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________________________________________ From: Miss G
<[FOI #799819 email]> Sent: Wednesday, October 13,
2021 4:31:49 PM To: MHRA Customer Services Subject: Freedom of Information
request - Covid vaccines ADR measures Dear Medicines and Healthcare
Products Regulatory Agency, Please provide the following information Your
weekly statistical analysis disproportionality scores in regards to
astrazeneca covid vaccine Pfzier covid vaccine and any others covid
vaccines being administered in UK? , Since week 1 of role out until 30th
September 2021. Also details of any time, if any, within same time period,
the drug reactions combinations for each of these vaccines were found to
met the defined criteria and assessed by scientists, physicians and
pharmacists to determine if the signal is likely to be described as a real
medicine-related concern?, as described in link below If this has occurred
please provide information that confirm who the scientists, physicians and
pharmacists were, who determined this? And provide or direct me to the
findings and outcomes of these determinations? Also please confirm what
the defined criteria is?, and what drug-related combinations must be
identified by the disproportionality score to meet the defined criteria?
https://eur01.safelinks.protection.outlo...
Yours faithfully, Miss G Simpson
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #799819 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
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For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
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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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Our Ref: FOI 21/1142

Dear Miss G Simpson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 14th October 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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Dear Miss G Simpson,

Thank you for your email.

I can confirm that the MHRA does hold some of the information that you
have requested. However, we have also determined that the information is
exempt under Section 12 of the Freedom of Information Act and we cannot
process your request any further.

Section 12 of the Act allows public authorities to 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.

We consider that this would take longer than 24 working hours to complete.

Please note that substantially similar requests made within 60 working
days of an original request can be aggregated into one for the purposes of
calculating a cost limit, meaning that section 12 could still apply.

If you have a query about the information provided, please reply to this
email

If you disagree with how we have interpreted the Freedom of Information
Act 2000 in answering your request, you can ask for an internal review.
Please reply to this email, within two months of this reply, specifying
that you would like an Internal Review to be carried out.

Due to the ongoing Covid-19 situation, we are not able to accept delivery
of any documents or correspondence by post or courier to any of our
offices

Please remember to quote the reference number above in any future
communications.

If you were to remain dissatisfied with the outcome of the internal
review, you would have the right to apply directly to the Information
Commissioner for a decision. Please bear in mind that the Information
Commissioner will not normally review our handling of your request unless
you have first contacted us to conduct an internal review. The Information
Commissioner can be contacted at:

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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