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Cuba-Egypt – Joint Manufacturing on Vaccines

Organization(s):

Cuba: Two companies; Finlay and Heber Biotec, Egypt: Vacsera, Ministry of Health

Country (ies):

Cuba: Provider - Egypt: Recipient

Overview:

The technical cooperation between Egypt's national vaccine producing institution; Vacsera, and Cuba's specialised vaccine producers, Finlay and Heber Biotec, aims at the transfer of Cuban technology and know-how to Egyptian technicians in the field of selected vaccine manufacturing. These particular vaccines are of high national priority and at the same time would foster the Cuban counterparts exportation of raw material used to produce such vaccines.

Background:

Egypt's responsibility to annually provide its growing population with mandatory vaccines called for the need to become more self-reliant by manufacturing such vaccines locally. This requires acquisition of relevant know-how in this field. Concrete steps were taken as a result of the Egyptian-Cuban Commission meeting in November 2007 in which a Cooperation Protocol was signed by Egypt and Cuba. This Protocol gives Vacsera, which is the Holding Company for Biological Products and Vaccines and Egypt's national vaccination producing institution, the right to manufacture selected vaccines locally in cooperation with Cuba's two specialised vaccine producers; Finlay and Heber Biotec. The Protocol was signed as an expression of solidarity between the two countries, supporting development efforts to their mutual advantage. A meeting between the Egyptian Minister of Health and the Cuban Ambassador in Cairo, with a representative from the Cuban Government, took place in 2008 to speed up the implementation of the Protocol.

The Protocol was followed by a Memorandum of Understanding (MoU) which was signed in June 2008. It was agreed that Vacsera would produce five selected vaccines after gaining pertinent know-how and upon receipt of the bulk (raw material) used to manufacture these vaccines from the two Cuban companies. The advantages of this agreement include the transfer of Cuban technology and know-how with comparatively lower costs, and the diversification of suppliers to avoid any unforeseen acts by Egypt's current suppliers, Glaxo and Pasteur. Vacsera plans to negotiate training of Egyptians as part of the "package". The main benefit to Cuba is access to the large and "attractive" Egyptian market to which it would sell large amounts of the bulk (raw material) used to manufacture vaccines.

Implementation:

Steps to operationalize the MoU signed by Vacsera and Finlay and Heber Biotec are underway as follows:

- Joint production of Meningococcal AC vaccine: This agreement permits the transfer of technology by Finlay which produces bulks of polysaccharides A&C (the two microbes present in Egypt) while Vacsera would do the formulation, mixing and filling of the vaccine using –in a first stage- the Cuban know-how. The timeframe attached to the MoU sets the action plan for the Meningococcal AC vaccine production project. This entails the following:

- Registration: A first step is the registration of the vaccine's raw material at Egypt's Central Administration for Pharmaceutical Affairs (CAPA). Since Cuba is not a reference country at the WHO, and according to Egyptian regulations, this registration procedure requires CAPA's specific decision to approve Finlay's bulk, a step that is also driven by the strategic importance of these vaccines to the Egyptian citizen. This process, which is currently ongoing, might involve the inspection of Cuban factories by Egyptian health control specialists. Product samples are to be prepared for necessary clinical and stability studies.

- On-site visit to Vacsera: An on-site visit would be conducted by a Cuban expert group to the production lines of Vacsera to ensure conformity with standards. During this visit, training would be provided to Vacsera's production team, and approval of the bulk for production would be given.

- Pilot production: Quantities of the bulk would be imported by Vacsera to produce three pilot batches of the Meningococcal AC vaccine locally. It is planned that a Cuban technical team would be sent to Egypt for surveillance.

- Manufacturing process: Once Finlay approves the production method that is to be applied on a larger scale by Vacsera and issues a Certificate of Analysis, a contract between the two institutions would be signed to start the manufacturing process in Egypt.

- Joint production of DTP-HB/Tetravaccine: A confidentiality/non-disclosure agreement was signed in August 2008 to jointly manufacture Tetravaccine using the DTP manufactured by Vacsera and HB produced by Heber Biotec. In this regard, after having sent vaccine samples to Heber Biotec in April 2009, studies proved that the combination of both vaccines into one (so as to produce the DTP-HB/Tetravaccine) is feasible.

- Production of DTP-HB-Hib vaccine: The same agreement also includes the production of the DTP-HB-Hib vaccine using the above-mentioned DTP-HB/Tetravaccine and the Hib vaccine produced by Heber Biotec. The production of this specific vaccine would start after the manufacturing of DTP-HB/Tetravaccine.

The MoU calls for the contribution of personnel in charge of technology transfer at Finlay and Heber Biotec to provide all necessary technical information and training to Vacsera's technicians.

Outcomes:

Although the project is not yet in the manufacturing phase, concrete actions are being taken to proceed within the next few months. Project outcomes are expected to include the following:
  1. Assurance of increased supply of these vaccines to meet Egypt's growing demand.
  2. Building Egypt's national technical and manufacturing capacity to become more self-reliant. It is expected that around two technical officers from Vacsera be trained in Cuba, and that Cuba would then provide on-site training to Vacsera's technicians in Egypt.
  3. Achieving substantial cost-savings - estimated by Vacsera to be around 50%.

Challenges:

Delays on the Egyptian side caused by registration impediments and in responses by the Cuban side have led to extension of the various phases of implementing this initiative.

Aid Effectiveness:

  • This experience, though not yet in the implementation phase, is aligned with Egypt's priority to provide vaccines to its growing population on an annual basis. Ownership of this cooperation would be supported as Egypt's national vaccination producing institution is directly involved in the project. Additionally, it would open a new and large market for Cuba.
  • Experience gained through this cooperation would strengthen Vacsera's understanding of the potential gains of South-South cooperation (SSC) and also with other countries.
  • This cooperation would contribute to aid effectiveness through capacity development by training Egyptian technicians to acquire know-how so as to become more self-reliant in this field.
  • Expected cost savings would allow for a decrease in national expenditure; a benefit that would not have been possible had Vacsera signed this agreement with a company from the North.

Capacity Development:

Technology transfer and training of Egyptian technicians would develop the capacity of Vacsera and extend its range of vaccines to meet demand. Vacsera, with its 130 years history, is already the largest vaccine producer in Africa and the Middle East and is in a position to support Egypt's humanitarian assistance through SSC initiatives in the health sector.

Duration:

November 2007 - (tentative 2009, but was extended due to the delays referred to above)

Budget (Optional):

10 million Egyptian Pounds

Name of Primary Contact Person:

1.Dr. Hamdallah H. Zedan or 2.Radwa Helmy Abdel-Raouf

Title of Primary Contact Person:

1. Chairman and CEO of Vaccines, Sera and Drugs (Affiliate of Vacsera Holding Company for Biologicals and Vaccines), 2. Executive Assistant to the Co-Chair, OECD/DAC Working Party on Aid Effectiveness

City:

Cairo