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Peer Reviewed Evidence for Pfizer Covid-19 vaccine

Herbert Gussett made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,
I seek the following information under the UK Freedom of Information act.

Please supply a copy of a peer reviewed publication in a scientific or medical journal providing evidence that the Pfizer-BioNtech covid-19 vaccine is both safe and efficacious.
Specifically it should answer the following questions:

1. How long does the vaccine confer immunity to sars-cov-2 infection? Provide published evidence.

2. Does the vaccine prevent transmission of Sars-cov-2 virus. Provide published evidence.

3. What are the most likely adverse reactions and long term unintended effects of the vaccine? Provide published evidence.

4. Does the vaccine improve health economic outcomes? For example reduce hospital admissions. If so, please provide published evidence.

Yours faithfully,

Herbert Gussett

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 Herbert Gussett,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 8 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

FOI 20/540
 
Dear Mr Gussett,
 
Many thanks for your email.
 
With regards to Question 1, 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. This article
states “collection of Phase 2/3 data on vaccine immunogenicity and the
durability of the immune response to immunization is ongoing.” A link to
this is provided below:
[1]https://www.nejm.org/doi/full/10.1056/NE...
 
Furthermore, MHRA has published a Public Assessment Report (PAR), which
consists of the non-confidential aspects of MHRA’s assessment of this
vaccine. A link to the MHRA PAR is provided below:
[2]https://www.gov.uk/government/publicatio...
 
Both the PAR and the NEJM article state that, cell-mediated immunity data
are available from study BNT162-01 in a limited number of subjects aged
18-55 years. These indicate that antigen-specific CD4+ and CD8+ T cell
responses are induced by the vaccine, with a favourable Th1 profile.
Longer-term antibody data at 6, 12 and 24 months after completion of
vaccination (including analysis by baseline serostatus); and additional
T-cell response data up to 24 months, including in older subjects,
immunocompromised adults and HLA typing of the subjects are being
collected. This is addressed via the RMP and proposed conditions for the
Regulation 174 approval.
 
With regards to Question 2, it is currently not known to what extent the
vaccine prevents transmission of the virus.
 
Further information concerning the conditions of authorisation, which you
may find useful, can be found at:
[3]https://www.gov.uk/government/publicatio...
 
With regards to Question 3, further information on the undesirable effects
that may be observed with this vaccine, are available in the "Information
for Healthcare Professionals" and "Information for UK Recipients on the
Pfizer/BioNTech COVID-19 vaccine". Links to these documents are provided
below:
[4]https://assets.publishing.service.gov.uk...
[5]https://assets.publishing.service.gov.uk...
 
With regards to Question 4, concerning "health economic outcomes", MHRA
holds no information on this. We advise that you contact NHS England
directly for this information, their contact details are provided below:
 
[6]https://www.england.nhs.uk/
 
Tel: 0300 311 22 333
 
Email: [7][email address]
 
If you have a query about the information provided, please reply to this
email.
 
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right to ask for an internal review. Internal review requests should be
submitted within two months of the date you receive this response and
addressed to: [8][MHRA request email]
 
Please remember to quote the reference number above in any future
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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
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Wilmslow
Cheshire
SK9 5AF
 
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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We don't know whether the most recent response to this request contains information or not – if you are Herbert Gussett please sign in and let everyone know.