Haylen Puertas
Sent via email:
xxxxxxxxxxxxxxxxxxxxxxx@xxxxxxxxxxxxxx.xxx
MHRA
151 Buckingham Palace
Road
London
SW1W 9SZ
United Kingdom
www.gov.uk/mhra
13thApril 2016
Dear Ms Puertas,
FOI 16/180
Thank you for your email dated 14th March 2016, where you requested:
• The number of reports made regarding Adverse Drug Reaction(s) (ADRs) after MMR
vaccination in children under 5 years of age between 2005 and 2015.
• Of these reports, how many were not serious?
• Of these reports, how many were serious?
• A further breakdown of the number of reports by seriousness criteria.
• How much does the MHRA estimate that these numbers are under-reported by?
As you are already aware, the Yellow Card Scheme is the UK system for collecting and monitoring
information on suspected ADRs in association with medicines and vaccines. The Scheme is run by
the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of the Commission on
Human Medicines (CHM), and currently relies on voluntary reporting of suspected ADRs by health
professionals and patients. There is also a legal obligation for pharmaceutical companies to report
serious side effects for their products. Spontaneous adverse reaction reporting is the commonest
source for identification of safety signals for medicines and vaccines, and often provides an early
warning of possible hazards.
MMR vaccines have been used extensively around the world for decades and surveillance has
shown they have an excellent safety record. The World Health Organisation (WHO) recognises
MMR as being the best way to protect people from these potentially serious infections. It is also
important to note that that the reporting of a suspected ADR does not necessarily mean it has been
caused by the vaccine, only that the reporter had a suspicion it may have. In the 10 year time period
in question, millions of doses of MMR vaccine have been given in the UK alone, 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 therefore
also be coincidental.
Further to your request, I can confirm that the total number of UK spontaneous suspected ADR
reports received between 1st January 2005 to 31st December 2015 in children under 5 years of age,
is 1076 reports. Please note, it is not obligatory to report the age of the patient when submitting a
Yellow Card report therefore only reports where the age or age group of the patient have been
reported are included.
A suspected ADR report is considered ‘serious’ according to two criteria; firstly whether the original
reporter considers the report to be serious. The seriousness criteria for ADR reporting were
determined by a working group of the Council for International Organizations of Medical Sciences
(CIOMS) and are defined as 6 possible categories which are documented on the Yellow Card. We
ask reporters to select one of the following criteria by ticking the appropriate box 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, seriousness of reaction terms has also been defined by the MHRA in our medical dictionary.
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 our medical dictionary.
Of the 1076 UK spontaneous ADR reports received, 384 have been classified as non-serious and
692 have been classified as serious.
Further to your request, please find below a table providing the number of UK spontaneous
suspected Adverse Drug Reaction (ADR) reports received between the 1st January 2005 and 31st
December 2015 for each CIOMS serious criterion. Please note one report may be contained within
multiple serious categories and therefore the total number of serious reports cannot be calculated
from the breakdown provided in this table.
Total number of UK spontaneous suspected ADR reports for each CIOMS criterion received
between the 1st January 2005 to 31st December 2015 associated with MMR vaccine, in children
under 5 years of age.
Serious Categories
Number of reports
Patient Died
8
Hospitalised Due To Reaction
143
Life Threatening
27
Disability/Incapacity
67
Congenital Abnormality
0
Other Medically Significant
381
Please note that it is not possible to estimate the actual incidence of side effects from the data
provided, nor the proportion of side effects that are reported via the Yellow card Scheme. This is
because suspected ADRs are not necessarily proven side effects and because the level of reporting
can be influenced by many factors. Factors include the seriousness of the reactions, their ease of
recognition, extent of use of a particular vaccine and promotion and publicity about a vaccine.
Reporting tends to be highest for newly introduced products during the first one to two years on the
market and then falls over time.
The incidence of known side effects is described in the SmPC and the PIL which can be found via
the following link:
https://www.medicines.org.uk/emc/medicine/20968. 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.
Please remember to quote the reference number above in any future communications.
If you are not content with the outcome of the internal review, you have the right to apply directly to
the Information Commissioner for a decision.
The Information Commissioner can be contacted at:
Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division
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.
