Yellow Card Reports

Caron Ryalls made this Freedom of Information request to Medicines and Healthcare products Regulatory Agency

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was partially successful.

Dear Medicines and Healthcare products Regulatory Agency,

I would like information relating to the HPV vaccines, Cervarix and Gardasil.

Please confirm your policy and methodology on investigating
adverse drug reaction reports highlighted by the yellow card
scheme in relation to the HPV vaccines.

It is generally thought that Adverse Reactions are substantially under-reported under the yellow card scheme. What is the estimated level of reporting of adverse reactions through yellow Cards.
Please confirm the number of Yellow Card submissions specifically from GlaxoSmithKline for Cervarix for each year from the date of it's introduction in the UK

Please confirm your methodology in determining benefits and risks when considering the safety of a vaccine. How were the benefits and risk quantified with Cervarix and Gardasil in order to make the decision of which carries the most weight.

With consideration specifically for Cervarix and Gardasil, how would the MHRA know if risks were outweighing the benefits and what investigations would be set in place to confirm this.

Yours faithfully,

Caron Ryalls

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

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References

Visible links
1. http://www.mhra.gov.uk/Contactus/Central...
2. http://www.mhra.gov.uk/Howweregulate/Med...
3. http://www.mhra.gov.uk/Howweregulate/Dev...
4. http://www.mhra.gov.uk/Howweregulate/Med...
5. http://www.mhra.gov.uk/Howweregulate/Dev...
6. http://www.mhra.gov.uk/Safetyinformation...
7. http://www.mhra.gov.uk/Safetyinformation...
8. http://www.mhra.gov.uk/Howweregulate/Med...
9. http://www.mhra.gov.uk/Howweregulate/Dev...

MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

Our Ref: FOI 12/075

Dear Caron Ryalls,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry which we received on 13th February.


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.

If you need to contact us again about this request, please quote the reference number above.

Yours Sincerely

Central Enquiry Point
Information Services
MHRA
Tel: 020 3080 6000

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MHRA Central Enquiry Point, Medicines and Healthcare products Regulatory Agency

1 Attachment

Dear Caron Ryalls,

Thank you for your recent enquiry to the MHRA.

Attached is the response to your FOI request.



Kind Regards,

Central Enquiry Point
Information Services
Medicines and Healthcare products Regulatory Agency
Tel: 020 3080 6000

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