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TABLE 2–1 Status of Vaccines Prioritized in 1985

Pathogen

Status

Hepatitis B virus

Recombinant hepatitis B virus surface antigen licensed and in widespread use.

Respiratory syncytial virus

Purified fusion (F) protein in phase II studies.

Haemophilus influenzae type b

Glycoconjugates licensed and in widespread use.

Influenza virus A and B

Cold-adapted live, attenuated virus vaccine in phase III trials; baculovirus-expressed recombinant HA subunit in phase III trials.

Varicella-zoster virus

Live attenuated virus licensed and in use.

Group B streptococcus

Glycoconjugates of five serotypes in phase II studies.

Parainfluenza viruses

Cold-adapted live, attenuated type 3 virus in phase II trials; bovine live, attenuated virus in phase II trials.

Cytomegalovirus

Glycoprotein subunit in phase I studies.

Rotaviruses

Attenuated live human-rhesus and bovine-human reassortants in phase III trials at beginning of project. Licensure in 1998 of one product.

Neisseria gonorrhoeae

Early basic research on various proteins.

Hepatitis A virus

Inactivated HAV particles licensed and in early use.

Coccidioides immitis

Formalin-killed spherules in phase III clinical trials.

Herpes simplex 1 and 2

Glycoprotein (D) recombinant of type 2 in phase II trials; attenuated recombinants in phase I studies.

Bordetella pertussis

Acellular products (DTaP) licensed and in widespread use.

toward licensure include unexpected obstacles in research progress (either in the more basic research phases, in clinical trials, or in scale-up processes for development and production). Alternatively, steady progress could have been made but at a much slower pace than expected. Slow progress could be attributed to either lack of scientific interest on the part of researchers or lack of adequate funding for the R&D. As discussed in Chapter 7 of the report, inadequate interest on the part of funders, such as private vaccine R&D companies, can reflect concerns about profitability because of either small market potential or possible costs due to liability for adverse events.

The committee had been told in early discussions with vaccine researchers that a primary weakness of the 1985 report was that it was overly optimistic about how long it would take for licensure of several candidates. The present analysis includes a longer time frame than the 1985 effort. Models such as that



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