Transcription of Annex 3 - World Health Organization
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Annex 3 - World Health Organization
137 Introduction 139 General considerations 139 Special considerations 140 Scope of the Recommendations 141 BCG vaccine strains 141 Potency-related tests 142 Part A. Manufacturing recommendations Definitions General manufacturing recommendations Control of source materials Control of vaccine production Filling and containers Control tests on final lot Records Retained samples Labelling Distribution and transport Stability, storage and expiry date 157 Part B. Nonclinical evaluation of BCG vaccines 159 Part C. Clinical evaluation of BCG vaccines General considerations Special considerations Post-marketing surveillance 164 Part D. Guidelines for NRAs General Release and certification 166 Authors and acknowledgements 166 References 170 Annex 3 Recommendations to assure the quality, safety and efficacy of BCG vaccinesReplacement of Annex 2 of WHO Technical Report Series, No.
by comparative genomics (19). BCG vaccine strains were thus divided into 18, the “early” strains, in which the original characteristics of “authentic Pasteur” were conserved with fewer deletions, insertions and mutations in the genome of the bacilli than the “late” strains. “Early” strains are represented by BCG Russia
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