Human Papillomavirus: Vaccination:Written question - HL229

Q
Asked on: 02 June 2015
Department of Health
Human Papillomavirus: Vaccination
Lords
To ask Her Majesty’s Government, to date, how many adverse reactions to (1) Cervarix, (2) Gardasil and (3) generic human papilloma virus vaccines have been reported to the Medicines and Healthcare products Regulatory Agency; for each category, how many of those reports are of serious adverse reactions; and what age-specific rate those figures represent.
A
Corrected answer by: Lord Prior of Brampton
Corrected on: 03 July 2015
An error has been identified in the written answer given on 16 June 2015.
The correct answer should have been:

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.

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.

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.

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.

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.

Vaccine Brand

Total number of reports

Number of serious reports (% of total)

Reporting rate per 1000 doses (serious reporting rates per 1000)

Cervarix

6,266

1,768 (28%)

n/a **0.78 (0.22)

Gardasil

1,471

504 (34%)

n/a **0.18 (0.06)

HPV Brand unspecified

507

326 (64%)

n/a ** 0.06 (0.04)

Total for Human Papilloma virus vaccines

*8,244

2,598 (32%)

1.03 (0.32)

Source: MHRA sentinel database for adverse reactions.

* 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.

**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.

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.

A
Answered by: Lord Prior of Brampton
Answered on: 16 June 2015

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.

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.

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.

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.

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.

Vaccine Brand

Total number of reports

Number of serious reports (% of total)

Reporting rate per 1000 doses (serious reporting rates per 1000)

Cervarix

6,266

1,768 (28%)

n/a **0.78 (0.22)

Gardasil

1,471

504 (34%)

n/a **0.18 (0.06)

HPV Brand unspecified

507

326 (64%)

n/a ** 0.06 (0.04)

Total for Human Papilloma virus vaccines

*8,244

2,598 (32%)

1.03 (0.32)

Source: MHRA sentinel database for adverse reactions.

* 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.

**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.

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.

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