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________________________________________ From: J Grove
<[FOI #813763 email]> Sent: Sunday, December 5,
2021 5:47:50 PM To: MHRA Customer Services Subject: Freedom of Information
request - BNT162b2 all case mortality data from Pfizer clinical trials
dossier, dates sent to scientific/medical advisers. Dear Medicines and
Healthcare Products Regulatory Agency, It is understood by this requester
from information in the public domain that legal clauses in the efficacy
and safety regulatory dossiers from big pharma companies that are
submitted to regulators prevent these regulators from releasing
information that has been recorded in these dossiers. These legal
requirements on the part of big pharma companies are analogous to so
called “gagging clauses”. It would reasonably be expected that such legal
restrictions would not prevent information within such regulatory dossiers
from being shared with the Government Chief Scientific Adviser (GCSA) and
Chief Medical Officer for England (CMO) together with other groups that
have an involvement in the use of drugs that have yet to complete phase 3
clinical trials. One such organisation that should reasonably receive
information from big pharma companies (via the regulator) is the Joint
Committee on Vaccination and Immunisation (JCVI). This request under the
Freedom of Information Act 2000 (FOIA 2000) asks for the dates when the
GCSA, CMO and JCVI received the all case mortality data (e.g. number of
deaths within 90 days of drug administration) from the Pfizer clinical
trials regulatory dossier for the novel capped messenger ribose nucleic
acid (mRNA) drug with the code BNT162b2 that the MHRA was in receipt of.
It would reasonably be expected that the GCSA, CMO and JCVI received the
information within the Pfizer dossiers at the same time so whilst this
request asks for a number of dates it would reasonably be expected that
these dates are the same, thus making the request easy to respond to by
the MHRA. To be clear this request relates to both the 2 dose and 3 dose
all case mortality data associated with the administration of this first
in class genetic therapy drug (that has yet to complete phase 3 clinical
trials). Under the FOIA 2000 please provide the following recorded dates:
1. The date that the MHRA sent the Chief Medical Officer for England (CMO)
Prof Chris Whitty (or the office of the CMO) the all case mortality data
for 2 doses of BNT162b2. 2. The date that the MHRA sent the Government
Chief Scientific Adviser (GCSA) Sir Patrick Vallance (or the office of the
GCSA) the all case mortality data for 2 doses of BNT162b2. 3. The date
that the MHRA sent the Joint Committee on Vaccination and Immunisation (or
the office of the JCVI) the all case mortality data for 2 doses of
BNT162b2. 4. The date that the MHRA sent the Chief Medical Officer for
England (CMO) Prof Chris Whitty (or the office of the CMO) the all case
mortality data for 3 doses (i.e. the so called booster dose) of BNT162b2.
5. The date that the MHRA sent the Government Chief Scientific Adviser
(GCSA) Sir Patrick Vallance (or the office of the GCSA) the all case
mortality data for 3 doses (i.e. the so called booster dose) of BNT162b2.
6. The date that the MHRA sent the Joint Committee on Vaccination and
Immunisation (or the office of the JCVI) the all case mortality data for 3
doses (i.e. the so called booster dose) of BNT162b2. Thanks. Yours
faithfully, J Grove
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #813763 email] Is [MHRA request email] the wrong
address for Freedom of Information requests to Medicines and Healthcare
Products Regulatory Agency? If so, please contact us using this form:
https://eur01.safelinks.protection.outlo...
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

Our Ref: FOI 21/1288

Dear J Grove,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6th December 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

show quoted sections

Dear Mr Grove,

Thank you for your FOI request dated 5^th December 2021.

The MHRA informs the people/ bodies listed in your request of our
licensing decisions; however, we do not provide raw data to them.

As observers JCVI have access to our safety papers which are presented to
the Expert Working Group, but the submissions that companies make for
authorisations are not provided to JCVI or DHSC.

Kind regards,

FOI Team

Vigilance and Risk Management of Medicines Division

Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

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. Ourguidance and information can be accessed here.

________________________________________ From: J Grove
<[FOI #813763 email]> Sent: Sunday, January 9, 2022
3:31:47 AM To: MHRA Customer Services Subject: Internal review of Freedom
of Information request - BNT162b2 all case mortality data from Pfizer
clinical trials dossier, dates sent to scientific/medical advisers. Dear
Medicines and Healthcare Products Regulatory Agency, Please pass this on
to the person who conducts Freedom of Information reviews. I am writing to
request an internal review of Medicines and Healthcare Products Regulatory
Agency's handling of my FOI request 'BNT162b2 all case mortality data from
Pfizer clinical trials dossier, dates sent to scientific/medical
advisers.'. Would you be so good as to check your systems again? It is the
understanding of this requester that the JCVI made the call that there was
not sufficient evidence to treat children with the experimental genetic
therapies known as “COVID-19” vaccines and in order to get the decision
changed to dose the kids with EUA modified mRNA drugs the UK Government to
let the CMO make the judgement call and the result of this is that
children are now “offered" these drugs. Based on the response to this
request it would appear that the CMO Chris Witty did not have access to
the mortality data for the “COVID-19 vaccines” to compare against the
vanishingly low mortality for COVID-19/SARS-CoV-2 in children. Given that
it is the understanding of this requester that a number of very senior
paediatricians have communicated with the JCVI to ask this committee to
re-think their initial assessments on the benefits of the “COVID-19
vaccines" (i.e. to perform a proper risk stratification analysis) then it
would be appropriate under the circumstances for the MHRA to respond in
full to each of my requests for recorded information. As a review I would
like the MHRA to provide the relevent exemption under the FOIA 2000 that
the recorded information is not held, for each of the six requests.
Thanks. A full history of my FOI request and all correspondence is
available on the Internet at this address:
https://eur01.safelinks.protection.outlo...
Yours faithfully, J Grove
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #813763 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections

Internal Review of FOI 21/1288

Dear J Grove,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/1288. We normally aim to respond to requests for internal review within 20 working days of receipt. However, due to high volumes of queries we are currently receiving related to COVID-19 please be aware that responses may take longer than usual.  

Kind Regards  

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU

show quoted sections

Internal Review of FOI 21/1288

Dear J Grove,

Thank you for taking an interest in the regulatory aspects of COVID-19
vaccines. We have now completed our internal review of FOI request:
21/1288.

In terms of assessing the handling of original response for under the FOI
Act, we uphold the approach taken and confirm that we do not hold the
dates requested. To make the original response more informative we would
like to add the following. The MHRA informs the people/ bodies listed in
your request of our licensing decisions; however, we do not provide raw
data to them. However, by way of example as observers JCVI have access to
our COVID-19 vaccine post-authorisation safety analysis papers which are
presented to the relevant Expert Working Group, but the submissions that
companies make for authorisations are not provided to JCVI or DHSC and so
forth.

In terms of clinical assessment of the vaccine in children, please refer
to the [1]EPAR on the extension of the approval to 5-11 year olds which
includes a very full discussion on the safety and efficacy of the vaccine
in that age group. Please also refer to the SmPC and Package Leaflet
published on the .gov website that are specific to the paediatric vaccine:

SmPC

[2]https://assets.publishing.service.gov.uk...

Package Leaflet:

[3]https://assets.publishing.service.gov.uk...

In summary,  we consider the original response to be appropriate; the
approach was not dismissive and sought to explain how information transfer
between the MHRA and other public health organisation/s occurs. However,
the original response may have merited from making it explicitly clear
that we do not hold the dates requested.

We understand the significant public interest in the COVID-19 vaccines,
including use in children, and would like to highlight that the dose of
the paediatric COVID-19 Vaccine Pfizer BioNTech is lower than that used in
adults, and to also highlight that use of the vaccine in the 5-11 year
olds is carefully guided by JCVI recommendations and the MHRA product
information (referred to above). And, in terms of transparency, a section
on events with a fatal outcome is present within [4]our coronavirus
vaccine - weekly summary of Yellow Card reporting which is regularly
updated on the MHRA website. 

Thank you for your enquiry under the FOI act. This concludes or internal
review. However, If you remain dissatisfied, you may ask the ICO to make a
decision on whether or not we have interpreted the FOIA correctly in
dealing with the request and subsequent internal review. The ICO’s address
is:

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000

show quoted sections

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. Ourguidance and information can be accessed here.

________________________________________ From: J Grove
<[FOI #813763 email]> Sent: Sunday, April 17, 2022
11:43:22 PM To: MHRA Customer Services Subject: Re: Internal Review of FOI
21/1288 - Internal review of Freedom of Information request - BNT162b2 all
case mortality data from Pfizer clinical trials dossier, dates sent to
scientific/medical advisers. Dear MHRA Customer Services, The MHRA are
thanked for undertaking the internal review and confirming that the
individuals who made the judgement call that the administration of
emergency use authorisation (EUA) experimental gene therapy drugs for
paediatric use did not have the raw data relating to mortality that the
MHRA had in it's possession that had been received from the drug
manufacturers. It is the understanding of this requester that a court
order in the United States of America (USA) has forced the US Food and
Drug Administration (FDA) to release the list of adverse drug events from
the clinical trials of the Pfizer-BioNTech drug BNT162b2 and that over 8
pages and over 1000 adverse reactions are recorded. It would reasonably be
expected that the CMO Chris Whitty would have received information on the
adverse events of BNT162b2 (including death and it's likelihood) prior to
Whitty's recommendation of the use of this drug in children. The MHRA are
thanked for informing this requester that Whitty did not have the raw
mortality data BNT162b2 prior to Whitty “rubber stamping” it’s use in
children. Yours sincerely, J Grove -----Original Message----- Internal
Review of FOI 21/1288 Dear J Grove, Thank you for taking an interest in
the regulatory aspects of COVID-19 vaccines. We have now completed our
internal review of FOI request: 21/1288. In terms of assessing the
handling of original response for under the FOI Act, we uphold the
approach taken and confirm that we do not hold the dates requested. To
make the original response more informative we would like to add the
following. The MHRA informs the people/ bodies listed in your request of
our licensing decisions; however, we do not provide raw data to them.
However, by way of example as observers JCVI have access to our COVID-19
vaccine post-authorisation safety analysis papers which are presented to
the relevant Expert Working Group, but the submissions that companies make
for authorisations are not provided to JCVI or DHSC and so forth. In terms
of clinical assessment of the vaccine in children, please refer to the
[1]EPAR on the extension of the approval to 5-11 year olds which includes
a very full discussion on the safety and efficacy of the vaccine in that
age group. Please also refer to the SmPC and Package Leaflet published on
the .gov website that are specific to the paediatric vaccine: SmPC
[2]https://eur01.safelinks.protection.outlo...
Package Leaflet:
[3]https://eur01.safelinks.protection.outlo...
In summary, we consider the original response to be appropriate; the
approach was not dismissive and sought to explain how information transfer
between the MHRA and other public health organisation/s occurs. However,
the original response may have merited from making it explicitly clear
that we do not hold the dates requested. We understand the significant
public interest in the COVID-19 vaccines, including use in children, and
would like to highlight that the dose of the paediatric COVID-19 Vaccine
Pfizer BioNTech is lower than that used in adults, and to also highlight
that use of the vaccine in the 5-11 year olds is carefully guided by JCVI
recommendations and the MHRA product information (referred to above). And,
in terms of transparency, a section on events with a fatal outcome is
present within [4]our coronavirus vaccine - weekly summary of Yellow Card
reporting which is regularly updated on the MHRA website. Thank you for
your enquiry under the FOI act. This concludes or internal review.
However, If you remain dissatisfied, you may ask the ICO to make a
decision on whether or not we have interpreted the FOIA correctly in
dealing with the request and subsequent internal review. The ICO’s address
is: The Information Commissioner’s Office Wycliffe House Water Lane
Wilmslow Cheshire SK9 5AF Yours sincerely MHRA Customer Experience Centre
Communications and engagement team Medicines and Healthcare products
Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 020 3080 6000
------------------------------------------------------------------- Please
use this email address for all replies to this request:
[FOI #813763 email] Disclaimer: This message and
any reply that you make will be published on the internet. Our privacy and
copyright policies:
https://eur01.safelinks.protection.outlo...
For more detailed guidance on safely disclosing information, read the
latest advice from the ICO:
https://eur01.safelinks.protection.outlo...
https://eur01.safelinks.protection.outlo...
Please note that in some cases publication of requests and responses will
be delayed. If you find this service useful as an FOI officer, please ask
your web manager to link to us from your organisation's FOI page.

show quoted sections