Safety signal reporting for Pfizer/BioNTech Covid 19 Vaccine
Dear Medicines and Healthcare Products Regulatory Agency,
Further to my request of 27 February 2023 concerning safety signal reporting and to your partial response of 2 June 2023 (your reference: FOI 23/162), this is a further more specific request for information under section 1 of the Freedom of Information Act 2000:
In relation to its Covid vaccine product authorised for use in the UK, please could you confirm for each calendar year from 2020 to 2023 how many validated safety signals have been notified to the MHRA by Pfizer/BioNTech 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')?
Separately, can you please provide a copy of each of the PSURs provided to the MHRA by Pfizer/BioNTech in relation to its Covid vaccine product during the period since 1 January 2021.
In view of the relative simplicity of this request, may I please receive your response within the statutory timescale?
Thank you. Yours faithfully,
Mr B Kingsley
Our Ref: FOI 23/474
Dear Mr B Kingsley,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 26 June.
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 Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Telephone 020 3080 6000
Dear Mr B Kingsley,
Thank you for sending a request for information. We would like to confirm that it is in hand with our Safety and Surveillance team however they will be unable to meet the deadline in this case. We apologise for any inconvenience this may cause and please be assured that a full response will be sent to you as soon as possible. We aim to provide a response by 2nd August.
Kind regards,
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Mr B Kingsley
Thank you for your email.
We apologise for the further delay in providing a response. We are still working on this and hope to be in a position to send this week.
Kind Regards
MHRA Customer Experience Centre
Communications and engagement team
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
FOI 23/474
Dear Mr B Kingsley
Thank you for your email.
Please find attached the response and documentation 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
We work to defend the right to FOI for everyone
Help us protect your right to hold public authorities to account. Donate and support our work.
Donate Now