Potential safety signals with COVID-19 vaccines

The request was partially successful.

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 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

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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: 

 

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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...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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

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Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

1 Attachment

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

 

 

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Kenneth MacArthur

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

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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

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Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

2 Attachments

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

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