Moderna COVID-19 vaccine waits for approval from Thai FDA

[webfact]

(FILES) In this file photo Dr. Nita Patel, Director of Antibody discovery and Vaccine development, lifts a vial with a potential coronavirus, COVID-19, vaccine at Novavax labs in Gaithersburg, Maryland on March 20, 2020, one of the labs developing a vaccine for the coronavirus, COVID-19. – The CEOs of nine companies developing vaccines against Covid-19 on September 8, 2020 pledged to “uphold the integrity of the scientific process” amid concern Donald Trump will pressure regulators to approve a vaccine ahead of the presidential election in November. “We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” said the CEOs.The statement was signed by AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi. (Photo by ANDREW CABALLERO-REYNOLDS / AFP)

 

Thailand’s Public Health Ministry is looking to procure the Moderna COVID-19 vaccine through the Government Pharmaceutical Organization (GPO), after a discussion with a Moderna representative today.

 

The Moderna COVID-19 vaccine was developed in cooperation with the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).

 

Thailand’s Public Health Minister, Anutin Charnvirakul, said that the ministry is ready to support Moderna’s registration with Thai FDA, after the company submitted the necessary documents, which the FDA confirms are complete. The Moderna vaccine could be approved within this month.

 

Full story: https://www.thaipbsworld.com/moderna-covid-19-vaccine-waits-for-approval-from-thai-fda/

 

-- © Copyright Thai PBS 2021-05-04

 

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[sammieuk1]

Always good to keep flip flopping as your population gets slain by a rampant disease no rush I suppose as the generals have been jabbed weeks ago ????

[edwinchester]

The UK bought stocks of this vaccine last November. Tragic that Thailand has waited so long to even begin the process.

[ikke1959]

we wait and wait and check and wait ... in the meantime we cry a bout the rising numbers. I am wondering why vaccines, working good in other parts of the world, which are tested several times already, why this countrry just can't say ok. we make a deal sent them asap, instead of waiting for what?? nobody knows.  Waste of time  

[arick]

A month. Should of been approved Months ago. But then this is a Country where there do a PAP screen on terminal cancer patients with weeks to live and offer chemo to everybody free just to kill them quicker. 

[Jeffr2]

4 minutes ago, arick said:

A month. Should of been approved Months ago. But then this is a Country where there do a PAP screen on terminal cancer patients with weeks to live and offer chemo to everybody free just to kill them quicker. 

Kill them quicker?  I've got many friends who went through chemo and are doing OK now.  And some, who didn't make it.

[Nowisee]

Greed.
Arrogance. 
Incompetence.
Corruption.

Edited May 4, 2021 by Nowisee

[internationalism]

moderna has applied already in march, probably around middle of month.

now they are saying it will be approved this month.

stretching the whole process to around 2 months.

But because earlier it was only private import for hospitals, the officials did not care about.

  

[spidermike007]

Anutin has already blown this, to a staggering degree. Way too late to the game, and no batting skills anyway. A true neophyte, too little, too late. Hopefully, he will go down in history, as one of the primary causes of this latest wave. Inaction has a price. 

 

Picking the lowest quality selection available, occasionally works if you are shopping at a swap meet, and only brought $5. It rarely works out for important ministerial positions, during a crisis, where skill, vision, talent and experience are needed. 

 

Prayuth does not have the guts or integrity to fire you, so do the Thai people a favor and just resign now and admit you failed on every single level. 

Edited May 4, 2021 by spidermike007

[mtls2005]

4 hours ago, webfact said:

The Moderna vaccine could be approved within this month.

 

Meanwhile Sinovac was approved, in four hours, while the first shipment sat on the runway at BKK (or was it DMK?).

 

Interesting.

 

 

[newnative]

1 hour ago, ikke1959 said:

we wait and wait and check and wait ... in the meantime we cry a bout the rising numbers. I am wondering why vaccines, working good in other parts of the world, which are tested several times already, why this countrry just can't say ok. we make a deal sent them asap, instead of waiting for what?? nobody knows.  Waste of time  

      We wait and wait and wait for the local production to get up and running.  They've nicely dragged their feet all these months on other vaccines and the local AZ plant comes online soon.  So, now they can start to begin the approval process for other vaccines. 

[Jeffr2]

17 minutes ago, spidermike007 said:

Anutin has already blown this, to a staggering degree. Way too late to the game, and no batting skills anyway. A true neophyte, too little, too late. Hopefully, he will go down in history, as one of the primary causes of this latest wave. Inaction has a price. 

 

Picking the lowest quality selection available, occasionally works if you are shopping at a swap meet, and only brought $5. It rarely works out for important ministerial positions, during a crisis, where skill, vision, talent and experience are needed. 

 

Prayuth does not have the guts or integrity to fire you, so do the Thai people a favor and just resign now and admit you failed on every single level. 

Agreed, but many other countries are in the same shape.  There's a huge backlog of orders.  I think the EU ordered a bunch of Pfizer.  J&J canceled their deliveries there.  And AZ didn't deliver like they promised.

 

Not easy dealing with this mess.  Though I agree, Thailand has screwed up royally on this.  Especially considering how they are tightly tied to tourism.

[Antifreeze]

One or all of the above. Why would it take so long to approve mRNA-based vaccines when most countries have already approved them and have been proven to provide the best possible protection? 

[poskat]

"Why would it take so long to approve mRNA-based vaccines when most countries have already approved them and have been proven to provide the best possible protection? "

 

Obviously its because Thailand is known worldwide for its exceptionally rigorous quality control measures....

[internationalism]

35 minutes ago, mtls2005 said:

 

Meanwhile Sinovac was approved, in four hours, while the first shipment sat on the runway at BKK (or was it DMK?).

 

Interesting.

 

 

sinovac was ordered on 4th of january, approved within a month, arrived on 24.2. Was several days faster than AZ ordered from Italy, but in the face of EU ban on export it arrived from Korea with 2 weeks delay.

no matter what vax there is a waiting time, many months, to get it.

 

the moderna was planned by private hospitals for august, so thai officials put the red tape and only now things will move on.

Still, yesterday meeting with moderna was the first official one, no date of import was given. Waiting time is longer, than for moderna or sinovac, maybe autumn. Just before the 4th wave

[hotchilli]

5 hours ago, webfact said:

Thailand’s Public Health Minister, Anutin Charnvirakul, said that the ministry is ready to support Moderna’s registration with Thai FDA, after the company submitted the necessary documents, which the FDA confirms are complete. The Moderna vaccine could be approved within this month.

Should have been completed last year.... 2nd & 3rd wave could have been avoided.

We all know why it wasn't.

[morrobay]

25 minutes ago, Jeffr2 said:

 

 Though I agree, Thailand has screwed up royally on this.  Especially considering how they are tightly tied to tourism.

And especially these days when all those  potential tourists are very informed about what's going on.

[cardinalblue]

Why do you hang out with such a healthy population?

[alyx]

1 hour ago, mtls2005 said:

 

Meanwhile Sinovac was approved, in four hours, while the first shipment sat on the runway at BKK (or was it DMK?).

 

Interesting.

 

 

Not that it matters but DMK is still in BKK (you meant Suwanhabhum I guess) ????

[skorp13]

Lets see here. Moderna was one of the approved vaccines for foreigners to have a reduced quarantine whlle they were making sense yet it was never approved for Thai consumption. Foreigners with this vaccine were good to go in Thailand but Thai's.....not yet.   DOH!

[Enzian]

3 hours ago, ikke1959 said:

we wait and wait and check and wait ... in the meantime we cry a bout the rising numbers. I am wondering why vaccines, working good in other parts of the world, which are tested several times already, why this countrry just can't say ok. we make a deal sent them asap, instead of waiting for what?? nobody knows.  Waste of time  

We know perfectly well why we're waiting, we just can't talk about it.

[John Drake]

3 hours ago, internationalism said:

moderna has applied already in march, probably around middle of month.

now they are saying it will be approved this month.

stretching the whole process to around 2 months.

But because earlier it was only private import for hospitals, the officials did not care about.

  

 

And at the same time, back in March, approval for Sinovac went through in less than 48 hours.

[connda]

Placed in the same file as the other "applications" no doubt:

[hotchilli]

2 hours ago, skorp13 said:

Lets see here. Moderna was one of the approved vaccines for foreigners to have a reduced quarantine whlle they were making sense yet it was never approved for Thai consumption. Foreigners with this vaccine were good to go in Thailand but Thai's.....not yet.   DOH!

Because Prayut didn't want to buy it... just wait fort AZ vaccine manufactured here in Thailand.

[connda]

3 hours ago, poskat said:

"Why would it take so long to approve mRNA-based vaccines when most countries have already approved them and have been proven to provide the best possible protection? "

It is in direct competition with the single, sole-sourced 'approved' $hot manufactured in Thailand.  The upper crust of Thai power elite like and $upport monopolies, and in this case, the public welfare be da*med.

[mtls2005]

3 hours ago, internationalism said:

sinovac was ordered on 4th of january, approved within a month, arrived on 24.2.

 

The Thai FDA approved Sinovac on 23 Feb.

 

The first batch was delivered on 24 Feb.

 

 

Interesting.

[placnx]

5 hours ago, Jeffr2 said:

Agreed, but many other countries are in the same shape.  There's a huge backlog of orders.  I think the EU ordered a bunch of Pfizer.  J&J canceled their deliveries there.  And AZ didn't deliver like they promised.

 

Not easy dealing with this mess.  Though I agree, Thailand has screwed up royally on this.  Especially considering how they are tightly tied to tourism.

WSJ reported that Moderna will be producing 3bn doses next year. Their contract manufacturer in Switzerland is doubling their production lines.

[Jeffr2]

31 minutes ago, placnx said:

WSJ reported that Moderna will be producing 3bn doses next year. Their contract manufacturer in Switzerland is doubling their production lines.

It would be nice to have some clarity as to when these jabs will arrive.  Since no specific dates have been set, I'm guessing end of the year.  Or so!

[Banana7]

Free Moderna and Pfizer vaccine starting June 1, upon landing at any airport in Alaska USA. You can also get the second jab free, if you stay 30 days.

[internationalism]

3 hours ago, mtls2005 said:

 

The Thai FDA approved Sinovac on 23 Feb.

 

The first batch was delivered on 24 Feb.

 

 

Interesting.

you might be right in this detail.

my point was that AZ emergency order took almost same time to deliver, as sinovac.

 

in fact the AZ was stored at the thai warehouse over 2 weeks while waiting for additional paperwork from Korea (the original approval was for the italian one, but not korean).

 

the point is, there is a red tape on thai side for import of every single vax. They want only locally made ones