Vaccine R&D success rates and development times

The real time saving in vaccine development is not in the preclinical development itself, but in the accelerated clinical development and reduced regulatory process of dossier preparation and review.

Access options

Rent or Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. 1

    Struck, M.-M. 1994. Biopharmaceutical R & D success rates and development times. Bio/Technology 12: 674–677.

  2. 2

    Drews, J. 1995. The impact of cost containment on pharmaceutical research and development, in 10th Center for Medicines Research Annual Conference Lecture, June 1995.

  3. 3

    Mercer Report. 1995. Report on the United States Vaccine Industry, June 14. Department of Health and Human Services, Washington, DC.

  4. 4

    World Health Organization. 1995. Weekly Epidemiological Record 70: 252–255.

  5. 5

    Efstratiou, A. 1995. Diphtheria in Europe: An update. PHLS Microbiol. Digest 12: 233–235.

  6. 6

    Jenum, P.A., et al. 1995. Immunity to diphtheria in northern Norway and northwestern Russia. Eur. J. Clin. Microbiol. Infect. Dis. 14: 794–798.

  7. 7

    Desselberger, U. 1995. Emerging infectious diseases PHLS Microbiol. Digest 12: 141–144.

  8. 8

    Bussiere, J.L., McCormick, G.C., and Green, J.D. 1995. Preclinical safety assessment: Considerations in vaccine development, pp. 61–79 in Vaccine Design: The subunit and adjuvant approach, Powell, M.R and Newman, M.J. (Eds.). Plenum Press, New York.

  9. 9

    Fast, P.E., Sawyer, L.A., and Wescott, S.L. 1995. Clinical considerations in vaccine trials with special reference to candidate HIV vaccines, pp. 97–134 in Vaccine design: The subunit and adjuvant approach, Powell, M.F and Newman, M.J. (Eds.). Plenum Press, New York.

  10. 10

    Orenstein, W.A. et al. 1984. Field evaluation of vaccine efficacy, World Health Organization, Geneva, Switzerland.

  11. 11

    Davenport, L.W. 1995. Regulatory considerations in vaccine design, p. 81–96 in Vaccine Design: The subunit and adjuvant approach, Powell, M.F and Newman, M.J. (Eds.). Plenum Press, New York.

  12. 12

    Parkman, P.D. and Hardegree, M.C. 1994. Regulation and testing of vaccines, p. 889–901 in Vaccines, Plotkin, S.A. and Mortimer, E.A. (Eds.). W.B. Saunders Company.

  13. 13

    Food and Drug Administration. 1995. Points to consider for the evaluation of combination vaccines, Office of Vaccines Research and Review, Center for Biologies Evaluation and Research (CBER), PDA, Rockville, MD.

  14. 14

    European Vaccine Manufacturers Association. 1995. Pharmaceutical aspects of combined vaccines: EVM view to be considered as a basis for discussion with authorities, EPPIA, Avenue Louise 250, Brussels.

  15. 15

    Pharmaceutical Projects, I. Hutton (Ed.). PJB Publications, London.

  16. 16

    Glück, R. et al. 1992. Immuno-potentiating reconstituted influenza virus virosome vaccine delivery system for immunization against hepatitis A. J. Clin. Invest. 90: 2491–2495.

  17. 17

    Levine, M.M. et al. 1988. Safety, immunogenlcity, and efficacy of recombinant live oral cholera vaccines, CVD 103 and CVD 103-HgR. Lancet 2: 467–470.

  18. 18

    Levine, M.M. et al. 1990. Comparison of enteric-coated capsules and liquid formulation of Ty21a typhoid vaccine in randomised controlled field trial. Lancet 336: 891–894.

  19. 19

    Miller, E. et al. 1993. Risk of aseptic meningitis after measles, mumps, and rubella vaccine in UK children. Lancet 341: 979–982.

  20. 20

    Parker, D.P. 1995. Laboratory empiricism, clinical design, and social value, pp. 135–139 in Vaccine design: The subunit and adjuvant approach, Powell, M.F. and Newman, M.J. (Eds.). Plenum Press, New York.

  21. 21

    Tacket, C.O. et al. 1993. Safety and immunogenicity of live oral cholera candidate CVD110, a DctxA Dzot Dace derivative of EITor Ogawa V. cholerae. J. Infect. Dis. 168: 1536–1540.

  22. 22

    Pharmaceutical R&D Statistical Sourcebook. 1995. Mathieu M.P. Parexel International Corporation.

  23. 23

    Gupta, R.K. and Siber, G.R. 1995. Reappraisal of existing methods for potency testing of vaccines against tetanus and diphtheria. Vaccine 13: 965–966.

Download references

Author information

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Struck, M. Vaccine R&D success rates and development times. Nat Biotechnol 14, 591–593 (1996).

Download citation

Further reading