Pfizer/BioNTech Covid-19 vaccine

Rowan Braithwaite made this Freedom of Information request to Medicines and Healthcare Products Regulatory Agency

Automatic anti-spam measures are in place for this older request. Please let us know if a further response is expected or if you are having trouble responding.

The request was partially successful.

Rowan Braithwaite

Dear Medicines and Healthcare products Regulatory Agency,

Please provide:

1. A list of the Pfizer/BioNTech Covid-19 vaccine ingredients.

2. A copy of the peer-reviewed (if applicable) or other study and trials data.

3. A demographic and health profile of test subjects (if not included in the study data).

4. The name of the journal or publication in which the study/trials data is published.

5. A copy of any emails, notes, and minutes from meetings about the vaccine, and/or its safety, and/or concerns about risks.

Yours faithfully,

Rowan Braithwaite

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency


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Rowan Braithwaite

Dear Medicines and Healthcare products Regulatory Agency,

Thank you for your acknowledgement.

Can you please clarify what you mean by, "Please note that we may not respond if your query .... is for information only"? The nature of a Freedom of Information request is that it is for information.

Yours faithfully,

Rowan Braithwaite

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 20/522

Dear Rowan Braithwaite,

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

Dear Rowan Braithwaite,

Thank you for your email.

Thank you for your email. The MHRA customer services mailbox receives a wide range of emails, some of which are not considered to require a response. If we receive an email which simply provides information but does not obviously require a response, a response may not be provided.

As you have clearly requested information from us, which is being handled under the Freedom of Information act, a response will be provided in due course.

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 20/522
 
Dear Mr Braithwaite,
 
Many thanks for your response, dated 05 December 2020, where you asked
questions concerning the Pfizer/BioNTech Covid-19 vaccine.
Please see the response to each of your questions in red below:
 
1. A list of the Pfizer/BioNTech Covid-19 vaccine  ingredients.
MHRA has published a list of ingredients in this vaccine in the
Information for Healthcare Professionals and the Information for UK
recipients of the Pfizer/BioNtech vaccine, links to these are provided
below:
 
[1]https://assets.publishing.service.gov.uk...
[2]https://assets.publishing.service.gov.uk...
 
2. A copy of the peer-reviewed (if applicable) or other study and trials
data.
 
3. A demographic and health profile of test subjects (if not included in
the study data).
 
4. The name of the journal or publication in which the study/trials data
is published.
Information on the ongoing clinical study and its results for this vaccine
are available in the New England Journal of Medicine. Links to these are
provided below:
[3]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:
[4]https://www.gov.uk/government/publicatio...
 
5. A copy of any emails, notes, and minutes from meetings about the
vaccine, and/or its safety, and/or concerns about risks.
The authorisation of the Pfizer/BioNTech vaccine was done through an
expedited rolling review. A ‘rolling review’ can be used to complete the
assessment of a promising medicine or vaccine during a public health
emergency in the shortest time possible. This is done as the packages of
data become available from ongoing studies on a staggered basis. The
temporary authorisation under Regulation 174 permits the supply of
identified COVID-19 mRNA Vaccine BNT162b2 batches, based on the safety,
quality and efficacy data submitted by Pfizer/BioNTech to MHRA in the
period from 1 October to 2 December 2020. The authorisation does not
constitute a marketing authorisation.
 
As no marketing authorisation has been granted for this vaccine, this
information is exempt under Section 41 (information provided in
confidence) and Section 43 (commercial interests) of the Freedom of
Information (FOI) Act. Section 41 is an absolute exemption and no
consideration of the public interest is required, except to state that we
would consider the release of this information to be an actionable breach
of confidence. Section 43 is a qualified exemption and requires that we
consider the public interest. We have considered the public interest and
cannot see any public interest argument that outweighs the commercial harm
in releasing information that would give competitors commercial secrets
that would aid the development of their own products and/or help them
overcome regulatory hurdles. MHRA’s assessment of the vaccine safety is
available in the PAR, a link to this is provided above. Additionally, data
from the clinical studies conducted are available in the New England
Journal of Medicine, also linked above.
 
MHRA will be publishing Yellow Card data associated with COVID-19
vaccinations. Yellow Card data for drugs is routinely published to the
Yellow Card website, with vaccine data available on request. However for
COVID-19 vaccinations we will be proactively publishing details of adverse
drug reactions (ADRs) received, including MHRA assessment of the data to
provide context
 
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: [5][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
 
Kind Regards,
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
 

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