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Risk Assessment generated by a regulatory process
(RA)
last updated: 09 Jan 2014
Risk Assessment of a biological product for veterinary use, namely VECTORMUNE® FP-LT+AE- Fowl Pox and avian Laryngotracheitis vaccine and avian encephalomyelitis
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16 Jun 2011
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Person:Dra Maria Sueli Felipe SoaresPresident,Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,Related OrganizationNational Technical Biosafety Comission (CTNBio)Government agency (National/Federal)Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,
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VECTORMUNE® FP-LT + AE Vaccine| Ceva Saúde Animal Ltda(CEVA) | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
- national Biosafety Comission [ English ]
Studies on the effect of the viral sample in non-target species, on the viral distribution in target
species and on virus dissemination and multiplication showed that the sample FPV/ILT fails to
behave in any way different from the sample FPV, Cutter sample. To assess genetic stability,
five retro-passages in chicken were conducted and the recombinant remained stable.
Administration of the vaccine is indicated for 4 to 8 week chicken. Several studies were carried
out to assess whether the behavior of the recombinant virus varies from that of the parental
vaccine. All parameters assessed showed that the biological features are not different from
that of the parental virus, regarding both in vivo replication and tissue tropism
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species and on virus dissemination and multiplication showed that the sample FPV/ILT fails to
behave in any way different from the sample FPV, Cutter sample. To assess genetic stability,
five retro-passages in chicken were conducted and the recombinant remained stable.
Administration of the vaccine is indicated for 4 to 8 week chicken. Several studies were carried
out to assess whether the behavior of the recombinant virus varies from that of the parental
vaccine. All parameters assessed showed that the biological features are not different from
that of the parental virus, regarding both in vivo replication and tissue tropism
As far as animal health is concerned, the following tests were conducted:
1. Safety test in commercial poultry (normal dose);
2. Safety test in commercial egg-layer poultry and slaughter matrices (normal dose);
3. Safety test (10 x normal dose) in 6 week susceptible poultry;
4. Safety test associated to viral lateral transmission of immunized to non-immunized
birds;
5. Safety test in different fowl species (quails, doves and turkeys);
6. Safety test in other non-avian species;
7. Assessment of tissue tropism in susceptible host; and
8. Master Seed Virus (MSV) retro-passage study of the recombinant vaccine.
EN
1. Safety test in commercial poultry (normal dose);
2. Safety test in commercial egg-layer poultry and slaughter matrices (normal dose);
3. Safety test (10 x normal dose) in 6 week susceptible poultry;
4. Safety test associated to viral lateral transmission of immunized to non-immunized
birds;
5. Safety test in different fowl species (quails, doves and turkeys);
6. Safety test in other non-avian species;
7. Assessment of tissue tropism in susceptible host; and
8. Master Seed Virus (MSV) retro-passage study of the recombinant vaccine.
No adverse reaction was found in the use of this vaccine.
The vaccine may be held as safe for human health, since there are no reports of productive
infection caused by FPV in any non-avian species. The FPV vaccine strain (receptor) has been
used around the world as a commercial vaccine for birds with no record of adverse effect
and/or risks to public health.
EN
The vaccine may be held as safe for human health, since there are no reports of productive
infection caused by FPV in any non-avian species. The FPV vaccine strain (receptor) has been
used around the world as a commercial vaccine for birds with no record of adverse effect
and/or risks to public health.
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The analysis of data related to vaccine stability, non-reversal to virulence on passages in the
target organism, inability to keep in the environment and host limitation leads to a conclusion
that the vaccine is environmentally safe
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target organism, inability to keep in the environment and host limitation leads to a conclusion
that the vaccine is environmentally safe
Traditional molecular methods
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
