Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka
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...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-05-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/11/5/961 |
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| author | Hasanthi Rathnadiwakara Mangala Gunatilake Alexandre Servat Marine Wasniewski Jean-Christophe Thibault Florence Cliquet |
| author_facet | Hasanthi Rathnadiwakara Mangala Gunatilake Alexandre Servat Marine Wasniewski Jean-Christophe Thibault Florence Cliquet |
| author_sort | Hasanthi Rathnadiwakara |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T03:15:05Z |
| format | Article |
| id | doaj.art-0e7322dc9f51400ab66f91753bb27a26 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-11T03:15:05Z |
| publishDate | 2023-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-0e7322dc9f51400ab66f91753bb27a262023-11-18T03:36:21ZengMDPI AGVaccines2076-393X2023-05-0111596110.3390/vaccines11050961Potency of Veterinary Rabies Vaccines Marketed in Sri LankaHasanthi Rathnadiwakara0Mangala Gunatilake1Alexandre Servat2Marine Wasniewski3Jean-Christophe Thibault4Florence Cliquet5Department of Physiology, Faculty of Medicine, University of Colombo, Colombo 00800, Sri LankaDepartment of Physiology, Faculty of Medicine, University of Colombo, Colombo 00800, Sri LankaEU/WOAH/WHO Reference Laboratory for Rabies, OMCL for Rabies Vaccines, 54220 Nancy, FranceEU/WOAH/WHO Reference Laboratory for Rabies, OMCL for Rabies Vaccines, 54220 Nancy, FranceBoehringer Ingelheim, 69007 Lyon, FranceEU/WOAH/WHO Reference Laboratory for Rabies, OMCL for Rabies Vaccines, 54220 Nancy, FranceSeven 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.https://www.mdpi.com/2076-393X/11/5/961antirabies vaccineNIH testrabiesSri Lankapotency |
| spellingShingle | Hasanthi Rathnadiwakara Mangala Gunatilake Alexandre Servat Marine Wasniewski Jean-Christophe Thibault Florence Cliquet Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka Vaccines antirabies vaccine NIH test rabies Sri Lanka potency |
| title | Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka |
| title_full | Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka |
| title_fullStr | Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka |
| title_full_unstemmed | Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka |
| title_short | Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka |
| title_sort | potency of veterinary rabies vaccines marketed in sri lanka |
| topic | antirabies vaccine NIH test rabies Sri Lanka potency |
| url | https://www.mdpi.com/2076-393X/11/5/961 |
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