Assessing the Potency of Inactivated Veterinary Vaccines and Oral Live Vaccines Against Rabies

Servat, Alexandre; Cliquet, Florence; Wasniewski, Marine

doi:10.1007/978-3-030-21084-7_10

Cited by 1 publication

(2 citation statements)

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“…To achieve this goal, potent vaccines and medicines are absolutely required. For this purpose, rabies vaccine manufacturers should conduct many in-process quality controls, including identification, purity, sterility, safety, inactivation, and potency [ 15 , 16 ]. The WHO and WOAH recommend that rabies vaccines for human and animal use should be approved by competent authorities and comply with national or international relevant standards [ 14 , 16 ].…”

Section: Discussionmentioning

confidence: 99%

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Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka

Rathnadiwakara

Gunatilake

Servat³

et al. 2023

Vaccines

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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.

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Section: Discussionmentioning

confidence: 99%

“…Eur) monograph 0451, derived from the NIH test. It was based on single vaccination of mice at Day 0, followed by the intracranial challenge 14 days after the vaccination in groups of ten animals per vaccine dilution in order to meet the first step toward the 3Rs [ 9 , 10 , 15 ].…”

Section: Discussionmentioning

confidence: 99%