MMWR), the CDC states that ““An estimated 1 million to 1,25 million people in the United States are chronically infected with hepatitis B.”(15) and that “each year approximately 4.000-5.000 of these people die from chronic liver disease”(16) and that “an estimated 200.000-300.000 new [hepatitis B] infections occurred each year during the period 1980-1991'(17) However, the CDC does not provide any scientific reference for this data. Made-up data? We leave the answer to you.
Both Recombivax HB vaccines(18) and Engerix-B(19) originally contained the mercury preservative thimerosal, which is used to prevent bacterial contamination of inactivated vaccines, particularly those packaged in multidose vials. The Food and Drug Administration (FDA) Modernization Act of 1997 required the FDA to review and evaluate the risk of all foods and drugs containing mercury. Subsequently, on July 9, 1999, the American Academy of Pediatrics (AAP), the U.S. Public Health Service, and vaccine manufacturers issued a joint statement calling for the elimination of thimerosal from childhood vaccines.(20) However, despite calls to eliminate thimerosal from vaccines, including hepatitis B, “as soon as possible,” it was recommended that children and adults continue to be vaccinated with thimerosal-containing vaccines.(21)
The FDA approved the thimerosal-free Recombivax HB on August 27, 1999.(22) The thimerosal-free Engerix-B was not approved until January 30, 2007.(23) Although the CDC has recommended that infants and children up to six months of age be vaccinated with the thimerosal-free version of the hepatitis B vaccine, they have stated that high-risk infants and those older than six months should continue to receive thimerosal-containing vaccines.(24)
The Dompé-Glaxo Bribes Scandal during Tangentopoli
The case of the bribe linked to the anti-hepatitis B vaccination represents one of the central points in the corruption scandal involving the former Minister of Health Francesco De Lorenzo and the Glaxo company.(25) In the Italian context of Tangentopoli,(26) in 1994 the former Minister of Health was arrested in relation to bribes for approximately nine billion lire (over 5 million euros) obtained from some pharmaceutical industries in the period from 1989 to 1992, during his ministry. For this he was later definitively sentenced to 5 years and 4 months of imprisonment.
As we were saying, 1991 was a key year when De Lorenzo, together with Duilio Poggiolini, director general of the national pharmaceutical service, decided to make the vaccine against hepatitis B mandatory with Law no. 165 of 27 May 1991.(27) What convinced him was a bribe of 600 million lire (550 thousand euros) paid by Glaxo, the only company producing the anti-hepatitis B vaccine, to ensure the mandatory introduction of the hepatitis B vaccine in Italy and the expansion of the group of citizens who were advised to have this vaccination.
Before its mandatory introduction, the hepatitis B vaccine was administered on a voluntary basis in Italy, mainly to subjects at risk, such as health workers and people with particular medical conditions. However, as early as 1988, several politicians, including Tina Anselmi,(28) They had put forward proposals to make neonatal vaccination mandatory and despite these proposals, the law was not passed until Glaxo stepped in with a bribe intended to speed up the process.(29)
Over the next few years, both De Lorenzo and Poggiolini were tried and convicted of corruption and extortion. The Court of Cassation, with a final ruling in 2012, confirmed the sentence to 5 million euros in compensation for damage to the image of the State.(30) Glaxo, despite its direct involvement, did not suffer significant legal consequences, but the affair brought to light the widespread system of bribes that characterized the relationship between politics and the pharmaceutical industry.(31)
