Potential safety signals with COVID-19 vaccines
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 information produced since 2020 which relates to the matters of:
a) Potential safety signals identified with any COVID-19 vaccine
b) Whether and how to publicly communicate about these potential safety signals
c) Whether and how to publicly communicate about any communication or collaboration on these 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 information exists, please can you provide it to me.
Yours faithfully,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here.
References
Visible links
1. https://www.gov.uk/government/collection...
Our Ref: FOI 21/415
Dear Kenneth MacArthur,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
Thank you for your enquiry which we received on 15 April 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
Dear Mr MacArthur,
Please find attached the response to your FOI request.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Medicines and Healthcare products Regulatory Agency (MHRA),
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 'Potential safety signals with COVID-19 vaccines'.
I am grateful for the information which you have provided me with. However, this information scarcely addresses any of the points in my request.
In particular:
(i) Point (a) of my request concerns _potential_ safety signals - ie, information on particular types of adverse event which you are considering, or have at any time considered, treating as a safety signal.
(ii) Point (a) also concerns not simply a list or brief description of such signals, but "any information ... which relates to the [matter] of" such signals.
(iii) Similarly, point (b) concerns "any information ... which relates to the [matter] of" whether and how to publicly communicate about such signals.
(iv) Finally, point (c) concerns "any information ... which relates to the [matter] of" whether and how to publicly communicate about any communication or collaboration on such signals with the listed institutions and individuals.
I draw particular attention to the deliberate and specific use of the phrases "_any_ information" and "which relates to" in my request.
Further to the above explanation, please can you provide all of the information that satisfies the criteria set out in my request. Alternatively, please confirm categorically that no information exists beyond that provided in your original response.
A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/p...
Yours faithfully,
Kenneth MacArthur
Thank you for your email. This auto-response is to inform you that your
email has been received and will be reviewed by our Customer Service Team.
We will respond to you as soon as possible.
Please note that we may not respond if your query:
• contains offensive language
• has already been answered in a previous reply to you
• is illegible
• is selling or promoting a product
• is for information only
Medicines and Healthcare products Regulatory Agency
10 South Colonnade,
Canary Wharf,
London
E14 4PU
gov.uk/mhra
Stay connected
For information on how the Agency uses your personal data and your data
protection rights, please see our three centres’ Privacy Notices: MHRA,
CPRD and NIBSC.
The UK has left the EU, and the transition period ends on 31 December
2020. Our [1]guidance and information can be accessed here.
References
Visible links
1. https://www.gov.uk/government/collection...
Dear Kenneth MacArthur,
Thank you for your email.
We confirm that an internal review will be carried out on FOI 21/413. We aim to respond to requests for internal review within 20 days of receipt.
Kind Regards
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Mr MacArthur,
Please find attached the response to your FOIA internal review request.
Kind regards,
FOI Team
Vigilance and Risk Management of Medicines Division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Dear Mr MacArthur,
Thank you for your email.
Please find attached response to Case Reference: IC-111457-W7C5 – FOI
21/413
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
DISCLAIMER This email and any files transmitted with it are confidential.
If you are not the intended recipient, any reading, printing, storage,
disclosure, copying or any other action taken in respect of this email is
prohibited and may be unlawful. If you are not the intended recipient,
please notify the sender immediately by using the reply function and then
permanently delete what you have received. Incoming and outgoing email
messages are routinely monitored for compliance with the Department of
Health's policy on the use of electronic communications. For more
information on the Department of Health's email policy, click
[1]DHTermsAndConditions
References
Visible links
1. https://www.gov.uk/help/terms-conditions
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
Chandra Singh left an annotation ()
Well, that was a surprise.