Safety signal and related safety event reporting for UK CV19 vaccine products

Mr B Kingsley made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

The request was partially successful.

Dear Medicines and Healthcare Products Regulatory Agency,

May I please request the following information concerning safety event reporting data, and could you please treat this as a request made under section 1 of the Freedom of Information Act 2000.

1. In relation to the Covid vaccine products currently authorised for use in the UK, in each calendar year from 2020 to 2023 how many notices of a safety issue which meets the applicable definition of an 'emerging safety issue' have been received by the MHRA from Marketing Authorisation Holders for those vaccine products? And of those notices received by the MHRA how many are known to have been received more than 3 working days after the reported date of establishment of that emerging safety issue (i.e. late-filed notices)?

2. In relation to the Covid vaccine products currently authorised for use in the UK, in each calendar year from 2020 to 2023 how many validated signals have been notified to the MHRA by MAHs by means of:

(a) a product information and/or RMP variation application or equivalent?

(b) inclusion in a PSUR?

(c) a standalone signal notification (including any signal also notified in a PSUR but which has been separately notified as an 'important risk')?

3. In relation to the Covid vaccine products currently authorised for use in the UK, in each calendar year from 2020 to 2023, on how many occasions has the MHRA been notified of the initiation of a safety referral procedure that affects any such product?

4. As part of pharmacovigilance procedures in relation to the Covid vaccine products currently authorised for use in the UK, in each calendar year from 2020 to 2023 on how many occasions has the MHRA received from MAHs notice (of any kind) of a suspected adverse event expressed to have been triggered by one or more members of the public reporting a suspected adverse event via social media?

5. In relation to the Covid vaccine products currently authorised for use in the UK, in the period from January 2020 to 2023 on how many occasions has the MHRA commenced either (i) a major safety review or (ii) any other safety review which falls short of a major safety review in response to a new safety signal or to support effective risk minimisation?

If it is possible to do so, please provide any or all of the above data broken down by reference to each authorised vaccine product; but if it is not possible to break it down in that way, whether as a practical matter or (in your view) as a legal matter, please then nevertheless provide the aggregated data for all such products.

Yours faithfully,

Mr B Kingsley

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 23/162

Dear Mr B Kingsley,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 27 February 2023.

We 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

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Dear Medicines and Healthcare Products Regulatory Agency,

Your initial acknowledgement of my FOI request of 28 February 2023 helpfully confirmed that I should expect a response within 20 working days. I understand that by law your response should have been provided promptly and by 28 March 2023. It is therefore now overdue by more than one week, and yet without explanation.

Please could you let me know as soon as possible after the long Easter weekend has passed:

1. by what date I may expect to receive a response to the request for information?

2. the cause of MHRA's delay in responding on this important safety-related topic?

Kind regards,
Mr B Kingsley

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr B Kingsley

Thank you for your email.

We acknowledge receipt of delay in response and we hope to respond to you as soon as we can.

We apologise for any inconvenience caused.

Kind Regards

MHRA Customer Experience Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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Dear Medicines and Healthcare Products Regulatory Agency,

Your initial acknowledgement of my FOI request of 28 February 2023 helpfully confirmed that I should expect a response within 20 working days. I understand that by law your response should have been provided promptly and by 28 March 2023. It is therefore now overdue by one full month, and yet without explanation.

I shall therefore ask again: please could you let me know as soon as possible specifically:

1. by what date I may expect to receive a response to the request for information?

2. the cause of MHRA's delay in responding on this important safety-related topic?

Yours sincerely,

Mr B Kingsley

Dear Medicines and Healthcare Products Regulatory Agency,

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

I am writing to request an internal review of the MHRA's handling of my FOI request 'Safety signal and related safety event reporting for UK CV19 vaccine products' (reference FOI 23/162).

The MHRA's response is now more than five weeks overdue and despite my having followed up twice (on 6 April and 28 April) since it became overdue I have received neither a substantive response nor an update on when a substantive response might be expected.

I therefore wish to request an internal review of my request and of the MHRA's failure to address my request within a remotely reasonable timescale (more than two months have now passed since it was confirmed as received).

Yours faithfully,

Mr B Kingsley

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

2 Attachments

FOI 23/162

Dear Mr B Kingsley,

Thank you for your email and we apologise for delay in response.

Please find attached the response to your FOI request.

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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