Affiliation:
1. Department of Physiology, Faculty of Medicine, University of Colombo, Colombo 00800, Sri Lanka
2. EU/WOAH/WHO Reference Laboratory for Rabies, OMCL for Rabies Vaccines, 54220 Nancy, France
3. Boehringer Ingelheim, 69007 Lyon, France
4. JC & P Life Science Partner, 04300 Forcalquier, France
Abstract
Seven brands of veterinary rabies vaccines are commercially available in Sri Lanka, but there is no established procedure to test the potency of the vaccines at the local level, especially prior to their release. The aim of this study was to test the potency of these vaccines using a mouse challenge test in collaboration with the EU/WOAH/WHO Reference Laboratory for Rabies, ANSES-Nancy, France. Based on the European Pharmacopoeia, the inactivated rabies vaccines complied with the mouse potency test if the estimated potency is ≥1.0 IU in the smallest prescribed dose. Among the eight tested vaccines, four single-dose preparations (Rabisin™, Raksharab™, Nobivac™ RL, and Nobivac™ Rabies) were compliant, with potencies of 12 IU/dose, 7.2 IU/dose, 4.4 IU/dose, and 3.4 IU/dose, respectively. Three of the single-dose preparations (Canvac™ R, Defensor™ 3, and Rabies killed vaccine) were not compliant, with potency values <1.0 IU/dose. One multidose preparation (Raksharab™ multidose) had a potency of 1.3 IU/dose, even though the test was not validated. Based on these results, it appears that some rabies vaccine batches that are currently available in the local market do not comply with the mouse potency test. Testing the vaccines’ potency before registration and release to the market appears to be an important step to allow good immunization to animals during pre-exposure vaccination programs.
Subject
Pharmacology (medical),Infectious Diseases,Drug Discovery,Pharmacology,Immunology
Reference21 articles.
1. Rabies;Fooks;Nat. Rev. Dis. Prim.,2017
2. Avoiding preventable deaths: The scourge of counterfeit rabies vaccines;Taylor;Vaccine,2019
3. Inferior rabies vaccine quality and low immunization coverage in dogs (Canis familiaris) in China;Hu;Epidemiol. Infect.,2008
4. Sri Lanka Death Statistics (2023, February 27). Public Health Veterinary Services, Available online: http://www.rabies.gov.lk/english/static.php.
5. Weekly Epidemiological Report (2021, July 13). Human Rabies, Available online: https://www.epid.gov.lk/web/images/pdf/wer/2017/vol_44_no_09-english.pdf.
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献