Covid vaccines ADR measures

Response to this request is delayed. By law, Medicines and Healthcare Products Regulatory Agency should normally have responded promptly and by (details)

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://assets.publishing.service.gov.uk...

Yours faithfully,

Miss G Simpson

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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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
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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

 

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.

 

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the cost of dealing with them would exceed the appropriate limit, which
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We consider that this would take longer than 24 working hours to complete.

 

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

 

 

MHRA Customer Service Centre

 

Medicines and Healthcare products Regulatory Agency

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