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March 1962

Perspectives for Testing Safety of Live Measles Vaccine

Author Affiliations

M. R. Hilleman, Ph.D., Merck Institute for Therapeutic Research, Merck & Co., Inc., West Point, Pa.; From the Division of Virus and Tissue Culture Research, Merck Institute for Therapeutic Research.; Director, Division of Virus and Tissue Culture Research (Dr. Hilleman), and Research Associate, Division of Virus and Tissue Culture Research (Dr. Goldner), Merck Institute for Therapeutic Research.

Am J Dis Child. 1962;103(3):484-495. doi:10.1001/archpedi.1962.02080020496070

The development by Enders et al.1,2 of a live attenuated measles-virus vaccine, the establishment of the safety of the vaccine for man, the demonstration of high-level efficiency for inducing measles antibody in human subjects, and the proof of efficacy in preventing natural measles have provided the rationale for this prophylactic measure.1-7 The process of conversion from small experimental batches of vaccine for clinical test purpose to lots of vaccine for mass application poses the need for minimum standards of quality to regulate the safety and efficacy of the material.

Historic Perspective  Development of standards for purity, safety, and efficacy of a new vaccine should take advantage of procedures employed successfully in the past, should correct or eliminate the technical difficulties encountered previously, should be in step with current technology, and should be guided by precedent when dealing with unknowns.At the present writing, there are in the U.S.A.

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