Dear Medicines and Healthcare Products Regulatory Agency,

Please provide the following information in relation to all types of covid vaccines being administered in the UK:

1. Breakdown of all reported adverse reactions to date by age and vaccine type
2. Breakdown of all reported adverse reactions to date by gender and vaccine type
3. Breakdown of all reported adverse reactions to date by onset interval and vaccine type
4. Breakdown of all reported adverse reactions to date by ethnicity and vaccine type
5. Breakdown of all reported adverse reactions to date by socio-economic status and vaccine type
6. Breakdown of all reported adverse reactions to date by BMI and vaccine type
7. Breakdown of all reported adverse reactions to date by comorbidity and vaccine type

I look forward to receiving your response.

Yours faithfully,

Melissa Smith

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 21/1023
       
Dear Melissa Smith,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 7th September 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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Melissa Smith,

 

Thank you for your email.

 

The MHRA intends to publish all suspected reactions reported in
association with available COVID-19 vaccines in an interactive format as
interactive Drug Analysis Profiles (iDAPs), along with our ADR summary
that is published each week. The use of iDAPs will enable users to view
the data by categories of their choice such as age, sex and seriousness of
reports. Users will also be able to download the data tables in CSV
format.

 

As we plan to publish the data, we consider that your request is covered
by Section 22 of the Freedom of Information Act (information intended for
future publication) and the information you have asked for is therefore
exempt from disclosure.

 

Section 22 is a qualified exemption which means we have considered whether
there is a greater public interest in releasing the information requested
or withholding it. We recognise there is strong interest in seeing this
data and accept it should not be withheld however wish to publish this
information alongside appropriate context and assessment.

 

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

 

In reference to points 5 and 6 this information is not held by MHRA and as
such we would be unable to provide this and this would not be present in
the iDAPs.

 

With regards to point 7, unfortunately, we are unable to provide details
of past medical history for individual cases. Because of the way this
information is captured within our database, this would require manual
extraction of the information from each individual case. Therefore, this
information is exempt from release under Section 12 of the FOI Act.
Section 12 of the FOI Act specifies that a public authority may refuse
requests where the cost of dealing with them would exceed the appropriate
limit, which for central government is set at £600. This represents the
estimated cost of one person spending 24 working hours in determining
whether the department holds the information, locating, retrieving and
extracting the information. Please be reassured that any information
provided regarding a patient’s past medical history or concurrent
conditions is taken into account during the routine assessment of all
cases that we receive.

 

I hope the information provided and explanation regarding the exemption is
helpful. If you disagree with how we have interpreted the Freedom of
Information Act 2000 with regards to your request, you can ask for the
decision to be reviewed. The review will be carried out by a senior member
of the Agency who was not involved with the original decision.

 

Kind regards,

 

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

 

 

 

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