answer text |
<p>As with all vaccines and medicines, the Medicines and Healthcare products Regulatory
Agency (MHRA) closely monitors the safety of human papillomavirus (HPV) vaccine. The
MHRA takes advice from the Government's independent expert advisory body, the Commission
on Human Medicines (CHM), when evaluating the risks and benefits of medicines and
vaccines.</p><p> </p><p>A total of 8,835 suspected adverse reaction reports (ADRs)
with HPV vaccines have been reported to the MHRA via the Yellow Card Scheme up to
17 April 2017. This follows administration of at least eight million doses of the
vaccine since the immunisation programme began in 2008.</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. Whilst Yellow Card reports
may represent side effects, they may also relate to coincidental events unrelated
to vaccination. The CHM has thoroughly reviewed the data reported in association with
HPV vaccines in the United Kingdom and has no concerns about the number or nature
of Yellow Card reports received. The CHM considered that the vast majority of suspected
side effects reports appeared to be similar in frequency and type to those that had
been reported with other vaccines routinely given to adolescents and adults and concluded
that the evidence does not support a link between HPV vaccination and chronic illnesses.</p><p>
</p><p> </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 8,835 ADRs relate to the known risks of vaccination that are well-described
in the available product information. The expected benefits in protecting against
HPV-related mortality and disease outweigh the known side effects of HPV vaccine.</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></tr><tr><td><p>Cervarix</p></td><td><p>6,312</p></td><td><p>1,812
(29%)</p></td></tr><tr><td><p>Gardasil</p></td><td><p>1,858</p></td><td><p>767 (41%)</p></td></tr><tr><td><p>Gardasil
9</p></td><td><p>10</p></td><td><p>6 (60%)</p></td></tr><tr><td><p>HPV Brand unspecified</p></td><td><p>658</p></td><td><p>456
(69%)</p></td></tr><tr><td><p>Total for Human Papilloma virus vaccines</p></td><td><p>8,835*</p></td><td><p>3,038
(34%)</p></td></tr></tbody></table><p> </p><p>Source: MHRA sentinel database for adverse
reactions.</p><p>Note 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>
|
|