15 October 2008

 

Dear Ms Filby,
 
Thank you for your email of 1 October requesting information about the side-effects of Cervarix, the number of incidents of anaphylaxis resulting from vaccinations and the number of deaths resulting from vaccinations in the UK during the last five years.  Your email has been passed to me for reply and is being answered in accordance with the Freedom of Information Act.

The human papillomavirus vaccine (HPV) factsheet was drafted to cover both HPV vaccines, and was printed before the selection of the HPV vaccine for use in the UK.  The advance printing was necessary to ensure that information materials would be distributed to allow sufficient time for local planning.  However, officials are grateful that you have pointed out this error.  The factsheet has been amended on the website and the Department will ensure that the next reprint of the HPV factsheet contains the correct information for Cervarix.

Health professionals have also been advised to use the Patient Information Leaflet (PIL) for Cervarix specific information.  The Immunisation against infectious disease (Green Book) states on page 8:

Health professionals should ensure that the individual (or those giving consent on their behalf) fully understands which immunisation(s) are to be administered; the disease(s) against which they protect; the risks of not proceeding; the side effects that may occur and how these should be dealt with; and any follow-up action required.

The summary of product characteristics for Cervarix and Gardasil were used to inform the text of the factsheet.

With regard to your second question, officials are not aware of any Departmental publications or correspondence that contains the Cervarix side effects data to which you refer. 

You also raise questions about the total number of suspected adverse drug reaction (ADR) reports of anaphylaxis and the total number of fatal UK suspected ADR reports received for vaccines during the past five years.

Between 1 January 2003 and 6 October 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) is aware of 163 UK spontaneous suspected ADR reports of anaphylaxis and related reaction terms associated with vaccines through the Yellow Card Scheme.  MHRA is also aware of 73 suspected ADR reports for vaccines with a fatal outcome for the same period.

It is particularly important to note that causality has not necessarily been established for fatal reports.  It is also important to bear in mind that clinical events reported to the MHRA are not necessarily confirmed diagnoses.  For example, it is often the case that a report of anaphylaxis may actually be a less serious allergic reaction.  A report of an adverse drug reaction does not necessarily mean that it was caused by the vaccine, only that the reporter had a suspicion that it may have been.  Many factors have to be taken into account in assessing the causal relationship between vaccines or medicines and a suspected reaction such as the temporal association and the role of underlying or undiagnosed illness or infection.

Certain reported ADRs are conditions that often occur spontaneously in a given age or risk group.  When there is large exposure to a medicine or vaccine (more than 80 million doses of routine childhood and influenza/pneumococcal vaccines were distributed to the NHS over the time period in question), it is inevitable that medical conditions, some fatal, may occur within a short space of time after vaccination.  These are often reported as suspected ADRs even if the association may be purely coincidental and the condition would have occurred anyway in the absence of vaccination.  For instance, influenza vaccines are given to several million elderly people, and people with serious underlying chronic morbidity, every year and it is inevitable that some patients may die not long after vaccination without the vaccine being responsible for the death.

ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular vaccine, and may be stimulated by promotion and publicity about a vaccine.  Therefore, the number of reports received through the Yellow Card Scheme does not directly equate to the number of people who suffer adverse reactions to vaccines.  In addition, the number of reports received should not be used as a basis for determining incidence of a reaction due to variable levels of reporting and as the number of individuals immunised is not always known.

I hope this reply is helpful.

If you have any queries about this email, please contact me. Please remember to quote the reference number above in any future communications.
 
If you are unhappy with the service you have received in relation to your request and wish to make a complaint or request a review of our decision, you should write to:
 
Section Head
Freedom of Information Unit
Department of Health
Room 334b
Skipton House
80 London Road
SE1 6LH
 
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 (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:
 
The Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
 
Yours sincerely, 

 

David Winks
Customer Service Centre
Department of Health