Thai Medical Sciences Department approves first 14 batches of locally-produced AstraZeneca vaccine

[GroveHillWanderer]

7 minutes ago, wensiensheng said:

Except if confident in their product, it would have saved time? And if it had to be changed, nothing lost except some changes to a document.

To me that would be illogical, if the final production protocol is contingent on approval being given. You could prepare the summary beforehand but you wouldn't submit it before approval, as that would be putting the cart before the horse.

[4MyEgo]

1 hour ago, jacko45k said:

Ooops, we still need just one more bit of red tape...flickering of fingers from behind back! They just cant stop themselves and bow to a sense of urgency can they?

It's called money up from before we give you the all clear, no money, no honey, same, same.

[bradiston]

7 minutes ago, internationalism said:

the last thursday 25th may they have approved 9 batches.

every few days they will approve more, but counting from 1 and calling them "first batches".

That way figures would multiply in public perception like rabbits

" that nine production lots of the AstraZeneca vaccine, manufactured locally by Siam Bioscience, passed quality inspection by the Department on May 25th."

 

 

There's some confusion over a "lot" and a "batch", but, if they're 1-1 equivalent, then anywhere from 1-3 million doses per batch. They delivered 9 on 25th, plus today's "batch". On that basis, they're on schedule it seems. But it's just guesswork.

[Caldera]

As clear as mud.

 

Do "batch" and "lot" refer to the same number of vials?

 

How many vials per lot and/or per batch?

 

Such an update is pretty much useless without knowing. 

[ezzra]

14 batches aye? well that a good start, another what? 70 millions to go?...

[wensiensheng]

43 minutes ago, GroveHillWanderer said:

To me that would be illogical, if the final production protocol is contingent on approval being given. You could prepare the summary beforehand but you wouldn't submit it before approval, as that would be putting the cart before the horse.

Agreed. I think that’s what I meant. Have it ready, when they approve production, hand over the production summery more or less simultaneously.

 

Maybe that is what is more or less happening behind the scenes and the comment about waiting for the document from the company badly worded.

 

hard to tell but provided the six million....whoops,  I mean two million doses for June are shipped on time, who cares?

[kamahele]

Well, that's a bit of good news

[wensiensheng]

40 minutes ago, bradiston said:

There's some confusion over a "lot" and a "batch", but, if they're 1-1 equivalent, then anywhere from 1-3 million doses per batch. They delivered 9 on 25th, plus today's "batch". On that basis, they're on schedule it seems. But it's just guesswork.

Impossible, even by the optimistic original schedule, they were only supposed to ship six million doses in June. And now that’s only going to be two million.

 

If they delivered 9 million already they would be way ahead of schedule.....and they aren’t.

[Srikcir]

1 hour ago, Jeffr2 said:

Per the manufactured, it's 10.  And has nothing to do with pigs.

 

Most vaccines have had issues.  J&J dump millions.  Russia's had issues.  AZ has had issues.  It's new stuff and they're making them as fast as they can.  And for sure, we need them!

 

Fingers crossed this new manufacturing facility will do well.

'Crossing Fingers' is not a scientific/medical process.

If Thai FDA monitored production since it started (government contract in December 2020, production in February 2021?), any formal acceptance now should be almost automatic, like 'checking the box' before formal distribution.

[ukrules]

2 hours ago, Nojohndoe said:

Given the urgency it has to be wondered why the Summary Protocol was not supplied with the batch  material !

 

Perhaps they're waiting for a new design of rubber stamp to be produced and approved.

 

[Justgrazing]

Always a catch when they are on about a batch .. 

And batch is also the name of a loaf of bread ( no kidding ) so you might say you may end up dead waiting for the bread ..

[bradiston]

1 hour ago, wensiensheng said:

Impossible, even by the optimistic original schedule, they were only supposed to ship six million doses in June. And now that’s only going to be two million.

 

If they delivered 9 million already they would be way ahead of schedule.....and they aren’t.

I'm sure you're right but what then did the 9 batches/lots delivered for approval on May 25th consist of?

 

I guess we'll soon find out.

[sandyf]

2 hours ago, mtls2005 said:

OK, so is "batch" a scientific term? Unit of measurement?

 

How many vials (5 ml, 10 doses) in a batch?

 

I searched a bit but it seems like most reports in the press use batch to denote a specific delivery amount.

 

Just once I'd like to see someone offer precise and transparent information.

 

 

Obviously never worked in manufacturing, a production "batch" is a variable quantity determined by the quality control dept, in either batch processing or continuous flow.

Not to be confused with a delivery batch which could be anything from part of a production batch to several production batches.

The OP would be referring to production batches and/or test batches.

[Pilotman]

manufactured in Thailand, tested and quality controlled in Thailand; humm. 

Edited June 1, 2021 by Pilotman

[Pilotman]

1 hour ago, kamahele said:

Well, that's a bit of good news

maybe 

[hotchilli]

3 hours ago, mtls2005 said:

 

There's always a catch.

 

So when can we expect the document?

 

 

 

"About six million doses of the vaccine are expected to be delivered this month."

 

This is great news.

 

Probably tomorrow.

[wensiensheng]

20 minutes ago, bradiston said:

I'm sure you're right but what then did the 9 batches/lots delivered for approval on May 25th consist of?

 

I guess we'll soon find out.

Goodness knows. I’m really only focused on how many vials they can get out the door of unquestionable quality. How they do it is up to them ????

[zoltannyc]

There was an article in The Guardian a couple of month ago.

-----------------------------------------

Australian drug regulator releases first batches of locally made AstraZeneca vaccine

This article is more than 2 months old

Therapeutic Goods Administration approves release of first four batches of Melbourne-made vaccine totalling 832,200 doses

---------------------------------------

So if the initial production capability is similar, 14 batches could mean close to 3million doses, which is not bad for a start.

[riclag]

I have my appointment with the village Dr. on the 28th up here in Sakon Nakhon !

Its AZ or nothing for me,unless of course the privates have somehow procured the Moderna for a October  offering, before than !

Edited June 1, 2021 by riclag

[RocketDog]

4 hours ago, mtls2005 said:

OK, so is "batch" a scientific term? Unit of measurement?

 

How many vials (5 ml, 10 doses) in a batch?

 

I searched a bit but it seems like most reports in the press use batch to denote a specific delivery amount.

 

Just once I'd like to see someone offer precise and transparent information.

 

 

Typically 'batch' is used in industry to denote the output of a single machine or manufacturing unit. So several machines might simultaneously produce several batches. A QA Batch number thus refers to the output of a particular machine so defects can be traced and corrected.

[mtls2005]

1 hour ago, sandyf said:

Obviously never worked in manufacturing, a production "batch"

 

 

 

3 minutes ago, RocketDog said:

Typically 'batch' is used in industry to denote the output of a single machine or manufacturing unit.

 

 

Yes, thank you for stating the obvious. D'oh.

 

Yes, I've watched many episodes of "How's That Made".

 

My question pertained to the usage by the Thai Department of Medical Sciences, director-general, Dr. Supakit Sirilak. Has he ever worked in manufacturing? The article mentioned both batches and lots.

 

Is a batch a lot? Is a lot a batch? How many units in a batch (if variable give the range)? 

 

I've got to believe the equipment, components and 'recipe' dictates the approximate size of the batch. And that each batch is probably +/- 10% in volume.

 

Honestly, all we need to understand is the total volume of all the batches. After all, batches aren't administered to people.

 

Forgive me if this is too much to ask.

 

 

 

 

 

 

 

 

 

[BestB]

Normally I would say hooray but knowing the pressure and all the internal and external factors pushing for vaccines being available I have my doubts how sincere the testing was to have it approved.

 

would have thought company that gave the licensing ie AZ would be doing the approvals to make sure it meets snd passes standards 

[mtls2005]

1 hour ago, zoltannyc said:

Therapeutic Goods Administration approves release of first four batches of Melbourne-made vaccine totalling 832,200 doses

 

 

Thanks.

 

I did search a fair bit, but was looking mostly at Korea's AZ output.

 

Assuming the equipment matches, then the batch size of 200,000-ish doses (100,000 ml) seems reasonable.

 

And 14 batches for 2.8 MM matches some press reports of between 2 and 3 million.

[edwinchester]

Just read on Twitter, courtesy of Reuters, that the Philippines has been told the first batch of vaccine it was due to receive from Thailand is delayed.

 

[placnx]

5 hours ago, mtls2005 said:

OK, so is "batch" a scientific term? Unit of measurement?

 

How many vials (5 ml, 10 doses) in a batch?

 

I searched a bit but it seems like most reports in the press use batch to denote a specific delivery amount.

 

Just once I'd like to see someone offer precise and transparent information.

 

 

Here Taiwan received a batch of AZ. It was 410,400 doses. One would think that this would be standard wherever made.

https://www.cdc.gov.tw/En/Bulletin/Detail/P2GKkWEQ6H7Yr21JWgzRGA?typeid=158

But then Malaysia got a batch with 268,800 doses!

https://www.reuters.com/world/asia-pacific/malaysia-receives-first-batch-astrazeneca-covid-19-vaccines-bernama-2021-04-24/

Another poster reported that Melbourne got 4 batches averaging 208,050 doses each.

 

Maybe it is entirely dependent on the varying yield of each batch.

Edited June 1, 2021 by placnx
more detail

[bangon04]

12 hours ago, wensiensheng said:

Except if confident in their product, it would have saved time? And if it had to be changed, nothing lost except some changes to a document?

 

Assuming time is of the essence in these things. Maybe it isn’t. But there IS a pandemic going on.  Don’t know much about summery production protocols tbh. ????‍♂️

maybe they are seeking royal approval.....

[Jeffr2]

16 hours ago, Srikcir said:

'Crossing Fingers' is not a scientific/medical process.

If Thai FDA monitored production since it started (government contract in December 2020, production in February 2021?), any formal acceptance now should be almost automatic, like 'checking the box' before formal distribution.

From what I've read, there are 4 "groups" dealing with the pandemic here.  Fighting each other for resources and probably money to pass around.  Hard to get a consensus on anything.  One reason we're in the current mess we're in.

[internationalism]

according to some reports: "There are 240,000 doses delivered this week and another 350,000 doses exclusively for Bangkok will be delivered in next two weeks. Less than 10% of what AstraZeneca promised".

so my calculation - a batch is some 17k doses

Edited June 2, 2021 by internationalism

[Srikcir]

20 hours ago, mtls2005 said:

OK, so is "batch" a scientific term? Unit of measurement?

 

How many vials (5 ml, 10 doses) in a batch?

 

I searched a bit but it seems like most reports in the press use batch to denote a specific delivery amount.

 

Just once I'd like to see someone offer precise and transparent information.

 

 

Note that the word "batch" comes from the news media Thai PBS. So a journalistic term.

SB uses the term "production lines" and Dr. Similar uses "lots." None of which denotes a number of doses. 

Why the vagueness?

Must as well say a "bunch."

 

But now we know Thailand will be exporting Thai-made AZ of the "first batches* of a promised 17 million doses to The Philippines....AstraZeneca and Siam Bioscience did not immediately reply to questions about production at the Thai plant."

htpps://www.reuters.com/world/asia-pacific/first-astrazeneca-vaccine-exports-thailand-philippines-delayed-govt-advisor-2021-06-01/

If I was SB the number of AZ doses produced for Thailand et al should be state secret.

 

* again a news media term.

 

[Lambou69]

Shouldn't it be passed through WHO, as all the others have been

I think a second opinion is better