Abstract
Eleven batches of BCG vaccine were divided into two parts each and sealed after lyophilization in ampoules under vacuum or under nitrogen , using appropriate techniques of gassing and sealing. Gothenburg-Marburg and 1331 Copenhagen strains were used for production. After 4 years of storage at +4 °C, the number of culturable particles decreased to 81 (74–89% of the initial) values, and after 4 weeks at +37 °C to 61 (56–66)%. (Confidence intervals given in parentheses; P = 0·95.) There was no significant difference in stability between BCG vaccines sealed under vacuum and under nitrogen, either at +4 °C or at + 37 °C ( P Five additional batches (strain 1331) were also divided and sealed in ampoules under nitrogen or under carbon dioxide . After 2 years of storage at +4 °C, the number of culturable particles in one group of vaccines decreased to 73 (61–86)%, and in a second group to 97 (84–114)% of the initial values, and after 4 weeks at +37 °C to 59 (53–66)% in both groups. Also, there was no significant difference in stability between BCG vaccines sealed under nitrogen and under carbon dioxide, either at +4 °C or at +37 °C.
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