HPV Vaccine Adverse Reactions

The request was successful.

Dear Medicines and Healthcare products Regulatory Agency,

In your Paper provided to the JCVI on Vaccine and Immunisation in 2012 it was reported (on the last page)that the Yellow Card reporting rate of adverse reactions to HPV vaccine was '1 report per 1,000 doses administered which was not considered unexpected for a vaccine that was so widely used within a novel immunisation programme'.

Please provide copies of all correspondence relating to:
- why 1 report per 1000 doses administered was not considered unexpected (this is 300 reports per 100,000 recipients, which is HUGE compared with other vaccines which typically have EER per 100,000 recipients ranging from 0.8 to 14)
- why this immunisation programme is considered to be novel.

Yours faithfully,

Steve Hinks

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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[6]http://www.mhra.gov.uk/Safetyinformation...
 
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[7]http://www.mhra.gov.uk/Safetyinformation...
 
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[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
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Kind regards
 
The Customer Services Team
External Relations
Medicines and Healthcare Products Regulatory Agency
 
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References

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2. http://www.mhra.gov.uk/Howweregulate/Med...
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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/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...
11. https://www.surveymonkey.com/s/MHRACusto...

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 14/047
       
Dear Mr Hinks,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 3 February 2014. 
       
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.
       
Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency
Tel: 020 3080 6000

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mr Hinks,
       
Thank you for your email.

Attached is the response to your FOI request.
       
Kind Regards,

Customer Services
External Relations
Medicines and Healthcare Products Regulatory Agency

Tel: 020 3080 6000

 

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
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Communications via the GSi may be automatically logged, monitored and/or
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Dear Medicines and Healthcare products Regulatory Agency,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Medicines and Healthcare products Regulatory Agency's handling of my FOI request 'HPV Vaccine Adverse Reactions'.

the response I received did not include copies of correspondence (emails, letters, etc)as requested. Please provide these.

A full history of my FOI request and all correspondence is available on the Internet at this address: https://www.whatdotheyknow.com/request/h...

Yours faithfully,

Steve Hinks

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Dear Enquirer,
 
Thank you for your enquiry to the Medicines and Healthcare Products
Regulatory Agency. This automated response confirms that we have received
your email and that it will be dealt with as quickly as possible.
 
You can expect a reply from us within a few days for a straightforward
request, however where a more detailed response or contribution from a
specialist is required this is likely to take longer; we endeavour to
respond to all requests within the Department of Health’s target response
time of 18 working days. Further information on how we handle different
requests can be found on our website at the link below:
 
[1]http://www.mhra.gov.uk/Contactus/Custome...
 
Our website contains a wealth of information which may assist with your
enquiry. Some of our popular pages are:
 
Clinical Trials of medicines:
 
[2]http://www.mhra.gov.uk/Howweregulate/Med...
       
Clinical Trials of medical devices:
 
[3]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Manufacturer’s and wholesale dealer’s licences:

[4]http://www.mhra.gov.uk/Howweregulate/Med...
 
Registration of medical devices, opticians and dental laboratories:

[5]http://www.mhra.gov.uk/Howweregulate/Dev...
 
Reporting a side effect to a medicine:

[6]http://www.mhra.gov.uk/Safetyinformation...
 
Reporting an adverse incident involving a medical device:
 
[7]http://www.mhra.gov.uk/Safetyinformation...
 
Does my product need a licence?:

[8]http://www.mhra.gov.uk/Howweregulate/Med...
 
Reporting a counterfeit medical product:
 
[9]http://www.mhra.gov.uk/Safetyinformation...
 
Buying medicines over the internet:
 
[10]http://www.mhra.gov.uk/Safetyinformation...
 
We’d like to thank you if you participated in our recent survey, the
result is now published on our Customer Services webpage at
[11]http://www.mhra.gov.uk/Contactus/Custome.... We are
continuously looking to make improvements to the service offered by our
Customer Services team, so if you have any feedback please don’t hesitate
to get in touch with us either on the number below or by completing the
form at the link below:
[12]https://www.surveymonkey.com/s/MHRACusto...
 
If you have not heard from us after 18 working days then please contact us
on 020 3080 6000.
 
Kind regards
 
The Customer Services Team
External Relations
Medicines and Healthcare Products Regulatory Agency
 
Please note this is an automated reply; please do not respond to this
message.
 
 

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.mhra.gov.uk/Contactus/Custome...
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/Safetyinformation...
10. http://www.mhra.gov.uk/Safetyinformation...
11. http://www.mhra.gov.uk/Contactus/Custome...
12. https://www.surveymonkey.com/s/MHRACusto...

Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

Dear Mr Hinks,

 

I am writing to you in respect of your recent request for an internal
review of your request ref: 14/047. The request has not yet been passed to
the MHRA’s Policy FOI team (who are responsible for conducting internal
reviews), as I was trying to ascertain why the information had been
withheld, and provide it to you short of a formal internal review.

 

I have discussed the matter with the team responsible for the original
reply and I have been informed that there exists no correspondence as
described in your request i.e.

“...copies of all correspondence relating to:

- why 1 report per 1000 doses administered was not considered unexpected
(this is 300 reports per 100,000 recipients, which is HUGE compared with
other vaccines which typically have EER per 100,000 recipients ranging
from 0.8 to 14)

- why this immunisation programme is considered to be novel.”

 

This information should have been communicated to you in our original
reply, and I would like to apologise for it having been overlooked. Please
let me know if this reply is satisfactory and  has answered your question?
If not, or if you  would still like to proceed with a formal internal
review of the way in which your request was handled, please let me know
and I will be happy to  pass the matter to the FOI team to initiate the
internal review  process.

 

Kind Regards.

 

Pharmacovigilance Service Team,

 

VRMM

 

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.