08 December 2025
The vaccine advisory committee of the U.S. CDC (Centers for Disease Control and Prevention) has voted to revoke the universal recommendation requiring the vaccination of all newborns against Hepatitis B at birth. This decision is sparking widespread uproar among pediatricians.
What do we know about the Hepatitis B vaccine?
Baruch Blumberg, a Jewish physician, identified an antibody in a hemophilia patient in New York in 1964. Due to multiple blood transfusions, this patient had been exposed to a wide variety of antigens. Blumberg found that this antibody reacted against a protein previously identified in an individual on the other side of the world - an Australian Aborigine. He named the antigen the Australia Antigen (AuAg). It was later discovered that this antigen is part of the Hepatitis B virus. Today, this antigen, which constitutes the viral envelope, is known as HBsAg (Hepatitis B Surface Antigen).
The Blumberg/Millman Vaccine: In 1969, a patent for vaccine production was registered by the Institute for Cancer Research, utilizing sera from individuals carrying the Australia Antigen in their blood. By 1975, sufficient pre-clinical work had been conducted in laboratories in the United States and elsewhere to warrant moving forward with the vaccine. The pharmaceutical company Merck expressed interest to the Fox Chase Cancer Center (FCCC). Following the signing of a licensing agreement between FCCC and Merck, Dr. Maurice Hilleman of Merck led the project with the goal of producing a Hepatitis B vaccine.
In 1976, Baruch Blumberg was awarded the Nobel Prize in Physiology or Medicine. Wolf Szmuness was a Polish-Jewish physician. His family perished in the Holocaust during World War II, while he survived by fleeing east to the Soviet Union, where he was sent to a Gulag in Siberia. He began his medical studies in Pisa, Italy, and completed them after the war at the University of Tomsk in Siberia. In the U.S., he worked as a lab technician at the New York Blood Center (as his medical credentials from the USSR and Poland were not automatically recognized). His vast knowledge and scientific talent were quickly identified there, and he was promoted to research roles that allowed him to focus on epidemiology. Szmuness conducted and led the observational trials for Merck's experimental vaccine. Based on these observations, the FDA approved the vaccine in the U.S. in 1981. This was the first and last time a vaccine was produced in this manner (a plasma-derived vaccine sourced from the blood of individuals infected with Hepatitis, who were potentially carriers of other pathogens, such as HIV).
In 1986, a recombinant vaccine was approved for use. Developed by Dr. Pablo Valenzuela and Dr. William Rutter in collaboration with Chiron and Merck, this vaccine contains only the viral envelope protein, HBsAg, and is produced in yeast (Saccharomyces cerevisiae). This was the first recombinant vaccine ever approved for use in humans.
In 1991, the World Health Organization (WHO) recommended including the vaccine in all national immunization programs.
Sci-B-Vac (marketed in the U.S. as PreHevbrio) was developed in Israel at the Weizmann Institute of Science by Prof. Yosef Shaul of the Department of Molecular Genetics. Approved for use in Israel in 2000, it contains all three viral envelope proteins: pre-S1, pre-S2, and S surface proteins. These proteins were produced in mammalian cells (CHO cells).Vaccine production in the United States ceased in 2024 after the manufacturer discontinued its operat