"Long term" definition

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

Please could you provide me with your definition of "long term" regarding risks and side effects, for example of vaccines, and specifically regarding the HPV vaccines Cervarix and Gardasil?

I would like to know the precise number of weeks or months.

Yours faithfully,

Grace Filby

http://www.relax-well.co.uk

MHRA Information Centre, Medicines and Healthcare Products Regulatory Agency

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MHRA Information Centre, Medicines and Healthcare Products Regulatory Agency

Dear Ms Filby,

Thank you for your recent enquiry to the MHRA.

There is no set definition for use of the phrase 'long term'. However,
in this context, we suggest that the available evidence does not
indicate that the vaccine may induce side effects lasting more than 7 to
10 days.

Please contact us again if you need further assistance with this, or any
other queries.


Kind Regards,

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

show quoted sections

Dear MHRA Information Centre,

Thank you for your prompt reply to my FOI question and your suggestion.

I understand that there is available evidence indicating that some of the side effects last a lot longer than 7 - 10 days. Apart from serious individual cases in the UK which parents and doctors have valiantly tried to bring to your attention via the Yellow Card Scheme, may I please refer you to the EMEA Scientific Discussion of the clinical trials results and my comments handed to Mark Simmonds MP last summer.
http://www.relax-well.co.uk/07.07.09Scie...

Also, page 45: Serious Adverse Events
"Overall, the most frequently reported SAEs: spontaneous abortions ..."

These may be spontaneous but sadly they are long term and irreversible, and the emotional/psychological effects can also be long term - greater than 7-10 days.

page 49: New Onset of Chronic Disease
"The most commonly reported NOCD were asthma, urticaria and hypersensitivity, which were each reported at similar frequencies in the HPV vaccine and control groups -
Reporting period: Month 0-7 - 1.2%
Month 7-12 - 0.4%
> Month 12 - 0.4%"

This can be explained by the fact that all the vaccines, including the control groups, contain aluminium, which is a nerve toxin. To quote from a scientific paper Exley et al 2009 Medical Hypotheses 72 (2009) 135–139 "as many as 1% of recipients of aluminium-containing adjuvants may be sensitised to future exposures to aluminium".

page 50: New Onset of Autoimmune Disease
"7 cases of neurological disorder (7 in the HPV group and 2 in the control group) have been identified...the adverse events might be explained just by chance."

But on the other hand, they might not.

I do think, for clarity, it would be very helpful if the MHRA could come up with a set definition of the phrase "long term".

Yours sincerely,

Grace Filby

MHRA Information Centre, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the Information Centre at the MHRA.

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enquiry has been received and will be dealt with as quickly as
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should expect a reply within a few days, those requiring a more detailed
response or contribution from a specialist are likely to take longer.
We endeavour to provide a response to all enquiries as quickly as
possible, and within the Department of Health's target response time of
20 working days. For further information about the service and
timeframes provided by the CEP, please view the information published at
the 'Contact Us' section of our website at the following link:

[1]http://www.mhra.gov.uk/Contactus/index.htm

If you have not heard from us after that time then please contact us on
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Kind regards

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency

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Grace Filby left an annotation ()

This page gives details of 52 British girls on the American VAERS database of adverse events after Cervarix vaccination.

http://www.relax-well.co.uk/longterm-adv...

MHRA Information Centre, Medicines and Healthcare Products Regulatory Agency

Dear Ms Filby,

Thank you for your comments.

We can confirm that we will take these into consideration.


Kind Regards,

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency
Tel: 020 7084 2000

show quoted sections

Dear MHRA Information Centre,

Many thanks for your kind response and confirmation.

Yours sincerely,

Grace Filby

MHRA Information Centre, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,

Thank you for your enquiry to the Information Centre at the MHRA.

Please accept this automated response as acknowledgement that your
enquiry has been received and will be dealt with as quickly as
possible.

Your enquiry will be dealt with as follows; straightforward requests
should expect a reply within a few days, those requiring a more detailed
response or contribution from a specialist are likely to take longer.
We endeavour to provide a response to all enquiries as quickly as
possible, and within the Department of Health's target response time of
20 working days. For further information about the service and
timeframes provided by the CEP, please view the information published at
the 'Contact Us' section of our website at the following link:

[1]http://www.mhra.gov.uk/Contactus/index.htm

If you have not heard from us after that time then please contact us on
020 7084 2000.

Kind regards

Central Enquiry Point
Information Centre
Medicines and Healthcare products Regulatory Agency

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Street, Hannah, Medicines and Healthcare Products Regulatory Agency

Thank you for your email. I am working away from the office and will not
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If your query is urgent, please contact my colleague Jane Viner on x2348,
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Thank you,

Hannah Street
T: 020 7084 2129
Head of Information Services
Communications Division
MHRA

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