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The NIH Division of Biologics Standards (DBS) licensed the rubella vaccine for use in June 1969. Explore this selection of items from the NLM Digital Collections to discover how scientists working at the DBS set policy, conducted research, and enforced standards to ensure the safety of vaccines.
“Rubella Research,” photograph by Jerry Hecht, Bethesda, Maryland, ca. 1970
Courtesy National Library of Medicine
Dr. Harry M. Meyer, Jr. (1928–2001), left, Hope Hopps (1926–1988), center, and Dr. Paul Parkman (b. 1932), right, worked with the rubella antigen in the National Institutes of Health’s Division of Biologics Standards. The researchers were motivated by their knowledge that rubella posed the greatest risk to young, growing families, and that women exposed to rubella were forced to make difficult decisions about their pregnancies. Their research improved the blood test used to screen pregnant women for rubella. Thanks to their work, women only had to wait three hours, instead of three weeks, for results.
Rubella, National Institute of Allergy and Infectious Diseases, 1969
Courtesy National Library of Medicine
This news clip, produced by the National Institutes of Health, reported on “the beginning of the end of rubella.” The short segment documented the rubella vaccine research conducted Drs. Harry M. Meyer, Jr. (1928–2001) and Paul Parkman (b. 1932). The segment includes footage of the vaccine tests at the Children’s Colony in Conway, Arkansas and laboratory procedures used to ensure the safety and efficacy of the vaccine.
NIH Building 29 housed the Division of Biologics Standards, photograph by N. MacVicar, undated
Courtesy National Library of Medicine
DBS’s staff grew rapidly in its early years. In 1960, nearly 190 staff members were spread across the campus in five buildings. Consolidating most of the staff under one roof facilitated cooperation and research among the various laboratories, researchers, and staff members. The building included state-of-the-art laboratories, a library, and flexible meeting spaces.
In 2018, building 29 is listed on the National Register of Historic Places.
“Highlights of Progress in Biologics Control,” Division of Biologics Standards National Institutes of Health, Bethesda, Maryland, 1956
Courtesy National Library of Medicine
Biologics are a vast category of medical products. This 1956 report on DBS’s activities mentions vaccines, blood products, tissue cultures, and more.
“Technical Report on Poliomyelitis Vaccine,” Public Health Reports, August 1955
Courtesy National Library of Medicine
The United States Public Health Service proposed creating an independent Division of Biologics Standards in their report on errors and oversights in the production of the polio vaccine. These mistakes paralyzed 113 children.
Staff of the Laboratory of Biologics Control, in front of the Public Health Service Laboratory on the campus of the NIH, Bethesda, Maryland, 1938
Courtesy National Library of Medicine
DBS’s roots reach back to the late 19th century. Both the Hygienic Laboratory, set up by the Marine Hospital Service, and the United States Public Health Service’s Rocky Mountain Laboratory and Biologics Control Laboratory were forerunners to DBS. In 1938, one year after the Rocky Mountain Laboratory became part of the NIH, the lab’s staff gathered for this photograph.
“Biologics Standards Division Established; Larson Named Chief,” NIH Record, Bethesda, Maryland, June 27, 1955
Courtesy National Library of Medicine
The NIH Record, an internal publication for NIH staff, celebrated the creation of DBS in 1955. It reported that the new division would increase research staff and improve their capacity to test products, visit factories and production sites, conduct investigations, and collect data on biologics products.
Portrait of Dr. Roderick Murray, photograph by Edward A. Hubbard, undated
Courtesy National Library of Medicine
Dr. Roderick Murray (1910–1980) served as DBS director for nearly its entire existence. Murray took a narrow view of DBS’ authority and mission. No major vaccine disasters occurred under his leadership.
“Suggested procedure for potency testing of poliomyelitis vaccine: 18 November 1957,” Division of Biologics Standards, Geneva, Switzerland, June 2, 1958
Courtesy National Library of Medicine
The World Health Organization (WHO) disseminated DBS standards for the manufacturing of polio vaccine in 1957. The procedures and policies developed at the DBS shaped production techniques around the world.
Pertussis Vaccine Symposium, Department of Health, Education and Welfare, Public Health Service, National Institutes of Health, Division of Biologics Standards, Bethesda, Maryland, 1963
Courtesy National Library of Medicine
DBS regularly hosted meetings between pharmaceutical companies, regulators, and researchers working at universities and government agencies. The transcript of the 1963 pertussis vaccine symposium captured the simultaneously adversarial and collegial relationship between them.
Merck Sharp, and Dohme Film Footage on Division of Biologics Standards Mumps Vaccine Testing, 1967
Courtesy National Library of Medicine
Drs. Harry M. Meyer, Jr. (1928–2001) and Paul Parkman (b. 1932), as well as several DBS lab technicians, appear in this silent film, produced by the pharmaceutical company Merck Sharp and Dohme. The film documents DBS staff testing the mumps vaccine in a laboratory setting.
“The Division of Biologics Standards,” National Institutes of Health, Division of Biologics Standards, Bethesda, Maryland, 1967
Courtesy National Library of Medicine
In the opening to this 1967 booklet describing the division and its work, DBS director Dr. Roderick Murray (1910–1980) explains its purpose as “to apply our present knowledge,” “find better ways of producing and testing” products, and “develop new immunizing agents.”
Infections and Birth Defects: A Research Approach, National Institutes of Health, 1966
Courtesy National Library of Medicine
This film profiled a National Institutes of Health study of infectious diseases that can cause abnormal pregnancy outcomes in women. Fifty thousand pregnant women and their infants participated in the Collaborative Perinatal Research Project, a joint effort of several institutes at NIH. The film records how NIH staff collect, store, and analyze blood for research purposes.
“Eight Members of the DBS Laboratory of Viral Immunology Received Cash Awards,” The NIH Record, Bethesda, Maryland, September 7, 1966
Courtesy National Library of Medicine
By the late 1960s, the scientific community and some members of the Division’s staff expressed concern that DBS scientists both regulated and developed vaccines. DBS’ decision to license a vaccine that used the rubella strain developed at the NIH, rather than a strain developed elsewhere, epitomized the potential conflict of interest that worried outside observers.
The NIH Record reported that several members of the DBS staff received cash awards for their work on the rubella vaccine. Although this was not unusual, it was poor optics for an agency tasked with regulating the vaccines they developed in an unbiased and “obviously fair” way.
“Indications for a Therapeutic Abortion,” Richard D. Lamm (moderator), Dr. Alan F. Guttmacher and Dr. Frank J. Ayd (guests), produced by the U.S. Public Health Service, 1969
Courtesy National Library of Medicine
As part of its series “Concepts and controversies in modern medicine,” the United States Public Health Service hosted a conversation about therapeutic abortion. Dr. Guttmacher, an obstetrician and gynecologist, argued that abortion laws should be relaxed to ensure all women, not only wealthy women, can access reproductive health care, and that the criteria for therapeutic abortion should be expanded. Dr. Ayd, a psychiatrist, claimed that the fetus is a living being, and expressed concerned that the psychological aftermath of an abortion could be as serious as the mental state induced by an unwanted or dangerous pregnancy.
“Rubella vaccine licensed, virus strain developed by scientists at NIH,” The NIH Record, Bethesda, Maryland, June 24, 1969
Courtesy National Library of Medicine
The NIH Record announced that DBS issued the pharmaceutical company Merck Sharp & Dohme the first license to produce a rubella vaccine in June 1969. The vaccine was based on the work of Parkman and Meyer at the NIH.
Challenge for Habilitation: The Child with Congenital Rubella Syndrome, Gloria Grimes Cochran and Winston Cochran, 1977
Courtesy National Library of Medicine
This film documents the rubella study group and nursery in the child development clinic at Texas Children’s Hospital. The program provided medical, educational, and social services to children with congenital rubella syndrome. The study also supported parents as they cared for their children and supported their development. The film documents occupational and physical therapy, children playing with their peers in a nursery, and a class for parents.
Abraham Ribicoff, then Secretary of Health, Education and Welfare, December 1961
Courtesy National Library of Medicine
Concerned by the claims made by NIH staff member J. Anthony Morris (1918–2014) who raised concerns about DBS’ management, policy, and procedures, Senator Abraham Ribicoff (1910–1998) launched an investigation of DBS activities in October 1971. His subcommittee on Government Operations held hearings into DBS’ work.
“DBS Will Transfer to FDA on July 1,” NIH Record, Bethesda, Maryland, June 7, 1972
Courtesy National Library of Medicine
To resolve tension between DBS’ role as an innovator and regulator, the Department of Health, Education, and Welfare (HEW) transferred the Division to the Food and Drug Administration (FDA) in July 1972 and renamed it the Bureau of Biologics. The NIH Record, an internal publication for NIH staff, reported that DBS’ move to the FDA involved an administrative change. All 258 employees remained on the NIH campus and continued to work with their peers.
FDA employees at a picnic on the lawn of NIH Building 29, June 27, 2014
NIH Record
The FDA’s Center for Biologics Evaluation and Research was based on the NIH campus until the summer of 2014 when it moved to a new campus in White Oak, Maryland. A staff picnic just before the move celebrated the spirit of collaboration between the NIH and FDA.
Poster promoting International Symposium on Potentiation of Immune Response to Vaccines, National Institutes of Health, Medical Arts and Photography Branch, Bethesda, Maryland, 1979
Courtesy National Library of Medicine
In 1979, the NIH and FDA cosponsored a conference about vaccines. Researchers in both institutions worked collaboratively after DBS transferred to FDA.
Rubella Testing in the Small Hospital Laboratory, Mark-Maris Inc., 1983
Courtesy National Library of Medicine
At the height of the rubella epidemic in 1964, women had to wait up to three weeks for the result of a blood test that could tell them if they had rubella. Thanks to research conducted by Drs. Harry M. Meyer, Jr. (1928–2001) and Paul Parkman (b. 1932) at the NIH, testing for rubella antibodies could be completed in about three hours. Even after the widespread use of the vaccine, many pregnant women required a blood test for rubella antibodies. This film presents information about procedures for conducting a blood test for rubella in the mid-1980s.
Congenital Deafness, Richard A. Buckingham, 1958
Courtesy National Library of Medicine
This silent instructional film, created in 1958, outlines the development of the inner and outer ear. It also presents some of the reasons that a child may be born without the ability to hear, including how maternal rubella infection impacts fetal development.
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