Dear Medicines and Healthcare products Regulatory Agency,

The Department of Health jave forwarded me to yourselves to answer my question.

What is the safe level of adjuvants in vaccines?

What is the maximum amount of adjuvant do you consider safe in a day and also under 4 weeks whether it be in 1 vaccine or several vaccines?

Thankyou in advance for this information!

Kind Regards,

gavin roberts

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 20/166

Dear Mr Roberts,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 6 April 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 020 3080 6000

dangos adrannau a ddyfynnir

FOILicensing, Medicines and Healthcare products Regulatory Agency

Dear Mr Roberts,

 

Many thanks for your information request on 4th April 2020 where you asked
what the safe level of adjuvants in vaccines is, and what the maximum
amount of adjuvant is that is considered safe in a day and also under 4
weeks whether it be in 1 vaccine or several vaccines.

 

The safety of each of the constituents of a vaccine is assured by testing
done to meet internationally agreed expectations, including from the World
Health Organisation and the European Medicines Agency. There are specific
expectations for testing of adjuvants which the UK also applies. To
include an adjuvant in a vaccine, the benefits from doing so must be
weighed against its potential toxicity and this judgement is made in every
case, including consideration of the amount of adjuvant in the vaccine.
This is supported by a testing programme that initially aims to show that
the adjuvant boosts the immune response to the vaccine in animals; this is
followed by safety testing in animals, prior to clinical trials where
efficacy and safety of the adjuvanted vaccine are determined. Therefore
the quantity of adjuvant may be different in each vaccine but the amount
used is always tested in order to demonstrate safety for that vaccine. All
these data are presented for an independent decision whether, or not, to
licence the product for use by the population for which it is intended.

 

The following link gives the quantities of aluminium adjuvants and
oil-based adjuvants in vaccines used in the UK:
[1]https://vk.ovg.ox.ac.uk/vk/vaccine-ingre.... As explained
above, it has been demonstrated in animal studies and clinical trials in
humans that these quantities are safe to administer.

 

The administration of paediatric vaccines according to the Public Health
England schedule has been shown to be both safe and effective and so it is
recommended to follow this schedule. For consideration of specific
circumstances that might apply for individual patients, it is recommended
to consult your health care professional to discuss your plans.

 

If you have a query about the information provided, please reply to this
email.

 

Yours sincerely,

 

Licensing Division

 

dangos adrannau a ddyfynnir

Dear FOILicensing,

Thankyou for your information, in that case i will be more specific.

How much adjuvant is currently within the Anthrax vaccine admi istered on our troops! What is the adjuvant used?

Thankyou

regards

gavin roberts

MHRA Customer Services, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 20/199

Dear Mr Roberts,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 5 May 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 020 3080 6000

dangos adrannau a ddyfynnir

FOILicensing, Medicines and Healthcare products Regulatory Agency

Dear Mr Roberts,

Many thanks for your information request dated 5th May where you asked how
much adjuvant is currently within the Anthrax vaccine and what is the
adjuvant used?

 

We are happy to provide you with the Summary of Product Characteristics
(SmPC) for the two currently granted UK Anthrax vaccines which you can
access via the following link [1]https://products.mhra.gov.uk/ and by
searching for 'anthrax'.

 

PL 44403/0001 Anthrax vaccine - this vaccine has aluminium potassium
sulphate as the adjuvant.

Section 2 of the SPC states the vaccine contains 0.4 mg of aluminium per
0.5mL dose of vaccine.

 

PL 49044/0001 BioThrax suspension for injection in multi-dose vial - this
vaccine has aluminium hydroxide as the adjuvant.

Section 2 of the SPC states the vaccine contains 0.6mg aluminium per 0.5ml
dose of vaccine.

 

If you have any queries about this information, please reply to this
email.

Kind regards

FOI Team

 

dangos adrannau a ddyfynnir