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<p>A total of 8,243 suspected adverse drug reaction (ADR) reports with human papilloma
virus (HPV) vaccines have been reported to the Medicines and Healthcare products Regulatory
Agency (MHRA), via the Yellow Card Scheme, up to 3 June 2015.</p><p> </p><p> </p><p>
</p><p>To date, more than 8 million doses of HPV vaccine have been given across the
United Kingdom as part of the routine immunisation programme. The MHRA does not hold
data on age-specific vaccine usage, and therefore age-specific reporting rates cannot
be calculated.</p><p> </p><p> </p><p> </p><p>It is important to note that a Yellow
Card report is not proof of a side effect occurring, but a suspicion by the reporter
that the vaccine may have been the cause. Yellow Card data cannot be used as a reliable
indicator of the frequency of suspected ADRs to vaccines or medicines. The level of
ADR reporting may fluctuate between given years due to a variety of reasons such as
a medicine being new (reporting rates are generally higher when a product is first
introduced), stimulated interest/publicity and variations in exposure to the medicine.</p><p>
</p><p> </p><p> </p><p>The possible known side effects, and the frequency, are listed
in the product information which is provided with the vaccines. The vast majority
of the 8,243 ADRs relate to the known risks of vaccination that are well-described
in the available product information. The proportion of suspected ADRs for HPV vaccines
that were reported as serious (32%) is less than the proportion reported as serious
for other routinely used vaccines (68% overall) during the same time period. The expected
benefits in protecting against HPV-related mortality and disease outweigh the known
side effects of HPV vaccine.</p><p> </p><p> </p><p> </p><p>The following table provides
a breakdown of UK suspected spontaneous ADRs received via the Yellow Card Scheme in
association with the HPV vaccine. The MHRA does not hold data on age-specific vaccine
usage, and therefore age-specific reporting rates cannot be calculated.</p><p> </p><p>
</p><p> </p><table><tbody><tr><td><p>Vaccine Brand</p></td><td><p>Total number of
reports</p></td><td><p>Number of serious reports (% of total)</p></td><td><p>Reporting
rate per 1000 doses (serious reporting rates per 1000)</p></td></tr><tr><td><p>Cervarix</p></td><td><p>6,266</p></td><td><p>1,768
(28%)</p></td><td><p><ins class="ministerial">n/a **</ins><del class="ministerial">0.78
(0.22)</del></p></td></tr><tr><td><p>Gardasil</p></td><td><p>1,471</p></td><td><p>504
(34%)</p></td><td><p><ins class="ministerial">n/a **</ins><del class="ministerial">0.18
(0.06)</del></p></td></tr><tr><td><p>HPV Brand unspecified</p></td><td><p>507</p></td><td><p>326
(64%)</p></td><td><p><ins class="ministerial">n/a ** </ins><del class="ministerial">0.06
(0.04)</del></p></td></tr><tr><td><p>Total for Human Papilloma virus vaccines</p></td><td><p>*8,244</p></td><td><p>2,598
(32%)</p></td><td><p>1.03 (0.32)</p></td></tr></tbody></table><p> </p><p><em>Source:</em>
MHRA sentinel database for adverse reactions.</p><p> </p><p>* It should be noted that
the total number of reports received will not be equal to the totals in the table
above as some reports of suspected adverse reactions may have included more than one
vaccine.</p><p><ins class="ministerial">**Updated UK-wide brand-specific usage data
are not available to MHRA at the time of writing based on a minimum of 8 million combined
doses of Cervarix and Gardasil administered across the UK to date.</ins></p><p> </p><p><ins
class="ministerial"> <p> </p><p> </p><p> </p></ins></p><p> </p><p> </p><p> </p><p>
</p><p> </p><p>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 explained on the Yellow Card. The MHRA
asks reporters to select one of the following criteria by ticking the appropriate
box on the Yellow Card: (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 its 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 the MHRA medical dictionary.</p><p>
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