The Vaccine Race

by Meredith Wadman

  12. “Wistar Institute Comparative Balance Sheets as of 10/31/67,” fourth page: “Percentage Report as of 10/31/67–Grants,” box 68, file folder 12 (“Wistar Institute 1966–67”), Isidor Schwaner Ravdin Papers, UPT 50 R252, University Archives and Records Center, University of Pennsylvania, “Wistar Institute Comparative Balance Sheet as of 4/30/66,” fourth page, Isidor Schwaner Ravdin Papers, UPT 50 R252, box 68, file folder 13 (“Wistar Institute 1966”); “Wistar Institute Comparative Balance Sheet as of 12/31/65,” fourth page, University Archives and Records Center, University of Pennsylvania, Isidor Schwaner Ravdin Papers, UPT 50 R252, box 68, file folder 14 (“Wistar Institute 1966”).

  13. Factual Chronology, 7.

  14. “Minutes of the Wistar Institute Board of Managers Meeting,” December 16, 1966, p. 1, UPT 50 R252, box 68, folder 12 (“Wistar Institute 1966”), Isidor Schwaner Ravdin Papers, University Archives and Records Center, University of Pennsylvania.

  15. Ibid., exhibit A; “Minutes of the Wistar Institute Board of Managers Meeting,” February 24, 1967, p. 2, UPT 50 R252, box 68, folder 12 (“Wistar Institute, 1966–1967”), Isidor Schwaner Ravdin Papers, University Archives and Records Center, University of Pennsylvania.

  16. Factual Chronology, 7.

  17. John D. Ross, “Memorandum on Diploid Contract Conference, Minutes of Meeting,” January 18, 1968, attachment B to Schriver Report, p 1.

  18. Ibid.

  19. Charles W. Boone to Hilary Koprowski, February 16, 1968, attachment C to Schriver Report, 2.

  20. Leonard Hayflick, interview with the author, March 3, 2013.

  21. Department of Health, Education, and Welfare, Public Health Service, National Institutes of Health, “Contract Number: PH43-62-157,” February 6, 1962, Section 30: “Termination for the Convenience of the Government,” part (g), p. HEW-315-6. Courtesy of Leonard Hayflick.

  22. “Chronicle Burroughs Wellcome Proposed Agreement,” folder “SKF Correspondence 1968,” Stanley Plotkin private papers, Doylestown, PA.

  23. Roger C. Egeberg (assistant secretary for health and scientific affairs) to Hilary Koprowski, August 13, 1970, Stanley Plotkin private papers.

  24. A.C.C. Newman to Hilary Koprowski, October 16, 1968, file folder “Smith Kline French,” Stanley Plotkin private papers.

  25. Leonard Hayflick, interview with the author.

  26. Hayflick Rebuttal to Schriver Report, 19; John Shannon to Leon Jacobs, May 7, 1976, investigations 9, file folder 1, Directors’ Files, Office of the Director, National Institutes of Health.

  27. Schriver Report, 4.

  Chapter Sixteen: In the Bear Pit

  1. Émile Roux is quoted in Stanley A. Plotkin, “Sang Froid in a Time of Trouble: Is a Vaccine Against HIV Possible?” Journal of the International AIDS Society 12, no. 2 (2009), http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2647531/ doi:10.1186/1758-2652-12-2.

  2. Maurice R. Hilleman et al., “Live Attenuated Rubella Virus Vaccines: Experiences with Duck Embryo Cell Preparations,” American Journal of Diseases of Children 118 (1969): 171.

  3. Samuel J. Musser and Larry J. Hilsabeck, “Production of Rubella Virus Vaccine: Live, Attenuated, in Canine Renal Cell Cultures,” American Journal of Diseases of Children 118 (1969): 361.

  4. George R. Thompson et al., “Intermittent Arthritis Following Rubella Vaccination,” American Journal of Diseases of Children 125 (1973): 526.

  5. Stanley A. Plotkin et al., “An Attenuated Rubella Virus Strain Adapted to Primary Rabbit Kidney,” American Journal of Epidemiology 88 (1968): 97.

  6. “Rubella: Vaccines May Be Licensed by Fall,” Science News 95 (March 1, 1969): 209.

  7. Stanley Plotkin to Sister Agape, April 4, 1968, folder “St. Vincent’s,” Stanley Plotkin private papers, Doylestown, PA.

  8. Stanley Plotkin to John Cardinal Krol (archbishop of Philadelphia), April 5, 1968, folder “St. Vincent’s,” Stanley Plotkin private papers.

  9. Archbishop of Philadelphia to Stanley Plotkin, April 11, 1968, Cardinal Krol papers, Philadelphia Archdiocesan Historical Research Center.

  10. S. A. Plotkin et al., “Further Studies of an Attenuated Rubella Strain Grown in WI-38 Cells,” American Journal of Epidemiology 39, no. 2 (1969): 236.

  11. Stanley Plotkin, interview with the author, June 1, 2015.

  12. Plotkin et al., “Further Studies,” 232.

  13. Ibid., 237.

  14. Stanley Plotkin, “Status of Negotiations with SKF, Merieux and Wellcome,” undated, file folder “SKF Correspondence 1968,” Plotkin private papers. This paper is physically placed among papers dated autumn 1968.

  15. Constant Huygelen, telegram to Robert Ferlauto, April 9, 1968, folder “SKF Correspondence 1968,” Stanley Plotkin private papers.

  16. Alan D. Lourie, memo to Ed Clay, January 8, 1968, file folder “SKF-Rubella,” Stanley Plotkin private papers.

  17. Stanley A. Plotkin et al., “A New Attenuated Rubella Virus Grown in Human Fibroblasts: Evidence for Reduced Nasopharyngeal Excretion,” American Journal of Epidemiology 86, no. 2 (1967): 468–77.

  18. Robert Ferlauto to Stanley Plotkin, August 28, 1968, folder “SKF Correspondence 1968,” Stanley Plotkin private papers.

  19. Robert Ferlauto to Hilary Koprowski, August 12, 1968, folder “SKF Correspondence 1968,” Stanley Plotkin private papers.

  20. R. Palmer Beasley et al., “Prevention of Rubella During an Epidemic on Taiwan,” American Journal of Diseases of Children 118 (1969): 304.

  21. Harold M. Schmeck Jr., “Test Finds Rubella Vaccine Effective,” New York Times, October 17, 1968, 1, 27.

  22. “Tests on Vaccines to Prevent Rubella Highly Effective,” NIH Record 20, no. 22 (October 29, 1968): 1, 8, https://nihrecord.nih.gov/PDF_Archive/1968%20PDFs/19681029.pdf (accessed February 8, 2016).

  23. Beasley et al., “Prevention of Rubella,” 304.

  24. Roderick Murray and Dorland J. Davis to Stanley Plotkin, September 30, 1968, folder “Washington, D.C.-1968,” Stanley Plotkin private papers.

  25. Plotkin et al., “Attenuated Rubella Virus Strain,” 97–102.

  26. Howard A. Rusk, “Rubella Vaccine Near: Likely to Be Available in 2 Months, After Production Guides Take Effect,” New York Times, April 13, 1969.

  27. Stanley A. Plotkin et al., “Attenuation of RA 27/3 Rubella Virus in WI-38 Human Diploid Cells,” American Journal of Diseases of Children 118 (1969): 184.

  28. Hilleman et al., “Live Attenuated Rubella Virus Vaccines,” 167.

  29. R. E. Weibel et al., “Live Rubella Vaccines in Adults and Children,” American Journal of Diseases of Children 118, no. 2 (1969): 226–29.

  30. Ibid.

  31. Louis Z. Cooper et al., “Transient Arthritis After Rubella Vaccination,” American Journal of Diseases of Children 118, no. 2 (1969): 218–25.

  32. Weibel et al., “Live Rubella Vaccines,” 229.

  33. “Recommendation of the Public Health Service Advisory Committee on Immunization Practices: Prelicensing Statement on Rubella Virus Vaccine,” Morbidity and Mortality Weekly Report 18, no. 15 (1969): 124–25.

  34. “Leads from the MMWR: Rubella Vaccination During Pregnancy—United States, 1971–1988,” Journal of the American Medical Association 261, no. 23 (1989): 3375.

  35. Centers for Disease Control and Prevention, “Control and Prevention of Rubella: Evaluation and Management of Suspected Outbreaks, Rubella in Pregnant Women, and Surveillance for Congenital Rubella Syndrome,” Morbidity and Mortality Weekly Report 50, no. RR-12 (2001): 16.

  36. Ibid., 33.

  37. J. E. Banatvala and D. W. G. Brown, “Seminar: Rubella,” Lancet 363 (2004): 1128.

  38. Plotkin et al., “Attenuation of RA 27/3 Rubella Virus,” 184.

  39. Roderick Murray, “Biologics Control of Virus Vaccines,” American Journal of Diseases of
Children 118 (1969): 336.

  40. “Gamma Globulin Prophylaxis; Inactivated Rubella Virus; Production and Biologics Control of Live Attenuated Rubella Virus Vaccines: Discussion on Session V,” American Journal of Diseases of Children 118 (1969): 377.

  41. Ibid., 378.

  42. Roger Vaughan, Listen to the Music: The Life of Hilary Koprowski (New York: Springer-Verlag, 2000), 54.

  43. Edward Shorter, “The Health Century Oral History Collection,” Bernice Eddy interview, December 4, 1986, p. 25, transcript at the National Library of Medicine, NIH.

  44. “Gamma Globulin Prophylaxis,” 378.

  45. Ibid., 379.

  46. Ibid., 379–80.

  47. Stanley A. Plotkin, ed., History of Vaccine Development (New York: Springer Science + Business Media, 2011), 226.

  48. Robert Q. Marston, director, National Institutes of Health, “Additional Standards; Rubella Virus Vaccine, Live,” Federal Register 34, no. 109 (1969): 9072–75.

  49. Louis Galambos with Jane Eliot Sewell, Networks of Innovation: Vaccine Development at Merck, Sharp & Dohme, and Mulford, 1985–1995 (Cambridge: Cambridge University Press, 1995), 112.

  50. Stanley A. Plotkin, “Rubella Vaccination,” Journal of the American Medical Association 215, no. 9 (1971): 1492–93.

  51. Thompson et al., “Intermittent Arthritis,” 526.

  52. William Schaffner et al., “Polyneuropathy Following Rubella Immunization: A Follow-up Study and Review of the Problem,” American Journal of Diseases of Children 127 (1974): 684–88.

  53. General Accounting Office, “Bid Protest-Negotiation-Specification Compliance Denial of Protest Against Rejection of Offer for Furnishing Live Rubella Vaccine to Veterans Administration on Basis That Vaccine Did Not Comply with the Requirements of the Amended Specifications,” B-170817, September 25, 1970, www.gao.gov/products/429478#mt=e-report (accessed February 15, 2016).

  54. Harold M. Schmeck Jr., “One of 3 Rubella Vaccine Producers Barred from Bidding for US Contract,” New York Times, September 15, 1970, 13.

  55. T. Norton, memo to Hilary Koprowski and Stanley Plotkin, January 15, 1970, folder “SKF-Rubella,” Stanley Plotkin private papers.

  56. Memorandum of a meeting held at Smith, Kline & French on September 22, 1970, folder “SKF-Rubella,” Stanley Plotkin private papers.

  57. Stanley Plotkin to Leonard Hayflick, October 2, 1970, folder “Correspondence-H,” Stanley Plotkin private papers.

  Chapter Seventeen: Cell Wars

  1. Leonard Hayflick, “The Coming of Age of WI-38,” Advances in Cell Culture 3 (1984): 303.

  2. Robert Roosa, interview with the author, December 19, 2013.

  3. Leonard Hayflick, telephone interview with the author, October 17, 2012.

  4. Roger Vaughan, Listen to the Music: The Life of Hilary Koprowski (New York: Springer-Verlag, 2000), 112.

  5. Stanley Plotkin, interview with the author, August 29, 2014.

  6. Stanley Plotkin to Leonard Hayflick, July 9, 1968, file folder “Correspondence-H,” Stanley Plotkin Rubella Papers.

  7. International Association of Microbiological Societies, Permanent Section of Microbiological Standardization, “Minutes of the Fourth Meeting of the Committee on Cell Cultures,” September 16, 1967, p. 63.

  8. Factual Chronology, 7.

  9. Schriver Report, 8–9.

  10. Ibid., 9.

  11. Hayflick Rebuttal to Schriver Report, 40–41.

  12. International Association of Microbiological Societies, Permanent Section of Microbiological Standardization, “Minutes of the Fifth Meeting of the Committee on Cell Cultures,” November 27, 1968, p. 20; Schriver Report, 8.

  13. Schriver Report, 8.

  14. Factual Chronology, 20.

  15. Ibid.

  16. Stanley Plotkin to Leonard Hayflick, December 8, 1969, file folder “Correspondence-H,” Stanley Plotkin private papers, Doylestown, PA.

  17. Factual Chronology, 32–33.

  18. Stanley A. Plotkin to Leonard Hayflick, March 17, 1969, file folder “Correspondence-H,” Stanley Plotkin private papers.

  19. Stanley Plotkin to Leonard Hayflick, August 1, 1969, file folder “Correspondence-H,” Stanley Plotkin private papers.

  20. Leonard Hayflick to Stanley Plotkin, August 11, 1969, file folder “Correspondence-H,” Stanley Plotkin private papers.

  Chapter Eighteen: DBS Defeated

  1. Testimony of Dr. Leonard Hayflick, Senate Subcommittee on Executive Reorganization and Government Research of the Committee on Government Operations, Consumer Safety Act of 1972: Hearings on Titles I and II of S. 3419, 92nd Cong., 2nd sess., April 20 and 21 and May 3 and 4, 1972, p. 34.

  2. Debbie Bookchin and Jim Schumacher, The Virus and the Vaccine: Contaminated Vaccine, Deadly Cancers and Government Neglect (New York: St. Martin’s, 2004), 127.

  3. Jane E. Brody, “Vaccine Produced in Human Cells,” New York Times, March 8, 1972, 18.

  4. Nicholas Wade, “Division of Biologics Standards: The Boat That Never Rocked,” Science 175 (1972): 1228.

  5. Abraham Ribicoff, “Exhibit 55: Vaccine Safety,” Senate Subcommittee on Executive Reorganization and Government Research, Consumer Safety Act of 1972: Hearings, 512–32.

  6. Nicholas Wade, “DBS: Agency Contravenes Its Own Regulations,” Science 175 (1972): 34.

  7. Ribicoff, “Exhibit 55: Vaccine Safety,” 527.

  8. Testimony of Dr. Leonard Hayflick, 29–38.

  9. Wade, “DBS: Agency Contravenes,” 35.

  10. Consumer Safety Act of 1972: Hearings, 36.

  11. P. Stessel, memo to R. A. Schoellhorn, H. Perlmutter, J. Rose, G. J. Sella Jr., R. J. Vallancourt, P. J. Vasington (Lederle Laboratories), April 26, 1972, cited in Bookchin and Schumacher, Virus and the Vaccine, 127, 306.

  12. Leonard Hayflick, “Human Virus Vaccines: Why Monkey Cells?” Science 176 (1972): 813–14.

  13. Stanley A. Plotkin to Senator Abraham Ribicoff, Consumer Safety Act of 1972: Hearings, 419–20.

  14. “Dr. Roderick Murray Named Special Assistant to the Director of NIAID,” NIH Record, June 7, 1972, 5.

  15. Bookchin and Schumacher, Virus and the Vaccine, 127.

  16. S. Kops, “Oral Polio Vaccine and Human Cancer: A Reassessment of SV40 as a Contaminant, Based upon Legal Documents,” Anticancer Research 20 (2000): 4746.

  17. Bookchin and Schumacher, Virus and the Vaccine, 124.

  18. David Oshinksy, “Polio,” in: Andrew W. Artenstein, ed., Vaccines: A Biography (New York: Springer Science + Business Media, 2010), 219.

  19. Nicoletta Previsani et al., “World Health Organization Guidelines for Containment of Poliovirus Following Type-Specific Polio Eradication: Worldwide, 2015,” Morbidity and Mortality Weekly Report 64, no. 33 (2015): 913, www.cdc.gov/mmwr/preview/mmwrhtml/mm6433a5.htm?s_cid=mm6433a5_w (accessed February 18, 2016).

  20. World Health Organization Media Centre: “Government of Nigeria Reports 2 Wild Polio Cases, First Since July 2014: New Cases Come on the Two-Year Anniversary Since the Last Confirmed Case of Polio Was Reported in Africa” (news release), August 11, 2016, http://www.who.int/mediacentre/news/releases/2016/nigeria-polio/en/ (accessed September 8, 2016); Leslie Roberts, “Nigeria Outbreak Forces Rethink of Polio Strategies,” Science Insider (online), September 6, 2016, http://www.sciencemag.org/news/2016/09/nigeria-outbreak-forces-rethink-polio-strategies (accessed September 8, 2016).

  Chapter Nineteen: Breakthrough

  1. Rebecca Sheir, “Ebola Researcher Says Vaccinology Isn’t Rocket Science—It’s Harder,” Metro Connection, WAMU Radio, October 23 2014. Transcript available here: http://wamu.org/programs/metro_connection/14/10/23/ebola_researcher_says_vaccinology_isnt_rocket_science_its_harder_transcript (accessed September 1, 2016).

  2. “Dr. Dorothy Horstmann dies—key
in development of polio vaccine,” Yale Bulletin & Calendar 29, no. 16 (2001), http://www.yale.edu/opa/arc-ybc/v29.n16/story18.html ; David M. Oshinsky, “Breaking the Back of Polio,” Yale Medicine 40, no. 1 (2005), http://yalemedicine.yale.edu/autumn2005/features/feature/52012/; Daniel Wilson, unpublished interview with Dorothy Horstmann, 1990, Dorothy M. Horstmann Papers (MS 1700), box 12, Folder 257, Manuscripts and Archives, Yale University Library.

  3. Jane E. Brody, “New Research on Rubella Challenges Effectiveness of Vaccination Program,” New York Times, September 29, 1970, 8.

  4. Dorothy M. Horstmann et al., “Rubella: Reinfection of Vaccinated and Naturally Immune Persons Exposed in an Epidemic,” New England Journal of Medicine 283, no. 15 (1970): 771–78.

  5. Scott B. Halstead et al., “Susceptibility to Rubella Among Adolescents and Adults in Hawaii,” Journal of the American Medical Association 210 (10): 1881–83.

  6. Te-Wen Chang, Suzanne DesRosiers, and Louis Weinstein, “Clinical and Serological Studies of an Outbreak of Rubella in a Vaccinated Population,” New England Journal of Medicine 283, no. 5 (1970): 246–48; J. M. Forrest, M. A. Menser, and M. C. Honeyman, “Clinical Rubella Eleven Months After Vaccination,” Lancet 300, no. 7774 (1972): 399–400.

  7. Dorothy M. Horstmann et al., “Rubella: Reinfection of Vaccinated and Naturally Immune Persons Exposed in an Epidemic,” New England Journal of Medicine 283, no. 15 (1970): 771–78.

  8. Ibid., 775.

  9. Chang, DesRosiers, and Weinstein, “Clinical and Serological Studies of an Outbreak of Rubella in a Vaccinated Population,” New England Journal of Medicine 283, no. 5 (1970): 246–48.

  10. Elias Abrutyn et al., “Rubella Vaccine Comparative Study: Nine-Month Follow-Up and Serologic Response to Natural Challenge,” American Journal of Diseases of Children 120 (1970): 129–33; William J. Davis et al., “A Study of Rubella Immunity and Resistance to Infection,” Journal of the American Medical Association 215, no. 4 (1971): 600–608; Jeanette Wilkins et al., “Reinfection with Rubella Virus Despite Live Vaccine-Induced Immunity,” American Journal of Diseases of Children 118: (1969): 275–94; Harvey Liebhaber et al., “Vaccination with RA27/3 Rubella Vaccine: Persistence of Immunity and Resistance to Challenge After Two Years,” American Journal of Diseases of Children 123 (1972): 134.