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March 15, 1995

Lengthy Tale of Varicella Vaccine Development Finally Nears a Clinically Useful Conclusion

JAMA. 1995;273(11):833-836. doi:10.1001/jama.1995.03520350015006

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THE VICISSITUDES that have delayed the licensing of a vaccine against varicella-zoster virus are finally ending. The manufacturer has indicated that this vaccine will shortly become available, although the Food and Drug Administration (FDA) does not comment on pending license applications.

"We are fairly comfortable with the clinical data. We believe they have been analyzed as carefully as they can be," Philip Krause, MD, an FDA senior research investigator, told a meeting in January of the Vaccines and Related Biological Products Advisory Committee to the FDA. However, he added, "we're still awaiting answers to questions regarding manufacturing and establishment issues."

Almost from the beginning, problems with manufacturing, efficacy, and safety have plagued this biological agent. Since critics of the FDA are currently charging the agency with undue delays in product licensing and approval procedures, it may be instructive to consider briefly the experience of the past decade and a half

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