Human Papillomavirus: Vaccination:Written question - HL1164

Q
Asked on: 07 July 2015
Department of Health
Human Papillomavirus: Vaccination
Lords
To ask Her Majesty’s Government why only 16.8 per cent of reports of serious adverse events relating to human papilloma virus (HPV) vaccines under the Yellow Card Scheme have been followed up, according to the response by the Medicines and Healthcare products Regulatory Agency to a freedom of information request on 25 June; how this compares to the percentage of yellow-card reports followed up for all vaccines; and whether they now plan to follow up all reported serious adverse events relating to HPV vaccines in order to ascertain recovery rates.
A
Answered by: Lord Prior of Brampton
Answered on: 20 July 2015

A total of 2,624 spontaneous suspected serious adverse reaction reports (ADRs) 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 7 July 2015.

To date more than eight million doses of HPV vaccine have been given in the United Kingdom since 2008, with close to 90% eligible teenagers vaccinated. The vast majority of suspected side effects reported so far relate to those we would expect with most types of vaccine; these are most commonly dizziness, headache, nausea, sore arms, vomiting, general malaise, tiredness, fever, and rashes. These tend to be mild and transient. Many serious reports relate to immediate fainting, which is not necessarily a side effect of the vaccine but a response that any type of needle insertion can provoke in some people.

The following table provides a breakdown of UK suspected spontaneous ADRs received via the Yellow card Scheme in association with all vaccines on the immunisation schedule. The table provides the total number of reports, the total number of serious reports and the number of serious reports followed up.

UK suspected spontaneous ADRs received via the Yellow card Scheme in association with all vaccines on the immunisation schedule.

Vaccine Brand

Total number of reports

Number of serious reports

Number of serious reports followed up

% of serious reports followed up*

Human Papilloma Virus (HPV)

8,276

2,624

441

17%

Diphtheria,tetanus, pertussis, polio and Haemophilus influenza type b (DTaP/IPV/Hib)

1,382

713

103

14%

Tetanus, diphtheria and polio (Td/IPV)

1,152

671

95

14%

Diphtheria,tetanus, pertussis and polio (DTaP/IPV)

1,326

509

65

12%

Rotavirus (Rotarix)

452

283

70

25%

Pneumococcal disease (PCV)

1,611

882

85

10%

Meningococcal group C disease (Men C)

14,671

4,241

81

2%

Hib/Men C

285

155

23

15%

Measles, mumps and rubella (MMR)

5,492

2,804

88

3%

Pneumococcal disease (PPV)

1,726

985

27

3%

Fluenz/ Fluenz Tetra

877

381

74

19%

Zostavax

646

408

105

26%

Influenza virus

5,745

3807

483

13%

* Percentage provided to the nearest whole number

It should be noted 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. Comparisons of ADR reporting rates would be an invalid estimate of relative vaccine safety.

Every reporter to the Yellow Card scheme receives an acknowledgement which asks that any new information relating to the case be reported. Follow up procedures for Yellow Card reports are in place and are designed to ensure that relevant information is sought if this is missing from reports of serious reactions which could potentially be new signals. While in an ideal world full details would be obtained for every report, given there are over 750,000 reports on the database with around 30,000 new reports each year, it will never be possible to ensure all reports on the database are complete. There are a number of difficulties with achieving satisfactory follow up. Time pressure on potential reporters has been identified as one of the reasons for under-reporting adverse reactions through the Yellow Card Scheme. This issue also applies to requests for follow up information and therefore there is a need to be selective and focussed about the reports for which follow up information is requested.

The HPV vaccine has a very good safety record, and surveillance shows it has contributed to a significant decrease in rates of infection with the two main cancer-causing human papillomaviruses. The UK programme is eventually expected to prevent hundreds of deaths from cervical cancer every year.

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