Human Papillomavirus: Vaccination:Written question - 70973

Q
(Cumbernauld, Kilsyth and Kirkintilloch East)
Asked on: 13 April 2017
Department of Health
Human Papillomavirus: Vaccination
Commons
To ask the Secretary of State for Health, how many reports of (a) all adverse and (b) serious adverse reactions to (i) Cervarix, (ii) Gardasil and (iii) generic human papilloma virus vaccines the Medicines and Healthcare Products Regulatory Agency has received to date.
A
Answered by: Nicola Blackwood
Answered on: 24 April 2017

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.

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.

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.

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.

Vaccine Brand

Total number of reports

Number of serious reports (% of total)

Cervarix

6,312

1,812 (29%)

Gardasil

1,858

767 (41%)

Gardasil 9

10

6 (60%)

HPV Brand unspecified

658

456 (69%)

Total for Human Papilloma virus vaccines

8,835*

3,038 (34%)

Source: MHRA sentinel database for adverse reactions.

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.

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