PFD report

Oli Akram Hoque · Prevention of Future Deaths report

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Issued 13 Oct 2022•East London

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

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Concerns
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
5

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised1

  1. Inability to compel timely production of relevant clinical data for safety investigations
    Part of recurring concern: Failure to provide safety-critical data promptly to regulators
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.3

  1. Action

    Establish relevant data flows before vaccination commenced to support proactive pharmacovigilance surveillance.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 14 October 2022.
  2. Action

    Conduct proactive follow-up and use data-sharing arrangements to obtain additional pharmacovigilance case details.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 14 October 2022.
  3. Action

    Work with the NHS to improve reporting-system interoperability and connectivity, including automatic electronic transfer from LPSE to MHRA databases.

    Stated by Department of Health and Social CareStated in progressThe respondent said that this action was in progress when they made their response on 14 October 2022.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    MHRA lacks jurisdiction over healthcare professionals and therefore cannot comment on legislative powers to access NHS case notes.

    Stated by Department of Health and Social CareOutside remitThe respondent said that this matter was outside its role or authority.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Inability to compel timely production of relevant clinical data for safety investigations

Wider context from the report

“The Inquest heard evidence from a senior medical assessor from the Medicines and Healthcare Regulatory Agency (MHRA). The Inquest heard that from the 25th February 2021 the MHRA investigated the potential signal of immune thrombocytopenia. This identified three cases of cerebral venous sinus thrombosis which could possibly be associated with the Astra Zeneca COVID 19 vaccine. The MHRA could not fully consider these cases as they did not receive all of the necessary clinical information. The Inquest heard that the MHRA do not have the power to compel relevant clinical information, to assist them with safety investigations. In light of the clear public interest in ensuring that the MHRA are able to carry out robust safety investigations, it is a matter of concern that the MHRA are unable to compel the timely production of relevant clinical data. ”

Is this part of a recurring concern?

Yes — Failure to provide safety-critical data promptly to regulators.

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Establish relevant data flows before vaccination commenced to support proactive pharmacovigilance surveillance.

Verbatim wording from the response

“MHRA recognises the importance of access to relevant clinical information for pharmacovigilance and ensured that relevant data flows were in place prior to commencement of vaccinations in December 2020 to support its four-stranded proactive vigilance strategy - 1) Enhanced passive surveillance – ‘observed vs expected’ analysis; 2) Rapid Cycle Analysis and Ecological analysis (analysing anonymised healthcare for pre-defined events as well as monitoring trends); 3) Targeted active monitoring; and 4) Formal epidemiological studies. It is the view of the MHRA that focus should be placed on encouraging reporting and working across the health family to streamline processes and reduce barriers to reporting.”

Source location

Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022

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Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Conduct proactive follow-up and use data-sharing arrangements to obtain additional pharmacovigilance case details.

Verbatim wording from the response

“MHRA conducted daily, proactive follow up and utilised a Data Sharing Agreement (DSA) with Public Health England (now UK Health Security Agency, UKHSA) for additional case details where needed. MHRA sought the advice of its COVID-19 Expert Working Group and the Commission on Human Medicines on emerging advice of timeframe for thrombosis with thrombocytopenia and issued regular press releases as evidence continued to amass.”

Source location

Response from Department of Health and Social Care
Page 1 · response
Published 14 October 2022

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Work with the NHS to improve reporting-system interoperability and connectivity, including automatic electronic transfer from LPSE to MHRA databases.

Verbatim wording from the response

“Steps taken to enable this include working with the NHS to enable interoperability and connectivity of reporting system such as the new Learning from Patient Safety Events System (LPSE) to allow automatic electronic upload into MHRA databases in a timely manner. The NHS Digital Clinical Safety Strategy¹ covers integration of LPSE with the Yellow Card system; improvement of adverse events and incident reporting is a commitment made by NHS and MHRA with a clear strategy and shared responsibilities. A recently published NHS standard contract (NHS England “2023/24 NHS Standard Contract) has a focus on interoperability which will help achieve those aims.²”

Source location

Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022

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Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

MHRA lacks jurisdiction over healthcare professionals and therefore cannot comment on legislative powers to access NHS case notes.

Verbatim wording from the response

“MHRA do not have jurisdiction over healthcare professionals, and therefore did not comment on your consideration of whether issuance of this Regulation 28 report regarding legislative powers to access NHS case notes would assist the MHRA. There are professional guidelines in place for healthcare professionals to report safety issues, however, the Department is not aware of any jurisdiction globally that compels relevant clinical follow up information.”

Source location

Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022

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Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.2

  1. 1

    Educate healthcare professionals and promote the Yellow Card reporting scheme through Yellow Card Centres and safety campaigns.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 14 October 2022.
  2. 2

    Seek expert advice on emerging vaccine safety evidence and issue regular public updates as evidence develops.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 14 October 2022.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Educate healthcare professionals and promote the Yellow Card reporting scheme through Yellow Card Centres and safety campaigns.

Verbatim wording from the response

“Finally, MHRA continues to educate and promote the Yellow Card scheme with healthcare professionals through its five Yellow Card Centres and campaigns such as the MHRA’s annual #MedSafetyWeek.”

Source location

Response from Department of Health and Social Care
Page 2 · response
Published 14 October 2022

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Seek expert advice on emerging vaccine safety evidence and issue regular public updates as evidence develops.

Verbatim wording from the response

“MHRA conducted daily, proactive follow up and utilised a Data Sharing Agreement (DSA) with Public Health England (now UK Health Security Agency, UKHSA) for additional case details where needed. MHRA sought the advice of its COVID-19 Expert Working Group and the Commission on Human Medicines on emerging advice of timeframe for thrombosis with thrombocytopenia and issued regular press releases as evidence continued to amass.”

Source location

Response from Department of Health and Social Care
Page 1 · response
Published 14 October 2022

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026