Annual reports

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare Products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Dear Medicines and Healthcare Products Regulatory Agency,

I would like to see a graph showing the total number of vaccine deaths and adverse reactions you have records for the last 20 years, or for as long your records go back, or for as long as you are able to produce within the 20 hour limit for FOI requests, whichever is greatest.

For example: 2021: number of deaths: xx number of adverse reactions: xx
2020: number of deaths: xx number of adverse reactions: xx
And so on.

Yours faithfully,

Ian Dalton

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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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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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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 21/986
       
Dear Ian Dalton,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
        
Thank you for your enquiry which we received on 23 August 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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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

2 Attachments

Dear Ian Dalton,

 

Please find the attached in response to your FOI requests.

 

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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Dear Medicines and Healthcare Products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare Products Regulatory Agency's handling of my FOI request 'Annual reports'.

The response you have provided does not in any way answer the question I asked about how many of the total adverse reactions get reported to you. My question was:

"I am aware that the yellow card reporting system is a voluntary reporting system, presumably a proportion of the total vaccine adverse reactions do not get reported to the yellow card system, or get misdiagnosed as something else. I would like to know roughly what percentage of the total adverse reactions to vaccines do get reported to you."

At no point did I mention anything about covid vaccines yet your response refers to them. The closest you got to answering my question was to say that the percentage of reports is "variable". That's not a valid answer. I would like to know roughly what percentage of the total vaccine adverse reactions get reported to you.

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

And here: https://www.whatdotheyknow.com/request/y...

Yours faithfully,

Ian Dalton

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. Ourguidance and information can be accessed here.

________________________________________ From: Ian Dalton
<[FOI #784164 email]> Sent: Thursday, September 16,
2021 6:44:22 PM To: MHRA Customer Services Subject: Internal review of
Freedom of Information request - Annual reports Dear Medicines and
Healthcare Products Regulatory Agency, Please pass this on to the person
who conducts Freedom of Information reviews. I am writing to request an
internal review of Medicines and Healthcare Products Regulatory Agency's
handling of my FOI request 'Annual reports'. The response you have
provided does not in any way answer the question I asked about how many of
the total adverse reactions get reported to you. My question was: "I am
aware that the yellow card reporting system is a voluntary reporting
system, presumably a proportion of the total vaccine adverse reactions do
not get reported to the yellow card system, or get misdiagnosed as
something else. I would like to know roughly what percentage of the total
adverse reactions to vaccines do get reported to you." At no point did I
mention anything about covid vaccines yet your response refers to them.
The closest you got to answering my question was to say that the
percentage of reports is "variable". That's not a valid answer. I would
like to know roughly what percentage of the total vaccine adverse
reactions get reported to you. A full history of my FOI request and all
correspondence is available on the Internet at this address:
https://urldefense.proofpoint.com/v2/url...
And here:
https://urldefense.proofpoint.com/v2/url...
Yours faithfully, Ian Dalton
------------------------------------------------------------------- Please
use this email address for all replies to this request:
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any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://urldefense.proofpoint.com/v2/url...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://urldefense.proofpoint.com/v2/url...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/986
 
Dear Ian Dalton,
 
Thank you for your email.
 
We confirm that an internal review will be carried out on FOI 21/986. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.
 
Kind Regards
 
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Internal Review of FOI 21/986

 

Dear Ian Dalton,

 

Thank you for your Internal Review Request, we apologise for the delay in
reply.

 

Having reviewed our initial response of 16 September we do not have
anything further to add. As we stated, the reporting rate for spontaneous
Adverse Drug Reactions (ADR) is variable and can depend on a multitude of
factors. The actual rate is unknown and variable because it is influenced
by public awareness and seriousness of the event.

 

In our reply we did make reference to COVID-19 vaccines, we did that
because you have previously contacted us with questions regarding these
vaccines.

 

If you remain dissatisfied, you may ask the Information Commissioner (ICO)
to make a decision on whether or not we have interpreted the FOIA
correctly in dealing with the request and subsequent internal review. The
ICO’s address is:

 

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

 

Yours sincerely

 

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

 

 

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