Target species
Chickens
Indications for use for each target species
For active immunisation of susceptible chickens from 7 days old against infectious bursal disease (IBD/Gumboro).
The vaccine reduces clinical signs of IBD and severe bursal lesions.
Onset of immunity: 2 weeks after vaccination
Duration of immunity: 4 weeks after vaccination (demonstrated by challenge), antibodies may last up to 15 weeks.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Vaccinated chickens may excrete the vaccine strain for at least 9 days following vaccination. Special precautions should be taken to avoid spreading of the vaccine strain to laying hens.
To reduce infection pressure before the onset of immunity, litter should be removed, and chicken housing cleaned between rearing cycles.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Live attenuated viral vaccine: do not spray or spill. Wash and disinfect hands and equipment after vaccinating.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Chickens:
Very common (>1 animal / 10 animals treated): | Bursa of Fabricius lymphocyte depletion1 |
Rare (1 to 10 animals / 10 000 animals treated): | Bursa of Fabricius degeneration2 |
1Of moderate intensity, seen on day 7 post vaccination. Lymphocyte repopulation occurs after day 7 post vaccination.
2Mild necrosis by day 28 post vaccination.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Laying birds:
Do not use in birds in lay and within 4 weeks before the start of the laying period.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Administration routes and dosage
In drinking water use: One dose (min. 103.0 EID50) should be administered per animal from the age of 7 days onwards.
The determination of the vaccination date is depending on a number of factors including status of maternal antibodies, type of bird, infection pressure, housing and management conditions.
Maternally derived antibodies (MDA) potentially interfere with the take of live IBD vaccines. The optimum age for vaccination therefore depends on both, the level of MDA against IBD in the flock and the capability of the vaccine to take in face of these MDA (“break-through-titre”). A high homogeneity of the flock MDA levels is important to define the timing of vaccination and guarantees the better take of the vaccine. To predict the age, when MDA have sufficiently decreased to allow effective vaccination, it is advised to test serum samples of at least 24 chicks by serology and apply the “Deventer Formula” for intermediate vaccines. For chicks from fully vaccinated or field virus infected breeders this may be at 14 days or more. Serologically negative birds may be vaccinated from day 7.
A further vaccination 7 days after the first may be necessary particularly in flocks where antibody levels vary widely between birds (i.e. CV greater than 30 %), or stock originates from different sources.
Broilers:
- with no maternal antibodies – from 7 days of age
- with maternal antibodies – from 14 days of age
Layers/Breeders:
- with no maternal antibodies – from 7 days of age
- with maternal antibodies – from 3 - 4 weeks of age
Dosage and administration:
Drinking water application:
- Determine the number of vaccine doses and amount of water (see below) required. Do not split large vials to vaccinate more than 1 house or drinking system, as this may lead to mixing errors.
- Make sure that all conduit pipes, tubing, troughs, drinkers etc are thoroughly clean and free of any trace of disinfectants, detergents etc.
- Ensure that the drinking water is cold, clean, and free from detergents and disinfectants to ensure the viability of the vaccine. Use only fresh water preferably non-chlorinated and free from metal-ions. Low-fat skimmed milk powder (i.e. < 1 % fat) may be added to the water (2 – 4 grams per litre) or skimmed milk (20 – 40 ml per litre of water) to improve the water quality and to increase the stability of the virus. This, however, has to be done 10 minutes prior to reconstitution of the vaccine.
- Open the vaccine ampoule under water and reconstitute contents thoroughly. Care should be taken to empty the ampoule and its top completely by rinsing them in water.
- Allow water to be consumed so that levels in drinkers are minimal before vaccine is applied. All tubing should be emptied of plain water, so that the drinkers contain only vaccine water. If water is still present, drain lines before applying vaccine.
- Apply vaccine over (up to) 2 hours, ensuring that all birds drink during this time. Birds drinking behaviour varies, it may be necessary to withhold water on some sites prior to vaccination in order to ensure that all birds drink during the vaccination period.
- The aim is to give every bird one dose of vaccine.
- Ideally vaccine should be administered in the volume of water consumed by the birds in up to 2 hours. As a general rule, apply reconstituted vaccine to cold and fresh water at the rate of 1 000 doses of vaccine to 1 litre of water per day of age for 1 000 chickens, e.g. 10 litres would be needed for 1 000, 10 days old chickens. Under hot climates or with heavy breeds this amount may have to be increased up to a maximum of 40 litres per 1 000 birds. If in doubt, measure water intake the day before administering vaccine.
- Administer the reconstituted vaccine to birds immediately. Make sure that birds do not have access to unmedicated water during vaccination.
- The contents of opened bottles should be used all at once.
- Only the volume of vaccine should be prepared which can be applied within 2 hours.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No other signs have been observed as described under “Adverse events” following administration of a ten-fold dose.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Zero days.