Quality Evaluation of Rubella Vaccine used in India
Journal Title: International Journal of Biomedical and Advance Research - Year 2016, Vol 7, Issue 1
Abstract
Objectives: Cold chain maintenance is essential to ensure vaccine quality till it reaches the end user. In tropical countries like India with hot and humid environment, the transport of vaccines with required cold chain is comparatively difficult. Also, the efficacy of live viral vaccines is dependent on proper attenuation of vaccine virus. The present study was carried out to analyse the quality of 41 batches of rubella vaccine stored at 2-8C and their thermostability after exposure at 37C for 7 days, as such no study is published from India. Accordingly, the trends for the potency and stability titres of these batches of rubella vaccine were analysed during the present study. Method: All the Rubella vaccines batches were tested in triplicates against reference vaccine as per the WHO formula. The number of wells showing cytopathic effect was counted and titres were calculated using Spearman-Karber formula. The geometric mean titre was calculated for the triplicate readings. The assay is considered valid only if confidence limits (P=0.95) of the logarithm of the virus concentration is greater than 0.3. WHO criteria state that minimum virus concentration should be 103.0CCID50 per human dose for both exposed and non-exposed rubella vaccine. Also, after incubation the loss in titre should not be more than 101.0. Result: The potency and thermostability titres of all the batches tested were found to be between 103.467 to 104.03 and 103.276 to 103.72 respectively and were well within prescribed specifications of WHO. Conclusion: Potency and thermostability of the rubella vaccine tested were found in the acceptable range indicating rubella vaccine used in India is quite potent and thermostable.
Authors and Affiliations
Manjula Kiran, Shalini Tewari, Jaipal Meena, Farha Hasan, Ajay Kumar Ade, Gurminder Bindra, Subhash Chand, Neeraj Malik, Gul Raj Soni, Surinder Singh
Keywords
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- EP ID EP356342
- DOI 10.7439/ijbar.v7i1.2900
- Views 97
- Downloads 0
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