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Environmental assessment for licensing in Canada porcine circovirus vaccine, type 1-type 2 chimera, killed virus

For Public Release

April 19, 2007

The information in this environmental assessment was current at the time of its preparation. It is possible that the situation may have changed since that time. Please consult the VBS if you have any questions.


Table of Contents


Summary

The Porcine Circovirus Vaccine, Type 1, Type 2, Chimera, Killed Virus, (Trade name: Suvaxyn PCV2 One Dose) was evaluated by the Veterinary Biologics Section, Canadian Food Inspection Agency for licensing in Canada. As part of the requirements for licensing this product in Canada, an Environmental Assessment was conducted and a public document was prepared..

1. Introduction

Veterinary Biologics Section (VBS), Animal Health and Production Division, Canadian Food Inspection Agency (CFIA) is responsible for licensing veterinary biologics for use in Canada. Any veterinary biologic manufactured, sold or represented for use in Canada must comply with the requirements specified by the CFIA regarding safety, purity, efficacy and potency of the product. Fort Dodge Animal Health has submitted the following veterinary biologic for licensing in Canada:

  • Porcine Circovirus Vaccine Type 1- Type 2 Chimera, Killed Virus, (Trade name: Suvaxyn PCV2 One Dose), USDA Product Code: 19K5.R0, VBS File: 880VV/P7.0/F3.2

The Environmental Assessment was prepared as part of the overall assessment for licensing the above vaccine in Canada. The above vaccine containing killed virus is manufactured by Fort Dodge Animal Health, Fort Dodge, Iowa, USA (US Veterinary Biologics Establishment License No. 112). The vaccine is licensed in the USA. The vaccine is indicated for the vaccination of healthy pigs 4 weeks of age or older as an aid in the prevention of Porcine Circovirus Type 2 (PCV2) viremia and aid in the control of lymphoid depletion caused by PCV2.

2. Background and characteristics of the vaccine

Porcine circovirus (PCV) type 1 (PCV1), originally recognized as a contaminant of a porcine kidney cell line, has not been shown to cause disease and is generally considered to be non-pathogenic in pigs. Porcine circovirus type 2 (PCV2) has been more recently identified as the viral agent associated with an important emerging disease in swine called post-weaning multisystemic wasting syndrome (PMWS), but all factors involved in the triggering of this disease are still unknown. Both PCV1 and PCV2 are present in swine in Canada.

The chimeric vaccine (cPCV1-2) was constructed using as the recipient the PCV1 genomic backbone in which was cloned the capsid gene of a PCV2 isolate from a pig with naturally occurring PMWS. No foreign regulatory genes or motifs were introduced into the cPCV1-2 construct. Infectious cPCV-2 virus was generated by transfection in porcine kidney cells.

Published animal studies using cPCV1-2 indicated that protective immunity against PCV2 infection in pigs was induced (Fenaux et al., 2004; Fenaux et al., 2003). This chimeric construct was used as the parent in the preparation of the Master Seed for the present proposed vaccine. The PCV Type 1-Type 2 chimera (cPCV1-2) is propagated in cell culture, inactivated (killed) and adjuvanted. Gentamicin and thimerosal are added as preservatives. The cPCV1- 2 vaccine is to be administered intramuscularly to healthy swine 4 weeks of age or older in a one dose (2 millilitre) regimen.

3. Safety

3.1 Animal Safety

Safety testing of cPCV1-2 Master Seed conducted in mice and pigs indicated that the seed was safe in both mice and pigs. In a field study performed in four US states, involving a total of 1,110 pigs of 4 weeks of age given a single 2 millilitre dose of vaccine administered intramuscularly followed by a 2 weeks observation period, no local or systemic adverse events associated with the vaccine were noted by the cooperators, indicating that vaccine was safe for pigs under field conditions. Serials of the killed vaccine have been tested in pigs and guinea pigs and no adverse reactions were observed, indicating the vaccine is safe for pigs and guinea pigs under laboratory conditions.

3.2 Human Safety

There are no expected safety concerns associated with human exposure. Both PCV1 and PCV2 are viruses of swine. There are no reports of human disease associated with porcine circovirus infection according to current knowledge. Furthermore, the cPCV1-2 vaccine is inactivated. In addition, there are no expected safety concerns based on safety studies in pigs and testing for safety in pigs and guinea pigs.

3.3 Potential environmental spread

There is no expected adverse impact on environmental safety. Both PCV1 and PCV2 are viruses of swine and are present in the swine population of Canada. The cPCV1-2 vaccine is inactivated and the killed vaccine virus should not establish in the environment. The product is for the vaccination of swine. The potential for escape and dispersion in the environment is unlikely to occur because this is a non-viable product.

4. Monitoring

4.1 General

The vaccine licensing regulations in Canada require manufacturers to report all suspected adverse reactions to CFIA within 15 days of receiving notice from an owner or a veterinarian. Veterinarians may also report suspected adverse reactions directly to the CFIA. If an adverse reaction complaint is received by VBS, the manufacturer is asked to investigate and prepare a report for the owner's veterinarian and CFIA. If the problem is resolved to the satisfaction of the veterinarian/client, no further action is usually requested by VBS. However, if the investigation is not satisfactory, VBS may initiate regulatory action depending on the case, which may include further safety testing, temporary stop sale or product withdrawal from the market.

4.2 Human

No special monitoring of the human safety of the product will be carried out.

4.3 Animal

Veterinarians, vaccinators and producers should report any suspected adverse reactions to VBS as indicated above. Suspected adverse reactions should be reported using form Notification of Adverse Reactions to Veterinary Biologics (CFIA/ACIA 2205).

5. Consultation and Contacts

Manufacturer

Fort Dodge Animal Health
800 5th Street NW
Fort Dodge, IA 50501

6. Conclusions and Actions

Following this assessment, and the completion of the Canadian licensing process, an Import Permit will be issued to Wyeth Animal Health to allow the importation and distribution of the following product in Canada:

  • Porcine Circovirus Vaccine Type 1- Type 2 Chimera, Killed Virus, (Trade name: Suvaxyn PCV2 One Dose), USDA Product Code: 19K5.R0, VBS File: 880VV/P7.0/F3.2

All serials of this product must be released by the USDA prior to importation into Canada. All conditions described in the Permit to Import Veterinary Biologics must be followed in the importation and sale of this product.

7. References

Fenaux M., T. Opriessnig, P.G. Halbur and X.J. Meng. 2003. Immunogenicity and pathogenicity of chimeric infectious deoxyribonucleic acid (DNA) clones of pathogenic porcine circovirus type 2 (PCV2) and nonpathogenic PCV1 in weanling pigs. J. Virol. 77: 11232-11243.

Fenaux M., T. Opriessnig, P.G. Halbur, F. Elvinger and X.J. Meng. 2004. A chimeric porcine circovirus (PCV) with the immunogenic capsid gene of the pathogenic PCV type 2 (PCV2) cloned into the genomic backbone of the nonpathogenic PCV1 induces protective immunity against PCV2 infection in pigs. J. Virol. 78: 6297-6303.


Prepared and revised by:

Veterinary Biologics Section
Animal Health and Production Division
Canadian Food Inspection Agency