Product Overview
BI-APHTHOVAC™ is an inactivated bivalent vaccine for immunization of cloven-hoofed animals against Foot and Mouth Disease.
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BI-APHTHOVAC™
Target Species
Cattle, buffalo, sheep, goat and pigs.
Foot and mouth disease (FMD) as Transboundary Challenge
Foot-and-mouth disease (FMD) is a highly contagious viral disease of cloven-hoofed animals. The disease was initially described in the 16th century and was the first animal pathogen identified as a virus. The transboundary spread and significant economic impact have increased the concern of national authorities worldwide to deploy integrated control measures under the frame of National Control Programs.1
The causal agent is the foot-and-mouth disease virus (FMDV) which belongs to the Aphthovirus genus of the Picornaviridae family. Seven serotypes (A, O, C, Asia 1, and South African Territories 1, 2, and 3) have been identified serologically, and multiple subtypes occur within each serotype.1
Traditional FMD vaccines contain defined amounts of one or more chemically inactivated preparations of a seed virus strain blended with a suitable adjuvant and excipients. According to WOAH, commercial FMD vaccines should comply with important criteria: i) formulated with sufficient antigen and appropriate adjuvant to have a minimum potency level of 3 PD50 [50% protective dose]; ii) provide 6 months of immunity after two initial vaccinations given 1-month apart; iii) vaccine strains are selected based on antigenic relationship with circulating strains.2
Product Details
Composition (before inactivation)
- Inactivated FMD A-Iran-05 strain ≥ 6.0 PD50/dose.
- Inactivated FMD O-PanAsia2 strain ≥ 6.0 PD50/dose.
Vaccine Adjuvant
- Oil adjuvant.
Indications
For immunization of cloven-hoofed animals against Foot and Mouth Disease (FMD).
Vaccination Program
Animals can be vaccinated from early age, as per advice from your veterinarian.
- Animals from vaccinated parents: from 3 months of age.
- Animals from unvaccinated parents: from 1 month of age.
- Booster dose shall be administered 4 weeks after the primary vaccination and then biannually.
Immunity
- Onset of immunity takes place after 4 weeks.
- Duration of immunity is at least 6 months.
Dosage
- Cattle and buffalo: 2 mL per animal via subcutaneous injection.
- Sheep and goat: 1 mL per animals via subcutaneous injection.
- Pigs: 2 mL per animal via intramuscular injection.
Withdrawal
Zero days for meat and milk.
Considerations
Some animals may develop swelling at the site of injection. These swellings will disappear within three days.
Administration
- Shake well before use.
- Allow the vaccine to reach room temperature (+20 to +25°C) before use.
- Use sterile injection equipment.
- Use the entire contents when first opened.
- The vaccine may occasionally separate into two layers on storage. This in no way affects its potency, but the vaccine should be shaken vigorously before and during use to ensure good emulsification.
- Do not use BI-APHTHOVAC™ if you notice critical irreversible separation of the emulsion.
- Shelf life: 24 months after manufacturing date.
- Shelf life after first opening the container: 3 hours.
Presentation
BI-APHTHOVAC™ is packed and presented in polyethylene terephthalate (PET) bottles of 50 mL and 100 mL, containing respectively 25 and 50 doses.
Download the Product Information Sheet
BI-APHTHOVAC™ product information sheet
References
1. Grubman and Baxt (2004). Foot-and-Mouth Disease. Clin Microbiol Rev. 2004 Apr; 17(2): 465–493. doi: 10.1128/CMR.17.2.465-493.2004
2. WOAH (2021). Technical Disease Cards. OIE Science Department. Last updated January 2021.
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