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Évaluation des risques générée par un processus de réglementation
(RA)
last updated: 16 juin 2026
Risk assessment of the modified Ingelvac ProvenzaVaccine live virus against Swine Influenza - Technical Opinion No. 6062/2018
EN
07 juin 2018
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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, BrésilTéléphone : (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 :Boheringer Ingelheim Química e Farmacêutica Ltda. ()Secteur privé (affaires et industrie)Avenida das Nações Unidas, 14171, 18º andar - Torre B - Vila Gertrudes. 04794-000.São Paulo, São Paulo
04794-000, BrésilTéléphone : 55 11 4949-4700,Télécopieur : 55 11 4949-4700,Site Web : http://www.boehringer-ingelheim.com.br/,
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Swine influenza virus vaccine| Boheringer Ingelheim Química e Farmacêutica Ltda. | Production de composés médicaux ou pharmaceutiques (humains ou animaux) (Vaccins)
- Commercial release 6062-2018.pdf [ Portugais ]
The bivalent NS1 swine flu virus vaccine, live virus (MLV), has an H1N1 NS1 isolate (lot # 241-192) and an H3N2 NS1 isolate (lot # 241-196).
The vaccine proved to be clinically safe in the study as no adverse effects were reported.
Results of a 1-day propagation and dispersal study in pigs with Swine Influenza H1N1 NS1 MSV were presented ( Study BIV 2012201-Laboratory Safety Study for Analysis of Propagation and Dispersion of Swine Influenza Vaccine, H1N1 and H3N2, Viruses Live Modified). In this study, 1 mL (6.60 log10 FAID50/dose of H1N1) was administered to pigs one to two days old. (FAID = 50% Infectious Dose determined by immunofluorescence assay). The vaccine proved to be clinically safe in inoculated pigs, was excreted for a maximum of 7 days in the nasal secretions of vaccinated pigs, and was observed to spread only minimally in inoculated pigs. Both vaccinated female piglets and non-vaccinated groups did not shed virus in nasal secretions. Ultimately, the vaccine proved to be clinically safe in the study, as no adverse effects were reported.
The Commission concluded that the present application fully meets the CTNBio's rules and the pertinent legislation that aim to guarantee the biosecurity of the environment, agriculture, human and animal health.
This genetically modified event poses no risk to the human and animal health and the environment.
event Ingelvac Provenza-Vacina genetically modified poses no risk to human, animal or environmental health.
Vaccine antigens could result in significant adverse ecological effects if they became infected and proved to be highly pathogenic for species with no indication of use, causing morbidity and mortality. On the other hand, the limited number of hosts, the low ability to survive in the environment and the host's susceptibility to interferon do not indicate that the use of this vaccine may cause damage to the environment.
In compliance with the norms and legislation in force that aim to guarantee environmental, plant, animal and human biosafety, CTNBio gave a favorable opinion at the request of the company Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda. of Commercial Release of Ingelvac Provenza - Modified Live Virus Vaccine against Swine Influenza.
Molecular traddicional methods.
Oui
Non
Non
FR
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| Décision de pays ou tout autre communication | Évaluation des risques | 1 | |
