How many case reports have been submitted to EMA for HPV vaccine

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Dear Medicines and Healthcare products Regulatory Agency,

As part of the ongoing review of POTS (including autonomic dysfunction and POTS-type symptoms) by the EMA, please can you tell me how many case reports have been submitted by the MHRA?

Yours faithfully,

Mrs K Hunter

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 15/271
       
Dear Mrs Hunter,
       
RE:  REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000
       
Thank you for your enquiry which we received on 6 Juner 2015. 
       
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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Customer Services
Communications division
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151 Buckingham Palace Road, London, SW1W 9SZ
Telephone: 020 3080 6000
Email: [MHRA request email]
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Pharmacovigilanceservice, Medicines and Healthcare Products Regulatory Agency

1 Attachment

Dear Mrs Hunter,

 

Thank you for your FOI request. Please find the attached response.

 

As an addition to the FOI response, further information has been provided.

 

Vaccine safety is of paramount importance and under constant review. The
overwhelming majority of suspected side effects reported so far relate to
those we would expect with most types of vaccine, and the expected
benefits of HPV vaccine far outweigh any known risks.

We have received some reports of suspected serious side effects that are
not known to be side effects of the vaccine. More than 8 million doses of
HPV vaccine have been given in the UK, with close to 90% of eligible
teenagers vaccinated. With this very high level of vaccine uptake, such
reports are to be expected. But the vaccine isn’t necessarily the cause
and coincidental illness is a factor. Every report is taken seriously and
these will remain under review. If new risks are confirmed, appropriate
action will be taken to minimise such risks.

The larger overall number of reports for HPV vaccine compared to other
vaccines gives no cause for concern. The overwhelming majority of these
reports relate to known side effects that are usually mild, transient and
common for most types of vaccine given to adolescents and adults – for
example sore arms, redness and swelling at the site of the injection,
headaches and tiredness. The volume of reports can be influenced by many
factors, such as higher vaccine usage and reporting of prior symptoms to
the nurse when people turn up for the second (and previously third) dose
of HPV vaccine. These figures cannot be used to compare the safety of
different vaccines.

The HPV vaccine has a very good safety record, and surveillance shows it
has contributed to a significant decrease in rates of infection with the
two main cancer-causing human papillomaviruses. The UK programme is
expected to eventually prevent hundreds of deaths from cervical cancer
every year.

 

Kind Regards,

 

FOI Team,

Vigilance and Risk Management of Medicines Division

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