report on btsf lsd training in sofia annex 13.2 1. … · 201612019 paza ii dse report on sofia lsd...

“Improving consumer protection against zoonotic diseases – Phase II” Project No: EuropeAid/133990/C/SER/AL

201612019 PAZA II DSE Report on Sofia LSD workshop

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Report on BTSF LSD training in Sofia

Toni Kirandjiski, Disease Surveillance expert

1. Background

In the frame of the BTSF framework, a workshop on Lumpy Skin Disease was organized in Sofia, from 22 to

25 November. It addressed specific issues related to the disease, dealing with: a general overview of LSDV,

international coordination of LSD and regulatory framework by the OIE and EU; Epidemiology and

diagnostics of LSDV; Control, eradication and bio security; etc. Training agenda is given as Annex 1 to this

report.

PAZA II DSE was invited to participate to the workshop together with the Albanian participants with the aim

to further support the organization and implementation of the control measures for LSD control in the

country.

2. Itinerary

21 November 2016 08:00 Depart Skopje

15:00 Arrive Sofia

25 November 16:00 Depart Sofia

22:00 Arrive Skopje

3. Presentation

3.1. Country presentations

Summary of the country presentations is provided in Table 1. Presentation for each country is provided in

??.

Table 1: Summary of country presentations

Country Index case

Affected holdings

Affected animals

Dead animals

Morbidity rate

Culled/ disposed animals

Vaccinated animals

Vaccination coverage

Last outbreak

Albania Jul-16

2,300

3,798

881 23% -

174,000 partial Continuing

Macedonia Apr-16

1,591

3,357

360 11%

3,454

212,531 full Oct-16

Kosovo Jun-16

5,000

1,100 22% -

245,000 full

Montenegro Jul-16

417

556 - 465

93,350 full Sep-16

Serbia Jun-16

225 - 709 full Oct-16

Croatia - - -

- - -

480,000 full -

Bosnia - - -

- - - - - -

ANNEX 13.2



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European Commission (EC) support the countries in the region with emergency supply of vaccine (Table 2).

Table 2: Vaccine supplied to the countries in the Western Balkan region from the EU vaccine bank

Country No. doses

supplied

Bulgaria 150,000

Greece 100,000

Macedonia 50,000

Serbia 50,000

Kosovo 25,000

Albania 25,000 + 50,000

Montenegro 25,000

Croatia 50,000

It is important to stress that the EC supply these quantities only as an emergency stock and given the

recommendation for full coverage, the country needs to supply remaining required doses.

Of particular interest is the case of Croatia where preventive vaccination was carried out before occurrence

of any outbreak in the country. Such approach prevent occurrence of any outbreaks. According to the

Commission Implementing Decision (EU) 2016/2008 of 15 November 2016 concerning animal health control

measures relating to lumpy skin disease in certain Member States, Croatia is declared as country free with

vaccination and hence movement and export of live animals and animal products is regulated. According to

this Implementing Decision, Croatia can export live animals and captive wild ruminants their semen, ova and

embryos, colostrum, milk and dairy products, unprocessed animal by-products, and untreated raw hides

and skins into the European Union Member States when conditions are fulfilled including the condition that

the vaccination was carried out at least 28 days prior to dispatch.

3.2. Content of the training course (summary of presentations)

Summary of the presentations is given in below sections. Links to each presentation is provided.

3.2.1. Overview and update on LSD in the South East Europe (E.Tuppurainen)

Within a short period of time, lumpy skin disease (LSD) spread widely throughout the Middle East, South-

East Europe and Northern Caucasus. In the beginning, the speed of spread of “an exotic cattle disease”

found the cattle farming industry, Veterinary Authorities as well as scientific communities in many cases

largely unprepared. Large scale and harmonized regional immunization of cattle has been proven to be

fundamental for successful control of LSD in South-East Europe.

Vaccination together with feasible stamping-out policy, well-prepared awareness campaigns, enhanced

diagnostic capacities and strict animal movement controls halt the spread of the disease in all countries

where vaccination of the whole cattle population was completed. In order to eradicate LSD from Europe,



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the need to continue LSD vaccination in the coming years remain to be seen but the vigilance and

preparedness to combat the disease should be maintained on top level in all affected and at-risk countries.

3.2.2. Overview of Lumpy Skin Disease in Bulgaria including clinical manifestation of Lumpy

Skin Disease (T.Alexandrov)

The first ever outbreak of LSD in Bulgaria was reported on 13th of April 2016. Within three months the

disease spread rapidly throughout the territory of the country affecting 17 out of 28 regions. In total 217

herds were affected with 2814 bovines, out of which 366 had shown clinical signs. The last outbreak was

reported on 1st August 2016.

Early detection, prompt implementation of the total stamping out policy of all susceptible animals in the

affected herds coupled with vaccination were parts of the Bulgarian approach in limiting and controlling the

spread of LSD. Considering the multiply LSD modes of transmission, a strict movement control, intensified

clinical surveillance, vector control and disinfection activities were also applied. Special focus was also given

on the education and awareness campaigns. Blanket vaccination against LSD of the whole population of

bovine reared in the country had been carried out in accordance with the vaccination programme approved

by the Decision (EU) 2016/1183. The vaccination had been completed since the middle of July 2016. Vector

control and desinsectisation over vector biotopes (along main rivers, valley and paddy fields) was

performed.

3.2.3. Epidemiology of Lumpy Skin Disease (P.Calistri)

Lumpy skin disease (LSD) is a viral disease clinically affecting domestic cattle and water buffaloes. The role

of other ruminant species and wildlife as a reservoir of the virus is not known. Infected animals excrete the

virus through saliva, ocular and nasal discharges. The virus can also contaminate common feeding or

drinking troughs. Trans-placental transmission may occur resulting in calves born with skin lesions. Sucking

calves may get infected also via milk or from skin lesions in the teats. Despite the capacity of the virus to be

transmitted by the above mentioned routes, LSD is mainly transmitted by vectors. Outbreaks of LSD, in fact,

are more common in spring, summer and autumn months.

Different mechanical vectors can transmit LSD and the main vector species are likely to vary between

affected regions, depending on the climatic and environmental conditions. A wide variety of blood-feeding

vectors may play a role. Transmission has been demonstrated for mosquito (Aedes aegypti) and strongly

suspected for stable fly (Stomoxys calcitrans). So far only mechanical transmission has been experimentally

demonstrated in African tick species: Rhipicephalus appendiculatus males and Amblyomma hebraeum. Since

2012 a large LSD epidemic affected the Middle East, spreading to Turkey in 2013 and 2014 and reaching

Greece in 2015. In 2016 LSD outbreaks were notified in several Balkan countries (Bulgaria, Former Yugoslav

Republic of Macedonia, Albania, Montenegro, Serbia).

Susceptibility of the host to LSDV depends on the virulence of the virus strain, the immune status, the stage

of production, age and breed of the host. Affected animals eventually clear the infection and do not become

carriers. The high percentage (till 50%) of sub clinical infected animals poses a risk for disease spreading.

Animal movements are considered one of the main drivers for the spread of the disease. The early

detection of the infection is of paramount importance for setting appropriate control measures, but the

clinical detection can be difficult (clinical signs are characteristic but early infections, very mild and

asymptomatic - but viraemic - animals cannot be easily detected) and especially in free-ranging herds the



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disease may remain undetected for weeks. Control of animal movements and vaccination in infected and at

risk (exposed) areas are the main control measures.

3.2.4. Potential vector species in South East Europe and Mediterranean basin (Y. Gottlieb)

There are several evidences that support mechanical transmission of LSD by arthropods. Yet, there is no

specific identified vector in the field. The dispersal of the disease point on flying insect vectors, and several

laboratory studies showed mechanical transmission by ticks. Potential vector groups including blood feeding

flies and ticks were described, along with a field study performed in the recent LSD outbreaks in Israel to

point on a specific vector.

3.2.5. Mechanical/biological vectors and methods to investigate the role of vectors (Y.

Gottlieb)

Vector borne disease agents are dependent on arthropod vectors for transmission. Biological transmission is

usually pathogen specific, and involves intimate association with the vector resulting in specific routes of

transmission. Mechanical transmission do not show specific association with the vector and is require for

efficient transmission. Identification of potential vectors and pathogen transmission mode include field and

laboratory tests. These are implemented in actual vector capacity and transmission efficiency.

3.2.6. Hygiene and disinfection for LSD in combination with other control measures (P.

Calistri)

Usually several types of disinfectants are used to kill viruses. LSD virus is particularly resistant in the

environment, especially in dried scabs and crusts from the skin lesions. For the decontamination of infected

premises a well detailed disinfection plan should be followed, which provides specific and detailed

instructions and procedures on how to proceed to the decontamination of buildings with wooden or

metallic structures, machinery of mostly metallic components, pipework of various types, water tanks,

animal food storage areas, sewage waste. In addition premises where animals are kept should have:

appropriate facilities of sufficient capacity and in particular inspection facilities and isolation

facilities,

appropriate facilities for unloading and where necessary adequate housing of a suitable standard

for the animals, for watering and feeding them, and for giving them any necessary treatment,

an appropriate reception area for litter and manure,

an appropriate system for collecting waste water.

3.2.7. Identification and measuring risk factors in a field setting (P. Calistri)

When risk factors have to be identified and measured, observational studies are frequently conducted.

These studies aim at establishing if an association between the occurrence of a disease and risk factor/s

exists. These types of surveys are essentially based on the observation of events in two groups of individuals



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that have to be compared. The two frequencies are compared by appropriate statistical tools to verify any

significant difference between the two groups.

These studies classify animals as:

Those with disease

Those without disease

Exposed to hypothesized risk factors

Unexposed to hypothesized risk factors

Two main types of observational studies exist: case-control and cohort studies. In the case of cohort study,

two groups of animals (exposed and not exposed to the hypothesized risk factor) are considered and the

frequency of the investigated disease (or health problem) in each group is recorded. The complete cohorts

of exposed and not exposed subjects are available. Cohort study can be divided into prospective and

retrospective studies. Prospective studies are based on the selection of two comparable groups of animals

(cohort). The hypothesized risk factor is applied on one of the two groups and the animals are observed

during time to register how many of them will develop the disease. In retrospective studies a discrete

population is considered (e.g. farm, restricted group of animals, etc.), which includes all exposed and not

exposed animals. The disease status and the presence of the risk factors were retrospectively investigated

for each animals. This approach is followed, for example in the case of outbreak investigations. In case-

control studies a group of diseased animals (cases) are compared with a randomly selected sample of not

diseased (controls) animals. The frequency of the exposure to the hypothesized risk factor in animals of

each group is recorded and compared. The strength of an association between a disease and a possible risk

factor is usually measured by statistics such as the relative risk (RR), the odds ratio (OR), or the attributable

risk (AR).

3.2.8. Efficacy of different vector control measures and environmental and public health

risks (Y. Gottlieb)

Vector control actions are aimed to reduce disease incidence. This can be done by suppressing the vector

populations, or by changing the vector capacity to transmit the pathogen. Population suppression is the

most common application that should be carefully applied according to integrated vector management

regime.

This include vector avoidance, surveillance and actual control. Various control strategies to suppress or

replace vector populations have environmental and public health risk. These were mostly studied for

chemical control application of mosquito borne human pathogens. Guidelines for risk assessment are

available from WHO.

3.2.9. Diagnostic tools and training opportunities (K. De Clercq)

Early detection of lumpy skin disease (LSD) infected animals and rapid laboratory confirmation of the

tentative field diagnosis are the cornerstones of successful control of the disease. Characteristic clinical

signs of LSD are clearly recognizable in severely infected animals, yet early stages of infection and mild cases

can easily go unnoticed, even by most experienced veterinarians.



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Diagnostic capacity of the national reference laboratories (NRL), a prerequisite for successful control and

eradication of LSD, relies on competent personnel and sufficient equipment, materials, reagents and

funding. Availability of molecular, virological and serological diagnostic tools, according to the OIE

international standards, allows swift confirmation of a tentative field diagnosis, epidemiological

investigations during the outbreaks and post-outbreak sero-surveillance.

Routine tests for LSDV diagnostics include molecular group methods for the detection of a CaPV. Several

species-specific PCR methods have been published. If vaccines containing attenuated LSDV are used in cattle

against LSDV, specific molecular tools for differentiating a virulent field strain from a LSDV vaccine strain

have been developed. Alternatively, sequencing of appropriate parts of the LSDV genome can be used for

this purpose.

Serological assays are suitable to investigate relatively recent outbreaks and can be used to demonstrate

the disease-free status of a country provided that testing is carried out on regular intervals. Currently

available tests include serum/virus neutralization tests (SNT) which is a gold standard assay. In addition,

immunoperoxidase monolayer assay (IPMA) can be used for serological surveys. Currently no ELISA for LSD

is commercially available.

3.2.10. Collection, management, transport of samples (A. de Vleeschauwer – K. De Clercq)

The initial steps towards successful laboratory diagnosis of lumpy skin disease are an adequate collection

and management of samples and their proper and timely storage and shipping to the laboratory. Based on

the current knowledge a general introduction on the window for diagnostic sampling for capripox virus

infections with emphasis on lumpy skin disease (LSD) will be presented. General rules on sample collection

will be complemented with guidance on the collection of the most appropriate sample types for three

diagnostic detection methods (infectious virus, viral genome and antibodies) for LSD. Key points to keep in

mind for sample management will be discussed. Transportation of infectious substances and biological

materials is subject to international regulations. The regulatory framework will be outlined followed by an

overview of the most important specific requirements for shipment of samples belonging to category A and

category B.

3.2.11. Clinical, virological and serological post-outbreak surveillance for Lumpy Skin Disease

(D. Lelli)

Lumpy skin disease (LSD) is an economically important Capripoxvirus-induced disease of cattle, of great

concern for animal health and welfare. LSD cause severe direct losses related to reduction in milk

production, sterility in bulls, damage to hides and death. The consequential losses related to trade

restrictions are even more important.

In this context the surveillance programs are the next big issue as soon as the countries need to

demonstrate the freedom from the disease or its eradication. Active surveillance programs of susceptible

populations to detect evidence of infection with LSDV are crucial to establish the status of LSD free-zone or

country. The presentation will provide specific knowledge on factors and strategies which should be taken

into account for the planning of interventions aiming to restore disease freedom in LSD affected areas.



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Clinical, virological and serological aspects, epidemiological characteristics of LSD, the available diagnostic

tools and vaccines will be consider in order to provide a realistic overview of how to carry out the LSD

surveillance concretely. Practical examples and hypothesis of possible surveillance plans for LSD will be

presented and discussed.

3.2.12. Vaccines and vaccination strategy (K. De Clercq)

Once LSD has entered a new country or region in more than a single site, a large-scale vaccination campaign

is the most effective way to control further spread of LSDV. Mass vaccinations should be conducted around

infected holdings and throughout the protection, surveillance and restriction zones. The vaccinated area

should include the whole affected region targeting 100% vaccination coverage. No pockets of unvaccinated

animals should be left within or between vaccinated zones. Vaccination is essential around slaughterhouses,

live animal markets, cattle collection and resting places, carcass disposal and rendering plants. Prevention of

the further spread of the virus to disease-free regions and countries should be prioritized.

Only live attenuated vaccines are currently available and their use needs to be authorized in non-endemic

countries. Independent challenge experiments, evaluating safety and efficacy of all live vaccines currently

used in cattle against LSDV and two newly developed inactivated vaccines, are on-going by the scientists at

CODA-CERVA, Belgium.

Equally important is to confirm the purity of the vaccine as the currently available vaccines are

manufactured using primary cells which makes quality assurance difficult and may cause issues with

endogenous agents and other contaminants.

Restrictions to or ban of international trade of live animals and their products are the major causes why

countries at-risk are hesitating to start preventive vaccination campaigns prior to the actual incursion of the

disease.

The most commonly used live LSDV vaccines are derived either from the South-African LSDV Neethling

strain or an attenuated LSDV field strain and are manufactured in South Africa. The efficacy of homologous

LSDV containing vaccine is superior to that of SPPV vaccine. Although no vaccines can provide 100%

immunity to every individual animal, these vaccines provide good protection if sufficient herd coverage is

achieved and is maintained by annual boosters.

SPPV and GTPV sourced vaccines can be used in cattle but it is essential that their safety and efficacy against

LSDV is demonstrated by using a challenge experiment in a controlled environment. SPPV vaccines, such as

the Yugoslavian RM65 SPPV (10 times stronger dose than used for sheep) and the Romanian SPP vaccine

have been used also in cattle in the Middle East.

It is believed that a replicating agent generates more broad protective immunity against LSDV than a non-

replicating one. However, a recent study has shown that inactivated SPPV vaccines can produce a protective

immunity in sheep, comparable to that provided by a live SPPV vaccine.



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3.2.13. Challenge model - Evaluation of vaccine efficacy in controlled environment (K. De

Clercq)

Lumpy skin disease (LSD) is a pox disease of cattle caused by the LSD virus (genus Capripox ) and

characterized by fever, nodules on the skin, the mucosal membranes and the internal organs.

The disease can cause a reduction in milk production, sterility in bulls, abortion and damage to hides,

leading to a significant loss of income. Originally affecting cattle across Africa, the disease has spread

outside the continent with outbreaks in Israel, Egypt and Lebanon in 2012-13 and currently or recently

(2013-16) epizootics in Turkey, Cyprus, Greece, Bulgaria, FYR Macedonia, Serbia, Kosovo, Albania,

Montenegro, Azerbaijan and the Russian Federation. During this epidemic mass vaccination seems to be the

only effective way to control this vector-borne disease. However, countries hesitate to use a live attenuated

vaccine, currently the only type commercially available, due to the lack of independent information on

efficacy and safety (side effects, contaminating agents) and due to international trade restrictions for live

cattle and some cattle products. Vaccination data on efficacy and safety are very scarce and mostly only

available under field conditions making the choice of the most suited vaccine difficult.

The objectives of the study at CODA-CERVA, in collaboration with The Pirbright Institute, were twofold: i)

optimize a LSDV infection model and ii) evaluate and compare LSDV live and inactivated vaccines under

standardized conditions using the optimized challenge model. In order to achieve the first objective two

challenge viruses were compared in vivo. Not only clinical signs were compared but also virological

parameters (viremia and virus secretion) and humoral (seroconversion) and cellular immunological (such as

IFNg release) parameters. Although certain parameters were very similar, like a fever spike on 7/8 dpi and

seroconversion, others were quite different (clinical signs, viremia, IFNg release). Based upon the gathered

data the most suited challenge virus for the vaccine evaluation experiments was selected.

This optimized challenge model was subsequently used to compare several commercially available live

attenuated (LSDV, sheeppox- and goatpox based) vaccines and newly developed inactivated LSDV vaccines.

Each vaccine group comprised of seven animals and 5 unvaccinated control animals were used per trial.

Vaccinated and unvaccinated animals could be clearly distinguished using the different virological, humoral

and cellular immunological parameters. Among the vaccinated groups, different parameter patterns could

be observed pre- and post-infection suggesting differences in safety and efficacy properties between the

analyzed vaccines. Based upon these data it was possible to distinguish between unsuited, moderately

suited and suited vaccine candidates.

3.2.14. Setting up vaccine efficacy field studies (P. Calistri)

Vaccine efficacy is considered the ability of a vaccine to give protection against the effects of the infection.

It is tested during preliminary phases, before its use in the field, together with safety and immunogenicity

studies. In general efficacy studies are performed in vivo under experimental conditions, challenging a

certain number of vaccinated animals (un-vaccinated control animals are needed). On the contrary, vaccine

effectiveness is the degree of disease incidence reduction attributable to vaccination under field conditions.

It is usually expressed as the percentage reduction of disease incidence among vaccinated animals

compared with unvaccinated. In vaccine effectiveness studies, therefore, it is fundamental to set a precise



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and proper case. Methods for calculating vaccine effectiveness under field conditions are based on

observational studies: cohort studies, case-control studies, screening studies.

3.2.15. Preparation of a strong contingency plan for Lumpy Skin Disease (T. Alexandrov)

A contingency plan can be defined as an important instrument in the preparation for and handling of a

disease emergency. In general the objectives of a contingency plan shall include that the veterinary services

will be able to deal quickly, efficiently and effectively with significant emergency diseases. All categories of

staff involved at all levels should be fully aware about their exact role during disease outbreaks and they will

be trained and competent in the tasks that they will be expected to carry out.

The farming community and relevant agencies over which the veterinary administration has no direct

control should co-operate with and provide assistance to the veterinary services in disease eradication.

Adequate personnel, equipment and financial resources can be made available quickly enough to avoid any

delays in dealing with the emergency situation. CP must cover the pre-epidemic, epidemic and post-

epidemic period. Strong contingency plan for LSD should take into account calculation of all direct and

indirect costs for all the different control strategies for different scenarios and the consequences and

include preparedness for many outbreaks at the same time, finalized tender procedure/contract for

immediately supply of all vaccine needed and readiness to vaccinate before the disease enters the country

or to perform emergency vaccination immediately after the first outbreaks.

3.2.16. Effective control of animal movements, including nomadic and transhumance farming

systems (T. Alexandrov)

Animal movements must be controlled for the purposes of anima diseases control, traceability, prove origin

of animals, animal welfare, intracommunity and international trade, imports, maintenance of disease free

status. Severe movement restrictions were imposed by Bulgaria in response to the LSD outbreaks including

establishment of a restricted zone covering the at the beginning the territory of South Bulgaria (comprises

14 regions including regions with LSD outbreaks confirmed) and later all Bulgaria; restricting the

movement/transport of susceptible species (including small ruminants in case of mixed ruminants farming)

and strengthening the control of movement/transport of all other animals in the entire country. Any

movement/transport of susceptible species (including small ruminants) - subject to official veterinary

supervision and must fulfil conditions. Tools for animal movement controls are the TRACES system, animal

identification and registration, national databases and the veterinary movement certificates.

Controls should be carried out at the place of origin and destination of the animals, animal markets staging

points/control posts, slaughterhouse, farms, roads, etc. Cooperation between official and private vets,

farmers, traders, police, border police and other governmental and nongovernmental institutions is crucial

for effective control of animal movements, including nomadic and transhumance farming systems.



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3.2.17. Safe disposal of carcasses on- and off-site considering different environmental and

public health issues (T. Alexandrov)

The primary objective of disposal of carcasses, animal products, materials and wastes is to prevent the

dissemination of infection. This process is therefore an essential part of LSD eradication program. Disposal

should be completed as soon as possible after destruction to minimize opportunities for infectious material

to disperse.

While rapid disposal is of primary importance, it must be undertaken in a way that does not increase the

risk of spread of the disease or adversely affect the environment or the community. Care needs to be taken

to classify all carcasses and waste according to its potential infectivity and then to dispose of it according to

the legislative requirements.

Disposal of carcasses can be done by rendering, incineration, burial or burning. Valuation of animals should

be done by a commission prior and disposal. Proper cleaning and disinfection should be performed of all the

contaminated locations. Application for grants and request for payments in respect to the emergency

measures for LSD should be prepared.

4. Salient points for Albania

(1) Preparedness to prevent spreading of the disease relies on:

- Sufficient vaccination coverage. Two equally effective live attenuated LSDV vaccines are available

(OBP and MSD Animal Health). Feasible packaging size shall be considered related to the prevailing

farming patterns in the country. Possible transboundary animal movements underlines importance

of regional coordination in mass vaccination.

- Control of animal movements. Most initial outbreaks are associated with cattle movements, hence,

strict control of animal movement at the onset of the outbreaks is of utmost importance. After the

whole cattle population in the whole country has been immunized, lifting/facilitating of the

movement restrictions shall be initiated.

- Functional ID/vaccination/movement/laboratory result database must be regularly updated.

- Feasible stamping out/culling policy. Heavily infected animals shall be removed from the herds for

the following reasons:

o The clinical signs and illness are often prolonged;

o Heavily infected animals are not likely to regain same level of production; and

o Welfare reasons

- Veterinary infrastructure must be in place and veterinary services need to have capacity to carry out

control/eradication measures and disease surveillance;

- National reference laboratories need to have sufficient laboratory capacity (competent staff,

equipment, kits, reagents and other materials).

(2) Albania is the only country in the region where full vaccination of cattle population was not yet

achieved.

(3) In Albania, vaccination of ≈50% of animals was finalized in September 2016. Calves of those vaccinated

animals will be fully susceptible in early 2017. Decision and provisions for their immunization is urgently

needed.



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(4) When supply national vaccine contingents, conditions shall be focused on the speed of delivery of

vaccine: sufficient points shall be given to the date of delivery the vaccine in the tendering procedure.

(5) In infected herds, number of infectious animals is much higher than those showing clinical signs,

therefore only removal of animals with clinical signs will not greatly contribute to the control of the

disease. Such measures can be only effective if combined with vaccination. None of the currently

infected countries could not stop the spreading of the disease without vaccination.

(6) Ring vaccination of animals within radius of 10 km was proved not to be effective for prevention of

spreading of the disease. None of the infected countries could not stop the spreading of the disease

only with ring vaccination.

(7) Mass vaccination campaigns effectively prevent spreading of the disease.

(8) Potential causes of failure of mass vaccination campaign are: - Delay in starting with the vaccination campaign; - Vaccination area too small; - Insufficient vaccination coverage on herd basis (not all herds are vaccinated); - Insufficient vaccination coverage on individual animal basis (not all animals within herd are

vaccinated); - Vaccination of already infected herd; - Inappropriate storage and failure of the cold chain; - Poorly administration or inappropriate dosage; - Interfering with maternal antibodies (vaccination of calves from vaccinated cows in the age of less

than 4-6 months); - Contaminated needles and diluents;

(9) EFSA developed a mathematical model to assess the effectiveness of different control programmes http://www.efsa.europa.eu/en/efsajournal/pub/4573 . According to the model, vaccination has a greater impact in reducing LSDV spread than any culling policy, even when low vaccination effectiveness is considered. When vaccination is evenly applied so that 95% of the farms are vaccinated with 75% of vaccinated animals effectively protected, then total stamping out and partial stamping out result in a similar probability of eradicating the infection.

(10) It is highly likely that mass vaccination in the region will continue in the coming years. The duration of

the mass vaccination currently is not known and will depend on the surveillance results.

(11) Full vaccination coverage is essential, especially during the vector activity season. Most appropriate

schemes for application of vaccine shall be adopted to the country conditions.

(12) Socio – economic impact of LSD is massive: poor smallholders with 1 – 2 animals are hit hardest. This

particularly apply to Albanian conditions

http://www.efsa.europa.eu/en/efsajournal/pub/4573



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Source: Country presentation Albania

(13) Further investigation is needed to identify specific vectors in local conditions.

(14) Transparent and swift notification and information exchange by affected countries across the regions is

essential.

(15) Presence of infected animals in a region/country may serve as a source of infection for calves that have

lost their maternal immunity.

(16) In the light of current global LSD situation and new scientific evidence, new Chapter of the OIE Code is

under development and is expected to be adopted on OIE General Session in May 2017. The new

chapter revises conditions for regain of free status, describes required surveillance, trade

recommendations for import, safe commodities, etc.

(17) Basic EU legislation regulating measures to combat LSD in EU remains Directive 92/119/EEC. New

Commission Implementing Decision (2016)/2008 of 15 November 2016 concerning animal health

measures relating to lumpy skin disease in certain Member States is adopted. The implementing

decision regulates restrictions on the dispatch on bovine animals and products from infected areas and

derogation thereof and set the minimum requirements for lumpy skin disease vaccination programmes.

The new EU implementing decision offers several advantages:

- Uniformity (one set of measure across the EU)

- Proportionality (establish of specific rules for affected zones and free with vaccination zones

respectively)

- Sustainability (reduced impact on trade)

- Flexibility (possible bilateral agreements)

- Lifting – refining of measures related to safe/low risk products (meat, milk)

All measures of Directive 92/119 on stamping out, suspicion, confirmation of LSD (surveillance – protection zones, measures and duration thereof) remain in place.

413

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400

600

800

1000

1200

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1 2-3 4-5 6-10 11-19 20-50 51+

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Affected herds in Albania

Herd Size



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(18) In addition to the common support provided through EU LSD vaccine bank, financial support and by EU

institutions (EFSA, EURL), EU provides expert advice and technical support through Community Veterinary Emergency Team (CVET) mission for EUMS and Non EU member countries (expert missions were provided for Serbia and Macedonia).

(19) The EC will continue to promote regional coordination and cooperation (EU and non EU Member countries) by providing technical assistance, training opportunities, and support for LSD vaccination programmes.

(20) ADNS: No reports are available to ADNS from Albania as at September 2016 (https://ec.europa.eu/food/animals/animal-diseases/surveillance_en )

Source: EC presentation

(21) Current scientific knowledge suggest that transmission by vectors occurs only by mechanical means. This suggest that multiple feeding on multiple hosts is required for spreading the disease.

(22) Training on diagnostic methods is available at CODA CERVA, Belgium, the newly appointed LSD EURL

5. In Albania

In the situation of general lack of detailed scientific information on the disease, an opportunity arise where

contribution may be given by collecting of field information from Albania where most of the infected

animals are not removed from the herds.

However, restricted availability of PAZA II project experts, limited time and budget prevents implementation

of appropriately scientifically developed epidemiological studies. Hence, proposed activities are a product of

above mentioned limitations:

https://ec.europa.eu/food/animals/animal-diseases/surveillance_en



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(1) Implementation of post vaccination monitoring by clinical and serological surveillance.

- The objective of the monitoring is to assess the efficacy of the vaccination campaign.

- Implementation may be in several preselected regions of the country.

- Time of implementation will be first half of 2017 when vaccination is expected to be carried out.

- PAZA II local and international experts will be involved in the implementation.

- “Passive reports” on the disease occurrence post vaccination and “Active clinical surveillance” will

be used to carry out further investigation which will include clinical and laboratory investigation.

- DIVA PCR testing will be used to distinguish between field and vaccine virus. Support for dispatch

and laboratory testing of collected samples will be requested by LSD EURL.

- Standard operating procedures will be developed and used during the implementation. Training will

be provided to the official veterinarians and PAZA II local experts involved in the activity.

(2) Investigation on the duration of humoral immunity after vaccination including the humoral

immunity in offspring of vaccinated animals

- The objective is to assess the duration of humoral immunity in vaccinated and their offsprings;


- Time of implementation will be first half of 2017 when vaccination is expected to be carried out.


- Sufficient number of vaccinated herds will be selected to achieve statistical evidence.

- Support for dispatch and laboratory testing of collected samples will be requested by LSD EURL.



(3) Investigation on the duration of humoral immunity after natural infection including the humoral

immunity in offspring of infected animals

- The objective is to assess the duration of humoral immunity in infected animals and their offsprings;


- Time of implementation will be January – September 2017.


- Sufficient number of newly infected herds will be selected to achieve statistical evidence.

- Support for dispatch and laboratory testing of collected samples will be requested by LSD EURL.



(4) Establishment of sentinel herds to assess circulation of virus

Organization and implementation of observational epidemiological studies goes beyond the PAZA II

objectives and time available and therefore can not be properly supported within limited time available.



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6. Recommendation

(1) Vaccination: a. Initially, complete vaccination process by vaccination of all unvaccinated animals as soon as

possible. This shall include both adult and young animals. b. Vaccination against LSD shall be formally regulated in appropriate contracts with the

veterinarians who will perform it. c. During vaccination, strict hygienic measures and use of new needle for each animal shall be

followed to prevent iatrogenic spread of the disease and to minimize p.v. complication. d. Individual animal data on vaccinated animals shall be recorded and reported to the

approved data management system. e. Cold chain and proper maintenance of the vaccine shall be reassured. f. Official veterinarians shall be effectively involved in monitoring of the vaccination

campaign. g. Monitoring efficacy of vaccination campaign by:

i. Clinical surveillance; ii. Serological surveillance and establishing of DIVA strategy (PCR testing).

(2) Revaccination: a. Vaccination area shall continue to be the whole country. All herds and all animals within the

country shall be revaccinated and maintained immune. b. Animals that were vaccinated until September 2016 and their offsprings shall be vaccinated

before the start of the vector season (April – May) in 2017 and hence to maintain full vaccination coverage. Next vaccination round in 2018 shall be foreseen for the approximate time April – May (before the start of the main vector season and with aim to maintain immunity of calves born during the vector season). All susceptible population shall be vaccinated.

c. Sufficient quantity of vaccine shall be supplied to be in time in Albania before the scheduled time for vaccination.

d. The tendering procedure for LSD vaccine shall incorporate timing of delivery as important factor in selection of the best bidder.

e. Vaccine shall be supplied in as smaller vials as possible. (3) Disease control:

a. LSD emergency control plan shall be reassessed and amended as appropriately in the light of new disease development.

b. Movement control of animals shall be reinforced in the light of the newly developed disease situation. Basic rules as prescribed with the new LSD Implementing Decision shall be used as driving principles.

c. Infected animals with severe clinical signs shall be removed from the herds and compensated.

d. Use of other institutions equipment such as diggers owned by municipalities for safe disposal shall be further maintained and developed as a model for interinstitutional cooperation.

(4) Training: a. Official veterinarians and private veterinarians who perform vaccination shall be trained in

general overview of LSDV, Epidemiology and diagnostics, Control and eradication, Bio security and data reporting.



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b. Introduction of the international responsibilities and reporting requirements of the Albanian State Veterinary Directorate to the official and private veterinarians may contribute to improved performance in their responsib2ilities.

(5) Data base management systems: a. The Database management system shall be appropriately tuned to accept individual animal

data on vaccinated animals. Training shall be provided to the responsible veterinarians who enter the data.

b. Data on disease occurrence shall be regularly updated to the WAHIS and ADNS to fulfill the international obligation for reporting of confirmed cases including numbers of vaccinated animals.

(6) Laboratory diagnosis: a. Veterinary Directorate shall allocate budget for supply of reagents for confirmation of

suspect cases. b. AHD – ISUV shall contact the LSD EURL for support in training of additional staff in

performing laboratory testing. c. PCR assay differentiating the field LSD strain from the vaccine virus shall be established. d. AHD – ISUV start participation in proficiency testing and ring trials. e. Initially, serological samples shall be sent to LSD EURL. f. AHD – ISUV shall develop simple guidelines for field sample collection.

(7) Public awareness: a. Farmers shall be made aware on the importance of biosecurity on the spread of the disease. b. Farmers shall be encouraged to use repellents on their animals especially during the high

vector season. c. Farmers shall be

(8) The EU Community Veterinary Emergency Team (CVET) mission shall be invited to assess the disease situation in the country and to give recommendation for continued effective control.

(9) Regional cooperation: a. Albanian Veterinary Directorate shall continuously participate to the regional meetings and

coordinate its activities with other countries from the region. (10) Entomological, including virological surveillance shall be initiated:

a. Entomological surveillance plan shall be established. b. Light traps shall be produced. c. Budget for entomological surveillance shall be assured.

PAZA II project will propose to the EU Delegation in Tirana to financially support the activity.

19 December 2016

report on btsf lsd training in sofia annex 13.2 1. … · 201612019 paza ii dse report on sofia lsd...

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