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Academic Journal of Agriculture & Life Sciences, 2024, 5(1); doi: 10.25236/AJALS.2024.050108.

Performance evaluation of reference substance for oral live rotavirus vaccines

Author(s)

Baoqin Jiang, Yan Cui, Mingxue Qi, Jun Liu, Yan Shi, Su Liu, Chenming Liu, Jing Ren, Dejie Feng

Corresponding Author:
Dejie Feng
Affiliation(s)

Lanzhou Institute of Biological Products Co. Ltd., Lanzhou, 730046, China

Abstract

The results showed that the appearance inspection and moisture content of the reference material for oral rotavirus live vaccine met the requirements; The titration results for 12 years showed that the reference titers of oral rotavirus live vaccines stored below -20 ℃ were within the quality control range of 6.2-7.2lgCCID50/mL, with an annual detection mean of 6.6-6.8lgCCID50/mL and an annual detection standard deviation of 0.17-0.23lgCCID50/mL. Trend analysis shows that the reference titer of the oral rotavirus live vaccine is stable and there is no downward trend. The reference material for oral rotavirus live vaccines currently in use has stable and effective performance, ensuring the accuracy and reliability of virus titer detection results for oral rotavirus live vaccines and oral trivalent reconstituted rotavirus attenuated live vaccines (Vero cells) in daily use. This can provide assurance for the quality control of the two types of rotavirus vaccines.

Keywords

Oral live rotavirus vaccine, Reference substance, Appearance, Moisture content, Virus titer, Overall trend analysis

Cite This Paper

Baoqin Jiang, Yan Cui, Mingxue Qi, Jun Liu, Yan Shi, Su Liu, Chenming Liu, Jing Ren, Dejie Feng. Performance evaluation of reference substance for oral live rotavirus vaccines. Academic Journal of Agriculture & Life Sciences (2024) Vol. 5 Issue 1: 52-56. https://doi.org/10.25236/AJALS.2024.050108.

References

[1] Rotavirus vaccines: WHO position paper – July 2021. Weekly epidemiological record. 2021; 96:301–320.

[2] Cohen AL, Platts-Mills, JA, Nakamura T, et al. Aetiology and incidence of diarrhoea requiring hospitalisation in children under 5 years of age in 28 low-income and middle-income countries: findings from the Global Pediatric Diarrhea Surveillance network. BMJ Global Health 2022; 7: e009548. doi: 10.1136/bmjgh-2022-009548.

[3] World Health Organization. The immunological basis for immunization series: module 21: rotavirus vaccines. 2020.

[4] Abbott C, Tiede B, Armah G, et al. Evaluation of cost-effectiveness of live oral pentavalent reassortant rotavirus vaccine introduction in Ghana [J].Vaccine, 2012, 30(15):2582-2587. DOI:10. 1016/j.vaccine. 2012.01.076.

[5] Burnett E, Parashar UD, Tate JE. Real-world effectiveness of rotavirus vaccines, 2006-19: a literature review and meta-analysis. Lancet Glob Health. 2020 Sep; 8(9): e1195- e1202. doi: 10.1016/S2214-109X(20)30262-X. PMID: 32827481; PMCID: PMC8097518.

[6] WHO. Guidelines on stability evaluation of vaccines//WHO Expert Committee on Biological Standardization: fifty-seventh report[R].WHO TRS, 2011, 962:184.

[7] Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China (Vol III) [S]. Beijing: China Medical Science and Technology Press, 2020:23-24.