Covid19 Vaccination Programme - Risk-Benefit Evidence

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2020. Our [1]guidance and information can be accessed here. 

References

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Our Ref: FOI 21/374

Dear Mr Bob Parkinson,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 8 April 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.

Kind Regards,

MHRA Customer Service Centre

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

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FOI 21/374
 
Dear Mr Parkinson
 
Thank you for your email.
 
The authorisation of the Pfizer/BioNTech and the Oxford/AstraZeneca
vaccines 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 vaccine batches, based on the safety, quality and
efficacy data submitted to MHRA. These authorisations do not constitute a
marketing authorisation.
 
All vaccines are tested through three phases of clinical trials to ensure
they meet the gold standard. Phase 1 trials are with a small group of
people to make sure there are no safety concerns and determines the
appropriate dosage for the best immune response. Phase 2 trials are
conducted on a larger group of people to check the vaccine works
consistently and that the immune response is sufficient. Phase 3 trials
test the vaccines on thousands of people for scientists to assess if the
vaccine is producing immunity that will prevent disease. Usually, these
phases are run in sequence, but in an effort to find a safe and effective
Covid-19 vaccine as quickly as possible, once safety has been ascertained
through Phase 1, Phases 2 and 3 are being run in parallel. Extensive
checks and balances are required at every stage of the development of a
vaccine, and this is no different for a Covid-19 vaccine. No stages in the
vaccine development processes were bypassed.
 
Information on the study conducted using the Pfizer/BioNTech vaccine and
its results are available in a peer-reviewed journal, the New England
Journal of Medicine (NEJM). A link to this is provided below:
[1]https://www.nejm.org/doi/full/10.1056/NE...
 
The approval for use of the Pfizer/BioNTech and Oxford/AstraZeneca
COVID-19 vaccines 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 and the
Oxford/AstraZeneca COVID-19 vaccines, further information (including
information for physicians and recipients of the vaccine, and Public
Assessment Reports [PARs] for each vaccine) are available on the MHRA
website. Links to these are provided below:
[2]https://www.gov.uk/government/publicatio...
[3]https://www.gov.uk/government/publicatio...
 
Further to the above, the Moderna vaccine was granted a marketing
authorisation by MHRA on 31 March 2021. Further information on this is
provided below:
[4]https://www.gov.uk/government/publicatio...
 
In addition, the European Commission, following recommendations from the
European Medicines Agency (EMA), have granted marketing authorisations for
the Pfzier/BioNTech and Oxford/AstraZeneca vaccines. Further information
is provided below:
[5]https://www.ema.europa.eu/en/medicines/h...
[6]https://www.ema.europa.eu/en/medicines/h...
 
MHRA is collecting data concerning any adverse reactions observed to
vaccine treatment through our Yellow Card Scheme. The MHRA are publishing
Yellow Card data associated with COVID-19 vaccinations. Yellow Card data
for drugs is routinely published on the Yellow Card website, with vaccine
data available on request. However, for COVID-19 vaccinations we are
proactively publishing details of adverse drug reactions received,
including MHRA assessment of the data to provide context.    Further
information is available on our website 
[7]https://www.gov.uk/government/publicatio...
 
 
Throughout this global pandemic, we have always been guided by the latest
scientific advice. Having studied evidence on both the Pfizer/BioNTech and
Oxford/AstraZeneca vaccines, the Joint Committee on Vaccination and
Immunisation (JCVI) has advised that we should prioritise giving as many
people in at-risk groups their first dose, rather than providing two doses
in as short a time as possible.
 
The four UK Chief Medical Officers agree with JCVI that at this stage of
the pandemic prioritising the first doses of vaccine for as many people as
possible on the priority list will protect the greatest number of at risk
people overall in the shortest possible time and will have the greatest
impact on reducing mortality, severe disease and hospitalisations and in
protecting the NHS and equivalent health services.
 
This is because the evidence shows that one dose of either vaccine
provides a high level of protection from Covid-19. 
 
For both vaccines, data provided to MHRA demonstrate that whilst efficacy
is optimised when a second dose is administered both offer considerable
protection after a single dose, at least in the short term. For both
vaccines the second dose completes the course and is likely to be
important for longer term protection.
 
The NHS across the UK will prioritise giving the first dose of the vaccine
to those in the most high-risk groups. Everyone will still receive their
second dose and this will be within 12 weeks of their first. The second
dose completes the course and is important for longer-term protection.
 
The JCVI’s independent advice is that this approach will maximise the
benefits of both vaccines allowing the NHS to help the greatest number of
people in the shortest possible time.  It will ensure that more at-risk
people are able to get meaningful protection from a vaccine in the coming
weeks and months, reducing deaths and starting to ease pressure on our
NHS.
 
For further information on prioritising the first COVID-19 vaccine dose
see the [8]statement from the Joint Committee on Vaccination and
Immunisation (JCVI). This information includes the rationale and evidence
for prioritising the first dose.
 
Updated information on the use of the authorised vaccines, such as the
recent update in advice for the AstraZeneca vaccine (which we have linked
below), is also available on the MHRA website.
[9]https://www.gov.uk/government/news/mhra-...
 
If you disagree with how we have interpreted the Freedom of Information
Act 2000 with regards to your request, you can ask for the decision to be
reviewed. The review would be carried out by a senior member of the Agency
who was not involved with the original decision.
 
If you have a query about the information provided, please reply to this
email.
 
 
Yours sincerely
 
MHRA Customer Service Centre
 
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
 

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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...

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...

Dear Bob Parkinson,

Thank you for your email.

We confirm that an internal review will be carried out on FOI 21/374. 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

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Dear Bob Parkinson,

After re-visiting previous years records we have realised that this
Internal Review request was not attended to, for this we apologise.

Given the delays, I first wanted to confirm if you still wish for use to
carry out this Internal Review. I also feel it may be helpful to mention
some advice regarding requests under FOIA.

In your request you asked,

"Your Agency and senior personnel continue to state in the media and
elsewhere that "the benefits of the Sars-Cov-2 Mass Vaccination programme
outway/continue to outway the risks.

Can you please supply the evidence to support this statement?"

And in your request for an internal review you mentioned,

"Your response is a mixture of process and sources.

It does not provide an evidence based judgement which would underwrite the
statements by your senior officials and others.

Until this is provided my FoI cannot be satisfied."

FOI requests are usually narrow in scope and aim to request information
held for example, please provide the clinical overview for x product (PL
number). Broad questions related to the evidence to support a statement,
are problematic to answer because the answer likely needs to seize upon
information also held by other authorities, whose work is interrelated to
that of the MHRA e.g. the resources on the Public Health England and the
Joint Committee on Immunisation and Vaccination.

The ICO have some helpful guidance on how to make a request for
information:
[1]https://ico.org.uk/for-the-public/offici....

Given the complexity of the data related to a pandemic, and the number of
COVID-19 vaccines that have been authorised, and because data will emerge
from multiple sources, e.g. clinical trial data, post-authorisation
surveillance studies, pharmacovigilance, and epidemiological data etc. A
mix of sources and data are necessary to support this statement,
additionally, the information in relation to processes helps to provide
key context on how the MHRA reached decisions to authorise the COVID-19
vaccines.

We hope that this update helpful,

Many thanks,

HQA FOI Team

show quoted sections

Internal Review of FOI 21/374

Dear Bob Parkinson,

Thank you for your email.

Please find attached the response to your Internal Review request and we
apologise for delay.

Kind Regards

MHRA Customer Service Experience

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

From: FOILicensing <[email address]>
Sent: Monday, September 11, 2023 9:39 AM
To: [FOI #745208 email]
Subject: RE: Internal review of Freedom of Information request - Covid19
Vaccination Programme - Risk-Benefit Evidence

Dear Bob Parkinson,

After re-visiting previous years records we have realised that this
Internal Review request was not attended to, for this we apologise.

Given the delays, I first wanted to confirm if you still wish for use to
carry out this Internal Review. I also feel it may be helpful to mention
some advice regarding requests under FOIA.

In your request you asked,

"Your Agency and senior personnel continue to state in the media and
elsewhere that "the benefits of the Sars-Cov-2 Mass Vaccination programme
outway/continue to outway the risks.

Can you please supply the evidence to support this statement?"

And in your request for an internal review you mentioned,

"Your response is a mixture of process and sources.

It does not provide an evidence based judgement which would underwrite the
statements by your senior officials and others.

Until this is provided my FoI cannot be satisfied."

FOI requests are usually narrow in scope and aim to request information
held for example, please provide the clinical overview for x product (PL
number). Broad questions related to the evidence to support a statement,
are problematic to answer because the answer likely needs to seize upon
information also held by other authorities, whose work is interrelated to
that of the MHRA e.g. the resources on the Public Health England and the
Joint Committee on Immunisation and Vaccination.

The ICO have some helpful guidance on how to make a request for
information:
[1]https://ico.org.uk/for-the-public/offici....

Given the complexity of the data related to a pandemic, and the number of
COVID-19 vaccines that have been authorised, and because data will emerge
from multiple sources, e.g. clinical trial data, post-authorisation
surveillance studies, pharmacovigilance, and epidemiological data etc. A
mix of sources and data are necessary to support this statement,
additionally, the information in relation to processes helps to provide
key context on how the MHRA reached decisions to authorise the COVID-19
vaccines.

We hope that this update helpful,

Many thanks,

HQA FOI Team

show quoted sections