The Serum and Vaccine Center (Institut Pasteur of Morocco) is a public industrial pharmaceutical establishment, placed under the supervision of the Ministry of Health. Its missions are: the manufacture, import and marketing of serums, vaccines, and biological products. For the realization of these missions, he is subject to the provisions of Law 17-04 on the Pharmacy and Medicine Code.
The Serum and Vaccine Center, a major player in the anti-Covid19 Vaccine manufacturing project by Morocco :
As part of the Atlas project, an anti-Covid19 vaccine production project in Morocco, a delegation of powers is assigned by the Minister of Health to the Serum and Vaccine Center (CSV) to ensure the management of all pharmaceutical acts related to the Thread & Finish project of the anti-COVID19 vaccine,
in particular the management of the following pharmaceutical procedures :
- The filing of the application for registration of the Sinopharm Vaccine object of the Fil & Finish operations in Morocco
- The technological transfer between the donor and the subcontractor of the Wire & Finish operations
- The analytical transfer of the Bulk and finished product control tests
- The release of lots for distribution ;
- Supervision of the pharmaceutical operations of Fil & Finish and packaging
- Supply and control of the bulk
- The supply of equipment, reagents and consumables required for the pharmaceutical operations of Fil and Finish, packaging and analytical control.
As such, the CSV carries out the following actions :
- Registration of the COVID19 vaccine with the health authorities with a view to obtaining marketing authorization (AMM) for the vaccine
- Signature of a subcontracting contract to carry out Fil and Finish and vaccine packaging operations under the supervision of the CSV
- Supervise industrial and analytical transfer operations between Laboratories and Moroccan pharmaceutical players
- Carry out expert analyzes to control the quality of the vaccine using the CSV's in vitro and in vivo analytical control laboratory for vaccines and biological products. This laboratory is equipped with state-of-the-art equipment and a qualified and trained team.
As such, the CSV is prepared to ensure: 1) the study of the in vivo toxicity of the vaccine at its animal facility located on the Tit Mellil farm, 2) the study of the stability of the finished product to ensure the effectiveness and tolerance of the vaccine in the short and long term, according to a protocol meeting international standards.
- Depending on the results of these analyses, the CSV will validate the vaccine and release it for distribution and use and will submit it to the Directorate of Medicines and Pharmacy for final release.
- Ensure monitoring of side effects and the effectiveness of the vaccine after its administration to citizens through the implementation of pharmacovigilance and pharmacoepidemiology studies.