Vietnam: To urgently approve Russia's SPUTNIK V vaccine

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.

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