Sample batch testing

The request was successful.

Dear Medicines and Healthcare Products Regulatory Agency,

Please supply the following information in relation to covid 19 vaccine sample batch testing on behalf of MHRA and or DHSC or other government agency by NIBSC or other laboratory:

1- date batch testing started?

2- product lines sample tested by manufacturer?

3- number of batches tested per manufacturer?

4- results of sample batch testing?

5- total number of failed batches?

6- details of reason of vaccine batch failures?

7- recall notices or evidence that failed batches were pulled from UK vaccine supply chain?

Yours faithfully,

Derek Reid

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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________________________________________ From: Derek Reid
<[FOI #819516 email]> Sent: Tuesday, January 4,
2022 2:49:58 PM To: MHRA Customer Services Subject: Freedom of Information
request - Sample batch testing Dear Medicines and Healthcare Products
Regulatory Agency, Please supply the following information in relation to
covid 19 vaccine sample batch testing on behalf of MHRA and or DHSC or
other government agency by NIBSC or other laboratory: 1- date batch
testing started? 2- product lines sample tested by manufacturer? 3- number
of batches tested per manufacturer? 4- results of sample batch testing? 5-
total number of failed batches? 6- details of reason of vaccine batch
failures? 7- recall notices or evidence that failed batches were pulled
from UK vaccine supply chain? Yours faithfully, Derek Reid
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 22/022

Dear Derek Reid,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 4th January 2022.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Please be aware that we publish FOIs replies and these are redacted and are located on our website at the following link below.
https://www.gov.uk/government/collection...

Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 22/022

 

Dear Derek Reid

 

Thank you for your email.

 

Please find below answers to the questions in raise in blue below.

 

1- date batch testing started? The first batch of COVID-19 vaccine was
certificated on 2nd December 2020.

 

2- product lines sample tested by manufacturer? All vaccines approved for
use in the UK are tested by NIBSC

 

3- number of batches tested per manufacturer? Each batch available to the
UK has been tested and certificated; over 210 batches in total

 

4- results of sample batch testing? We cannot make available raw data (see
below)

 

5- total number of failed batches? 2 batches did not meet specification
for one test for one product – these batches were therefore not
certificated.

 

6- details of reason of vaccine batch failures? Covered in question 5.

 

7- recall notices or evidence that failed batches were pulled from UK
vaccine supply chain? Only certificated batches are used in the UK supply
chain.

 

Any release of the data or details of specific vaccines are subject to
Section 41 (Information provided in confidence) and Section 43 (Commercial
interests) of the FOI Act.

 

 

If you disagree with how we have interpreted the Freedom of Information
Act 2000 in answering your request, you can ask for an internal review.
Please reply to this email, within two months of this reply, specifying
that you would like an Internal Review to be carried out.

 

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communications.

 

If you were to remain dissatisfied with the outcome of the internal
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Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:

 

Information Commissioner’s Office

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Cheshire

SK9 5AF

 

Yours sincerely

 

 

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

 

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