FOI release

Freedom of Information request on analytical techniques used by MHRA/NIBSC relating to independent analysis of COVID-19 vaccines, and with particular reference to contaminants identified by laboratories around the world (FOI 22/465)

Published 1 June 2022

FOI 22/465

11th March 2022

Dear

Thank you for your information request, dated 13th February 2022, where you asked for information related to analytical techniques used by MHRA/NIBSC relating to independent analysis of COVID-19 vaccines, and with particular reference to contaminants identified by laboratories around the world, including, but not limited to:

• Graphene and its associated compounds

• Iron oxide

• Martenistic stainless steel

• Calcium Carbonate

• Glass.

I am pleased to provide you with the information requested, see below. A response is provided following each of your questions.

1) Given that you are aware, or ought to be aware of said contaminants, what techniques are used in routine batch testing which would detect these before distribution? Please provide raw data for a non-conforming vial.

Tests for such materials are not undertaken in Independent batch release testing. The types of tests performed are indicated on the NIBSC website: https://nibsc.org/control_testing.aspx

2) Given that many of these contaminants are mictoscopic, non-biocompatible and could cause harm if injected, is a microscope and directional lighting used in the visual inspection process?

The visual inspection is performed by eye and to European Pharmacopoeia (EP) monographs. It is a review against two monochrome backgrounds to observe particulate matter visible to the naked eye.

3) How many vials of COVID-19 vaccines have been rejected due to particulate contamination:

a) By MHRA/NIBSC prior to distribution?

Independent batch release testing does not test every vial of a batch and thus the rejection of individual vials does not occur. Vials representative of the batch are tested.

b) By healthcare professionals?

NIBSC would not hold this information.

c) Of the number in b), how many were “passed” by MHRA/NIBSC?

Healthcare professionals would only receive batches of vaccine passed by MHRA/NIBSC. As described above, a full batch is sampled and passed, not individual vials.

d) Please release details of CAPA processes relating to nonconformances.

All of our product testing is undertaken to ISO 17025 compliance under our externally assessed UK Accreditation Service (UKAS) ISO 17025 accredited Quality Management System and a CAPA process is included in this Quality Management system. Any product testing that fails the specified criteria will not be issued for use.

4) Please detail the methods by which MHRA/NIBSC investigate nonconformant vials discovered by:

1. • MHRA/NIBSC prior to distribution.

   Non-conformant batches are not issued for use. Individual vials are not certificated. A manufacturer will be informed of a failed batch.

2. • Healthcare professionals post-distribution.

   NIBSC is not requested to carry out any post-distribution testing by healthcare professionals.

   5) Do MHRA/NIBSC have access to any of the following analytical methods? if so, provide details on any applicable excitation source(s), resolution and sensitivity of the equipment.

   • Mass spectrometry- Chromatography- Raman spectroscopy- X-ray photoelectron spectroscopy- X-ray energy-dispersive spectroscopy- Optical microscopy- Electron microscopy- Scanning Auger microscopy

   MHRA/NIBSC does have access to some of the analytical methods listed. Details of analytical science facilities available in NIBSC are provided at https://nibsc.org/science_and_research/analytical_sciences.aspx They are not used in the assessment of COVID-19 vaccines, other than optical microscopy that is used for some potency assays.

   Please also provide any other analytical methods used by MHRA/NIBSC used to independently verify nonconformances, and also routine quality and safety testing.

   Independent batch release testing includes a range of techniques specific to the product and includes a range of visual, molecular, serological, cell-based tests to confirm identity of material, potency, integrity https://nibsc.org/control_testing/batch-release.aspx

   The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about the information provided, please reply to this email.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information 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

Wycliffe House

Water Lane

Wilmslow

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 6000FOI 22/465

11th March 2022

Dear

Thank you for your information request, dated 13th February 2022, where you asked for information related to analytical techniques used by MHRA/NIBSC relating to independent analysis of COVID-19 vaccines, and with particular reference to contaminants identified by laboratories around the world, including, but not limited to:

• Graphene and its associated compounds

• Iron oxide

• Martenistic stainless steel

• Calcium Carbonate

• Glass.

I am pleased to provide you with the information requested, see below. A response is provided following each of your questions.

1) Given that you are aware, or ought to be aware of said contaminants, what techniques are used in routine batch testing which would detect these before distribution? Please provide raw data for a non-conforming vial.

Tests for such materials are not undertaken in Independent batch release testing. The types of tests performed are indicated on the NIBSC website: https://nibsc.org/control_testing.aspx

2) Given that many of these contaminants are mictoscopic, non-biocompatible and could cause harm if injected, is a microscope and directional lighting used in the visual inspection process?

The visual inspection is performed by eye and to European Pharmacopoeia (EP) monographs. It is a review against two monochrome backgrounds to observe particulate matter visible to the naked eye.

3) How many vials of COVID-19 vaccines have been rejected due to particulate contamination:

a) By MHRA/NIBSC prior to distribution?

Independent batch release testing does not test every vial of a batch and thus the rejection of individual vials does not occur. Vials representative of the batch are tested.

b) By healthcare professionals?

NIBSC would not hold this information.

c) Of the number in b), how many were “passed” by MHRA/NIBSC?

Healthcare professionals would only receive batches of vaccine passed by MHRA/NIBSC. As described above, a full batch is sampled and passed, not individual vials.

d) Please release details of CAPA processes relating to nonconformances.

All of our product testing is undertaken to ISO 17025 compliance under our externally assessed UK Accreditation Service (UKAS) ISO 17025 accredited Quality Management System and a CAPA process is included in this Quality Management system. Any product testing that fails the specified criteria will not be issued for use.

4) Please detail the methods by which MHRA/NIBSC investigate nonconformant vials discovered by:

1. • MHRA/NIBSC prior to distribution.

   Non-conformant batches are not issued for use. Individual vials are not certificated. A manufacturer will be informed of a failed batch.

2. • Healthcare professionals post-distribution.

   NIBSC is not requested to carry out any post-distribution testing by healthcare professionals.

   5) Do MHRA/NIBSC have access to any of the following analytical methods? if so, provide details on any applicable excitation source(s), resolution and sensitivity of the equipment.

   • Mass spectrometry- Chromatography- Raman spectroscopy- X-ray photoelectron spectroscopy- X-ray energy-dispersive spectroscopy- Optical microscopy- Electron microscopy- Scanning Auger microscopy

   MHRA/NIBSC does have access to some of the analytical methods listed. Details of analytical science facilities available in NIBSC are provided at https://nibsc.org/science_and_research/analytical_sciences.aspx They are not used in the assessment of COVID-19 vaccines, other than optical microscopy that is used for some potency assays.

   Please also provide any other analytical methods used by MHRA/NIBSC used to independently verify nonconformances, and also routine quality and safety testing.

   Independent batch release testing includes a range of techniques specific to the product and includes a range of visual, molecular, serological, cell-based tests to confirm identity of material, potency, integrity https://nibsc.org/control_testing/batch-release.aspx

   The Freedom of Information Act only entitles you access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about the information provided, please reply to this email.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information 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

Wycliffe House

Water Lane

Wilmslow

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