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

[webfact]

AFP

 

The first 14 batches of AstraZeneca vaccine, produced by Thai pharmaceutical company Siam Bioscience, have passed the quality tests of the Thai Department of Medical Sciences.

 

The department director-general, Dr. Supakit Sirilak, said that samples of the first five lots of AstraZeneca vaccine and the next nine lots, sent to the department by Siam Bioscience, have met the department’s quality standard, following tests.

 

He said, however, that the department is waiting for a summary production protocol from the drug company before it can issue the release document for use.

 

Full story: https://www.thaipbsworld.com/thai-medical-sciences-department-approves-first-14-batches-of-locally-produced-astrazeneca-vaccine/

 

-- © Copyright Thai PBS 2021-06-01

 

- Whatever you're going through, the Samaritans are here for you

- Follow Thaivisa on LINE for breaking COVID-19 updates

[mtls2005]

7 minutes ago, webfact said:

He said, however, that the department is waiting for a summary production protocol from the drug company before it can issue the release document for use.

 

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.

 

Edited June 1, 2021 by mtls2005

[Nojohndoe]

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

[Tropicalevo]

4 minutes ago, Nojohndoe said:

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

Maybe they are buying time?

[Susco]

Just now, Tropicalevo said:

Maybe they are buying time?

 

Shouldn't they be buying vaccines instead?

[sammieuk1]

I would want to wait or batch 15 personally ????

[Nojohndoe]

7 minutes ago, Tropicalevo said:

Maybe they are buying time?

Perhaps. Or they were not 100% confident about quality approval?

[jacko45k]

16 minutes 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.

 

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?

[mtls2005]

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.

 

 

[holy cow cm]

Oh but because fortune teller tell to big guy in control that bad luck to use number 13 and number 4, and no good - no good and cannot multiples number four as beware bad omen bad luck and amulet cannot protect, we cancel 4, 8, 12, 13, and because 14 have 4 in it we no use same same. 

[petedk]

36 minutes 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.

 

 

If it's anything like the government offices I have dealt with - anything from 3 weeks to 6 months.

The papers have to be signed by 3 or 4 different people and the one who has to sign is always "not in the office", "travelling on business".

[rodknock]

how many doses in a batch?

pigs fly

[worgeordie]

Read yesterday, they have contaminates in the UK produced Astra Zeneca ,

but I am sure  the Thai produced Vaccine will be better......

regards worgeordie

[bradiston]

And what the heck is a "summary production protocol" and why hasn't it been supplied already? I thought the FDA was in charge, but now we have the Thai department of medical science running the show. It's impossible to figure out the chain of command in the Thai government. Endless departments, committees, ministries.

[Hayduke]

23 minutes ago, mtls2005 said:

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

 

That is not a valid option....please make another selection.

 

 

 

Edited June 1, 2021 by Hayduke

[Geoffggi]

4 minutes ago, rodknock said:

how many doses in a batch?

pigs fly

Will this be a big batch or small batch??? .................LOL

[Jeffr2]

5 minutes ago, rodknock said:

how many doses in a batch?

pigs fly

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

 

1 minute ago, worgeordie said:

Read yesterday, they have contaminates in the UK produced Astra Zeneca ,

but I am sure  the Thai produced Vaccine will be better......

regards worgeordie

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.

[Excel]

Just now, Geoffggi said:

Will this be a big batch or small batch??? .................LOL

How about the only batch for a few weeks ? Possibly flown in to pretend it was actually manufactured in Thailand perhaps ? wouldn't put that past them.

[ourmanflint]

16 minutes 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.

 

 

Batch is a term to denote that its production is completely independent and verifiable. That's all really

[rodknock]

6 more days, then another excuse!

[wensiensheng]

1 hour ago, mtls2005 said:

 

 

4 minutes ago, rodknock said:

6 more days, then another excuse!

It’s so exciting. I can hardly wait!

Edited June 1, 2021 by wensiensheng

[Excel]

10 minutes ago, ourmanflint said:

Batch is a term to denote that its production is completely independent and verifiable. That's all really

Actually that is incorrect. The definition of a batch is thus:-

noun

 

1. a quantity or consignment of goods produced at one time.

   "a batch of cookies"

 

[GroveHillWanderer]

1 hour ago, Nojohndoe said:

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

Presumably because if the batches had not passed muster, then they would potentially have had to go back and make changes to the production protocol.

 

It would make no sense to submit a production protocol summary if it was going to have to be changed.

Edited June 1, 2021 by GroveHillWanderer

[wensiensheng]

1 hour 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.

 

I believe that six million figure has been superseded with one of just two million. Unfortunately.

[bradiston]

5 minutes ago, GroveHillWanderer said:

Presumably because if the batches had not passed muster, then they would very probably have had to go back and make changes to the production protocol.

 

It would make no sense to submit a production protocol summary if it was going to have to be changed.

But the production protocol would need to be checked in any event. Surely a routine matter. It should accompany every batch. Not sure of Siam Bioscience's previous experience in these matters to be honest.

Edited June 1, 2021 by bradiston
Extra

[wensiensheng]

Just now, GroveHillWanderer said:

Presumably because if the batches had not passed muster, then they would very probably have had to go back and make changes to the production protocol.

 

It would make no sense to submit a production protocol summary if it was going to have to be changed.

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. ????‍♂️

[internationalism]

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."

 

 

[GroveHillWanderer]

36 minutes 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.

IIRC, earlier reports said there were 1 or 2 million doses in different batches that were submitted for testing. There was no indication in the articles I saw, that the batches were submitted as separate vials, they could have been submitted in a large vat containing all the doses together.

 

Some comments on these earlier reports suggested the numbers might have been incorrect but I don't know whether that's the case or not.

[Nojohndoe]

7 minutes ago, GroveHillWanderer said:

Presumably because if the batches had not passed muster, then they would potentially have had to go back and make changes to the production protocol.

 

It would make no sense to submit a production protocol summary if it was going to have to be changed.

Which would imply there already exists a detailed production record to refer to for correction of one or more processing steps . The "protocol summary" is exactly that and reference to it by the manufacturer to any variations of all or any  batch can be useful in streamlining future production.

[ourmanflint]

15 minutes ago, Excel said:

Actually that is incorrect. The definition of a batch is thus:-

noun

 

1. a quantity or consignment of goods produced at one time.

   "a batch of cookies"

 

at one time == completely independent

 

so both are correct