Testing of the Covid vaccine

Shane Fallas made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

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Dear Medicines and Healthcare products Regulatory Agency,

Can toy please explain how you have approved the Pfizer vaccine. Can you please confirm that the vaccine has an active component and is not just water. And how you have confirmed this and what method has been used. Can you explain how the vaccine with be administered in a sterile manner. Can you please explain why you have given approval to an experimental vaccine and there reasoning why you have granted approval. Also why no one is liable if anything happens.

Yours faithfully,

Shane Fallas

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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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

FOI 20/559
Dear Mr Fallas,
 
Many thanks for your email, dated 04 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 composition of the vaccine, the documents Information for
Healthcare Professionals and Information for UK Recipients on the
Pfizer/BioNTech COVID-19 vaccine provide more details on the vaccine,
including the qualitative composition. Links to these documents are
provided below:
[3]https://assets.publishing.service.gov.uk...
[4]https://assets.publishing.service.gov.uk...
 
Regarding your question concerning liability, MHRA holds no information on
this. We suggest that you contact the Department of Health and Social Care
(DHSC) for further information. Their contact details are provided below:
 
[5]Web contact form - https://contactus.dh.gov.uk/?openform 
 
020 7210 485
  
If you have a query about the information provided, please reply to this
email.
 
If you are dissatisfied with the handling of your request, you have the
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: [6][MHRA request email]
 
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
 
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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Dear MHRA Customer Services, this does not answer the question I have asked. And I still await the details of my question and the answer you will provide.

Yours sincerely,

Shane Fallas

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. Our [1]guidance and information can be accessed here. 

References

Visible links
1. https://www.gov.uk/government/collection...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Mr Fallas,
 
Thank you for your email of 8 January 2021, where you have stated:
 
“Dear MHRA Customer Services,  this does not answer the question I have
asked.  And I still await the details of my question and the answer you
will provide”
 
Please find below answers to the questions you raise in blue below.
 
Can you please explain how you have approved the Pfizer vaccine
 
In our previous correspondence of 15 January 2021, we provided the link to
the Public Assessment Report (PAR), which contains MHRA’s assessment of
the Pfizer/BioNTech vaccine and explains how this vaccine was approved. 
 
Can you please confirm that the vaccine has an active component and is not
just water and how you have confirmed this and what method has been used
 
In our previous correspondence of 15 January 2021, we stated that details
concerning the active substance are in the PAR and also in the New England
Journal of Medicine (NEJM) article, both of which we provided links to.
 
Can you explain how the vaccine with be administered in a sterile manner
 
In our previous correspondence of 15 January 2021, we provided the link to
the Information for Healthcare Professionals, which details how the
vaccine will be administered.
 
Can you please explain why you have given approval to an experimental
vaccine and there reasoning why you have granted approval
The PAR provides details of the MHRA’s assessment and the positive
benefit/risk balance.
 
Also why no one is liable if anything happens
 
MHRA holds no information on this, we recommended that you contact the
Department of Health and Social Care (DHSC). In addition you might also
find the below informative:
[1]https://www.gov.uk/government/news/gover...
 
In conclusion, MHRA consider that we have provided you with the relevant
documents we hold. Where MHRA does not hold the information (i.e.
concerning liability/indemnity), we have referred you to other relevant
organisations who may hold the information and have now provided the link
to a UK Government webpage concerning this.
 
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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