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FDA approves use of Sinopharm vaccine

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

COVID-19CoronavirusVaccine
By Bangkok Post

Saturday 29 May 2021, 09:05AM


Dr Nithi Mahanonda (left), secretary-general of Chulabhorn Royal Academy, and Public Health Minister Anutin Charnvirakul, at a press conference on a plan to procure doses from Sinopharm. Photo: Chanat Katanyu / Bangkok Post

Dr Nithi Mahanonda (left), secretary-general of Chulabhorn Royal Academy, and Public Health Minister Anutin Charnvirakul, at a press conference on a plan to procure doses from Sinopharm. Photo: Chanat Katanyu / Bangkok Post

The FDA on Friday (May 28) 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 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.

Internal - Phuket News TV

“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.

CRA to sell Chinese shots privately

One million doses of COVID-19 vaccine from Chinese state-owned Sinopharm will arrive in June and be offered as a paid alternative for particular groups who don’t want to wait, the Chulabhorn Royal Academy (CRA) announced on Friday.

Dr Nithi Mahanonda, the CRA secretary-general, said that as the vaccine will be procured with the academy’s budget, it could not be offered free of charge.

The private sector or any agencies which are at risk and want to speed up the process for their staff can contact the academy, Dr Nithi told a press conference.

The price of the vaccine will not exceed B1,000 per shot, including insurance, said Dr Nithi.

On Thursday, the CRA announced the plan to procure a supply from Sinopharm vaccine, manufactured by the Beijing Institute of Biological Product Co, as an alternative to the two formulas from Sinovac and AstraZeneca that are currently being relied on.

The announcement received a warm welcome from many, particularly as the Sinovac shot has still not been granted emergency approval by the World Health Organization.

However, most people assumed that the imports would be offered free of charge as an adjunct to the state vaccination programme.

"As I have clarified, this is another choice. I do not think that members of the public can come to receive it or it may get mixed up with the state vaccines," said Dr Nithi.

"This supply is being reserved to help alleviate current shortages among high-need groups and enable the Public Health Ministry to give some schools and private sector businesses another avenue to secure protection for their pupils and employees."

A number of organisations have already made inquiries about buying doses of the vaccine, including the Federation of Thai Industries and PTT Plc, according to Dr Nithi.

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