The Covid-19 Abdala vaccine has just been conditionally approved by the Ministry of Health, in order to serve the urgent needs in the prevention and control of the Covid-19 epidemic.
The Ministry of Health, based on the provisions of Article 67 of Decree No. 54/2017/ND-CP dated May 8, 2012 of the Government, detailing a number of articles and measures to implement the Law on Pharmacy, to approve vaccines. Abdala.
The Abdala vaccine is manufactured by AICA Laboraries, Base Business Unit (BBU) AICA – Cuba and the Center for Genetic Engineering and Biotechnology (CIGB) – Cuba is the place to export semi-finished products and pack level 2. In Vietnam, the place where this vaccine is proposed to be approved is the Center for Research and Production of Vaccines and Medical Biologicals (POLYVAC).
The packaging of Abdala vaccine is 10 vials per box, and each vial corresponds to 10 doses of vaccine. Each 0.5ml dose contains 50 mcg of recombinant protein vaccine containing the receptor-binding region (RBG) of the SARS-CoV-2 virus, and is prepared in suspension for intramuscular injection.
The Ministry of Health also stipulates the conditions attached to the approval of Abdala. Specifically, when receiving the dossier of the importing establishment, the Drug Administration of Vietnam will be the unit responsible for licensing the import of Abdala vaccine. At the same time, this unit will also be responsible for strictly complying with the provisions of the law on import management and quality control of imported vaccines.
Regarding the unit that is qualified to evaluate the safety and effectiveness of the vaccine, the Department of Science, Technology and Training is the unit responsible for selecting. This decision is made based on the advice of the Advisory Council on the use of vaccines and medical biological products of the Ministry of Health (Advising Council) during use.
At the same time, in order to evaluate the safety and effectiveness of the Abdala vaccine, this unit will also be responsible for guiding and directing the unit that has the prescribed conditions to organize the assessment, based on the advice of the Advisory Council during the use.
The responsibilities related to Abdala vaccination are regulated, the Department of Preventive Medicine will be the implementing unit. The responsibility for testing and issuing the Certificate of Ex-works for Abdala vaccine batches before being put into use belongs to the National Institute for Testing of Vaccines and Medical Biologicals.
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