Version 1
: Received: 12 August 2024 / Approved: 13 August 2024 / Online: 14 August 2024 (07:16:51 CEST)
How to cite:
Meena, J.; Shiekh, F.; Bindra, G.; Yadav, S.; Kasana, H.; Chander, H.; Anvikar, A. R.; Chand, S. Challenges in Ensuring the Safety of Aluminum Adjuvanted Vaccine: A Case Study of Inactivated Rabies Vaccines by National Control Laboratory. Preprints2024, 2024080951. https://doi.org/10.20944/preprints202408.0951.v1
Meena, J.; Shiekh, F.; Bindra, G.; Yadav, S.; Kasana, H.; Chander, H.; Anvikar, A. R.; Chand, S. Challenges in Ensuring the Safety of Aluminum Adjuvanted Vaccine: A Case Study of Inactivated Rabies Vaccines by National Control Laboratory. Preprints 2024, 2024080951. https://doi.org/10.20944/preprints202408.0951.v1
Meena, J.; Shiekh, F.; Bindra, G.; Yadav, S.; Kasana, H.; Chander, H.; Anvikar, A. R.; Chand, S. Challenges in Ensuring the Safety of Aluminum Adjuvanted Vaccine: A Case Study of Inactivated Rabies Vaccines by National Control Laboratory. Preprints2024, 2024080951. https://doi.org/10.20944/preprints202408.0951.v1
APA Style
Meena, J., Shiekh, F., Bindra, G., Yadav, S., Kasana, H., Chander, H., Anvikar, A. R., & Chand, S. (2024). Challenges in Ensuring the Safety of Aluminum Adjuvanted Vaccine: A Case Study of Inactivated Rabies Vaccines by National Control Laboratory. Preprints. https://doi.org/10.20944/preprints202408.0951.v1
Chicago/Turabian Style
Meena, J., Anupkumar R. Anvikar and Subhash Chand. 2024 "Challenges in Ensuring the Safety of Aluminum Adjuvanted Vaccine: A Case Study of Inactivated Rabies Vaccines by National Control Laboratory" Preprints. https://doi.org/10.20944/preprints202408.0951.v1
Abstract
The vaccines have to undergo independent testing at National Control laboratory (NCL) for various quality control tests to ensure safety, purity, and potency before market authorization and surveillance testing. In this study, five different inactivated cell culture rabies vaccine preparations (Aluminum adjuvanted and non-adjuvanted) marketed in India were evaluated using compendial safety test of mouse inoculation test (MIT) for residual live virus. Investigations were done to see the interference of aluminum adjuvant in rabies vaccine preparation to ensure safety as per the in-vivo compendial test for virus inactivation. After intracerebral injections, mice received the aluminum phosphate adjuvanted inactivated rabies vaccine (ARV) had neurological complications that resulted in their deaths between days 4 and 10. Further investigations were carried out to find out the root cause for mice death including fluorescent antibody test (FAT), rabies virus amplification test. Additionally, alamar blue based cell cytoxicity assay was carried out using BHK-21 cells to estimate the cell toxicity of aluminum phosphate adjuvanted inactivated rabies vaccine. The present study highlighted the challenges in ensuring the safety of adjuvated inactivated rabies vaccine at level of NCL. Further, study demonstrated the toxicity of aluminum under both in vitro and in vivo settings, sparking controversy regarding the safety of aluminum adjuvants in vaccines at the suggested compendial limit of 1.25 mg/single human dosage.
Keywords
Toxicity; aluminum adjuvant; rabies vaccine; cell culture; mouse inoculation test
Subject
Biology and Life Sciences, Toxicology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
