|Moderna COVID-19 vaccine vials. — AFP/VNA Photo|
HÀ NỘI — Việt Nam's health ministry has granted conditional approval for the Moderna COVID-19 vaccine for emergency use.
The product, Spikevax, is the fifth vaccine to be authorised, following AstraZeneca, Sputnik V, Pfizer, and Sinopharm vaccines.
The authorisation document said each dose of 0.5ml contains 100mcg mRNA materials protected by lipid nanoparticles SM-102, and that the vaccines come in a box containing 10 vials which hold 10 doses.
The manufacturing plants of Moderna vaccines approved for use in Việt Nam are listed as Rovi Pharma Industrial Services, S.A. in Spain, and Recipharm Monts in France, which could be subjected to changes depending on supply capacity.
The Việt Nam’s branch of Zuellig Pharma, distribution partner of Moderna in Asia, was the one submitting the dossiers – with data on vaccine safety, quality, and efficacy updated to June 23, 2021 – for approval.
Zuellig Pharma Việt Nam Co Ltd is responsible for coordinating with the vaccine manufacturers to ensure the production of the vaccines imported into Việt Nam and to ensure the safety, effectiveness and quality.
The company must also coordinate with vaccine distributors and users to deploy a comprehensive drug safety system for this vaccine in Việt Nam in accordance with the law.
The company is ordered to work with the Department of Preventive Medicine to issue instructions on storage, distribution and use of Spikevax in Việt Nam, and coordinate with the health ministry to implement risk management for the vaccine during its circulation in Việt Nam.
In April, the World Health Organization has approved Moderna vaccines for emergency use, with efficacy found to reach 94.1 per cent.
Moderna vaccines, similar to its mRNA-based Pfizer counterpart, requires ultra cold chain storage set at -25 to -15 degrees Celsius, but WHO notes that vials could be stored at normal fridge temperature of 2-8 degrees Celsius about a month prior to withdrawal of first dose.
WHO’s Strategic Advisory Group of Experts on Immunization (SAGE)’s interim guidance recommend the vaccine for all age groups 18 and above.
Vietnamese health authorities said early June they had placed an order for five million doses of Moderna vaccines, in addition to potential donation from the US following President Joe Biden’s pledge to share its surplus doses totalling some 580 million with the developing nations, which include Việt Nam. — VNS