Georgios Christodoulou

Dear National Institute for Health and Care Excellence,

Is it possible to have access to any reports regarding vaccines and their side affects please.

Yours faithfully,

Georgios Christodoulou

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

Dear Mr Christodoulou,

 

Reference No: EH-301427

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on Wednesday 25 September
2019, in which you asked NICE for the following information:

 

Is it possible to have access to any reports regarding vaccines and their
side affects please.

Your request will now be considered and you will receive a response within
the statutory timescale of 20 working days as defined by the Act, subject
to the information not being exempt or containing a reference to a third
party. In some circumstances we may be unable to achieve this deadline. If
this is likely you will be informed and given a revised time-scale at the
earliest opportunity.

 

There may be a fee payable for the retrieval, collation and provision of
the information you request. If this is the case you will be informed and
the 20 working day timescale will be suspended until we receive payment
from you. If you chose not to make a payment then your request will remain
unanswered.

 

Some requests may also require either full or partial transference to
another public authority in order to answer your query in the fullest
possible way. Again, you will be informed if this is the case.

 

I would like to take this opportunity to thank you for your interest in
NICE.

 

Yours sincerely,

Natalie

 

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [1]http://nice.org.uk

 

 

 

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National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

Dear Mr Christodoulou,

 

Reference No: EH-301427

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on Wednesday 25 September
2019, in which you asked NICE for the following information:

 

“Is it possible to have access to any reports regarding vaccines and their
side affects please”.

Before we move forward with your request, we require clarification in
order to appropriately respond to you. We wish to clarify what you mean
when you refer to ‘reports regarding vaccines’. This additional
information will help us to ensure we focus our search on the exact
information you are looking for. For example, do you mean reports
published by NICE that specifically relate to the safety and side effects
of vaccines?

 

Please can you provide further details. We will not be able to continue
with your FOI request without this additional information.

 

I hope the following background information is helpful for you.

 

One of the key roles of NICE is to produce guidance for health, public
health and social care practitioners. All of our current guidance (and
background evidence documents) can be found on [1]our website.

 

We have published guidance relating to vaccinations, such as:

o [2]Flu vaccination: increasing uptake (NG103): This guideline covers
how to increase uptake of the free flu vaccination among people who
are eligible. It describes ways to increase awareness and how to use
all opportunities in primary and secondary care to identify people who
should be encouraged to have the vaccination.
o [3]Immunisations: reducing differences in uptake in under 19s (PH21).
This guideline covers increasing immunisation uptake among children
and young people aged under 19 years in groups and settings where
immunisation coverage is low.

 

However, NICE is not responsible for the licensing and safety of medicines
and medical devices, and does not have a role in monitoring adverse
reactions of medicinal products. NICE does not publish reports on a
medicine’s safety or reported side effects.

 

In the UK, the [4]Medicines and Healthcare products Regulatory Agency
(MHRA) is the organisation responsible for the regulating and licensing of
medicines and medical devices, and for ensuring that they meet applicable
standards of safety, quality and effectiveness. The MHRA monitors the
safety of medicines and medical devices after they have been licensed, and
can issue safety warnings, alerts and recalls. The MHRA oversee the
[5]Yellow Card Scheme, which supports the reporting of all suspected
problems or incidents to all healthcare products, including suspected side
effects to medicines. Anyone who has concerns over the safety or side
effects of any drug or device is encouraged to submit a “Yellow Card”
report to the MHRA.

 

Information about licensed medicines (such as details about dose,
contraindications, adverse effects and special warnings) can be found
within the summary of product characteristics (SmPC) information on
the [6]electronic Medicines Compendium (eMC) website. The SmPC information
tells health professionals how to prescribe and use a medicine correctly.
Healthcare professionals are expected to refer SmPCs to a when making
prescribing decisions. An SmPC is produced by the company and in the UK is
approved by the MHRA.

 

Public Health England is responsible for publishing [7]information for
immunisation practitioners. They publish the [8]Green Book, which has the
latest information on vaccines and vaccination procedures, for vaccine
preventable infectious diseases in the UK. It contains information on
adverse reactions (and includes a link to the vaccine’s SmPC for a full
list of side effects).

 

The NICE website features the [9]British National Formulary (BNF). The BNF
provides prescribers, pharmacists, and other healthcare professionals with
up-to-date information about the selection, prescribing, dispensing and
administration of medicines. Although the BNF is available via our
website, we are not responsible for its content. The BNF is published
jointly by the British Medical Association and the Royal Pharmaceutical
Society. The BNF page on [10]Vaccination, general principles links to
individual vaccine names. If you click on one of the listed vaccine names,
you will be taken to a page in the BNF that includes important safety
information, cautions, contra-indications and side-effects for that
product. This includes safety advice from the [11]Medicines and Healthcare
products Regulatory Agency (MHRA) and its independent advisor the
[12]Commission on Human Medicines (CHM), where appropriate.

 

You can also search for individual safety information and drug alerts
relating to ‘immunology and vaccination’ aimed at healthcare professionals
via the [13]Drug Safety Update section of the gov.uk website.

 

If you would like NICE to continue with your FOI request, please can you
provide us with the additional clarification, and then we can consider
your request further.

 

Yours sincerely,

Natalie

 

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [14]http://nice.org.uk

 

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Georgios Christodoulou

Dear National Institute for Health and Care Excellence (NICE),

Please provide reports that prove the effectivess of vaccines, and any side affects; and confirm what is actually put in vaccines, particularly the current flu vaccine.

Yours sincerely,

Georgios Christodoulou

National Institute for Health and Care Excellence (NICE), National Institute for Health and Care Excellence

Dear Mr Christodoulou,

 

Reference No: EH-301427

 

FREEDOM OF INFORMATION ACT 2000

 

Thank you for your request, sent to our office on Wednesday 25 September
2019, in which you asked NICE for the following information:

 

“Is it possible to have access to any reports regarding vaccines and their
side affects please”.

 

To help us to ensure we focus our search on the exact information you are
looking for, we asked for further clarification. You replied to say:

 

“Please provide reports that prove the effectivess of vaccines, and any
side affects; and confirm what is actually put in vaccines, particularly
the current flu vaccine”.

 

Thank you for this additional information.

 

The Freedom of Information Act relates to recorded information held by a
public authority, at the time of the request.

 

Please find below our response to your request.

 

Additional background information has also been included (provided outside
the scope of the FOI Act) in order to be helpful.

 

Response

 

NICE does not hold reports that prove the effectiveness of vaccines and
lists their side effects and their ingredients.

 

However, NICE holds some information that we consider is relevant the
scope of your request. We hold information relating to adverse side
effects of vaccines (including the influenza vaccine). This information
can be found published on our website ([1]www.nice.org.uk). We therefore
consider it to be exempt from disclosure under section 21 of the Act
(since it is information that is reasonably accessible to you, as it’s
published on our website).

 

To be helpful, I can direct you to where you can access the information.

 

As described in my previous email, the NICE website features the
[2]British National Formulary (BNF). There is information within the BNF
relating to all vaccines (see: [3]vaccination, general principles), and
the influence vaccine in particular (see: [4]treatment summary overview
and [5]cautions and side effects and safety information).

 

If you have any questions on this response you are welcome to call me on
the enquiry handling team number: 0300 323 0141 (weekdays 09:00 – 17:00).

 

If you are unhappy with this response and want an internal review of how
we handled your request, you must write to us within 40 working days of
our response. Send your request to: Associate Director, Corporate Office,
National Institute for Health and Care Excellence, 10 Spring Gardens,
London SW1A 2BU or email: [6][email address]. When we receive your
request, we will send you an acknowledgement within 5 working days.

 

The Associate Director, Corporate Office, will review your complaint and
send you a full reply usually within 20 working days. If you are
dissatisfied with the outcome of this review, you can apply directly to
the Information Commissioner for a decision at: The Information
Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9
5AF.

 

Additional background information

 

The following external organisations and resources appear most relevant to
your request, as highlighted in my earlier email.

 

Public Health England is responsible for publishing [7]information for
immunisation practitioners. In particular, they publish the [8]Green Book,
which has the latest information on vaccines and vaccination procedures,
for vaccine preventable infectious diseases in the UK. It contains
information on adverse reactions. Chapter 19 relates to [9]influenza.

 

In the UK, the [10]Medicines and Healthcare products Regulatory Agency
(MHRA) is the organisation responsible for the regulating and licensing of
medicines and medical devices, and for ensuring that they meet applicable
standards of safety, quality and effectiveness. The MHRA monitors the
safety of medicines and medical devices after they have been licensed, and
can issue safety warnings, alerts and recalls. The MHRA oversee the
[11]Yellow Card Scheme, which supports the reporting of all suspected
problems or incidents to all healthcare products, including suspected side
effects to medicines.

 

We consider it would be appropriate of you to contact Public Health
England and the MHRA for the type of information you are seeking.

 

Yours sincerely,

Natalie

 

Natalie Whelan

Communications Executive

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United
Kingdom

Tel: 0300 323 0141 | Fax: 0300 323 0149
Web: [12]http://nice.org.uk 

 

 

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