Correspondence on safety signals with COVID-19 vaccines

Currently waiting for a response from Medicines and Healthcare products Regulatory Agency, they should respond promptly and normally no later than (details).

Kenneth MacArthur

Dear Medicines and Healthcare products Regulatory Agency (MHRA),

I am writing to make a request for information under section 1 of the Freedom of Information Act 2000.

Please can you confirm whether the MHRA holds any correspondence produced since 2020 which relates to the matters of:
a) Safety signals, or potential safety signals, identified with any COVID-19 vaccine
b) Whether and how to publicly communicate about these safety signals/potential safety signals
c) Whether and how to publicly communicate about any communication or collaboration on these safety signals/potential safety signals that has taken place with the European Medicines Agency (EMA), including, but not limited to, with the EMA's Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC), or members thereof, and with national medicines regulators and vaccination/immunization advisory bodies in EU/EEA countries.

If any such correspondence exists, please can you provide it to me.

For clarity, by "correspondence" I mean written communications - including all electronic forms of written communications - between individuals within the MHRA, and between the MHRA and external parties. I accept that this correspondence may be redacted to the extent permitted and/or required by law.

For additional clarity, point (c) above is not requesting the correspondence between the MHRA and the EMA (and other listed parties) on the topic of safety signals/potential safety signals, as this is covered by point (a). Rather, it is requesting the correspondence on the 'meta' issue of whether and how to publicly communicate the existence of communication or collaboration on this topic between the MHRA and the EMA (and other listed parties).

Yours faithfully,

Kenneth MacArthur

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 21/648

Dear Kenneth MacArthur,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 9 June 2021.

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 Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000

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