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

For Public Release

November 9, 2006

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 2, Killed Baculovirus Vector, (Trade name: Ingelvac® CircoFLEXTM) 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. Boehringer Ingelheim Vetmedica, Inc. has submitted the following veterinary biologic for licensing in Canada:

  • Porcine Circovirus Vaccine, Type 2, Killed Baculovirus Vector, (Trade name: Ingelvac® CircoFLEXTM), USDA Product Code: 19K5.R0, VBS File: 880VV/P7.0/B8.2

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 Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Highway, St. Joseph, MO 64506, US (US Veterinary Biologics Establishment License No. 124). The vaccine has recently been licensed in the US. The vaccine is indicated for the vaccination of healthy pigs 3 weeks of age or older as an aid in the reduction of lesions associated with Porcine Circovirus Type 2 (PCV2) infection.

2. Background and characteristics of the vaccine

The vaccine is a recombinant product consisting of a recombinant Baculovirus containing the gene for immunogenic protein(s) of PCV2. Insect cells infected with the recombinant Baculovirus will produce the PCV2 immunogenic protein(s). Insect cell harvests containing the PCV2 protein(s) are filtered and inactivated. The fluids are tested to assure complete inactivation of the Baculovirus (killed virus). The inactivated fluid is mixed with an adjuvant to provide the final vaccine. The vaccine is to be administered intramuscularly to healthy susceptible pigs 3 weeks of age or older in a single 1 millilitre dose.

3. Safety

3.1 Animal Safety

Field safety testing of the Porcine Circovirus Type 2, Killed Baculovirus Vector vaccine was performed in three US states, involving a total of more than one thousand vaccinated and control pigs, between 10-30 days of age, vaccinated intramuscularly. No adverse reactions based on clinical observations after administration could be attributed to the vaccine. Vaccine was safe for pigs under field conditions. Serials of the killed vaccine have been tested in pigs and no adverse reactions were observed.

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 and Baculovirus is not known to be associated with disease in healthy swine or humans. Furthermore, the PCV2 Baculovirus Vector vaccine is inactivated (killed virus). Concerns regarding safe use should be minimal.

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 virus 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 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

Boehringer Ingelheim Vetmedica Inc.
2621 North Belt Highway
St. Joseph, MO USA 64506

Importer

Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario L7L 5H4

6. Conclusions and Actions

Following this assessment, and the completion of the Canadian licensing process, the import permit of Boehringer Ingelheim (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: Ingelvac® CircoFLEXTM), VBS File: 880VV/P7.0/B8.2

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 and Production Division
Canadian Food Inspection Agency