FDA to fast-track COVID-19 vaccine approvals

 

 

BANGKOK (NNT) - The Food and Drugs Administration will provide special facilitation for all COVID-19 vaccine approval requests both within the country and from abroad, while assuring the general public the process will be faster, with an emphasis on safety and effectiveness.

 

The Food and Drugs Administration (FDA) Secretary General Dr Paisarn Dunkum, has announced that any COVID-19 vaccine to be used in Thailand must be approved by the FDA for safety and effectiveness, while the vaccine approval process will be specially processed to reduce the waiting time.

 

He said the FDA has created a special channel for COVID-19 vaccine approval applications, via which vaccine manufacturers in Thailand or aboard can file for approval.

 

As a safeguard measure for consumers, Dr Paisarn said the FDA has prepared measures to monitor and evaluate the safety of vaccine candidates in all respects, while the public can rest assured all FDA-approved vaccines will have been assessed for their effectiveness and safety.

 

-- © Copyright NNT 2020-12-31

 

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2 minutes ago, snoop1130 said:

while assuring the general public the process will be faster, with an emphasis on safety and effectiveness.

bet they dont succeed in any of those three; this IS thailand after all; here action is defined as talking about action, not results

Can anyone tell me why every time I see a picture of the Health Minister he is never wearing a mask?  Is he pushing to be the first in line for the vaccine?  He better let his boss go first.

14 hours ago, Mango Bob said:

Can anyone tell me why every time I see a picture of the Health Minister he is never wearing a mask?  Is he pushing to be the first in line for the vaccine?  He better let his boss go first.

He's not a dirty farang, Duh

you think Thai FDA will do clinical trial or lab test to see if it i safe for the precious THAI people or just put an OK  stamp & collect payment for their services ?

Why does every country FDA need to approve the vaccines?

 

Surely it is a waste of time, money, resources and will end up the same result.

 

Why doesn't an International standards body do more thorough testing than any country could do, and approve it worldwide - this is not a country problem.

2 hours ago, Bender Rodriguez said:

you think Thai FDA will do clinical trial or lab test to see if it i safe for the precious THAI people or just put an OK  stamp & collect payment for their services ?

I could be wrong, but if Thailand FDA follows same or similar process as USA, they don’t conduct trials. It is the responsibility of the applicant to follow FDA procedures and submit application and all related studies for review. As far as you alluding to corruption, many FDA staffers in the USA look forward to better paying jobs in the private sector; so they don’t want to make a bad impression on a company that might be your future... Not saying system is corrupt, but does make for fertile ground. 

2 hours ago, Bender Rodriguez said:

you think Thai FDA will do clinical trial or lab test to see if it i safe for the precious THAI people or just put an OK  stamp & collect payment for their services ?

 

Thai FDA is a big joke, when I was importing health food I needed their approval for the products, I was told that if I pay 100.000 thb I can get the approval very fast with out any local side effect or contraindication tests needed. I did not pay them and spent months with crazy paper works and red tape but at the end we got the approval for the products. Costed us more but we were sure of that we could not be black mailed in the future from this department or their employees. 

2 hours ago, DLock said:

Why does every country FDA need to approve the vaccines?

 

Surely it is a waste of time, money, resources and will end up the same result.

 

Why doesn't an International standards body do more thorough testing than any country could do, and approve it worldwide - this is not a country problem.

 Well I wouldn’t say waist of time, inefficient bureaucracy yes; but that’s government, it’s all about systems and processes. Corporations are about outcomes and profit by whatever means necessary. Government is about asking for permission, Corporations are about asking for forgiveness, payoffs bribes... IMO, neither is well suited for the task, but it’s what we have, and seems to me so far we’re seeing amazingly good results; as far as record breaking development speed... sad we haven’t seen this level of commitment to cure other killer diseases... something short of creating the greatest economic disaster the world has seen of course.

21 hours ago, snoop1130 said:

He said the FDA has created a special channel for COVID-19 vaccine approval applications, via which vaccine manufacturers in Thailand or aboard can file for approval.

Probably a Rapid Gateway for the Chinese Vaccines from Sinopharm Etcto enter Thailand.

Good luck with those, they certainly wont be for me.

19 hours ago, DB58 said:

I could be wrong, but if Thailand FDA follows same or similar process as USA, they don’t conduct trials. It is the responsibility of the applicant to follow FDA procedures and submit application and all related studies for review. As far as you alluding to corruption, many FDA staffers in the USA look forward to better paying jobs in the private sector; so they don’t want to make a bad impression on a company that might be your future... Not saying system is corrupt, but does make for fertile ground. 

 

look up FDA REVOLVING DOOR, it is a doorway to a much better pay,, free company shares ...

 

 

https://www.google.com/search?q=FDA+REVOLVING+DOOR

 

but same people will claim again this is conspiracy theory

Bet they do something daft like reject the Oxford vaccine, because they are not sure if it is 70 or 90% effective.

ive dealt with the thai FDA here and theyre competent and do a good job,they will pass the vacc according to int standards and also use foreign guidelines as a way to do it quickly and go thru their clearing procedure.the problem is where are the vaccs!!thats up to nat govt and theyve loads a money  see their wish to buy 3 PRC subs but where when will they they get them?astra china ummm

23 minutes ago, mommysboy said:

Bet they do something daft like reject the Oxford vaccine, because they are not sure if it is 70 or 90% effective.

 

It's cheap and easy to store, compared to moderna and pfizers vaccines so even if it only has a 70% reduction in the chance of getting infected, it's a good option for Thailand. 

On 12/31/2020 at 9:00 PM, DLock said:

Why does every country FDA need to approve the vaccines?

 

Surely it is a waste of time, money, resources and will end up the same result.

 

Why doesn't an International standards body do more thorough testing than any country could do, and approve it worldwide - this is not a country problem.

That's a good question that nobody seems to have a good answer to.  I think the WHO does have an an organization trying to do something like that called COVAX.

https://www.who.int/initiatives/act-accelerator/covax

 

But it still needs to go through each countries local approvals, for now.

Edited January 2, 20215 yr by shdmn