Suspected adverse reactions to COVID-19 vaccines

Waiting for an internal review by Medicines and Healthcare products Regulatory Agency of their handling of this request.

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 provide the list of suspected adverse reactions to COVID-19 vaccines received by the MHRA since December 2020 broken down by the following attributes:
i) Vaccine type
ii) Patient age (or age band of a maximum of 5 years)
iii) Patient sex
iv) Patient ethnicity

For clarity:
- This request is for the above attributes to be provided simultaneously for each reaction type - ie, so that it is possible to determine, for example, the number of White British female recipients of COVID-19 Vaccine AstraZeneca in the 35-39 age band who have suffered from an infected dermal cyst following receipt of this vaccine (and not simply the number of White British people, or the number of females, or the number of 35-39 year olds).
- The "list of suspected adverse reactions to COVID-19 vaccines received by the MHRA since December 2020" is those enumerated in the most recent analysis prints published at https://www.gov.uk/government/publicatio...

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
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We will respond to you as soon as possible. 

 

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Medicines and Healthcare products Regulatory Agency
10 South Colonnade, 
Canary Wharf, 
London 
E14 4PU
gov.uk/mhra
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protection rights, please see our three centres’ Privacy Notices: MHRA,
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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

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1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 21/351

Dear Kenneth MacArthur,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6 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.

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 MHRA,

Thank you for your response to my request.

However, it is now over two weeks since that response, and, as far as I can tell, interactive Drug Analysis Profiles (iDAPs) for COVID-19 vaccines have still not been published. I also note that you provided a similar response to another FOI request around two months ago, in the week of 22 March 2021.

The Information Commissioner's Office states:
"Section 22 is a qualified exemption. This means that, even if the requested information falls within it, the public authority must go on to consider whether the public interest in maintaining the exemption is greater than the public interest in disclosing the information."

And:
"the public interest in releasing the information will often be stronger if the publication date is far in the future or where it isn’t set."

iDAPs for the current generation of COVID-19 vaccines will of course be of increasing irrelevance the further in the future they are published.

Could you either confirm the date on which the iDAPs will be published, or provide a one-off release of the requested information?

Yours sincerely,

Kenneth MacArthur

Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

Thank you for your email.
 
The Pharmacovigilance Service Team will aim to provide a response to your
query within seven working days – however where a contribution from a
specialist is required this may take longer; we endeavour to respond to
all requests within ten working days.
 
If you have not received a response within 10 working days, please feel
free to follow up via email.
 
If you are unsatisfied with the handling of your request, or for any
urgent matters, please contact the Service Team Manager Faiza Farooq on
0203 080 6511
 
All information provided is handled in line with our privacy policy, which
can be viewed on our website at
https://www.gov.uk/government/publicatio....
 
Kind Regards,
Pharmacovigilance Service Team
Vigilance and Risk Management of Medicines
MHRA
10 South Colonnade
Canary Wharf
London
E14 4PU

Pharmacovigilanceservice, Medicines and Healthcare products Regulatory Agency

Dear Mr MacArthur,

Thank you for your email. Unfortunately at this moment we are unable to provide a publication date for the interactive Drug Analysis Profiles. We recognise that there is strong interest in seeing this data and accept it should not be withheld.

We will send you a link to the iDAPs as soon as they are published.

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 'Suspected adverse reactions to COVID-19 vaccines'.

You have confirmed that the MHRA holds the information I have requested, and that there is a public interest in its being published. However, you have relied on the 'information intended for future publication' exemption in section 22 of the Freedom of Information Act (FOIA) 2000 to withhold the information for the time being.

As you will be aware, the Information Commissioner's Office states the following about section 22 of FOIA 2000:
"Section 22 is a qualified exemption. This means that, even if the requested information falls within it, the public authority must go on to consider whether the public interest in maintaining the exemption is greater than the public interest in disclosing the information."

Please can you confirm:
a) Why specifically you believe the public interest continues to be in withholding the information for the time being, and
b) Why you cannot provide a one-off extract of the information collected to date.

The Information Commissioner's Office goes on to state:
"the public interest in releasing the information will often be stronger if the publication date is far in the future or where it isn’t set."

Please can you also confirm:
c) Why specifically you believe the public interest continues to be in withholding the information despite your refusal to provide a publication date.

Finally, please can you confirm:
d) Why, when the iDAPs platform already exists (https://yellowcard.mhra.gov.uk/iDAP/) - on which it is stated that "iDAPs are provided for all licensed drugs for which we have received reports of suspected adverse reactions" - you are unable to publish iDAPs for the COVID-19 vaccines forthwith, and indeed why you did not publish iDAPs for the COVID-19 vaccines as soon as these vaccines were licensed.

I look forward to your reply, and would ask that you respond individually to points (a) to (d) above.

If you are unwilling to reconsider your decision, I will be happy to ask the Information Commissioner for final adjudication.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/s...

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 21/351. 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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