Dear National Biological Standards Board,

I note from your web site that your organisation is responsible for ensuring quality standards for each batch of Covid vaccines, prior to deployment.

"As is the case for current, licensed vaccines, the quality of each batch of any potential COVID-19 vaccine will be evaluated by an independent laboratory. The independent laboratory will also carry out a thorough review of the manufacturer batch documentation that describes the production process and quality control testing performed by the company"

In view of the many concerns about potential contamination / adulteration of Covid 19 vaccines can you please provide the following information:-

1) A description of the procedures and processes that are in place to ensure compliance with the above commitment.

2) How many physical quality tests have actually been completed since the introduction of the Covid 19 vaccines.

3) Can you provide confirmation that such tests have been applied to all Covid 19 vaccine batches prior to deployment into the public domain.

4) Can you confirm that these quality tests are capable of detecting any unwanted genetic material either plasmid or chromasomal , along with any other nanoparticles that are not specified by the manufacturer.

Yours faithfully,

Peter A Hickey

Information Rights,

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Dear Peter Hickey,
The National Institute for Biological Standards and Control (NIBSC),
previously part of the Health Protection Agency (HPA), is a centre of the
Medicines and Healthcare Products Regulatory Agency alongside the Clinical
Practice Research Datalink (CPRD).
You may therefore wish to contact NIBSC directly with your request at: 
[email address]
Further information is available at:
[1]NIBSC - Home
Yours sincerely,
Information Rights Team
Parliamentary and Public Accountability Team
UK Health Security Agency
[2][email address
[3]www.gov.uk/ukhsa  Follow us on Twitter @UKHSA

══════════════════════════════════════════════════════════════════════════

From: Peter Hickey <[FOI #1049203 email]>
Sent: 18 November 2023 11:27
To: FOI <[email address]>
Subject: Freedom of Information request - Covid 19 Vaccine Quality Testing
 
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Dear National Biological Standards Board,

I note from your web site that your organisation is responsible for
ensuring quality standards for each batch of Covid vaccines, prior to
deployment.

"As is the case for current, licensed vaccines, the quality of each batch
of any potential COVID-19 vaccine will be evaluated by an independent
laboratory. The independent laboratory will also carry out a thorough
review of the manufacturer batch documentation that describes the
production process and quality control testing performed by the company"

In view of the many concerns about potential contamination / adulteration
of Covid 19 vaccines can you please provide the following information:-

1) A description of the procedures and processes that are in place to
ensure compliance with the above commitment.

2) How many physical quality tests have actually been  completed since the
introduction of the Covid 19 vaccines.

3) Can you provide confirmation that such tests have been applied to all
Covid 19 vaccine batches prior to deployment into the public domain.

4) Can you confirm that these quality tests are capable of detecting any
unwanted genetic material either plasmid or chromasomal , along with any
other nanoparticles that are not specified by the manufacturer.

Yours faithfully,

Peter A Hickey

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Sent request to The National Institute for Biological Standards and Control again, using a new contact address.

MHRA Customer Services, The National Institute for Biological Standards and Control

Our Ref: FOI 23/918

Dear Peter A Hickey,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 27 November.

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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Telephone 020 3080 6000

show quoted sections

FOILicensing, The National Institute for Biological Standards and Control

Dear Peter A Hickey,

 

Thank you for your request for information, dated 27 November 2023, where
you requested the following:

                                   

I note from your web site that your organisation is responsible for
ensuring quality standards for each batch of Covid vaccines, prior to
deployment.

 

"As is the case for current, licensed vaccines, the quality of each batch
of any potential COVID-19 vaccine will be evaluated by an independent
laboratory. The independent laboratory will also carry out a thorough
review of the manufacturer batch documentation that describes the
production process and quality control testing performed by the company"

 

In view of the many concerns about potential contamination / adulteration
of Covid 19 vaccines can you please provide the following information:-

1) A description of the procedures and processes that are in place to
ensure compliance with the above commitment.

2) How many physical quality tests have actually been completed since the
introduction of the Covid 19 vaccines.

3) Can you provide confirmation that such tests have been applied to all
Covid 19 vaccine batches prior to deployment into the public domain.

4) Can you confirm that these quality tests are capable of detecting any
unwanted genetic material either plasmid or chromasomal , along with any
other nanoparticles that are not specified by the manufacturer.

 

Please find our response beneath each of your questions below.

 

1) A description of the procedures and processes that are in place to
ensure compliance with the above commitment.

Independent laboratory testing of vaccines is carried out by the MHRA’s
Official Medicines Control Laboratory (OMCL). The independent testing
assesses key parameters that focus on biological quality of the product,
such as Potency/sequence ratio, identity, RNA encapsulation, RNA content,
RNA integrity, for example. Independent assessment also confirms that the
manufacturer has reported on its wide-ranging tests on the product.
Batches of vaccine that meet the specifications in the approval are
certificated allowing the manufacturer to market them in the UK for use
before the batch expiry date.

 

Please see the link below for further information on the independent batch
release testing process:

[1]NIBSC - Independent batch release testing at the NIBSC

 

Please also note, all vaccine manufacturers must operate to Good
Manufacturing Practices and their facilities are licensed, and are
inspected periodically.

 

2) How many physical quality tests have actually been completed since the
introduction of the Covid 19 vaccines.

The MHRA’s OMCL undertake a series of specific laboratory tests on sample
vials from batches of COVID vaccines. A certificate is applied to those
batches that meet the specifications in the product authorisation. This
certificate is required by the authorisation holder (the manufacturer /
company) before the batch can be released onto the market for use. Over
360 compliant batches across all COVID-19 vaccines authorised for use in
the UK have been certificated since December 2020. Typically, between 3
and 5 tests are applied to each batch, depending on the product.

 

3) Can you provide confirmation that such tests have been applied to all
Covid 19 vaccine batches prior to deployment into the public domain.

As described above, the MHRA’s OMCL undertake a series of specific
laboratory tests on sample vials from batches of COVID vaccines. A
certificate is applied to those batches that meet the specifications in
the product authorisation. This certificate is required by the
authorisation holder (the manufacturer / company) before the batch can be
released onto the market for use.

 

4) Can you confirm that these quality tests are capable of detecting any
unwanted genetic material either plasmid or chromasomal , along with any
other nanoparticles that are not specified by the manufacturer.

In addition to the manufacturer’s full battery of batch release tests, the
MHRA undertakes a series of specific laboratory tests on sample vials from
batches of COVID vaccines. Our lab-based tests do not include tests for
residual plasmid DNA or chromosomal DNA.

 

We hope that you find the above information useful. We now consider this
request closed. If you are unhappy with our decision, you may ask for it
to be reviewed. That review will be undertaken by a senior member of the
Agency who has not previously been involved in your request. If you wish
to pursue that option please email: [2][NIBSC request email]

 

After that, if you remain dissatisfied, you may write to the Information
Commissioner at; The Information Commissioner’s Office Wycliffe House
Water Lane Wilmslow Cheshire

SK9 5AF

 

They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.

 

Yours sincerely,

FOI Team

 

 

 

 

 

 

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Dear FOILicensing,

Many thanks for your reply to my FOI request. I would just appreciate some further clarification.

1) Could you please confirm that the 360 batches tested since Dec 2020 covers all batches distributed in the UK, including those issued under emergency use authorisation (EUA) and that those issued under EUA were tested to the same standards as those that were eventually approved and by the same independent authority.

2) I note the tests do not include checking for residual plasmid DNA or chromosomal DNA, however, can you also confirm whether or not tests also check for any contaminants, particularly any unwanted or unspecified nanoparticulate matter.

Many thanks

Yours sincerely,

Peter Hickey

Dear The National Institute for Biological Standards and Control,

Please pass this on to the person who conducts Freedom of Information reviews.

Your Ref : FOI 23/918

I am writing to request an internal review of The National Institute for Biological Standards and Control's handling of my FOI request 'Covid 19 Vaccine Quality Testing'.

Good Afternoon,

I issued a follow up question in relation to this particular FOI request (Copy below)

1) Could you please confirm that the 360 batches tested since Dec 2020 covers all batches distributed in the UK, including those issued under emergency use authorisation (EUA) and that those issued under EUA were tested to the same standards as those that were eventually approved and by the same independent authority.

2) I note the tests do not include checking for residual plasmid DNA or chromosomal DNA, however, can you also confirm whether or not tests also check for any contaminants, particularly any unwanted or unspecified nanoparticulate matter.

As of yet, I have still not received a follow up response.

Could you please look into this and respond accordingly.

Many thanks

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/c...

Yours faithfully,

Peter Hickey

MHRA Customer Services, The National Institute for Biological Standards and Control

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MHRA Customer Services, The National Institute for Biological Standards and Control

Ref IR 23/918

 

Dear Peter,

 

Thank you for your email which we received on 21^st February 2024. We will
deal with this as an internal review and look into why your follow up
enquiry to FOI 24/918 has not received a response.

 

In line with the FOI Code of Practice and ICO guidance, we work to conduct
internal reviews within 20 working days of receipt, and will respond by
20^th March 2024. However, if we are able to respond sooner in this case
we will do so.

 

Kind Regards,

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf,

London E14 4PU

 

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