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Sinopharm vaccine approved by FDA

The Food and Drug Administration (FDA) has approved the Sinopharm coronvirus vaccine for emergency use in Thailand.

The FDA on Friday approved the registration application for Sinopharm’s Covid-19 vaccine  submitted by Biogenetech Co.

It is the fifth coronavirus vaccine approved so far in Thailand, FDA secretary-general Paisarn Dankum told a news conference.

It is an inactivated vaccine, manufactured by Beijing Institute of Biological Product Co, and  requires two doses with the recommended interval being 28 days.

Sinopharm has already been approved by the World Health Organisation for emergency use listing, Dr Paisarn said.

He said registration of Covid-19 vaccines in Thailand focused on safety and effectiveness of the vaccine. The FDA had examined documents submitted by the vaccine importer before approving it for emergency use. 

The approval shows that the FDA is not preventing the private sector applying for registration of Covid-19 vaccines, the FDA secretary-general said.

On reports that Accap Assets Co would sell 20 million doses of the Chinese-made Sinopharm vaccine to the Chulabhorn Royal Academy, Dr Paisarn said said an initial examination found that the firm had not received a permit to import medicines. It had not  registered for Covid-19 vaccine with the FDA.

Legally, those who wanted to import a vaccine must receive permission and must apply for registration of the vaccine with the FDA before importing it.

In the case of the Sinopharm vaccine, the FDA had approved the registration of the vaccine to Biogenetech Co, which submitted documents and followed proper procedures, the FDA secretary-general said.

Applications to register two other Covid-19 vaccines — Sputnik V and Covaxin – were in the process of submitting documents for approval.

The Thai FDA earlier approved the vaccines made by AstraZeneca Thailand on Jan 20 this year, Sinovac Biotech imported by GPO on Feb 22, Johnson & Johnson on March 25, and Moderna on May 13.

A spokesman for the royal academy chaired by Princess Chulabhorn confirmed on Friday that it would import one million doses of Sinopharm’s Covid-19 vaccine next month, Reuters reported.

“We want to help plug in the gaps for business, schools, so they can move forward,” Nithi Mahanonda, secretary-general of the Chulabhorn Royal Academy told a news briefing.

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