COVID-19 vaccines only authorised with sufficient scientific data, says health official

by NDO23 June 2021 Last updated at 15:23 PM

A volunteer is getting a dose of home-grown Nano Covax COVID-19 vaccine in the third phase of its human trials. (Photo: Laodong.vn)
A volunteer is getting a dose of home-grown Nano Covax COVID-19 vaccine in the third phase of its human trials. (Photo: Laodong.vn)

VTV.vn - In the current context, the emergency authorisation of a type of COVID-19 vaccine is necessary but must be based on the principle of having sufficient scientific data, a health official said.

On June 22, the Nanogen Pharmaceutical Biotechnology JSC recommended to the Ministry of Health (MOH) on the emergency authorisation of COVID-19 vaccine Nano Covax, which is currently in phase 3a of clinical trials, with the involvement of 1,000 volunteers.

Responding to the company’s suggestion, Dr. Nguyen Ngo Quang - Deputy Director of the Science, Technology and Training Department (MOH) - stated that in principle, the ministry must acquire full data on safety, immunogenicity and especially efficacy of a vaccine before widely rolling out the immunisation for the people.

The issuance of a decision on the emergency authorisation of a vaccine depends on many factors, he said, adding that the MOH needs sufficient scientific data to decide on whether to grant emergency authorisation or not.

“The goal of the health sector is to protect people’s health, so it is necessary to carefully weigh the benefits and risks. The cautious approval of a vaccine is not meant to trouble businesses,” Quang affirmed.

According to the official, current data has shown that COVID-19 vaccine Nano Covax is safe and immunogenic, but its efficacy is still under research and further testing.

Regarding the completed phase-three trial of Nano Covax on 1,000 volunteers, Quang said: “In the event that Vietnam cannot access imported vaccine sources by August-September 2021 and the COVID-19 situation in the country becomes tense, the MOH’s scientific and morality councils will base on data proving Nano Covax’s safety, immunogenicity and efficacy from the first 1,000 injection cases when considering authorisation in emergency situations.”

If Vietnam can negotiate and access imported vaccine sources regarding the vaccines with specific research results such as Pfizer, Moderna, Sputnik or other WHO-approved ones, the imported sources will be prioritised for use, he added.

Quang also reiterated the MOH’s viewpoint of supporting the research and development of domestic COVID-19 vaccines to facilitate Vietnam’s vaccine proactivity, hailing this as a righteous direction of the Government.

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