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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment Poulvac® Procerta HVT-IBD - Technical Opinion 7666/2021.
EN
02 sept. 2021
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Autorité nationale compétente :National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200,Téléphone : (5561) 3411-5516,Télécopieur : (5561) 3317-7475,E-mail : ctnbio@mct.gov.br,Site Web : http://www.ctnbio.gov.br,
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VECTORMUNE® HVT-IBD| Ceva Saúde Animal Ltda(CEVA) | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins)
- Commercial release 7666-2021.pdf [ Portugais ]
The vaccine against Marek's disease - Bursa (from Gumboro), consists of the live turkey herpesvirus (HVT) serotype 3, which is the protein for chickens, expressing a structural protein VP2 of the infectious bursal disease virus (IBDV).
Marek's disease virus is a risk group 1 organism, according to NIH/CDC guidelines. All research with the HVT-IBD recombinant was performed under the guidelines of BSL-2 (biosafety level 2). As the IBDV VP2 gene does not provide any new virulence factors to the HVT backbone and as the HVT vaccine backbone itself is known to be safe.
The safety risk to the environment is low. The vaccine has been shown to be safe in target and non-target animals. The vaccine was genetically stable when it was passed through chickens five times. The security profile of the HVT backbone was not changed by the addition of the F NDV gene. In the spread/spread study, the infectious virus was not detected in the environment and the vaccine virus did not infect unvaccinated chickens in contact with vaccinated birds. The potential for horizontal recombination is low and with negligible consequences.
It is not potentially causing significant degradation of the environment or human and animal health.
The live frozen vaccine vectored against Gumboro and Marek's diseases (POULVAC® PROCERTA HVTIBD) presents extremely low risk to animals. Previous tests carried out in birds have shown that the vaccine is innocuous for the species. The agent was administered to birds in several controlled studies; with rare local injection site reactions and no systemic adverse events reported. In addition to birds, the vaccine is also harmless to mice and guinea pigs.
No adverse reactions occurred during the 120-day study. There were no serious injuries associated with Marek's disease seen at necropsy. At day 120, the mean body weight of birds vaccinated in ovo and subcutaneously in birds vaccinated at hatch was not significantly different from the weight of controls. Thus, there was no evidence that the initial inoculum virus (MSV) HVT-IBD is virulent for the target animal.
Recombinant virus (RBA) is not expected to cause safety problems in non-target species.
Recombinant virus (RBA) is not expected to cause safety problems in non-target species.
The risk to public health is low. The vaccine is not pathogenic or toxic, and viruses only used for production are attenuated. There are no reports of human disease related to the agent. The risk to the environment is also low. The occurrence of an eventual escape and dispersion of the agent in the environment is unlikely.
The documents sent by the applicant comply with the relevant legislation aimed at ensuring the biosafety of the environment, agriculture, human and animal health, provided for in Law 11.108/05 and its Decree 5.591/05 and in Normative Resolution No. 21 of CTNBio of June 21 de 2018. Thus, given the conditions described in the process and in this technical opinion, this activity is not potentially causing significant degradation of the environment or human and animal health.
Molecular traditional methods.
Oui
Oui
Oui
Non
Non
FR
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