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Environmental assessment for licensing porcine circovirus vaccine, type 2, killed baculovirus vector in Canada

For Public Release

January 28, 2008

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 (PCV), Type 2, Killed Baculovirus Vector, (Trade name: Circumvent PCV) 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 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. Intervet Canada Ltd. has submitted the following veterinary biologic for licensing in Canada:

  • Porcine Circovirus Vaccine, Type 2 , Killed Baculovirus Vector, (Trade name: Circumvent PCV), USDA Product Code 19K5.R0, VBS File 880VV/P7.0/I6.2

The Environmental Assessment was prepared as part of the overall assessment for licensing the above vaccine in Canada. The above vaccine is manufactured by Intervet Inc., USA (US Veterinary Biologics Establishment Licence No. 286). The vaccine has recently been licensed in the US. The vaccine is indicated for the vaccination of healthy swine, 3 weeks of age or older, as an aid in the prevention of viremia and virus shedding caused by Porcine Circovirus Type 2 (PCV2).

2. Background and characteristics of the vaccine

The major structural gene of PCV2, isolated from lung tissue of a feeder pig with a clinical case of postweaning multisystemic wasting syndrome, was inserted in Baculovirus. Infection of insect cells in culture with the recombinant Baculovirus lead to the expression of PCV2 protein encoded by the Baculovirus-PCV2 construct. The vaccine consists of culture fluid harvests that are inactivated. An inactivation test is conducted to assure that inactivation of virus is complete. Inactivated fluids are mixed with an adjuvant. The vaccine is to be administered intramuscularly to healthy pigs, 3 weeks of age or older, using a 2 mL dose with a 2 mL booster dose 3 weeks later.

3. Safety

3.1 Animal safety

Field safety of the Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector was performed in three US states, involving a total of more than one thousand pigs of approximately 3 weeks of age vaccinated twice intramuscularly. Overall, the adverse event level was acceptable to demonstrate safety of the product for pigs under field conditions. Local injection site reactions may occur and a caution statement appears on labels. Serials of the killed vaccine have been tested in mice and guinea pigs with no unfavourable reactions reported.

3.2 Human safety

There are no expected safety concerns associated with human exposure. PCV2 is a virus of swine and Baculovirus is a virus of insects. There are no reports of human disease associated with PCV2 infection according to current knowledge. Although Baculovirus can infect mammalian cells there is no evidence that Baculovirus can replicate in mammalian cells. Baculovirus is not known to be associated with disease in healthy swine or humans. Furthermore, the PCV2 Baculovirus Vector vaccine is inactivated (killed virus).

3.3 Potential Environmental Spread

There is no expected adverse impact on environmental safety. The PCV2 Baculovirus Vector vaccine is inactivated (killed virus), so concerns regarding safe use should be minimal. The killed vaccine should not establish in the environment.

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 the 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 Events to Veterinary Biologics (CFIA/ACIA 2205).

5. Consultations and contacts

Manufacturer

Intervet Inc.
29160 Intervet Lane
P.O. Box 318
Millsboro, Delaware, USA 19966

Importer

Intervet Canada Ltd.
250 Water Street
Whitby, Ontario L1N 9T5

6. Conclusions and actions

Following this assessment, and the completion of the Canadian licensing process, the Import Permit of Intervet Canada Ltd. will be amended to allow the importation and distribution of the following product in Canada:

  • Porcine Circovirus Vaccine, Type 2 , Killed Baculovirus Vector, (Trade name: Circumvent PCV), USDA Product Code 19K5.R0, VBS File 880VV/P7.0/I6.2

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.


Prepared and revised by:

Veterinary Biologics Section
Animal Health Division
Canadian Food Inspection Agency