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Thai regulator approves AstraZenca vaccine for emergency use: sources


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Thai regulator approves AstraZenca vaccine for emergency use: sources

By Panarat Thepgumpanat

 

2021-01-21T104607Z_1_LYNXMPEH0K0LZ_RTROPTP_4_HEALTH-CORONAVIRUS-ASTRAZENECA-RUSSIA.JPG

FILE PHOTO: A health worker fills a syringe with a dose of the Oxford/AstraZeneca COVID-19 vaccine at the Appleton Village Pharmacy, amid the coronavirus disease (COVID-19) outbreak, in Widnes, Britain, January 14, 2021. REUTERS/Jason Cairnduff

 

BANGKOK (Reuters) - Thailand's Food and Drug Administration (FDA) has granted emergency use approval for the COVID-19 vaccine of AstraZeneca Plc, three health ministry sources said on Thursday.

 

Thailand is set to import 200,000 doses of the AstraZeneca vaccine with the first 50,000 doses expected to arrive next month, Health Minister Anutin Charnvirakul said on Wednesday.

 

The three senior ministry sources, who requested anonymity because they were not authorised to speak to media, said the regulator had approved the AstraZeneca vaccine on Wednesday, applicable for a period of one year.

 

One of the sources said approval applied only to doses manufactured overseas.

 

Thailand has signed a deal with AstraZeneca to produce 26 million doses of its vaccine locally through the firm Siam Bioscience.

 

Thailand's FDA has so far received registration requests for vaccines from AstraZeneca and China's Sinovac Biotech.

 

It hopes to secure 63 million doses altogether and has so far ordered 2 million doses of that made by China's Sinovac Biotech.

 

The approval comes as Thailand tries to contain its biggest coronavirus outbreak yet, which has seen cases triple in the pasty five weeks, albeit from a low base.

 

It reported 142 new infections on Thursday, taking the total to 12,795, with 71 deaths.

 

Bangkok authorities said on Thursday some business activities would be allowed to resume, in response to declining coronavirus infections in the capital after curbs were imposed.

 

Thirteen types of businesses including gyms, traditional massage services, sport facilities and bowling alley can reopen from Friday, but with strict health protocols. Schools, daycare centres and bars will remain closed.

 

A spokesman for the city government said Bangkok had received at the most 49 COVID-19 new daily patients and that number was now down to about 10.

 

"We have rapidly controlled the situation during this one month," spokesman Pongsakorn Kwanmuang said.

 

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-- © Copyright Reuters 2021-01-21
 
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5 minutes ago, snoop1130 said:

One of the sources said approval applied only to doses manufactured overseas

thais being thais will never be able to keep this straight

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19 minutes ago, snoop1130 said:

The three senior ministry sources, who requested anonymity because they were not authorised to speak to media

So why did they?  On any subject they just can't keep their mouths shut.

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16 minutes ago, snoop1130 said:

One of the sources said approval applied only to doses manufactured overseas.

May be they went cap in hand to India who are already mass producing AZ's vaccine and shipping it abroad, its a pity its taking so long to produce here, not till middle of this year but what do you expect from a company that has never produced a vaccine before.

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16 hours ago, snoop1130 said:

The three senior ministry sources, who requested anonymity because they were not authorised to speak to media, said the regulator had approved the AstraZeneca vaccine on Wednesday, applicable for a period of one year.

So much for transparency....

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3 hours ago, Srikcir said:

Supply by Siam Bioscience...

In 2018 ranked 6th out of top 10 pharma companies in Thailand.

Among top 5:

Pfizer

GSK

MSD

Novartis

Roche

https://pharmaboardroom.com/facts/top-10-pharma-companies-in-thailand-2018/

 

Seems to be a sufficient field of competent & qualified competitors to bid on the government's supply of A-Z as normally required by Thailand procurement laws. 

But I see no mention of any bidding or solicitation process (even if there was only 1 bidder). 

Perhaps clarification is needed to assure the Thai taxpayers that the government is making cost-effective purchases of the Covid-19 vaccines in a time of a very "delicate" economy.


The way of getting clarification would be, if this issue becomes more controversial with the entry of Thanathorn into the arena. The Thai government is not accountable but AZ is a UK listed company and any unpleasantness could encourage activists to pop up with embarrassing questions about the selection process in the next shareholders meeting.

 

Interestingly Thai press releases published overseas last year emphasized the ‘not for profit’ nature of the deal. It was not explained why the government would want to provide financial assistance to a ‘not for profit’ venture that planned to export 87% of its production but perhaps what was meant was that the sales to Thailand would be ‘not for profit’. Siam Cement was also said to be involved then but no further mention of it now.

 

One interesting point made in a VOA article last year was that Thai regulators made approval partly dependent  the percentage of local production. That implies lack of efficiency just like the local content rules in the auto industry. Probably the most efficient and safest mode of local production in Thailand would be to import the vaccine in bulk and merely bottle it here.

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FDA approves COVID-19 AstraZeneca vaccine for emergency use

 

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BANGKOK (NNT) - The FDA Secretary General Paisal Dunkhum, said today the FDA had approved the registration of the COVID-19 vaccine produced by AstraZeneca in Italy, after the company had sent nearly 10,000 pages of documents for registration in Thailand for approved use during the state of emergency since December 22, 2020. Efficacy, quality and safety of the vaccine was considered by the FDA.

 

He added that the first delivery of vaccine from AstraZeneca is due in February, consisting of 50,000 doses. The import license lasts one year. When the vaccine arrives in Thailand, the Department of Medical Sciences will conduct a random inspection of the vaccine to determine its quality before providing it to people. More deliveries, numbering 150,000 doses of vaccine in total, will follow in March and April, he said.

 

As for the production of the COVID-19 vaccine by AstraZeneca and Siam Bioscience, he said registration of a production facility in Thailand will allow it to become effective in Thailand in May.

 

 

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