CAG minutes May 2024

Summary

The requester sought unredacted Clinical Advisory Group minutes and correspondence regarding COVID-19 vaccine safety discussions from May 2024 to June 2025, along with details on oversight committees. Manx Care responded that some information was provided, but not all requested data was held by the authority.

Key Facts

• The request was received by Manx Care on 25 June 2025.
• The outcome was determined on 14 November 2025 as 'Some information sent but not all held'.
• The response letter is dated 21 July 2025.
• The request specifically targeted minutes from the May 2024 CAG meeting and subsequent meetings up to June 2025.
• The requester challenged previous redactions of names under Section 26, 35, and 36 of the Isle of Man FOI Act 2015.

Data Disclosed

• 76.26%
• 5 deaths
• 7 public FOIs
• 2021-2024
• 2 supporting papers
• Section 26
• Section 35
• Section 36

Original Request

1. Please provide full, unredacted minutes (including all attachments and appendices) from the Clinical Advisory Group (CAG) meeting in May 2024, in which Public Health submitted a response to the COVID-19 vaccine safety and efficacy concern raised, with 2 supporting papers for discussion, during the February 2024 meeting. 2. Please provide minutes, attachments, and any follow-up reports or responses from any subsequent CAG meetings to date (June 2025), in which vaccine safety, efficacy, or related concerns were discussed. 3. Vaccine Safety Oversight Committees: As it appears neither CAG nor the Vaccine Board have reviewed or discussed the Isle of Man Yellow Card reports (there are at least 7 public FOIs between 2021-2024 showing manx specific data, the latest indicating 76.26% of reports involved serious adverse events, including 5 deaths), please clarify: a. Which committee, working group, or internal body is tasked with ongoing oversight of COVID-19 vaccine safety? b. Who reviews Yellow Card reports, published safety studies, signals, or alerts, and how are such findings escalated or actioned? c. Feb 2024 minutes state "...the Covid-19 review recommended that decisions regarding vaccination are island specific with a group to be formed. ", was a group formed and if not, please provide more information on this. 4. Please provide email communications or correspondence between CAG members (including forwarded attachments, memos, or notes) regarding the safety and efficacy discussion raised in the February 2024 meeting, or in response to the May 2024 submission. Include communications to JCVI as mentioned in the Feb 2024 minutes on this topic for their response. Redactions: In the prior FOI response, most names in the CAG minutes were redacted. I therefore request that any redactions be strictly justified under the Isle of Man FOI Act 2015 and cite specific statutory exemptions (including section and subsection). In particular: Section 26 (Personal Information) may only apply if disclosure would breach data protection principles. However, the Terms of Reference for CAG confirm all members are jointly accountable for decisions and operate under the Nolan Principles of transparency, accountability, and openness. Thus, redaction of names or views expressed in formal meetings which influence policies and protocols for health cannot be justified unless a clear and specific harm can be demonstrated. Section 35 (Formulation of Government Policy) does not justify withholding information once a decision/policy has been implemented or publicly acted upon, as appears to be the case. Section 36 (Prejudice to the effective conduct of public affairs) requires a public interest test ' which, in the context of a matter involving public health risk, leans heavily toward disclosure.

Data Tables (3)

Full Response Text

Manx Care Noble’s Hospital, Strang Braddan, Isle of Man IM4 4R (01624) 650 000

Our ref: 4753989 21 July 2025

Dear

We write further to your request, received 25 June 2025, which states:

"1. Please provide full, unredacted minutes (including all attachments and appendices) from the Clinical Advisory Group (CAG) meeting in May 2024, in which Public Health submitted a response to the COVID-19 vaccine safety and efficacy concern raised, with 2 supporting papers for discussion, during the February 2024 meeting.

1. Please provide minutes, attachments, and any follow-up reports or responses from any subsequent CAG meetings to date (June 2025), in which vaccine safety, efficacy, or related concerns were discussed.

2. Vaccine Safety Oversight Committees:

As it appears neither CAG nor the Vaccine Board have reviewed or discussed the Isle of Man Yellow Card reports (there are at least 7 public FOIs between 2021-2024 showing manx specific data, the latest indicating 76.26% of reports involved serious adverse events, including 5 deaths), please clarify:

a. Which committee, working group, or internal body is tasked with ongoing oversight of COVID-19 vaccine safety?

b. Who reviews Yellow Card reports, published safety studies, signals, or alerts, and how are such findings escalated or actioned?

c. Feb 2024 minutes state "...the Covid-19 review recommended that decisions regarding vaccination are island specific with a group to be formed. “ was a group formed and if not, please provide more information on this.

1. Please provide email communications or correspondence between CAG members (including forwarded attachments, memos, or notes) regarding the safety and efficacy discussion raised in the February 2024 meeting, or in response to the May 2024 submission. Include communications to JCVI as mentioned in the Feb 2024 minutes on this topic for their response.

Redactions: In the prior FOI response, most names in the CAG minutes were redacted. I therefore request that any redactions be strictly justified under the Isle of Man FOI Act 2015 and cite specific statutory exemptions (including section and subsection).

In particular:

Section 26 (Personal Information) may only apply if disclosure would breach data protection principles. However, the Terms of Reference for CAG confirm all members are jointly accountable for decisions and operate under the Nolan Principles of transparency, accountability, and openness. Thus, redaction of names or views expressed in formal meetings which influence policies and protocols for health cannot be justified unless a clear and specific harm can be demonstrated.

Section 35 (Formulation of Government Policy) does not justify withholding information once a decision/policy has been implemented or publicly acted upon, as appears to be the case.

Section 36 (Prejudice to the effective conduct of public affairs) requires a public interest test ' which, in the context of a matter involving public health risk, leans heavily toward disclosure."

Response

While our aim is to provide information whenever possible, in this instance the public authority does not hold or cannot, after taking reasonable steps to do so, find some of the information that you have requested. Enter the reason why the information requested is not held

I have enclosed copies of the information that is held.

1. Please provide full, unredacted minutes (including all attachments and appendices) from the Clinical Advisory Group (CAG) meeting in May 2024, in which Public Health submitted a response to the COVID-19 vaccine safety and efficacy concern raised, with 2 supporting papers for discussion, during the February 2024 meeting.

Please see attached copy of the May meeting minutes. Redactions have been applied, please see exemption below.

While our aim is to provide information whenever possible, in this instance we are unable to provide some of the information you have requested because it is absolutely exempt under section 25 of the Act (absolutely exempt personal information).

The reasons why exemption s25(b)(i)&(ii) applies are that: • Manx Care is satisfied that the information amounts to personal data of which you are not the data subject; and • Manx Care is satisfied that disclosure of the information would contravene one of the data protection principles as set out at Article 5 of the General Data Protection Regulation as it applies in the Isle of Man pursuant to the Data Protection (Application of GDPR) Order 2018, namely that the Manx Care can only disclose the information where it would be fair, lawful and meet one of the conditions for lawful processing in Article 6 [or if you are dealing with sensitive personal data “and one of the conditions in Article 9 of the GDPR and Schedule 2 of the Implementing Regulations is met”] and in this case, none of those

conditions have been met therefore names have been redacted.

1. Please provide minutes, attachments, and any follow-up reports or responses from any subsequent CAG meetings to date (June 2025), in which vaccine safety, efficacy, or related concerns were discussed.

All minutes have been provided previously.

1. Vaccine Safety Oversight Committees:
   As it appears neither CAG nor the Vaccine Board have reviewed or discussed the Isle of Man Yellow Card reports (there are at least 7 public FOIs between 2021- 2024 showing manx specific data, the latest indicating 76.26% of reports involved serious adverse events, including 5 deaths), please clarify:

a. Which committee, working group, or internal body is tasked with ongoing oversight of COVID-19 vaccine safety?

I believe the new Vaccine, Immunisation and Screening Partnership will do this. This group has been recently established, led by Public Health and the Terms of Reference are attached.

The objectives include
• Monitor high-level outcomes and risks across all vaccination, immunisation and screening activities. b. Who reviews Yellow Card reports, published safety studies, signals, or alerts, and how are such findings escalated or actioned?

Once a yellow card has been submitted the MHRA have stated it’s their data and not ours anymore. We therefore have no specific way of pulling out IOM data. It’s just part of the whole MHRA data. This makes it Very hard if not impossible to follow up a particular case or patient as MHRA data is anonymized. Our medicines safety Pharmacist in Manx Care is working with MHRA to get IOM attached to the North West so we may have a better chance of understanding the yellow card position for the IOM

c. Feb 2024 minutes state "...the Covid-19 review recommended that decisions regarding vaccination are island specific with a group to be formed. “was a group formed and if not, please provide more information on this.”

Please see response to 3a.

1. Please provide email communications or correspondence between CAG members (including forwarded attachments, memos, or notes) regarding the safety and efficacy discussion raised in the February 2024 meeting, or in response to the May 2024 submission. Include communications to JCVI as mentioned in the Feb 2024 minutes on this topic for their response.

Redactions: In the prior FOI response, most names in the CAG minutes were redacted. I therefore request that any redactions be strictly justified under the Isle of Man FOI

Act 2015 and cite specific statutory exemptions (including section and subsection).

In particular:

Section 26 (Personal Information) may only apply if disclosure would breach data protection principles. However, the Terms of Reference for CAG confirm all members are jointly accountable for decisions and operate under the Nolan Principles of transparency, accountability, and openness. Thus, redaction of names or views expressed in formal meetings which influence policies and protocols for health cannot be justified unless a clear and specific harm can be demonstrated.

Section 35 (Formulation of Government Policy) does not justify withholding information once a decision/policy has been implemented or publicly acted upon, as appears to be the case.

Section 36 (Prejudice to the effective conduct of public affairs) requires a public interest test ' which, in the context of a matter involving public health risk, leans heavily toward disclosure.

Please quote the reference number 4753989 in any future communications.

Your right to request a review

If you are unhappy with this response to your freedom of information request, you may ask us to carry out an internal review of the response, by completing a complaint form and submitting it electronically or by delivery/post.

An electronic version of our complaint form can be found by going to our website at https://services.gov.im/freedom-of-information/Review . If you would like a paper version of our complaint form to be sent to you by post, please contact me and I will be happy to arrange for this. Your review request should explain why you are dissatisfied with this response, and should be made as soon as practicable. We will respond as soon as the review has been concluded.

If you are not satisfied with the result of the review, you then have the right to appeal to the Information Commissioner for a decision on; 1. Whether we have responded to your request for information in accordance with Part 2 of the Freedom of Information Act 2015; or 2. Whether we are justified in refusing to give you the information requested.
In response to an application for review, the Information Commissioner may, at any time, attempt to resolve a matter by negotiation, conciliation, mediation or another form of alternative dispute resolution and will have regard to any outcome of this in making any subsequent decision. More detailed information on your right to a review can be found on the Information Commissioner’s website at www.inforights.im. Should you have any queries concerning this letter, please do not hesitate to contact me.

Further information about freedom of information requests can be found at www.gov.im/foi.

I will now close your request as of this date.

Yours sincerely

NOTES Clinical Advisory Group Meeting

Tuesday, 14th May 2024 1700-1800 hrs

Present:

Notes:

Item No. Subject Action by: 35/24 Apologies for Absence

36/24 Review notes/Matters arising from previous meeting

Approved

Notes CAG
2024.04.17.docx 37/24 Review of Action Log

Action log reviewed and updated

CAG Action Log 2024.xlsx

38/24 Immunisation Committee Following a request from previous meetings a written response (to the papers circulated by in relation to Covid 19 vaccination research) has been received from Public Health.
introduced herself as Interim Head and presented the paper prepared by Public Health. The paper provides comments in response to the papers sent by however their response is cautious to the select group of papers, where usually a broader context of research and published papers is needed and undertaken.

advised there is a separate advisory group (SCPAG) in existence that all screening and vaccination issues go through and this is chaired by

. The recommendation from SCPAG is that they recommend that JCVI is followed. However, they have been clear that (with the exception of COVID vaccinations) deviations are able to be made in relation to Island specific roll out/operational matters, however the technical scientific evidence behind the recommendations on vaccination and immunisation is accepted as a principal and a recommendation.

Therefore based on a few individual papers Public Health see no reason to take a different position, but would advise SCPAG is the forum for this type of discussion.

Public Health have given due consideration to the issues raised with the conclusion that they continue to support the existing principal in relation to COVID vaccination as recommended by JVCI and are very supportive that informed consent is an underpinning principle and should inform an individual’s decision making.

MB raised a concern about the ability to deviate from the advice/recommendations of JCVI - as on island there is limited capacity and competence in what is a highly specialised field. Very few people have the knowledge.

advised that although SCPAG makes recommendation there is no set pathway where decision points are recorded. However, they are in the process of setting up a Task & Finish group in order to design such a pathway for governance/decision making/transparency and would enable the recording of a rationale being made from deviating from the advice/recommendations of JVCI and the NSC in relation to screening.

recommended that as medical adviser to DHSC, would be good to sit on the task & finish group.

In order to conclude the discussion, taking into account response,

asked for views from the group. agreed with last line of response (…perhaps individual colleagues may follow their own conscience. I know that I will). At the end of day it is about informed consent and making individual choices.

May 2024 Public Health Response to

also agrees that in terms of practice he supports vaccination with informed consent.

will check whether has any further comments however it was agreed that this subject has been fully discussed. 39/24 Updated Draft Cannabis Based Medicinal Products Policy – for discussion Presented by

This is V2 as the Original policy was never published. The policy is around cannabis based medicinal products in acute care. I.e. Inpatient setting for patients who may have accessed and are using cannabis based medicinal products (CBMP). It is brought back to CAG for consultation/comment following a change to the flow diagram (p.3) to include flowers for tisane or products to be smoked. (This follows a case recently where a patient was allowed to continue using a smoking product for anxiety issues whilst an inpatient).

Following a question and recommendation by it was established that the policy will be available on Manx Care SharePoint and will also be publicly available via the DHSC website. Once published will advise Comms accordingly.

No further comments therefore will take through SNLT and IMOG for ratification.

24-05 v3-2 Manx Care Acute Approach

40/24 AOB None

41/24 Date of next meeting: Wednesday, 26th June 2024 @ 1600 hrs