Heptavac® P Plus - potential risk of reduced protection against blackleg
The HPRA has been notified of a potential risk of reduced protection against blackleg involving five specific batches of Heptavac® P Plus, Suspension for Injection for Sheep:
| Batch no. | Expiry date |
| 080HWA01 | 12.2027 |
| 080HWA02 | 12.2027 |
| 080HWB01 | 12.2027 |
| 081HXA01 | 12.2027 |
| 081HXA02 | 12.2027 |
The product contains 15 other antigenic components, all of which have met their respective testing acceptance criteria, providing protection to reduce mortality and clinical signs of lamb dysentery, pulpy kidney, struck, tetanus, braxy, black disease, and pneumonic and systemic pasteurellosis.
The product in question is:
- Heptavac® P Plus, Suspension for Injection for Sheep (VPA10996/146/001, Intervet Ireland Limited)
Problem or issue
The standard release testing of the five Heptavac® P Plus batches listed above found below-specification results for one of the product antigenic components (Clostridium chauvoei). Due to the below-specification results for Clostridium chauvoei, there is a potential risk of reduced protection against blackleg.
Product information
- Product name
-
Active Substances:
Clostridium perfringens beta toxoid
Clostridium perfringens epsilon toxoid
Clostridium septicum toxoid
Clostridium tetani toxoid
Clostridium novyi toxoid
Inactivated Clostridium chauvoei
Inactivated Mannheimia haemolytica A1 A2 A6 A7 A9
Inactivated Pasteurella trehalosi T3 T4 T10 T15 - Authorisation holder
- Intervet Ireland Limited
- Manufacturer or supplier
-
MSD Animal Health Ltd
- Human or veterinary medicine
-
Veterinary Medicine
- Target audience
-
Veterinary practitioners, Veterinary nurses, Licensed retailers, farmers
Background information
Heptavac P Plus is a vaccine used for the active immunisation of sheep to reduce mortality and clinical signs of lamb dysentery, pulpy kidney, struck, tetanus, braxy, blackleg and black disease, caused by Clostridium perfringens types B, C and D, Cl. septicum, Cl. novyi, Cl. chauvoei and Cl. Tetani and for the active immunisation of sheep to reduce mortality and clinical signs of pneumonic and systemic pasteurellosis.
The manufacturer has observed below specification results for the Cl. chauvoei antigen on potency testing of the finished product immediately prior to release. All other antigenic components met their respective testing acceptance criteria.
Due to the below-specification results for Clostridium chauvoei, there is a potential risk of reduced protection against blackleg.
Only the batches listed above are affected.
This vaccine is designated by the HPRA as ‘LR’ (Licensed Retailer).
Actions to be taken
Where any clinical signs of blackleg are observed in animals vaccinated with product from the Heptavac® P Plus batches listed above, contact your veterinarian for advice. Early clinical signs of blackleg in sheep include pyrexia, depression, sudden severe lameness and localised heat and pain.
When a veterinary medicinal product does not work as intended (lack of efficacy), this should be reported as a suspected adverse event. Suspected adverse events should be reported to the marketing authorisation holder, or alternatively to the HPRA.