Bovine Nodular Dermatitis Disease Vaccine
Bovine Nodular Dermatitis Disease Vaccine
Name of Veterinary Biological Product
LUMPYVAC®, (Lumpy Skin Disease Virus Vaccine)
Qualitative and Quantitative Composition
Attenuated LSDV-Neethling virus
Quantitative: Vaccine virus is an attenuated Neethling strain produced in VERO cell culture.
The amount of virus contained in one dose (2 ml) of the lyophilized live vaccine is at least 103.5 TCID50.
Composition of the vaccine (1 dose, 2 ml):
Neethling virus strain
103.5 TCID50 / dose
It is an attenuated live vaccine in lyophilized form.
2. Clinical Features
2.1. Target Species
Cattle, (Cow and calves)
LUMPYVAC® is used to protect cattle against nodular dermatitis (lumpy skin, LSD) disease and to reduce the mortality, clinical findings and lesions caused by the disease.
Scientific data obtained to date reveal that vaccination is the most effective method in combating LSD. Data obtained from vaccinations in countries with LSD show that the probability of disease in non-vaccinated cattle is 5 times higher (Brenner et al., 2009). ).
When the vaccine is used at recommended doses, there is no known contraindication against the active substance or the vaccine ingredient. No contraindications were encountered in vaccine safety tests (mice, guinea pigs, cattle), in addition to the number of animals specified in the OIE guideline, similar data were obtained in limited field studies with pregnant cattle, young male cattle and calves. More detailed data on this subject will be available through field follow-up studies to be carried out with the start of the use of the vaccine in the field.
Vaccination should not be administered to animals with fever or clinical symptoms. In the field study applied, no harm was found in its administration to pregnant and advanced pregnant animals. Although comprehensive data will be obtained later, there is no significant reproductive contraindication reported in equivalent studies (Abutarbush, 2014).
Co-administration with other vaccines (live, inactive / viral, bacterin, toxoid) is not recommended.
2.4. Specific Warnings for Each Target Species
The vaccine has been prepared for use in cattle, (cow and calves) . There are no restrictions on the vaccine administration regarding race, gender and physiological status. LSD vaccines can generally be applied to all healthy cattle older than 3 / 4 months old . In limited field studies, no negative findings were observed in the administration of a single dose to calves older than 1 month. It should not be used concurrently or recently with immunosuppressants and corticosteroids. In this case, the expected level of protection from the vaccine may not be achieved.
2.5. Precautions to be Taken by Persons Applying Veterinary Biological Product
There is no direct biological risk for practitioners due to the vaccine content. Practitioners must comply with the following rules in order to practice healthy:
Vaccination should be administered by veterinarians or technicians under the supervision of a veterinarian.
Asepsis and antisepsis rules must be strictly followed in vaccine applications. Each animal should be vaccinated using a separate syringe or needle tip.
Autoclaving, incineration, biological destruction or burying in septic pits should be applied to destroy used vaccine bottles, needles and injectors.
2.5.1 Specific Precautions for Use in Animals
The vaccine should only be administered to healthy animals. Animals showing signs of high fever and disease should be separated from the herd and should not be vaccinated.
Calves should also be included in the vaccination program as they are susceptible to the disease.
Calves born to mothers who have had nodular dermatitis and who receive colostrum (colostrum) should not be vaccinated for 2 / 4months.
Following vaccination, a slight increase in body temperature and a temporary decrease in milk yield can be seen.
There are no definitive data on the use of Lumpy skin disease vaccine in pregnant animals all over the world. However, vaccination is recommended considering epidemic prevention and benefit / harm relationships.
2.5.2. Other Precautions
LUMPYVAC® commercially named vaccine and its ingredients have no known adverse effects on the environment. On the other hand, general environmental health practices should be given importance, and unused vaccine materials and packages of used vaccines should be disposed of with an appropriate method.
2.6. Side Effects (Frequency and Severity)
A temporary fever after vaccination and hard or soft swelling in the application area is considered normal. Local and general vaccine reactions may be seen individually in highly sensitive individuals and in very rare cases. These reactions are delayed type hypersensitivity reactions and usually occur on the 4th day after vaccination. The expected rate of such cases is in the range of 0.1-1%. It is recommended that vaccinated animals be followed up and those showing local or general reactions should be taken into anti-allergic treatment under the supervision of a veterinarian.
2.7 Use in Pregnancy, Lactation and Ovulation
There is no restriction on the use of the vaccine in lactation. There are no precise data on the use of lumpy skin disease vaccine in pregnant animals all over the world. However, there is no situation that would require restrictions regarding the use of the vaccine during pregnancy. No significant difference was reported between the groups with and without LSD vaccine in terms of abortion rates (Abutarbush, 2014).
Vaccination is recommended considering epidemic prevention and benefit / harm relationships. In the field studies conducted with LUMPYVAC® Vaccine, no adverse effects on reproductive performance were detected in any of the pregnant cattle used.
2.8. Dosage and Route of Administration
The application dose of LUMPYVAC® Vaccine is 2 ml subcutaneously. Vaccination is applied from the lower part of the neck and in accordance with the necessary antisepsis rules. It is recommended that calves born to vaccinated or infected mothers and who received colostrum should not be vaccinated until they are 2/ 4 months old. However, an emergency vaccination program can be applied in areas where the disease has just emerged and for calves born to unvaccinated mothers who have not encountered the virus before. The vaccine is administered as a single dose to cattle of all ages, sexes and races.
The booster dose interval is 2 years ın low rısk area.
The booster dose ınterval ıs 1 year ın hıgh rısk area.
2.9. Overdose (Overdose) - Symptoms, Emergency Plans, Antidotes
Overdose study details are shared in Chapter 3 Safety. Accordingly, no negative findings were observed in the animals that received 10 doses of vaccine; It can be used safely up to 10 doses.
2.10. Legal Withdrawal Period (Withdrawal Period)
Zero (0) day.
There is no established legal withdrawal period for Lumpy skin disease vaccines. The legal withdrawal period for LUMPYVAC® Vaccine has been evaluated as zero (0) day, considering the fact that it is not a zoonotic agent and there is no substance in its content that will threaten human health.
Like all capripoxviruses, Lumpy skin disease virus basically stimulates the cellular immune response. However, it has also been reported that a humoral immune response occurs and this response can be demonstrated by IFAT and serum neutralization methods (OIE, 2017; Gari et al.2012). It is known that the active immunity that occurs is long-term and probably continues for life in animals with the disease (OIE, 2017).
4. Pharmaceutical Properties
4.1 List of excipients
It is recommended not to mix the product with any medicinal product, except for the diluent and other components provided with the product.
4.3 Shelf Life
4.4 Specific Warnings on Storage Conditions
It should be stored at at 2 - 8 ° C.
5 doses of lyophilized vaccine is packaged with 10 ml, 10 doses of lyophilized vaccine with 20 ml, 25 doses of lyophilized vaccine with 50 ml, 50 doses of lyophilized vaccine with 100 ml and 100 doses of lyophilized vaccine with 200 ml of diluent.