All documentation relating to Covid vaccine authorisations

Ryan Underwood made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,

Please provide relevant documentation including, but not limited to, SPCs, patient information leaflets, medical practicioner guidance, and authorization documents in relation to any and all vaccine products approved by MHRA and other government agencies for the prophylaxis / prevention / elimination / inoculation of the Covid-19 virus.

Yours faithfully,
Ryan Underwood.

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 20/539

Dear Mr Ryan Underwood,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 7 December 2020.

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 Telephone 0203 080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Reference: CSC 20/539
 
Dear Mr Underwood
 
Many thanks for your email, dated 05 December 2020.
 
The approval for use of the Pfizer/BioNTech COVID-19 vaccine in the UK
followed a rigorous scientific assessment of all the available evidence of
quality, safety and effectiveness by the UK regulator, the Medicines and
Healthcare products Regulatory Agency (MHRA). The MHRA expert scientists
and clinicians reviewed data from the laboratory pre-clinical studies,
clinical trials, manufacturing and quality controls, product sampling and
testing of the final vaccine, and also considered the conditions for its
safe supply and distribution. The decision was made with advice from the
Commission on Human Medicines (CHM), the government’s independent expert
scientific advisory body. Regarding the MHRA approval of the
Pfizer/BioNTech COVID-19 vaccine, a Public Assessment Report (PAR) has
been published, which consists of the non-confidential aspects of MHRA’s
assessment of this vaccine. A link to the MHRA PAR is provided below:
[1]https://assets.publishing.service.gov.uk...
 
In addition to the above, information on the studies conducted using the
Pfizer/BioNTech COVID-19 vaccine and their results are available in a
peer-reviewed journal, the New England Journal of Medicine. A link to this
is provided below:
[2]https://www.nejm.org/doi/full/10.1056/NE...
 
Regarding the Summary of Product Characteristics (SmPC), Patient
Information Leaflet (PIL) and medical practitioner guidance on this
vaccine, the documents "Information for Healthcare Professionals" and
"Information for UK Recipients on the Pfizer/BioNTech COVID-19 vaccine"
provide more details. Links to these documents are provided below:
[3]https://assets.publishing.service.gov.uk...
[4]https://assets.publishing.service.gov.uk...
 
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Yours sincerely
 
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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