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Risk Assessment generated by a regulatory process
(RA)
last updated: 29 Apr 2026
Risk assessment of the Biotech Vac COX vaccine, derived from Genetically Modified Microorganism (MGM) - Technical Opinion No. 8962/2024.
EN
07 Mar 2024
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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,Phone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Organization:Vetanco do Brasil Importação e Exportação Ltda (Vetanco)R. Edgar Marchiori, 255 - Distrito Industrial Benedito Storani, Vinhedo - SP, 13280-000Vinhedo - SP,
,Phone: [49] 9 9119.1020,Fax:Email: contato@vetanco.com.br,Website: https://www.vetanco.com/br/,
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Biotech Vac COX| Vetanco do Brasil Importação e Exportação Ltda(Vetanco) | Production of medical or pharmaceutical compounds (human or animal) (Vaccines)
- Commercial release 8962-2024.pdf [ Portuguese ]
BIOTECH VAC COX is an oral vaccine for animals consisting of a GMO derivative, with the genetic transformation event consisting of the amplification of the Eimeria TUBSUB1 gene (Figure 1) inserted by direct ligation into the Bacillus subtilis expression plasmid pHT01. The objective of the modified Bacillus subtilis is the expression of the TUBSUB1 protein subunit, responsible for the immunological effect of the vaccine.
The main difference between the two is that the Biotech Vac Salmonella vaccine has the TolB protein of Salmonella spp as its antigen, while the Biotech Vac Cox vaccine uses the TUBSUB1 protein as its antigen, which has an essential function for the integrity of the micronema of parasites of the genus Eimeria. Both the gene construction, the expression vector and the binding sites are the same in both vaccines, their safety for animals, humans and the environment has already been observed. It is important to emphasize that in both vaccines the microorganism that produces the vaccine antigen is inactivated before commercial formulation, with no possibility of its dispersion in the environment or other forms of dissemination.
If any occurrence of medium to high severity regarding the use of the BIOTECH VAC COX product is evidenced, a series of actions will be initiated to mitigate risks and possible problems, such as carrying out an in-depth investigation, traceability of sales/batch of products, notification to competent health authorities and even the recall and withdrawal of products from the market, always following the good practice procedures in force in the quality system (POPs Product recall, GQ-013 – Vetanco do Brasil and AC-005- Vetanco Argentina).
The expression of the TUBSUB1 protein (Biotech Vac Cox) by Bacillus subtilis does not generate any change in the phenotype, or growth pattern, or nutrient consumption or in any other factor related to the survival of the expression vector used in the production of both vaccines, when compared to the production of ToIB protein for Biotech Vac Salmonella. As we mentioned previously, both vaccines are inactivated, thus mitigating the possible risks of an MGM product.
The documents sent by the applicant comply with the relevant legislation that aims to guarantee the biosafety of the environment, agriculture, human and animal health, set out in Law 11,108/05 and its Decree 5,591/05 and in RN-21 of CTNBio. Therefore, if the conditions described in the process and in this technical opinion are met, this activity does not potentially cause significant degradation of the environment or human and animal health.
The analysis of the request, taken together with the other information previously presented for the Biotech Vac Salmonella vaccine, indicates that the Biotech Vac COX vaccine does not present any risks to human, animal or environmental health. Therefore, the National Biosafety Technical Commission - CTNBio decided to grant the request for Commercial Release of the Biotech Vac COX vaccine.
The analysis of the request, taken together with the other information previously presented for the Biotech Vac Salmonella vaccine, indicates that the Biotech Vac COX vaccine does not present any risks to human, animal or environmental health. Therefore, the National Biosafety Technical Commission - CTNBio decided to grant the request for Commercial Release of the Biotech Vac COX vaccine.
For monitoring in the field, both the use of the BIOTECH VAC COX vaccine and any event related to the use of its products, VETANCO DO BRASIL has fully implemented procedures that are part of its Quality Management System. These procedures provide for numerous preventive, investigation and risk containment actions relating to the use of its products.
To carry out this monitoring, Vetanco has its own technical support team made up of 26 experienced professionals, 24 of whom are veterinarians who regularly visit their customers, helping them with the main challenges of field production and investigating the main causes of problems. The technical support team assists its customers by carrying out monitoring that includes data analysis, necropsies and sending materials for laboratory tests. With this, our professionals update a database with information about the health events of each establishment/client visited, thus defining a health map used both for detection and to collaborate in the control of risks in establishments served by Vetanco's technical support.
To carry out this monitoring, Vetanco has its own technical support team made up of 26 experienced professionals, 24 of whom are veterinarians who regularly visit their customers, helping them with the main challenges of field production and investigating the main causes of problems. The technical support team assists its customers by carrying out monitoring that includes data analysis, necropsies and sending materials for laboratory tests. With this, our professionals update a database with information about the health events of each establishment/client visited, thus defining a health map used both for detection and to collaborate in the control of risks in establishments served by Vetanco's technical support.
Although the BIOTECH VAC COX vaccine does not present risks to animals, humans and the environment, if its own monitoring detects it or there are complaints from customers, Vetanco do Brasil will apply a severity classification to the event. If any occurrence of medium to high severity regarding the use of the BIOTECH VAC COX product is evidenced, a series of actions will be initiated to mitigate risks and possible problems, such as carrying out an in-depth investigation, traceability of sales/batch of products, notification to competent health authorities and even the recall and withdrawal of products from the market, always following the good practice procedures in force in the quality system (POPs Product recall, GQ-013 – Vetanco do Brasil and AC-005- Vetanco Argentina).
The analysis of the request, taken together with the other information previously presented for the Biotech Vac Salmonella vaccine, indicates that the Biotech Vac COX vaccine does not present any risks to human, animal or environmental health.
Molecular traditional methods.
Yes
No
No
EN
| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 1 | |
