HPV Vaccine: Over 2000 Serious Adverse Events
Dear Medicines and Healthcare products Regulatory Agency,
I understand that your definition of a serious adverse event (SAE) are as follows:
Any adverse event, that:
(a) results in death
(b) is life-threatening
(c) requires hospitalisation or prolongation of existing hospitalisation
(d) results in persistent or significant disability or incapacity
(e) consists of a congenital anomaly or birth defect.
I understand that the number of SAE reported by Yellow Card for HPV vaccines now exceed 2000 and many of the patients affected are now long term disabled.
Please provide:
the actual number of SAE since HPV vaccination was introduced
how many of these reported SAE remain unresolved, or undetermined, by each illness type, including the 4 deaths reported.
Please provide the estimated reporting rate (ERR) for SAE for this vaccine since it was introduced (I understand that it is approximately 50/100,000 vaccines distributed, which presumably equates to 150/100,000 children vaccinated).
Please explain why an SAE of 150/100,000 children vaccinated is acceptable for HPV vaccines when other vaccines have approximate rates as follows:
MenC/Hib: 2/100,000
Pneumacoccal: 5/100,000
DTPa/IPV/Hib: 2/100,000
MMR: 8/100,000
Men.C: 2/100,000
dTAP/IPV 4/100,000
Flu: 2/100,00
Please also take into consideration that the MHRA consider that only 10% of SAE are reported and therefore the actual rate of SAE is typically 20/100,000 for many common vaccines but 1500/100,000 for HPV vaccines.
The eMC Medicine Guide for HPV vaccines states ‘some side effects may be serious’. There are over 2000 SAE reported by Yellow Card and yet the patient information leaflet (PIL), for Cervarix, never mentions any serious side effects, neither does the NHS Choices web page (except in the public comments).
You often state:
no ‘new’ safety issues were identified
benefit risk balance of HPV vaccine remains positive.
Please identify which ‘old’ safety issues are considered to be serious SAE.
P.S. you might think the benefit risk balance remains positive. I know of 2000 families that almost certainly don’t agree with you, particularly all of those that were not allowed the opportunity to make an informed choice.
Please also explain how the ‘benefit risk balance remains positive’ when Cancer Research UK tell us that deaths due to cervical cancer have reduced from 8/100,000 to 2/100,000 over the last 40 years, without any help from this vaccine.
Yours faithfully,
Steve Hinks
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Our Ref: FOI 14/555
Dear Mr Hinks,
RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
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Richard Taylor left an annotation ()
An unprecedented and hopefully one-off human error by a member of the WhatDoTheyKnow.com team resulted in the response to this request being accidentally deleted.
A replacement copy of the response was obtained from the public body and has been published above.
--
Richard - WhatDoTheyKnow.com volunteer
Richard Taylor left an annotation ()
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Caroline Wheeler left an annotation ()
What has happened to the response to this request? I know it was here a few months ago?