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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of the Vectormune FP-LT-AE Vaccine - Technical Opinion No. 2958/2011.
EN
16 juin 2011
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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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Organisation :Ceva Saúde Animal Ltda (CEVA)Secteur privé (affaires et industrie)Rua Manuel Joaquim Filho, 303 Pulínia - SPPaulínia, São Paulo
13140-000,Téléphone : 551938337700,Télécopieur : 55193833-7722,E-mail : alexisgoux@ceva.com,Site Web : http://www.ceva.com.br/,
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VECTORMUNE® FP-LT + AE Vaccine| Ceva Saúde Animal Ltda(CEVA) | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins)
- Commercial release 2958-2011.pdf [ Portugais ]
The Fowlpox virus (FPV) Cutter sample, is the source of most live vaccines against avian pox. were introduced in this virus, two ILT genes, UL-32 and Gb, in addition to an E.coli Lac Z marker gene, using two promoters synthetic compounds and a region for homologous recombination with the FPV to occur.
No adverse reactions were observed with the use of this vaccine. This vaccine is safe for human and animal health and the environment.
The analysis of the data presented on the stability of the vaccine, its non-reversion to virulence in passages in the target organism, its inability to maintain in the environment and its host limitation results in the conclusion that this vaccine is safe for human and animal health and for the environment. In view of the effective and safe use of FPV in vaccines around the world for more than four decades and the lack of evidence that points to a different behavior of the recombinant form in relation to the parental version. This activity is not potentially causing significant environmental degradation or harmful to human and animal health.
It is not potentially causing significant degradation of the environment or harmful to human and animal health.
For human health, the vaccine can be considered safe, as there are no reports of productive infection caused by FPV in any species other than avian. The FPV vaccine strain (recipient) has been used worldwide as a commercial vaccine for birds, with no reports of adverse effects and/or risks to public health. For the environment, the risks are very low. The ability to scavenge and spread the recombinant vaccine is limited, and the host specificity is not altered from wild-type FPV.
The analysis of the data presented on the stability of the vaccine, its non-reversion to virulence in passages in the target organism, its inability to maintain in the environment and its host limitation results in the conclusion that this vaccine is safe for human and animal health and for the environment.
No adverse reactions were observed with the use of this vaccine.
The Commission considered that the experimental protocols and other proposed biosafety measures comply with the CTNBio norms and the pertinent legislation that aim to guarantee the biosafety of the environment, agriculture, human and animal health.
Molecular traditional methods.
Oui
Oui
Oui
Non
Non
FR
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
