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DMS Approves Siam Bioscience’s AstraZeneca Vaccine

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By Paphamon Arayasukawat

   

BANGKOK (NNT) - The Department of Medical Sciences (DMS) has approved the standard for samples of AstraZeneca vaccine licensed to be produced locally, which has been registered with the Food and Drug Administration (FDA) and was manufactured using AstraZeneca’s viral vector technology.

 

DMS Director-General Dr Supakit Sirilak said on Tuesday that samples of five models of the vaccine, which had been tested for consistency in production, were presented to the department for approval. The department has run tests on them and found they satisfied all manufacturing criteria specified in the registration.

 

He said the vaccine passed the full tests for requirements such as chemical composition and safety. The results of the analysis of the vaccine’s quality will be cited in support of having the vaccine mass-produced by Siam Bioscience.

 

The company is expected to deliver the first batch of locally produced vaccines to the government next month, with further supplies earmarked for export.

 

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Good news, a step closer

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I really , REALLY hope it's good news for Thailand and the vaccine roll out and getting back to the wife and daughter after 13 months away. I just worry in a country ridden with corruption something will go awry 

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...and after sending to the Government next month, then to Europe and the USA for quality inspections and then finally to Astra Zeneca for final approval  (it still may need Thai FDA approval after that) - no dates on that yet.

 

Latest is that Siam Bioscience says that July delivery "is still feasible" but with no comment on numbers.

11 minutes ago, DLock said:

...and after sending to the Government next month, then to Europe and the USA for quality inspections and then finally to Astra Zeneca for final approval  (it still may need Thai FDA approval after that) - no dates on that yet.

 

Latest is that Siam Bioscience says that July delivery "is still feasible" but with no comment on numbers.

It will be rubber stamped approved.

2 minutes ago, holy cow cm said:

It will be rubber stamped approved.

 

It wont be rubber stamped if it fails quality control in US or Europe, or fails AZ tests...they cannot risk that, regardless of who owns SB.

 

Thailand will rubber stamp if as long as it gets approval. 

1 minute ago, DLock said:

 

It wont be rubber stamped if it fails quality control in US or Europe, or fails AZ tests...they cannot risk that, regardless of who owns SB.

 

Thailand will rubber stamp if as long as it gets approval. 

Already is approved here. 

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6 minutes ago, holy cow cm said:

Already is approved here. 

 

Those batches already here from other factories have already gone through the same regulatory testing and approval process that all new factories and samples go through.

 

SB now needs to go through the exact same process.

 

After being approved by AZ in Europe, it will still need to be registered by the Thai FDA, but I can't see that taking more than a few seconds.

 

So, while other AZ vaccines are approved here, the SB version of the vaccine is not.

3 hours ago, webfact said:

DMS Director-General Dr Supakit Sirilak said on Tuesday that samples of five models of the vaccine, which had been tested for consistency in production, were presented to the department for approval. The department has run tests on them and found they satisfied all manufacturing criteria specified in the registration

Was it tested in the same lab as the samples from the weightlifters?

4 hours ago, webfact said:

with further supplies earmarked for export.

There you have the reason for all the " confidence  " in SB

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This is excellent news, the AZ vaccine is proving to be very effective in the UK where they are using it to vaccinate about half the people (the older half) based on what I've read, Pfizer being the other main vaccine used over there.

 

I believe they're not manufacturing this in isolation and it's supervised by AstraZeneca - the vaccine output from the factory should be identical in every way to that being produced in Europe.

 

This will stop COVID dead, they should still however not only rely on one vaccine.

 

If I was in charge we would be have tens of millions of doses of both the Pfizer and Moderna vaccines on order as well.

 

It has been suggested that the Moderna vaccine is more suited for the younger members of the population.

 

 

so it's not July (quoted the last week), nor June, but May.

Good news, if true news.

I will mark 30.05 to check, if the vax is already at hospitals

5 hours ago, webfact said:

The Department of Medical Sciences (DMS) has approved the standard for samples of AstraZeneca vaccine licensed to be produced locally, which has been registered with the Food and Drug Administration (FDA) and was manufactured using AstraZeneca’s viral vector technology.

Wow!  How impressive.  April 28th 2021 in the middle of regional epidemics while first-world countries have been administering this shot for months. 

Kudos Thailand!  Fantastic job!  ????

 

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5 hours ago, webfact said:

The company is expected to deliver the first batch of locally produced vaccines to the government next month, with further supplies earmarked for export.

I wonder how many doses get "exported" while local Thais languish without adequate inoculations?

12 minutes ago, ukrules said:

This is excellent news, the AZ vaccine is proving to be very effective in the UK where they are using it to vaccinate about half the people (the older half) based on what I've read, Pfizer being the other main vaccine used over there.

 

I believe they're not manufacturing this in isolation and it's supervised by AstraZeneca - the vaccine output from the factory should be identical in every way to that being produced in Europe.

 

This will stop COVID dead, they should still however not only rely on one vaccine.

 

If I was in charge we would be have tens of millions of doses of both the Pfizer and Moderna vaccines on order as well.

 

It has been suggested that the Moderna vaccine is more suited for the younger members of the population.

 

 

 

The next step would be to discuss whether or not to follow the UK's vaccination strategy. That is concentrating on getting as many first doses into arms as fast as possible and then delay the second dose to up to 12 weeks. 

 

It doesn't seem necessary given the relatively low spread of the virus in Thailand. But given the latest numbers on the AZ vaccine being giving 70% protection and reducing transmission by 67% in the UK, it would help Thailand reduce the risks in opening up quicker for tourism. 

Just now, connda said:

I wonder how many doses get "exported" while local Thais languish without adequate inoculations?

Tricky balance between sufficient to stop people getting antsy, controlling the virus and yet maximizing profits by selling to desperate countries.....tough one.

So what does this mean?

 

Is this the one and only "approval"?

 

Or the first of a dozen?

 

I guess we'll know "next month"?

 

5 hours ago, webfact said:

The company is expected to deliver the first batch of locally produced vaccines to the government next month,

 

was June, then July, now May?

 

 

Honestly how hard would it be to be transparent and publish a plan?

 

 

55 minutes ago, Surelynot said:

Tricky balance between sufficient to stop people getting antsy, controlling the virus and yet maximizing profits by selling to desperate countries.....tough one.

 

Not tough at all.

 

Siam Bioscience is AZ's chosen manufacturing partner in Asia, and will have orders for countries and COVAX well into the hundred of million vaccines. Thailand will just be one of those orders.

 

This is not a Thailand initiative, merely a manufacturing plant based in Thailand for AZ, so Thailand, behind what it has ordered and paid AZ for, get's no special benefit.

 

They have USA and Euro quality tests to pass, then AZ must approve the samples, then each country that will be importing must approve.

 

I sure hope it's May.

 

 

1 hour ago, DLock said:

 

Not tough at all.

 

Siam Bioscience is AZ's chosen manufacturing partner in Asia, and will have orders for countries and COVAX well into the hundred of million vaccines. Thailand will just be one of those orders.

 

This is not a Thailand initiative, merely a manufacturing plant based in Thailand for AZ, so Thailand, behind what it has ordered and paid AZ for, get's no special benefit.

 

They have USA and Euro quality tests to pass, then AZ must approve the samples, then each country that will be importing must approve.

 

I sure hope it's May.

 

 

You do know who owns Siam Bioscience?

7 minutes ago, Surelynot said:

You do know who owns Siam Bioscience?

 

Ah...yes.

 

...and it's completely irrelevant. SB is a contract manufacturer for AZ and Thailand is just another Customer.

 

Why, are you suggesting something else?

2 minutes ago, DLock said:

 

Ah...yes.

 

...and it's completely irrelevant. SB is a contract manufacturer for AZ and Thailand is just another Customer.

 

Why, are you suggesting something else?

OMG.....no, no, no....never no.

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