The Ministry of Health adds 0.25ml injection dose for Moderna . vaccine
On March 31, the Ministry of Health decided to amend Article 1 of Decision No. 3122/QD-BYT dated June 28, 2021 of the Minister of Health to conditionally approve vaccines for urgent needs in the room. fight against the COVID-19 pandemic.
The Ministry of Health adds 0.25ml injection dose for Moderna . vaccine
Accordingly, in Article 1 of this latest Decision, the Ministry of Health conditionally approves vaccines for urgent needs in the prevention and control of the COVID-19 epidemic according to the provisions of Article 67 of Decree No. 54/2017/ND -CP dated May 8, 2017 of the Government detailing a number of articles and measures to implement the Law on Pharmacy (Decree 54/2017/ND-CP), specifically:
Vaccine name: Spikevax (Other names are: COVID-19 Vaccine Moderna; Moderna COVID-19 Vaccine; Moderna mRNA-1273 Vaccine, COVID-19 mRNA Vaccine (nucleoside modified)).
Active ingredients, concentration/content:
Each dose (0.5ml) contains 100mcg elasomeran, Covid-19 vaccine mRNA (encapsulated in SM-102 lipid nanoparticles).
Each dose (0.25ml) contains 50mcg elasomeran, Covid-19 vaccine mRNA (wrapped in SM-102 lipid nanoparticles) ( supplementing this dose compared to the previous decision 3122/QD-BYT dated June 28, 2021)
Dosage forms: Suspension for intramuscular injection.
Packing: Box contains 10 multi-dose vials.
For 0.5ml dose: Each multi-dose vial contains 10 doses.
Each multidose vial contains a maximum of 11 doses: in the range of 10 -11 doses; Each multidose vial contains a maximum of 15 doses: in the range of 13-15 doses (addition of this information compared to previous decision 3122/QD-BYT dated June 28, 2021)
For the 0.25ml dose: Each multi-dose vial contains up to 20 doses.
Manufacturer’s name – Country of manufacture:
Rovi Pharma Industrial Services, SA – Spain.
Recipharm Monts – France.
Moderna TX, Inc – USA;
Catalent Indiana, LLC – USA;
Lonza Biologics, Inc – USA
Baxter – USA;
Moderna Biotech – Spain;
Samsung Biologics Co., Ltd. – South Korea.
In this latest decision, the Ministry of Health annulls the Decision No. 3122/QD-BYT dated June 28, 2021 of the Minister of Health on conditionally approving vaccines for urgent needs in the prevention and control of the COVID-19 epidemic. -19 and decisions amending Decision 3122.
As of March 27, the Ministry of Health said that Vietnam has received 227.8 million doses of COVID-19 vaccine, of which more than 14 million doses of Moderna vaccine.
Regarding the Moderna vaccine, based on the conclusions of the Advisory Council for the issuance of circulation registration certificates of drugs and medicinal ingredients, the Drug Administration of Vietnam has agreed to update the expiry date of the COVID-19 vaccine Spikevax (another name for the vaccine). Moderna) from 7 months to 9 months (from the date of manufacture) at storage conditions of -25 degrees Celsius to -15 degrees Celsius for these vaccine production facilities that have been approved by the Ministry of Health for urgent needs. in the prevention and control of the COVID-19 epidemic.
This update to the expiry date applies to batches of Spikevax vaccine imported into Vietnam from March 2, 2022.
Previously, updating the expiry date of the COVID-19 vaccine Spikevax was also approved by the World Health Organization (WHO) on February 9, 2022, and the European Medicines Agency (EMA) approved the date. December 8, 2021, the US Food and Drug Administration (US FDA) approved on January 31, 2022 and the drug regulatory agencies of the UK, Australia, Canada, Switzerland…
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