Vaccine Development & Licensing Events
Most of the vaccines in use today were developed in the 20th century. Here we collect a group of vaccine development and licensing events from our timelines to illustrate the extent of vaccine research that occurred in the wake of Louis Pasteur's development of the first laboratory-created vaccine in the late 1800s.
Timeline Entry: 1936 Max Theiler Develops Yellow Fever Vaccine
Max Theiler and his colleagues developed a live attenuated vaccine for yellow fever using tissue cultures prepared from embryonated chicken eggs. Among the many subcultures of the yellow fever virus in the laboratory, the one designated “17D” was used, giving the vaccine its name. The vaccine was easily adapted for mass production, and became the universal standard.
See This Item In The TimelineTimeline Entry: 1944 Vaccine for Japanese Encephalitis
Maurice Hilleman, working at E. R. Squibb and Sons, helped develop a Japanese encephalitis vaccine to protect American troops in the World War II Pacific theater of operations.
Hilleman’s vaccine was never widely tested. It was given to thousands of U.S. soldiers in wartime and likely prevented disease in many of them. Later, other vaccines replaced it.
See This Item In The TimelineTimeline Entry: 4/12/1955 Polio Vaccine Results Announced
In a press conference at the University of Michigan, Thomas Francis Jr., MD (a scientist with extensive experience with influenza vaccines), and colleagues announced the results of the Salk poliovirus vaccine trial. The vaccine, they said, was 80-90% effective against paralytic polio.
The U.S. government licensed Salk’s vaccine later this same day. The press conference and licensure paved the way for widespread distribution and use of the vaccine.
See This Item In The TimelineTimeline Entry: 8/24/1960 Sabin's Polio Vaccine Licensed
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Albert Sabin’s live poliovirus vaccine was recommended by the U.S. Surgeon General to be licensed. This vaccine provided protection against Type 1 poliovirus. Soon, vaccines for Types 2 and 3 would be licensed. A 1963 vaccine would combine all three types.
See This Item In The TimelineTimeline Entry: 1968 Vaccine for Hong Kong Influenza Pandemic
Hilleman and colleagues received a new influenza A virus, Type A2, Hong Kong strain, that had caused widespread illness in Hong Kong. They rushed to manufacture a vaccine from the new flu strain. In four months, Merck had manufactured over nine million doses of vaccine.
See This Item In The TimelineTimeline Entry: 1969 Rubella Vaccine Licensed
Meruvax, Hilleman’s HPV-77 rubella vaccine, was licensed. Later, it would be replaced by vaccines derived from Stanley Plotkin’s RA 27/3 strain of rubella virus.
Rubella is typically a mild illness. Its symptoms are low fever, rash, and swollen glands. If, however, a pregnant woman contracts rubella, especially early in her pregnancy, the effects can be devastating. Babies exposed to rubella in utero may suffer deafness, blindness, mental retardation and other deformities. A devastating rubella pandemic developed during 1962-1965. In the United States, more than 20,000 babies were born with congenital rubella syndrome. Tens of thousands of women suffered miscarriages or elected to have abortions due to rubella infection. The pandemic focused medical researchers’ attention on the need for an effective vaccine.
See This Item In The TimelineTimeline Entry: 1971 Measles, Mumps, Rubella Vaccine Licensed
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The U.S. government licensed Merck’s combined trivalent measles, mumps, and rubella vaccine (MMR).
Combination vaccines have several advantages over single vaccines. They reduce the need for several separate injections, and they reduce costs of stocking and shipping multiple containers. Combination vaccines can help improve overall vaccination rates by simplifying the vaccination process.
See This Item In The TimelineTimeline Entry: 4/2/1974 Meningococcal Polysaccharide Vaccine Licensed
Hilleman ushered a series of meningococcal polysaccharide vaccines to licensure (group A, group C, combined groups A+C, and then a quadrivalent vaccine against groups A, C, Y, and W-135) beginning in 1974 with a vaccine that was effective against meningococcal group A, one of five major types of meningococcal bacteria.
The vaccines represented a new approach in vaccine science: using not live or attenuated pathogens, but rather the polysaccharide (complex sugar) outer coating of these bacteria. Much of the work on isolating the polysaccharides for both group A and group C was done at Walter Reed Army Institute of Research by Army researchers at Hilleman's earlier professional base.
See This Item In The TimelineTimeline Entry: 3/24/1976 Swine Flu Vaccine
Maurice Hilleman and other scientists met with U.S. President Gerald Ford to discuss a vaccine response to an outbreak of swine influenza at Fort Dix, New Jersey. Congress committed funds to a nationwide vaccination program.
Merck intended to produce 50 million swine-flu vaccine doses by January 1977 and delivered about 11 million doses in late September 1976. The nationwide vaccination program, however, ended after vaccination was associated with an increased risk of a condition called Guillain-Barré syndrome (GBS). GBS has several causes, the most common of which is infection with bacteria called Campylobacter. But GBS occurred in recipients of the 1976 swine-flu vaccine at a rate higher than usual: beyond the normal "expected" rate for the general population, about one additional case occurred for every 100,000 vaccine recipients. And, despite what first promised to be a widespread outbreak, few cases of swine flu actually developed among the American people.
See This Item In The TimelineTimeline Entry: 1981 Hepatitis B: First Subunit Viral Vaccine in U.S.
The FDA licensed Hilleman’s human-blood-derived hepatitis B vaccine, Heptavax-B. It was the first subunit viral vaccine developed in the United States.
Hilleman transformed the hepatitis B surface protein, discovered by Baruch Blumberg and known as the Australia antigen, into an effective vaccine. Hilleman harvested serum from several IV drug users and homosexual men, in whom the disease was sometimes present, to obtain the antigen. He used three methods to purify the blood so that the infectious particles were assuredly killed, but the antigen remained.
The vaccine proved effective at preventing hepatitis B. But, because of concerns about HIV infection, it was superseded in 1986 by a product that did not use human serum. This new effort produced the first vaccine based on recombinant technology--in this case, changing yeast cells so that they produced the protein that is the active ingredient in the current hepatitis B vaccine.
See This Item In The TimelineTimeline Entry: 7/23/1986 Hepatitis B: Recombinant Vaccine Licensed
The FDA licensed Merck’s Recombivax HB. This hepatitis B vaccine was the first human vaccine produced by recombinant DNA methods.
A challenge in creating the vaccine involved avoiding the use of human blood products, as did Maurice Hilleman’s first hepatitis B vaccine. Therefore, Merck used an enzyme to remove the virus’s surface protein (HBsAg, the Australia antigen). Researchers inserted the code for the antigen into yeast cells, which produced more of the surface protein. The yeast-derived surface protein produced immunity to the hepatitis B virus.
See This Item In The TimelineTimeline Entry: 1995 Hepatitis A: Vaccine Licensed
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The FDA licensed Maurice Hilleman’s hepatitis A vaccine.
Hilleman had been working on hepatitis A for decades. He was one of the first scientists to detect the hepatitis A virus and its antibodies. Tests in 1992 showed that the vaccine was 100% effective in preventing the disease. Hepatitis A vaccine would later be added to the recommended vaccination schedule for children, and its incidence subsequently decreased by about 75%.
See This Item In The TimelineTimeline Entry: 3/17/1995 Chickenpox Vaccine Licensed
The FDA licensed Varivax, the first chickenpox vaccine. Hilleman had adapted a Japanese chickenpox virus for use in the United States.
Before the chickenpox vaccine, each year in the United States chickenpox infected 4 million people, leading to about 10,000 hospitalizations and about 100 deaths. In the post-vaccine era, hospitalization and death rates from chickenpox have decreased dramatically.
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