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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-MG Vaccine - Technical Opinion 2214/2009.
EN
27 févr. 2009
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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 MG Vaccine| Ceva Saúde Animal Ltda(CEVA) | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins)
- Commercial release 2214-2009.pdf [ Portugais ]
VECTORMUNE® FP-MG - Freeze-dried live yaws vaccine Avian and Mycoplasma gallisepticum.
Vaccine safety was also evaluated during the efficacy study. Chickens were vaccinated at 8 weeks of age. Birds were kept for three weeks to develop immunity before challenge. During this period, birds were observed daily and no adverse reactions or clinical signs of FP or MG were observed. After the observation period, the birds were challenged and the vaccine was effective against FP and MG challenge. Thus, the vaccine is effective for use in chickens and poses no safety risk.
Safety was demonstrated in other avian species (turkeys, quails, finches, and doves) by: (1) vaccination with the vaccine or the parental FPV strain and (2) comparison of clinical signs, adverse reactions, and viral isolation between the two groups. vaccinated. The results showed that other avian species vaccinated with the vaccine showed no signs of clinical or adverse reactions and no virus was isolated from the inoculation site or from the blood or trachea of quails, birds and pigeons.
No adverse reactions were observed.
No adverse reactions were observed. Thus, the vaccine is effective for use in chickens and poses no safety risk.
The safety of vaccine transmission of vaccine from vaccinated to non-vaccinated chickens by contact was assessed on: (1) contact transmission in the evaluation of FPV efficacy, (2) contact transmission in the evaluation of MG efficacy, and (3) comparison transmission to the parental FPV strain. Chickens were vaccinated with a 100X dose of vaccine. Twenty-four hours post-vaccination, unvaccinated chickens began contact with vaccinated chickens for three weeks. During this period, no adverse vaccine reaction or clinical signs of FP or MG. To assess transmission, all birds were challenged with either FPV or MG. Vaccinates were protected from challenge while unvaccinated birds were susceptible. Birds vaccinated with the parental FPV strain had similar results. It is concluded that neither the vaccine nor the parental FPV strain was transmissible. Thus, the vaccine is safe for use in chickens and does not present any safety risk.
It is not potentially causing significant degradation of the environment or harmful to human and animal health.
The Commission considered that the experimental data and other information on the biosafety of the product presented by the company 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
Non
Non
FR
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
