FINAL REPORT SUMMARY:

Foot and Mouth Disease – Assessment Report Drafted by: Terry Wollen, Livestock Advisor for USAID’s Office of U.S. Foreign Disaster Assistance (USAID/O...
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Foot and Mouth Disease – Assessment Report Drafted by: Terry Wollen, Livestock Advisor for USAID’s Office of U.S. Foreign Disaster Assistance (USAID/OFDA) 26 – 29 March 2012 Cairo, Egypt FINAL REPORT SUMMARY: Terms of Reference: The objective of this investigation was to provide a technical understanding of the current Foot and Mouth Disease (FMD) outbreak in Egypt and help determine the needs and USG response options. In the discovery process, we had very helpful collaboration from the USAID Mission staff and USDA APHIS. My first interest was to find the centers of knowledge and control of the livestock situation. We visited: 1. APHIS USDA Cairo. Dr. Mahmoud Orabi accompanied us on field visits and provided valuable statistics and interpretation of animal health services and service providers in the country. 2. Ministry of Agriculture and Land Reform (MALR). Dr. Osama Selim, Chairman of the Government Veterinary Service, provided assessments of surveillance and quarantine efforts. Dr. Selim highlighted the need to control the outbreak. 3. The Central Laboratory for Evaluation of Veterinary Biologics1. Presented the current source of veterinary biological made in the country (including an older strain of SAT2) and a new Bio Safety Level 3 (BSL3) Laboratory that is under construction. 4. The Veterinary Serum & Vaccine Research Institute2: produces monovalent and bivalent FMDV vaccines and on its way to produce a new FMDV SAT2 vaccines. 5. U.N. Food and Agriculture Organization (FAO). Dr. Yilma Jobre, Team Leader for FAO’s Emergency Center for Transboundary Animal Diseases Operations in Egypt, provided a Rapid Assessment Mission Report on FMD, links to disease watch reports, and a candid assessment of the current ability of the Government of Egypt (GoE) to provide surveillance, manage quarantine of animals, and respond with appropriate vaccination protocols. I visited a technical agriculture technical school that manages small herds of dairy cattle and milking buffalo; all animals were infected with the current FMD strain. The team learned about the ability of the Egyptian veterinary program to manage a vaccination campaign throughout the country. Recommendations – mid-term approach:  Administer a quality FMD SAT2 strain vaccine to all susceptible livestock throughout Egypt as soon as possible. Update: USDA is supporting the acquisition of the vaccine from available sources. Recommendation – longer term approach:  To build resiliency, implement a capacity building program for veterinary services and field veterinarians to manage this vaccination campaign and, in the longer term, adequately secure the borders, provide quarantine services, and track livestock movement in Egypt. Update: NSS and USDA/APHIS are facilitating interagency dialogue on surveillance. 1

The laboratory is in charge of all evaluation processes of veterinary biologics, and issuance of certificates for local and imported veterinary biologics. It develops protocols for evaluation of veterinary biologics by improving and facilitating the quality control method of evaluation. - It conducts research on veterinary biologics evaluation with special focus on biotechnology aiming to develop new, more accurate and effective techniques, test & evaluate SPF eggs produced by a biosecured SPF farm and cooperate with national and international organizations in the field of veterinary biologics evaluation. 2

formerly called the Veterinary Serum Laboratory, is one of the oldest in the Middle East and the most prestigious in Africa. the Laboratory was established in 1903 in the Abbassia district, East of Cairo.

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The USG may consider supporting the procurement of equipment for a Vaccine Institute with improved production protocols and completion of the newly established BSL3 laboratory and vaccine production unit. Continue to monitor the impact of livestock morbidity on affected populations.

Outstanding questions:  What / When is the peak of the infection? o This question comes when we read the weekly statistics on outbreak / mortality numbers. I am not sure who provides these numbers, but am cautioned by the FAO Program Control Pathway strategy team that they may be inflated (I sense that is a fair statement). The reported numbers seem not yet to have peaked. I would caution our interpretation of numbers for concluding the spread of infection. In addition to its air-borne nature, the infection will continue to grow as long as there are susceptible livestock and movement of animals spreads the infection. If there were quarantine procedures in place to limit the spread and if the health of the animals was excellent (most healthy animals do not get symptoms or die from FMD) and if the owners had found a way to use one of the available SAT2 vaccines, then the infection will subside. Any one of these will slow the infection rate. The best control mechanism that the livestock keepers and various governorates have is to keep their herds as closed as possible. The best control mechanism that we can provide is to get vaccine to the veterinary clinics for vaccination programs with local animals.

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Please see details on the unabridged report, which follows: Primary Team participants:  Dennis Johnson, Regional Advisor, USAID/OFDA  John Pasch, Productive Sector Development, USAID/Egypt  Shari Cahill, Agriculture Officer, USAID/Egypt  Mahmoud Orabi, Ag Specialist, APHIS, USDA, Cairo  Mohamed Abo Elwafa, Program Manager / Agriculture & Agri-business, USAID/Egypt  Terry Wollen, Livestock and Animal Health Advisor, USAID/Washington Monday, March 26 Orientation Meeting – Dennis, John, Mahmoud, Mohammed, Shari, Terry Assumptions:  The GoE would like for the private sector to supply vaccine doses and USAID to assist in procurement.  The small farmer suffers the most in an FMD outbreak. How can s/he be supported?  Need a clear understanding of the source, extent and response to the disease outbreak. There is an understanding that the source of the outbreak is understood, the virus has been laboratoryidentified, and that vaccine is available if money is found for purchase. These assumptions were the subject of the meetings during the following three days. Meetings were arranged to learn about the diagnosis, type of the infectious organism, source of vaccine, production of vaccine in Egypt, surveillance in the field, infection rate in cattle, calves, sheep, goats and water buffalo, and distribution and administration of vaccine. Faculty of Veterinary Medicine – Cairo University, Dr. Amr El Sayed, Dr. Adel Abd El Aziem: Discussed initial discovery of novel FMD outbreak in Egypt (2/18) identified as SAT2 type, as well as the prevalence and location of other types. Pigs (few numbers in Egypt) can carry viruses; Bactrian camels are known to get infections in China and Russia but not in large numbers in Egypt; and dromedary camels do not suffer from infection. Large/commercial farms have access to most vaccines, even SAT2 (although not the new type). Small farmers are the most affected by a lack of vaccine and veterinary support. There is a need to identify all animals and to restrict movement until vaccination protection is provided. The group discussed Merial/France as a source of vaccine, but also raised concerns that they have declined to provide vaccines directly. Minister of Agriculture, Chairman of General Organization for Veterinary Service, Prof. Dr. Osama Mahmoud Ahmed Selim: (Recently re-appointed from Chief of Veterinary Department of the Army.) He described the illegal movement of cattle over the border into Egypt from Libya and the Gaza Strip sector. The Ministry is trying to limit livestock movement until vaccination protection can be provided. Merial/France cannot donate SAT2 vaccines, but has approximately 2 million doses available for sale. He mentioned that Merial representative who visited before the group tried to impose some conditions (something like that). Merial can provide 500,000 doses by the end of April and 2 million doses by the end of May 2012. Also, Merial has 400,000 doses of SAT2 available in Botswana, but the supply is not available for Egypt. The GoE used to pay for vaccines for herds of less than 50 animals. The GoE is currently planning to charge 75 LE per year for all vaccines (an insurance mechanism). [Note: Approximately 6 LE equal 1 USD.) Tuesday – 27 March

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Morning: Debrief telecom between USAID Mission and U.S. Embassy. Morning: Central Laboratory for Evaluation of Veterinary Biologics: [Note. The laboratory is located near the Vaccine Research Institute (VRI). The team visited the Central Laboratory on the way to VRI.] The Veterinary Serum & VRI: VRI is a combination of a research laboratory for animal diseases and a manufacturing facility for biological products used in Egypt. VRI sells vaccines from an outlet on this campus. Currently, VRI is producing FMD Type O and A (bivalent) vaccine. The lab is also waiting for the characterization of the current infective strain that is being analyzed in the World Health Organization for Animals (OIE) reference lab in Pirbright, UK. With that new strain, VRI will make first a monovalent SAT2 vaccine and later a tri-valent product for the Egypt market, including Type A, O and (new) SAT2. The Institute’s livestock stable can only house animals being tested for monovalent products, so upgrading the facility would be needed to support the trivalent product testing. Dr. Monseur thinks that the new SAT 2 outbreak is more virulent for buffalo than goats, sheep, and cattle. The laboratory director predicts the need for 20 million doses of SAT2 for use in goats, sheep, cattle, and buffalo. He reports that institute can produce the first 3 million doses in the next 3 to 5 months. Producing 180,000 doses will cost 6 million LE, or approximately 1 million USD. We also met with the Deputy Director for Vaccine Production and his assistant director, Dr. Sayed, who explained that the institute is over 110 years old and produces biological products for FMD, Rift Valley Fever, Sheep Pox, Brucellosis, Tuberculosis, and more. He added that their capacity is good as evidenced by the 10 million doses of FMD Type A produced in response to the 2006 outbreak. When asked about their needs, the response was for a new filling line (filling and labeling). The notable feature of this institution is the construction of a BSL3 laboratory. The new structure appears to be about 80 percent complete, with modern utility service, gas-fired generator back-up, and controls for contaminated outflows. This is the type of facility that can safely investigate FMD viruses. Facility staff reported that the facility’s priority need is equipment, especially a laminar-flow bio-safety system to use with the fermenters. Afternoon: Yilma Jobre, DVM, MVSc, Ph.D., FAO Egypt FAO conducts their work around a Technical Cooperation Program (TCP), using the terminology of a Program Control Pathway (PCP) as their system. Field samples of the current FMD virus/outbreak were sent about 4 months ago to the OIE’s FMD laboratory at the Institute of Animal Health in Pirbright, UK. No characterization of the virus (the type description of the antigen) has been returned yet. In the meantime, the virus is being called SAT2 prototype 7 with suspicion that it came out of east Africa. Identification of the virus is critical for vaccine development, as the best vaccine will be the one from the actual outbreak. Poor matching will result in poor immunity development when administered to livestock. - According to the WRL (Perbright), the Libya’s SAT2 isolate (topotype 11) can give 55 percent immunity to Egyptian cattle. - The Eriteria SAT2 2009 topotype 10 isolate may give 75 percent immunity for this SAT2 topotype 7 of Egypt. Once the Pirbright laboratory characterizes the invasive virus, it can then be used to develop the specific vaccine needed in the Egyptian facility. It is estimated to take about four months to grow the virus seed stock, harvest, make the vaccine, and test for potency, safety, and sterility before introducing 4

the vaccine for commercial use. Meanwhile, vaccine stocks for this new SAT2 strain already exist in North America (Mexico, U.S., and Canada) and Botswana vaccine banks. FAO is in the process of assessing the GoE’s compliance on a variety of aspects. Concerns fall in the following areas:  The morbidity and mortality figures from the field are not verified leading to skepticism and suspicion that the numbers are inflated.  Compensation to small holder farmers is not yet addressed with objectives and response by the government.  Bio-security is the first line of defense. This means border control of livestock movement and identification/separation of infected animals.  An overall strategic plan for FMD control is presently lacking. FMD is becoming the #1 animal health disease in the world and must be approached with an excellent response plan. This is not yet seen in the country. What is the livestock value chain in the country? Who and where are the traders? Where are the imports coming from? Where are animals moving?  A regional strategy needs to be addressed, too, harmonized with other countries and other trans-boundary disease practices. This inter-sectorial coordination is needed. The management of the Avian Flu response several years ago is held up as an example of a very effective program from the government, poultry industries and small holder poultry farmers. So, what are the lessons learned from that experience, which would relate to the present infection? The immediate need in the country is to contain the outbreak by getting vaccine shipped in and administered to susceptible animals. The GoE is projecting the eventual need for 2 million doses. At the present time, any of the SAT2 vaccines would be the best choice; so selection of supplier should be based on timing to delivery. After the virus has been characterized by the Pirbright lab, then the final and most appropriate vaccine can be propagated in the Central Laboratory for Evaluation of Veterinary Biologics and made into a vaccine product for the field. Small holders of beef, goat, sheep, and buffalo should receive vaccines first. Large farms, that are most often closed, can purchase vaccine at any time. However, it should be mandatory that they also vaccinate their animals with SAT2. A second immediate need is to support the diagnostic capabilities and vaccine manufacture in Egypt. This could be done by supporting the new BSL 3 facility that is being constructed at the Veterinary Serum & Vaccine Research Institute. We toured that facility and were told of the need for specific equipment to complete the laboratory. Funding options:  Purchase vaccine for the GoE to distribute  Support the Central Laboratory with equipment  An FAO Donor Meeting is scheduled for April that will include funding for FAO response activity. FAO References: Several press reports, including a Rapid Assessment, from the FAO:  Major foot-and-mouth outbreak in Egypt threatens the region  http://neareast.fao.org/Pages/events.aspx?ID=926&lang=EN&I=104130&DId=10011&CId=0&C MSId=736  http://www.fao.org/docrep/015/an380e/an380e00.pdf  A further analysis document and a basic Fact Sheet are also currently under development.

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Afternoon: Debrief telecom with USAID Mission, U.S. Embassy, USAID/OFDA Washington, APHIS Cairo, APHIS US, and National Security Staff (NSS) Wednesday – 28 March 



Suzanne Basilios, large-scale dairy farm, meeting at office: Ms. Basilios owns a 2,000-head Holstein dairy plus buffalo steer finishing feed lot in the Nile delta. She has a closed herd with tight security, five veterinarians on the premises. Vaccination protocols on the farm include a 6strain FMD product every six months; obtained from their supplier, International Free Trade Company (they supply the Merial vaccine). They have not been affected by this recent outbreak, or the 2006 outbreak. Mr. Ali Kamel, Senior Economic Advisor, Policy & Private Sector Office, USAID/Egypt: Discuss agriculture situation within Egypt with focus on response to FMD. Kamel has livestock experience raising buffalo calves for meat sales. His experience with FMD is that vaccination is very useful, although not always totally successful. o Kamel says that FMD is a serious challenge for the small holder, as livestock are often the only source of income for the family. Short-term and longer-term support to address the problem would both be helpful. The immediate need for vaccine is a good choice. It must be accompanied with a fair and accurate system of distribution with defined criteria and monitoring. o Longer-term support with equipment for the Veterinary Biologics laboratory is also useful. Along with the equipment, some capacity building would be necessary. o A third need is for a more functional extension service. There are government veterinarians, but they often do private work on the side and that takes more of their time than the government duties. Thus, the development of technical awareness in the extension system is needed with training and monitoring and surveillance systems in place. This is needed in order for the implementation of a disease control strategy.

Thursday – 29 March Field visit: Technical Secondary School for Agriculture – one of 117 such agriculture technical schools in Egypt. USAID program support: Midwest Universities Consortium for International Activities; linked to Dr. Sami from agriculture college in Cairo.  

Dr. Ahmed Abban – PhD Animal Science from Penn State University Dr. Mustafa and numerous other veterinarians and staff from the school

The impact of this outbreak of FMD on the small farmer has been severe. The school’s veterinary staff assessment of the morbidity in cattle and buffalo is 100 percent% infection with a mortality of approximately 75 percent mortality of calves. They report that veterinary services in the rural villages comes from GoE veterinarians, who sometime work by private contract and also for the government. Private farmers pay an insurance fee to the government and received veterinary care, medicines, and vaccines, as needed. The staff reported that all farmers would get service if there were a blanket vaccination campaign. When asked how the farmers would learn that a vaccination campaign was underway, individuals noted that radio stations, and mosques make announcements, and the mayor may even send representatives out to alert the farmers. Both sedentary and pastoral farmers exist in Egypt, based on the type of grazing and arable land available.

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Veterinary clinics are all equipped with refrigerators and the vets have equipment and chill boxes available to take vaccine to the field. In terms of quality of medications and vaccines available in Egypt, there was concern raised. Medications made in the country, including vaccines, are perceived as not very effective. They reported outbreaks of disease after animals had been vaccinated. Whether the outbreak came from the product used or was a natural outbreak that was not protected by the product is not known. It’s also worth mentioning that some unofficial reports stated that undermining the local vaccines is in part of it by some vaccine importers and foreign pharmaceutical companies. Denmark and Israel were reported to have good veterinary products. They reported that their greatest need at this time is an effective vaccine to protect against this outbreak of FMD. End of report. Terry S Wollen, DVM Livestock and Animal Health Advisor Office of Foreign Disaster Assistance / USAID Washington, DC Tel: 202-712-5941 [email protected]

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