Our ref: DE00000455594


18 November 2009

 

Dear Mr McGillivray,

 

Thank you for your email of 30 October requesting, under the Freedom of Information (FOI) Act, information relating to the swine flu vaccination programme.  Your email has been passed to me for reply.

 

You ask a number of questions and I will address these in the order they are raised.

 

The Department of Health does not collect or hold any data on invitations for vaccination or acceptance of invitations.

 

The Department does not currently have data on vaccination uptake by numbers of individuals or by vaccine brand but aims to collect that data in the coming weeks.

 

You also request information on reported side effects of vaccine brands.  The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines (including vaccines) and medical devices work and are acceptably safe.  The MHRA has a special web-based system for reporting suspected side effects to H1N1 (swine flu) vaccines and the antivirals Tamiflu and Relenza - the Swine Flu ADR portal which can be found at www.mhra.gov.uk/swineflu.  The portal enables reports of suspected side effects to be promptly captured and evaluated, allowing 'real-time' safety surveillance of the vaccines by a dedicated team of drug safety scientists. 

 

The MHRA publishes weekly summaries (updated every Thursday) of all suspected side effects reported for the vaccines and antivirals on its website detailed above. 

 

Up to and including Thursday 5 November 2009 , the MHRA received a total of 188 UK reports of suspected ADRs to the H1N1 vaccines.  The 188 reports include a total of 460 suspected reactions (a single report may contain more than one reaction).

Reports of suspected adverse reactions to Pandemrix make up 91 per cent of all reports received for H1N1 vaccines to date.  This is not unexpected given the presumed difference in the extent of use of the two vaccines.  The vaccine brand was not reported in six per cent of reports.

 

The most frequently reported suspected adverse reactions are non-serious injection site reactions (e.g. pain, swelling, redness), or are well-established minor adverse effects of many vaccines, including the swine flu vaccines (e.g. nausea, vomiting, dizziness muscle pain, fever, fatigue, headache, swollen glands).  No new safety issues have been identified from reports received by the MHRA to date.

 

If you have any queries about this response, please contact me.  Please remember to quote the reference number above in any future communications.

 

I hope this reply is helpful.  If you are dissatisfied with the handling of your request, you have the right to ask for an internal review.  Internal review requests should be submitted within two months of the date of receipt of the response to your original letter and should be addressed to:

 

Head of the Freedom of Information Team

Department of Health

Room 317

Richmond House

79 Whitehall

London

SW1A 2NS

  

Email: xxxxxxxxxxxxxxxxxxxx@xx.xxx.xxx.xx

 

If you are not content with the outcome of your complaint, you may apply directly to the Information Commissioner’s Office (ICO) for a decision. Generally, the ICO cannot make a decision unless you have exhausted the complaints procedure provided by the Department.  The ICO can be contacted at:

 

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

Yours sincerely,

 

Deepa Shah

Freedom of Information Team

Department of Health