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Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

M. Carolyn Hardegree, M.D.
(1933-status unknown)


Carolyn Hardegree was born in 1933 in Wichita Falls, Texas. She received her M.D. from the University of Texas and is board certified in pediatrics and a fellow of the American Academy of Pediatrics.

Hardegree’s research was in bacterial toxins and vaccines. She worked with Dr. Margaret Pittman and Dr. Michael Barile on tetanus toxoids studies in humans and guinea pigs. She published the article “Immunization Against Neonatal Tetanus in New Guinea” in 1970 (linked below in publications).

Hardegree worked in the National Institutes of Health (NIH) Division of Biologics Standards (DBS) Laboratory of Bacterial Products and became chief of the Section on Bacterial Toxins in 1969.

Newspaper wedding announcement with photo of Dr. M. Carolyn Hardegree

Carolyn Hardegree's portrait from her wedding announcement (from the San Angelo Weekly Standard [Texas], Friday, October 6, 1961).  FDA History Office 
In 1985, she was director of the Division of Bacterial Products and worked in Building 29, Room 122A. By 1990, she was the director of the Office of Vaccine Research and Review at the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) where she worked in Building 29B, Room 1H16. In 1995, Hardegree became the director of the Office of Biologics Research and she returned to working in Building 29, Room 122A. She retired in 1999 as the director of the Office of Vaccines Research and Review at CBER.

Hardegree served on various committees including the World Health Organization Steering Committee on Immunization Safety, the National Vaccine Advisory Committee’s Pandemic Influenza Working Group, the Institute of Medicine Vaccine Safety Forum, and the Institute of Medicine Committee to Study the Interaction of Drugs, Biologics, and Chemicals in Deployed U.S. Military Forces.

Her awards include the Department of Health and Human Services Secretary's Award for Distinguished Service. She received the FDA Distinguished Alumnus Award in 1999 for outstanding contributions to the FDA's public health mission by oversight of the development, licensing, and use of safe and effective childhood vaccines.

Hardegree worked in Building 29, Room 418 in 1969, 1971, and 1972. After the Division of Biologics Standards was transferred administratively to the FDA, she was in Building 29, Room 414 in 1980, and Room 122A in 1985 and 1995. She worked in Building 29B at the end of her career.

Publications:

  • “Immunization against neonatal tetanus in New Guinea” by Michael F. Barile, M. Carolyn Hardegree, and Margaret Pittman. Bulletin, World Health Organization (1970). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2427675/?page=1.
  • “Introductory Remarks” by M. Carolyn Hardegree from Panel Session, Women’s Health: Pregnancy and Childbirth, at the National Conference on Women’s Health, June 17–18, 1986, Bethesda, MD. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1478049/?page=1.
  • “Serum antibody responses of juvenile and infant rhesus monkeys injected with Haemophilus influenzae type b and pneumococcus type 6A capsular polysaccharide-protein conjugates” by Rachel Schneerson, John B. Robbins, C. Chu, A. Sutton, J.C. Vickers, W.T. London, M. Carolyn Hardegree, K. Shiloach in Infection and Immunity (1984). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC263334/.
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