What is the History of Hepatitis B Vaccine Use in America?
The first vaccine against hepatitis B, Heptavax-B, (Merck Sharp & Dolme) licensed and approved by the FDA in November of 1981,1 was comprised of antigen from human serum harvested from several IV drug users and homosexual men.2 When the vaccine became available in 1982, the Immunization Practices Advisory Committee (ACIP) recommended the vaccine for individuals who were at risk for contracting hepatitis B due to their lifestyles or their employment. The targeted population included IV drug users, homosexual males, individuals with multiple sex partners, newborn infants of hepatitis B positive mothers and health care workers and patients exposed to blood and blood products.3
Concerns over 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 1986.4 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 gene of the HBV protein envelope was inserted into yeast cells, eliminating the risk of viral contamination from using human serum to produce the vaccine.5
Between 1982 and 1991, the hepatitis B vaccine was recommended for individuals considered at moderate to high risk for developing hepatitis B. These populations consisted of health-care professional exposed to blood and blood products, staff and patients of institutions for the developmentally delayed, staff and patients in hemodialysis units, infants born to hepatitis B positive mother, IV drug users, homosexual males and heterosexuals with multiple sex partners.6, 7
While hepatitis B vaccine uptake was slow but progressing in health care professionals, as well as those working and living in institutions and those administering and receiving hemodialysis, by 1987, there was little improvement in the rate of use among IV drug users, homosexual males or individuals with multiple sex partners.8
By 1989, a second recombinant hepatitis B vaccine, Engerix-B (SmithKlineBeecham), was approved for use in the U.S.9 However, even though two vaccine manufacturers had produced two new hepatitis B vaccines that had been licensed by the FDA for use by children and adults, the vaccine was not being used.
By 1990, CDC officials expressed concerns that targeting high risk populations was an ineffective strategy because high risk populations do not understand the risk of hepatitis B or need for the vaccine; the vaccine’s cost is a barrier for those who can’t afford it; and there is no infrastructure with staffing to reach high risk populations by adequately identifying and vaccinating those most at risk. Further, vaccine education programs targeting IV drug users “failed to motivate them to receive three doses of vaccine.”10
While acknowledging that “The sources of infection for most cases include intravenous drug abuse (28%), heterosexual contact with infected persons or multiple partners (22%), and homosexual activity (9%),” CDC officials also stated that, “Between 25% and 50% of children infected before 5 years of age become carriers, whereas only 6%-10% of acutely infected adults become carriers.”
Therefore, in 1990, the CDC made the recommendation that a comprehensive strategy be developed to give hepatitis B vaccine to every child - “before they engage in behaviors or occupations that place them at risk of infection."11
In 1991, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) recommended that all infants be injected with the first dose of hepatitis B vaccine at birth before being discharged from the hospital newborn nursery. This recommendation was also supported by the Committee on Infectious Diseases of the American Academy of Pediatrics (AAP), despite little knowledge about the health of an individual baby's immune and neurological systems at birth.12
In advance of the 1991 ACIP recommendations, stories appeared in the media portraying Hepatitis B as a deadly disease that was rampant in the United States. News sources were reporting hepatitis B was spreading quickly and everyone was at risk of infection from over 1.5 million persons in the U.S. living with the disease.13
These media reports generated by the CDC used hepatitis B disease statistics that were not anchored in documented fact but are still used today to promote mass hepatitis B vaccination. Most of the inflated disease statistics originate with statements generated by officials at the Centers for Disease Control. In the 1991 ACIP Recommendations calling for mass vaccination with hepatitis B vaccine published in the Morbidity and Mortality Weekly Report, the CDC stated that there are an "estimated 1 million-1.25 million persons with chronic hepatitis B infection in the United States"14 and that, "each year approximately 4,000-5,000 of these persons die from chronic liver disease"15 and that, "an estimated 200,000-300,000 new hepatitis B infections occurred annually during the period 1980-1991."16 However, the CDC gives no scientific reference for this data other than the CDC.
Both Recombivax HB17 and Engerix-B18 vaccines originally contained the mercury preservative, thimerosal, which is used to prevent bacterial contamination of inactivated vaccines, particularly vaccines packaged in multi-dose vials. The Food and Drug Administration (FDA) Modernization Act of 1997 called for FDA to review and assess the risk of all mercury-containing food and drugs. Subsequently, the American Academy of Pediatrics (AAP), the U.S. Public Health Service and vaccine manufacturers published a joint statement on July 9, 1999 calling for the removal of thimerosal from childhood vaccines. 19 However, despite calling for removal of thimerosal from vaccines, including hepatitis B, “as soon as possible,” there was a recommendation that vaccination of children and adults continue using thimerosal-containing vaccines.20
The FDA approved thimerosal-free Recombivax HB on August 27 1999.21 thimerosal-free Engerix-B was not approved until January 30, 2007.22 While the CDC recommended that newborns and infants up to the age of six months be vaccinated with the thimerosal-free version of the hepatitis B vaccine, they stated that high-risk infants and those over the age of six months should continue to receive thimerosal-containing vaccines.23
More recently the FDA approved HEPLISAV-B in 2017 for use in adults 18 years of age and older. The CDC’s Advisory Committee on Immunization Practices voted to add notations to their adult vaccination schedule that would include usage of HEPLISAV-B.24
As well, in December of 2018, the FDA approved VAXELIS, a 6 in 1 (hexavalent) vaccine containing Haemophilus influenzae type b conjugate vaccine in combination with diphtheria and tetanus toxoid and acellular pertussis (DTaP), inactivated poliomyelis (IPV), and recombinant hepatitis B vaccine.1 Manufactured in a partnership between Sanofi Pasteur and Merck, VAXELIS combines the diphtheria and tetanus toxoids, acellular pertussis and inactivated poliomyelis antigens manufactured by Sanofi Pasteur with the Haemophilus influenzae type b conjugate and hepatitis B recombinant vaccines, manufactured by Merck. VAXELIS, approved for use in infants and children between 6 weeks and 4 years of age and recommended to be administered at 2, 4, and 6 months of age, is expected to become available for use in the United States in 2020.1 The CDC’s Advisory Committee on Immunization Practices (ACIP), however, has not made any recommendations regarding the use of VAXELIS at this time.
Recommendations for vaccination are made by federal health officials at the CDC, but legal requirements for admission to daycare and schools are made by health officials in health departments in each individual state. When federal health officials set the goal of achieving a 100 percent vaccination rate in the U.S. with new vaccines developed by drug companies and licensed by the FDA, they must persuade states to turn federal vaccine policies into state law.
During the past 70 years, many state legislatures have turned over the power to mandate vaccines to state health department officials, and rarely do state legislators take a vote to approve the mandating of a new vaccine, such as hepatitis B vaccine. Following the 1991 CDC recommendation for universal use of hepatitis B vaccine by all children,25 state health department officials began issuing mandates requiring children to show proof they have received three doses of hepatitis B vaccine in order to attend daycare or school.
By the end of 1997, 35 states had regulations on the books requiring children to get three doses of hepatitis B vaccine,26 yet only 15 states had passed laws requiring prenatal screening of pregnant mothers for hepatitis B infection. As of 2016, 47 states and Washington, D.C. required three doses of hepatitis B vaccine for school and/or daycare entry,27 while only 27 states required prenatal screening of pregnant mothers for hepatitis B infection.28
In October 2018, the CDC published its annual vaccine report on vaccination rates of infants, children and adults and reported that 73.6 percent of all newborns receive their first dose of hepatitis B within the first three days of life, and meeting Healthy People 2020 goals with 91.4 percent of all children receive all three doses of the vaccine before the age of 36 months.29 The CDC also reported 91.9 percent of adolescents ages 13-17 as having received all three doses of hepatitis B.30
While vaccination rates for infants, children and adolescents is estimated at over 91 percent, in 2013, just over 24 percent of adults had received all three doses of the hepatitis B vaccine. Adults aged 19 to 49, considered to be most at risk for developing hepatitis B, have a vaccination rate of 32 percent.31
In 2016, of the 1,651 acute hepatitis B cases containing information about death, 44 deaths were reported.32
IMPORTANT NOTE: NVIC encourages you to become fully informed about Hepatitis B and the Hepatitis B vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
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1 Schmeck Jr. H. VACCINE FOR HEPATITIS B, JUDGED HIGHLY EFFECTIVE, IS APPROVED BY F.D.A. New York Times. Nov. 17, 1981.
2 History of Vaccines.org. Hepatitis B: First Subunit Viral Vaccine in U.S. No Date.
3 CDC. Recommendation of the Immunization Practices Advisory Committee (ACIP) Inactivated Hepatitis B Virus Vaccine. MMWR. Jun. 25, 1982, 31(24);317-22,327-8
4 Boffey PM. U.S. APPROVES A GENETICALLY ALTERED VACCINE. New York Times. Jul. 24, 1986
5 CDC Hepatitis B – Hepatitis B Vaccine Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.
6 CDC. Recommendation of the Immunization Practices Advisory Committee (ACIP) Inactivated Hepatitis B Virus Vaccine. MMWR. Jun. 25, 1982, 31(24);317-22,327-8
7 CDC Recommendations of the Immunization Practices Advisory Committee Update on Hepatitis B Prevention. MMWR. Jun 19, 1987, 36(23);353-366
9 FDA. Summary of Bases for Approval - Engerix - B. No Date.
10 CDC. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Nov. 22, 1991, 40(RR-13);1-19
11 CDC. Protection against Viral Hepatitis Recommendations of the Immunization Practices Advisory Committee (ACIP).MMWR Feb. 09, 1990; 39(RR-2);1-26
12 CDC. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Nov. 22, 1991, 40(RR-13);1-19
13 Conis E. “Do We Really Need Hepatitis B on the Second Day of Life?” Vaccination Mandates and Shifting Representations of Hepatitis B. J Med Humanit. 2011 Jun; 32(2): 155–166
14 CDC. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR Nov. 22, 1991, 40(RR-13);1-19
17 FDA. Summary of Basis for Approval – Recombivax HB. No Date/Pre-1999 Approval.
18 FDA. Summary of Bases for Approval – Engerix-B. No Date/Pre-1998 Approval.
19 CDC. Notice to Readers: Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service. MMWR Jul. 09, 1999, 48(26);563-565
21 FDA. August 27, 1999 Approval Letter - Recombivax HB. Aug. 27 1999
22 FDA. January 30, 2007 Approval Letter - Engerix-B. Jan 30 2007
23 CDC. Notice to Readers: Availability of Hepatitis B Vaccine That Does Not Contain Thimerosal as a Preservative MMWR Sept. 10, 1999, 48(35);780-782
24 Schaffner, W. ACIP recommends HEPLISAV-B for HBV vaccination. Healio. Feb. 21, 2018
25 CDC. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the Immunization Practices Advisory Committee (ACIP).MMWR. Nov. 22, 1991, 40(RR-13);1-19
26 Immunization Action Coalition. State Information Hepatitis B Prevention Mandates for Daycare and K-12. Nov. 11, 2018
28 CDC. Maternal Hepatitis B Screening and Reporting Requirements. Revised Sept. 12 2014
29 CDC. Vaccination Coverage Among Children Aged 19–35 Months — United States, 2017 MMWR Oct. 12, 2018; 67(40);1123–1128
30 CDC National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2017 MMWR Aug. 24, 2018; 67(33);909–917
31 CDC. Surveillance of Vaccination Coverage Among Adult Populations – United States, 2015. MMWR Surveillance Summaries. May 5, 2017. 66(11);1-28.
32 CDC. Table 3.2. Select Clinical Characteristics of Acute Hepatitis B Cases* Reported in the United States, 2016. Apr. 16, 2018