A/H1N1 Vaccine Human Trials Results

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References

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

Our Ref: FOI 09/475

Dear Mr Moore,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 1st December 2009.

I confirm that your request is being handled under the Freedom of
Information Act and you should receive a reply within 20 working days
from our date of receipt.

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Dear Mr Moore,

REF: FOI 09/475

Thank you for your communication dated 1st December 2009 regarding results
from studies evaluating potential and observed side effects in humans of
"Swine Flu" vaccines.

Details of side effects associated with the "Swine Flu" vaccines
Pandemrix, Celvapan and Focetria can be located in section 4.8 of the
Summary of Product Characteristics (SmPCs). These SmPCs will be updated as
new data is received and reviewed. You can access the full SmPCs using the
following web links:

[1]http://www.emea.europa.eu/influenza/vacc...
[2]http://www.emea.europa.eu/influenza/vacc...
[3]http://www.emea.europa.eu/influenza/vacc...

The European Medicines Agency (EMA) also publishes weekly reports on
adverse reactions reported after the use of pandemic vaccines in the
European Union, the second of which (dated 9 December 2009) can be located
via this web link:

[4]http://www.emea.europa.eu/pdfs/influenza...

Kind Regards,

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

This email and any files transmitted with it are confidential. If you are
not the intended recipient, any reading, printing, storage, disclosure,
copying or any other action taken in respect of this email is prohibited
and may be unlawful.

If you are not the intended recipient, please notify the sender
immediately by using the reply function and then permanently delete what
you have received.Incoming and outgoing email messages are routinely
monitored for compliance with the Department of Healths policy on the use
of electronic communications.

For more information on the Department of Healths email policy, click

http://www.dh.gov.uk/DHTermsAndCondition...

show quoted sections

Communications via the GSi may be automatically logged, monitored and/or
recorded for legal purposes.

References

Visible links
1. http://www.emea.europa.eu/influenza/vacc...
2. http://www.emea.europa.eu/influenza/vacc...
3. http://www.emea.europa.eu/influenza/vacc...
4. http://www.emea.europa.eu/pdfs/influenza...