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Risk Assessment generated by a regulatory process
(RA)
last updated: 29 Feb 2016
Risk assessment for production, marketing, and export of the product named VAXXITEK MD/IBD
EN
04 May 2004
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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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VAXXITEK® HVT+ IBD| Merial Saúde Animal Ltda(Merial) | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
- National Biosafety Commission [ English ]
This GMO, subject of the present application of the marketing release, is a recombinant virus named vHTV013-69. This virus is originating from a non- pathogenic serotype of Peruvian herpesvirus routinely used as live vaccine against Marek’s disease, an avian illness that affects economically several countries. A Gumboro’s disease-virus gene was added to this herpesvirus. The added gene cannot cause the disease and it can promote protection against Gumboro’s disease virus
EN
ccording to a favorable approach from Ministry of Agriculture and Fishing (General Food Management) and French Ministry of Interior and Environment (Management of Pollution and Risk Prevention), the recombinant virus is originating from a parental strain FC126 of Peruvian herpesvirus (HVT) used in the United States and France for producing live vaccines against Marek's disease, without undesirable effects. The virus HVT belongs to the risk classification Ea1, for confinement category L1. The expression strand, which integrates the gene encoding protein of interest, is inserted in an uncoded intergenic region. Also according this approach, this recombinant virus does not show tropism change and nor spread from chicken to chicken. Mammals are refractory to HVT infection, not constituting, therefore, risks for public health.
EN
The vaccine will be supplied frozen in glass ampoules with a suspension of tissue culture medium from cells infected with recombinant virus.
Characterization of GMO:
Receiver microorganism - Meleagrid herpesvirus 1 or Peruvian herpesvirus (HVT), strain FC-126, the vHVT-013 will be the vector virus. This strain has been widely used since 1971 as a vaccine against Marek's disease;
Donor Microorganism - Birnavirus or Gumboro’s Disease Virus (IBDV), strain 52/70 Faragher. The gene, which is not capable of causing diseases, inserted into vector genome is the VP 2, whose toxic effect not has been still identified (the gene is encoded for one of the IBDV capsid proteins).
EN
Characterization of GMO:
Receiver microorganism - Meleagrid herpesvirus 1 or Peruvian herpesvirus (HVT), strain FC-126, the vHVT-013 will be the vector virus. This strain has been widely used since 1971 as a vaccine against Marek's disease;
Donor Microorganism - Birnavirus or Gumboro’s Disease Virus (IBDV), strain 52/70 Faragher. The gene, which is not capable of causing diseases, inserted into vector genome is the VP 2, whose toxic effect not has been still identified (the gene is encoded for one of the IBDV capsid proteins).
Once met the biosafety recommendations and measures included in the process, this activity does not cause a potentially significant environmental degradation nor it is harmful to the human health.
EN
For animal health: The virus did not show any virulent property when inoculated in 1-day chicks in a 10-fold higher the field dose recommended; no adverse immune interaction is expected with this vaccine use; retro-transport studies has shown that the vHVT-013-69 virus does not revert to virulence when administered to chicks; the HVT FC-126 strain is avirulent for chickens; the inserted gene, and its products, do not have known pathogenic or toxic properties; there is no evidence showing that vaccine recombinant strain is different from HVT; studies of viral proliferation have detected no viral recovery in mice tissue samples inoculated with recombinant virus; it is not expected that the recombinant virus will be a safety problem for non-target species.
For human health: Risks for public health are not expected; there are no reports of HVT productive infection in any species other than the avian as well as there no report of human infection; the human exposure will be limited to the personnel who administer the vaccine and conduct field studies; the parental HVT vaccine has been used in Europe, as marketed vaccine for chickens, without any report of adverse effects or danger for public health; once the man never has been inoculated with recombinant virus, the effective result of an accidental inoculation is unknown; the experts on human and poultry cancer believe that Marek's disease and respective vaccines do not represent any risk for human health.
EN
For human health: Risks for public health are not expected; there are no reports of HVT productive infection in any species other than the avian as well as there no report of human infection; the human exposure will be limited to the personnel who administer the vaccine and conduct field studies; the parental HVT vaccine has been used in Europe, as marketed vaccine for chickens, without any report of adverse effects or danger for public health; once the man never has been inoculated with recombinant virus, the effective result of an accidental inoculation is unknown; the experts on human and poultry cancer believe that Marek's disease and respective vaccines do not represent any risk for human health.
Once met the biosafety recommendations and measures included in the process, this activity does not cause a potentially significant environmental degradation nor it is harmful to the human health
EN
The risks for environmental safety are low; the recombinant vaccine-shedding/diffusion capacity is limited; the specificity of the host/band of the experimental vaccine does not show changes in relation to wild-type HVT that is restricted to the avian species; the in vivo potential recombination with field virus and other vaccine viruses is unknown; the Marek's disease virus has worldwide distribution; it is expected that the potential recombinant virus transmission will be minimum, even occurring transmission, the attenuated properties of vHVT-013-69 should not be changed.
EN
molecular thaditional methods
EN
EN
- National Biosafety Commission [ English ]
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
