On March 23, 2021, the Ministry of Health of Vietnam had Decision 1654/QD-BYT on conditional vaccine approval for urgent covid-19 prevention and control
Vietnam: To urgently approve Russia's SPUTNIK V vaccine (Artwork)
Conditional approval is granted to the following vaccine, which is used for urgent COVID-19 prevention and control, according to regulations in Article 67 of the Decree 54/2017/ND-CP:
(1) Vaccine name: Gam-COVID-Vac (also known as SPUTNIK V).
(2) Active ingredient and concentration/content:
- Component I (first dose): each dose of 0,5ml contains (1,0 ± 0,5) x 1011 particles of recombinant human adenovirus serotype number 26 containing SARS-CoV-2 protein S gene.
- Component II (second dose): each dose of 0,5ml contains (1,0 ± 0,5) x 1011 particles of recombinant human adenovirus serotype number 5 containing SARS-CoV-2 protein S gene.
(3) Dosage form: injection solution.
(4) Packaging specification: each box shall contain 1 vial of 3ml (equivalent to 5 doses).
(5) Manufacturer - manufacturing country: JSC Generium - Russia.
(6) Vaccine approval applicant: Center for Research and Production of Vaccines and Biologicals (POLYVAC).
In which:
- Drug Administration of Vietnam shall:
+ Grant permits for Gam-COVID-Vac vaccine import according to regulations in Article 67 of Decree 54/2017/ND-CP after receiving applications from importers.
+ Comply with regulations of law on import management and imported vaccine quality control.
- Administration of Science Technology and Training shall take charge of clinical evaluation of the safety and immunogenicity of Gam-COVID-Vac vaccine in Vietnam.
- General Department of Preventive Medicine shall take responsibility for matters concerning administration of the Gam-COVID-Vac vaccine according to regulations in Decision No. 1464/QD-BYT dated 05/03/2021 by the Minister of Health on guidelines for receiving, preserving, distributing and using COVID-19 vaccine and Decision No. 1467/QD-BYT dated 05/03/2021 by the Minister of Health of Vietnam approving 2021 - 2022 COVID-19 vaccination plan.
- National Institute for Control of Vaccine and Biologicals shall inspect the Gam-COVID-Vac vaccine before it is put to use.
More details of conditions attached to the approval of the Gam-COVID-Vac vaccine can be found in: Vietnam's Decision 1654/QD-BYT effective from 23/3/2021.
- Key word:
- Decision 1654/QD-BYT in Vietnam