xxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxxxxx.xxx
MHRA
10 South Colonnade
Canary Wharf
London
E14 4PU
United Kingdom
www.gov.uk/mhra
1 April 2019
Dear Hayley,
FOI 19/151
Thank you for your Freedom of Information request dated 25th March 2019 where you requested:
• all information on safety studies /trials of the HPV vaccine (Gardasil)
• all independent information on safety studies/trials of the HPV vaccine (Gardasil)
• statistics of the HPV vaccine efficacy against cervical cancer cases and deaths.
• safety studies/ tests on Amorphous Aluminium Hydroxyphosphate Sulfate [AAHS] in the use
of vaccines.
• information on the total of HPV adverse reactions reported from vaccines to date (25-03-19).
Can this be categorised from mild to severe and death.
The MHRA does not hold information on the safety studies/trials and efficacy studies for Gardasil
vaccine. Gardasil was authorised for use in the European Union under the centralised procedure and
was approved by the European Medicines Agency. Further information regarding the authorisation
details can be found on the EMA website.
https://www.ema.europa.eu/en/medicines/human/EPAR/gardasil. You may wish to contact the EMA
directly to request any data they hold.
The MHRA does not hold specific safety study/test data on aluminium in vaccines. When vaccines are
authorised for the use, the safety of the product as a whole, including any ingredients such as
aluminium adjuvants, are evaluated for safety. More information on the safety of aluminium in
vaccines can be found via the following link for the World Health Organisation’s Global Advisory
Committee on Vaccine Safety (GACVS):
https://www.who.int/vaccine_safety/committee/topics/adjuvants/en/ Further to your request, for adverse reaction data received by the UK I have enclosed the Drug
Analysis Print (DAP) for Human Papillomavirus (HPV). The DAP lists all UK spontaneously reported
adverse reactions (ADRs) on the MHRA database associated with HPV vaccines up to and including
25th March 2019.
Please refer to table 1 below for a breakdown of the total number of reports received in report
categories non-serious, serious and fatal. Please note: the fatal reports fall within the serious category
and are not additional to the stated total.
Table 1. UK spontaneous ADR reports for HPV vaccines received up to and including
25/03/2019
Report Category
Number of Reports
Non-serious
5972
Serious
3396
Fatal
9
Total
9368
*Data Extraction date: 02/04/2019
When considering the number of serious reports stated above it is important to note, the seriousness
criteria for ADR reporting are defined as 6 possible categories which are documented on the Yellow
Card. The criteria are: (1) patient died due to reaction (2) life threatening (3) resulted in hospitalisation
or prolonged inpatient hospitalisation (4) congenital abnormality and (5) involved persistent or
significant disability or incapacity or (6) if the reaction was deemed medically significant. In addition to
this, reaction terms are also defined as serious or non-serious in the Medical Dictionary for regulatory
Activities (MedDRA) which we use to code ADRs in our database. Therefore, an ADR report can be
serious because the reporter considers the reaction to be serious or because the reaction term itself
is considered serious in MedDRA.
When assessing the data within this response, it is important to note that the inclusion of a report on
our database does not necessarily mean that the events described were caused by the vaccination,
only that the reporter had a suspicion it may have, or it had a close temporal relationship to the
administration of the vaccine. More than 10 million doses of HPV vaccine have been administered in
the UK since 2008, and when any vaccine is administered to very large numbers of people, some
recipients will inevitably experience illness following vaccination. The fact that symptoms occur after
use of a vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are
proven to have been caused by the vaccine. Underlying or concurrent illnesses may be responsible
and such events can also be coincidental. Ongoing safety reviews by EU and international regulatory
and health authorities, as well as numerous published epidemiological studies from independent
academics, have found no evidence of chronic illness or serious harms from HPV vaccines.
Furthermore, the number of reports received should not be used as a basis for determining incidence
of a reaction as neither the total number of reactions occurring, nor the number of patients receiving
the vaccination is known. ADR reporting rates are influenced by the seriousness of ADRs, their ease
of recognition, the extent of use of a particular vaccination, and may be stimulated by promotion and
publicity about a vaccination.
I hope the information provided is helpful, but 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 this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division
The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA
only entitles you to access to MHRA information.
For information on the reproduction or re-use of MHRA information, please visit
https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-
use-mhra-information
If you have a query about this email, please contact us. If you are unhappy with our decision, you may
ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has
not previously been involved in your request. If you wish to pursue that option please write to the
Communications Directorate, Medicines and Healthcare products Regulatory Agency, (via this email
address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:
The Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Copyright notice
The information supplied in response to your request is the copyright of MHRA and/or a third party or
parties, and has been supplied for your personal use only. You may not sell, resell or otherwise use
any information provided without prior agreement from the copyright holder.
