Việt Nam authorises single-dose J&J Janssen COVID-19 vaccine for emergency use

July, 16/2021 - 07:40
Janssen is the sixth COVID-19 vaccine to be given authorisation for use in Việt Nam so far, following Oxford/Astra Zeneca, Sputnik V, Pfizer/BioNTech, Sinopharm’s Vero Cell and Moderna.

 

 

Johnson & Johnson's Janssen COVID-19 vaccines. — AFP/VNA Photo

HÀ NỘI — The Vietnamese health ministry has given conditional approval for the Johnson & Johnson single-dose COVID-19 vaccine to be used in emergency in the country.

Janssen is the sixth COVID-19 vaccine to be given authorisation for use in Việt Nam so far, following Oxford/Astra Zeneca, Sputnik V, Pfizer/BioNTech, Sinopharm’s Vero Cell and Moderna.

WHO has added Janssen vaccine for emergency use in all countries and for distribution in its global vaccine sharing initiative COVAX.

The packaging is described in the decision document, signed by Deputy Health Minister Trương Quốc Cường, as a box having 10 vials, with each 2.5ml vial containing five doses (0.5ml/dose).

The vaccine's ideal storage condition is at -20 degrees Celsius, but it could be kept at standard fridge temperatures of 2-8 degrees Celsius for three months.

A single dose of COVID-19 Vaccine Janssen is given just like any other vaccine (intramuscular injection).

The vaccines given the permission to be imported into Việt Nam are manufactured at Janssen Pharmaceutica NV in Belgium and Janssen Biologics BV in the Netherlands.

The ministry asked the Drug Administration of Việt Nam to license the import of the vaccine and abide by regulations on the management of import and the quality of imported vaccines.

Meanwhile, the Administration of Science Technology and Training will select and guide qualified units to assess the vaccine's safety and efficacy based on advice from the advisory council on use of vaccines and biologicals.

The General Department of Preventive Medicine is responsible for coordinating with the company to issue guidelines on storage, distribution and use of the Janssen products for vaccination centres.

The ministry said the approval was given after reviewing the safety, quality and efficacy data of the vaccine as provided by Johnson & Johnson Việt Nam Co Ltd by July 3.

The company must work with the health ministry to implement risks management for the vaccine during its circulation in Việt Nam.

It’s not yet known how many doses the Vietnamese health ministry is negotiating with Johnson & Johnson or that a shipment is imminent.

The last publicised meeting between the two sides was in early June, and no specific amount has been mentioned, though the military – which was put in charge of organising cold chain storages – has already accounted for the Janssen’s storage requirements in its logistics plan. — VNS

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