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780496

registered interest
date	30/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, how many Yellow Cards submitted to the Medicines and Healthcare Products Regulatory Agency on the HPV vaccination have been classified as serious in the last three years.
tabling member constituency	Mansfield
tabling member printed	Ben Bradley
uin	110248
answer	answer is ministerial correction date of answer 07/11/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) encourages anyone to report a suspected adverse reaction (ADR) to a vaccine or medicine through the Yellow Card Scheme:</p><p> </p><p><a href="http://www.mhra.gov.uk/yellowcard" target="_blank">www.mhra.gov.uk/yellowcard</a></p><p>A Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine or medicine may have been the cause. Such reports are kept under continual review to identify potential new risks.</p><p> </p><p>Between 31 October 2014 – 30 October 2017 a total of 649 serious suspected adverse 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 (data run date: 1 November 2017). In this three year period, at least 1 million doses of HPV vaccine were administered in the United Kingdom.</p><p> </p><p>A breakdown of UK serious suspected spontaneous ADR reports received via the Yellow Card Scheme beween 31 October 2014 – 30 October 2016 by brand and year received is shown in the following table.</p><p> </p><table><tbody><tr><td><p>HPV Vaccine</p></td><td><p>Number of serious reports</p></td></tr><tr><td><p>HPV brand unspecified</p></td><td><p>181</p></td></tr><tr><td><p>Cervarix</p></td><td><p>64</p></td></tr><tr><td><p>Gardasil</p></td><td><p>390</p></td></tr><tr><td><p>Gardasil 9</p></td><td><p>18</p></td></tr><tr><td><p>Total</p></td><td><p>649</p></td></tr></tbody></table><p> </p><p>Source: MHRA sentinel database for adverse reactions</p><p> </p><p>Notes:</p><p> </p><p>The total number of reports received by vaccine brand is not equal to the totals in the table above as some reports included more than one HPV vaccine brand.</p><p> </p><p>The MHRA has received a total of 3,159 serious suspected adverse reaction reports associated with HPV vaccine (data run date 1 November 2017).</p><p> </p><p>All serious reports received via the Yellow Card Scheme are reviewed based on the details received from the reporter. Follow up letters may be sent for missing information such as vaccine brand name, batch number, medical history, results of investigations, diagnoses and details of outcome.</p><p> </p><p>The Commission on Human Medicines has thoroughly reviewed the safety of HPV vaccines and concluded that the evidence does not support a link between HPV vaccination and the development of chronic illnesses.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 110360 question first answered 07/11/2017 11:31:40 answering member 4067 label Biography information for Steve Brine
tabling member	4663 label Biography information for Ben Bradley

780519

registered interest
date	30/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health, how many Yellow Cards submitted to the Medicines and Healthcare Products Regulatory Agency for the HPV vaccination were classified as serious; and how many of those cases were reviewed to establish whether the patient had returned to full health in each of the last 12 months.
tabling member constituency	Mansfield
tabling member printed	Ben Bradley
uin	110360
answer	answer is ministerial correction date of answer 07/11/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) encourages anyone to report a suspected adverse reaction (ADR) to a vaccine or medicine through the Yellow Card Scheme:</p><p> </p><p><a href="http://www.mhra.gov.uk/yellowcard" target="_blank">www.mhra.gov.uk/yellowcard</a></p><p>A Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine or medicine may have been the cause. Such reports are kept under continual review to identify potential new risks.</p><p> </p><p>Between 31 October 2014 – 30 October 2017 a total of 649 serious suspected adverse 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 (data run date: 1 November 2017). In this three year period, at least 1 million doses of HPV vaccine were administered in the United Kingdom.</p><p> </p><p>A breakdown of UK serious suspected spontaneous ADR reports received via the Yellow Card Scheme beween 31 October 2014 – 30 October 2016 by brand and year received is shown in the following table.</p><p> </p><table><tbody><tr><td><p>HPV Vaccine</p></td><td><p>Number of serious reports</p></td></tr><tr><td><p>HPV brand unspecified</p></td><td><p>181</p></td></tr><tr><td><p>Cervarix</p></td><td><p>64</p></td></tr><tr><td><p>Gardasil</p></td><td><p>390</p></td></tr><tr><td><p>Gardasil 9</p></td><td><p>18</p></td></tr><tr><td><p>Total</p></td><td><p>649</p></td></tr></tbody></table><p> </p><p>Source: MHRA sentinel database for adverse reactions</p><p> </p><p>Notes:</p><p> </p><p>The total number of reports received by vaccine brand is not equal to the totals in the table above as some reports included more than one HPV vaccine brand.</p><p> </p><p>The MHRA has received a total of 3,159 serious suspected adverse reaction reports associated with HPV vaccine (data run date 1 November 2017).</p><p> </p><p>All serious reports received via the Yellow Card Scheme are reviewed based on the details received from the reporter. Follow up letters may be sent for missing information such as vaccine brand name, batch number, medical history, results of investigations, diagnoses and details of outcome.</p><p> </p><p>The Commission on Human Medicines has thoroughly reviewed the safety of HPV vaccines and concluded that the evidence does not support a link between HPV vaccination and the development of chronic illnesses.</p> answering member constituency Winchester answering member printed Steve Brine grouped question UIN 110248 question first answered 07/11/2017 11:31:40 answering member 4067 label Biography information for Steve Brine
tabling member	4663 label Biography information for Ben Bradley

775947

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the 2.5 per cent level of serious adverse events in clinical trials of Gardasil and Gardasil 9; and whether this represents an acceptable level of risk for patients.
tabling member printed	The Countess of Mar
uin	HL2355
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>Safety data from the clinical trials of Gardasil and Gardasil 9 vaccines were thoroughly reviewed by the European Medicines Agency (EMA) as part of the licensing process of the vaccines. A serious adverse event (SAE) in a clinical trial is any untoward medical occurrence in a study subject and does not necessarily have a causal relationship with the treatment.</p><p>The overall proportions and types of SAEs reported in the Gardasil, Gardasil 9 and placebo or comparator groups were comparable, indicating that most were not related to the vaccines. The EMA authorised Gardasil and Gardasil 9 vaccines for use on the basis that the benefits of vaccination outweighed the possible side effects. The potential side effects of Gardasil and Gardasil 9 vaccines are listed in the product information.</p><p> </p><p>As with all vaccines and medicines, the safety of human papillomavirus (HPV) vaccines has remained under continual review in the post-licensing period. At least three million girls have been vaccinated so far in the United Kingdom, with tens of millions more worldwide. Thorough reviews undertaken by health authorities across the world have found no evidence to support a link between HPV vaccine and the development of chronic illnesses, and concluded that the balance of benefits and risks remains favourable.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:52:32 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775948

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the 3.3 per cent of patients presenting with new medical conditions potentially indicative of autoimmune disorders in clinical trials of Gardasil and Gardasil 9.
tabling member printed	The Countess of Mar
uin	HL2356
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>Safety data from the clinical trials of Gardasil and Gardasil 9 vaccines were thoroughly reviewed by the European Medicines Agency (EMA) as part of the licensing process of the vaccines. A serious adverse event (SAE) in a clinical trial is any untoward medical occurrence in a study subject and does not necessarily have a causal relationship with the treatment. SAEs potentially indicative of an autoimmune disorder were evaluated in the Gardasil and Gardasil 9 vaccine clinical trials. The rates of autoimmune disorders were similar to that seen in the placebo or comparator groups, indicating that they were not related to the vaccines. The EMA authorised Gardasil and Gardasil 9 vaccines for use on the basis that the benefits of vaccination outweighed the possible side effects. The potential side effects of Gardasil and Gardasil 9 vaccines are listed in the product information.</p><p> </p><p>As with all vaccines and medicines, the safety of human papillomavirus (HPV) vaccines has remained under continual review in the post-licensing period. At least three million girls have been vaccinated so far in the United Kingdom, with tens of millions more worldwide. Thorough reviews undertaken by health authorities across the world have found no evidence to support a link between HPV vaccine and the development of chronic illnesses, and concluded that the balance of benefits and risks remains favourable.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:58:12 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775949

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government why the Medicines and Healthcare products Regulatory Agency record individual symptoms relating to suspected adverse reactions to human papilloma virus vaccines instead of correlating those reported for each individual patient so that a complete picture of the patient’s condition is formed.
tabling member printed	The Countess of Mar
uin	HL2357
answer	answer is ministerial correction date of answer 01/11/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) encourages anyone to report a suspected adverse reaction to a vaccine or medicine through the Yellow Card Scheme. A Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine or medicine may have been the cause. Such reports are kept under continual review to identify potential new risks.</p><p> </p><p>All information provided in the report such as signs, symptoms or diagnoses are recorded by the MHRA. The full information included in a Yellow Card report is reviewed by the MHRA as this gives the most complete picture for evaluation. If required, the MHRA may follow up for more information.</p> answering member printed Lord O'Shaughnessy question first answered 01/11/2017 12:56:29 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775950

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government how many reports of suspected adverse reactions to human papilloma virus vaccines have been followed up with individual patients.
tabling member printed	The Countess of Mar
uin	HL2358
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) encourages anyone to report a suspected adverse reaction (ADR) to a vaccine or medicine through the Yellow Card Scheme. A Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine or medicine may have been the cause. Such reports are kept under continual review to identify potential new risks.</p><p> </p><p>Follow up procedures for Yellow Card reports are in place and are designed to ensure that relevant information is sought where it is missing and could help with the evaluation of a report and associated safety signals.</p><p> </p><p>The MHRA has received 780 reports of suspected ADRs to human papilloma virus (HPV) vaccines directly from United Kingdom members of the public up to 20 October 2017. Of these, 278 (35%) have been followed up for further clinical details. This does not include reports for which detailed information had already been provided by the reporter and thus did not require further MHRA follow up.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:53:10 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

775951

registered interest
date	23/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government, further to the Written Answer by Lord O'Shaughnessy on 18 October (HL1965), on what evidence the enhanced pharmacovigilance relating to human papilloma virus vaccines was based.
tabling member printed	The Countess of Mar
uin	HL2359
answer	answer is ministerial correction date of answer 02/11/2017 answer text <p>In evaluating vaccine and medicines safety, the Medicines and Healthcare products Regulatory Agency (MHRA) takes account of all available sources of evidence. The enhanced form of pharmacovigilance for human papillomavirus vaccine was based primarily on the evaluation of Yellow Card reports alongside data from the Clinical Practice Research Datalink. As part of routine pharmacovigilance, the MHRA also takes account of information contained in periodic safety update reports from the marketing authorisation holders, any ongoing safety studies, any information from other worldwide health authorities and evidence from published medical literature.</p> answering member printed Lord O'Shaughnessy question first answered 02/11/2017 14:50:53 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

773568

registered interest
date	19/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what steps they are taking to ensure that the families of children believed to have suffered serious adverse reactions to human papilloma virus vaccinations are treated with the same levels of dignity and respect accorded to families whose children have other medical conditions.
tabling member printed	The Countess of Mar
uin	HL2283
answer	answer is ministerial correction date of answer 01/11/2017 answer text <p>Anyone suffering ill health deserves access to appropriate clinical investigation and care, and to be treated with dignity and respect. This is an important responsibility of doctors and other healthcare providers.</p><p>The Medicines and Healthcare products Regulatory Agency takes every report of a suspected adverse reaction seriously and has closely evaluated the safety of the human papillomavirus vaccine since the vaccination programme was introduced in the United Kingdom in 2008. All reports, including any submitted by patients and their families, are kept under continual review to identify potential new risks.</p> answering member printed Lord O'Shaughnessy question first answered 01/11/2017 12:47:48 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar

773014

registered interest
date	18/10/2017
answering body	Department for Education
answering dept id	60
answering dept short name	Education
answering dept sort name	Education
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the provision of, and access to, educational materials for girls whose education has been disrupted due to symptoms developed after human papilloma virus vaccination.
tabling member printed	The Countess of Mar
uin	HL2215
answer	answer is ministerial correction date of answer 31/10/2017 answer text <p>All children regardless of their circumstances are entitled to a good education and the necessary support to attain it.</p><p> </p><p>Schools have a duty to ensure that arrangements are made to support pupils with medical needs to have full access to education. Where health needs mean a child of compulsory school age would not receive suitable education due to health needs, including because they cannot attend school, local councils have a duty to ensure that alternative education arrangements are put in place.</p><p>The education must be full time, or as close to full time as in the best interests of the child, because of their health needs, and it must be on par with what the child would have received if they were in a mainstream school.</p> answering member printed Lord Agnew of Oulton question first answered 31/10/2017 17:27:04 answering member 4689 label Biography information for Lord Agnew of Oulton
tabling member	1861 label Biography information for The Countess of Mar

773015

registered interest
date	18/10/2017
answering body	Department of Health
answering dept id	17
answering dept short name	Health
answering dept sort name	Health
hansard heading	Human Papillomavirus: Vaccination
house id	2
legislature	25277 pref label House of Lords
question text	To ask Her Majesty's Government what assessment they have made of the number of girls diagnosed with mental health problems shortly after human papilloma virus vaccination, particularly when there has been no record of previous mental health disorder or serious health issues prior to vaccination.
tabling member printed	The Countess of Mar
uin	HL2216
answer	answer is ministerial correction date of answer 31/10/2017 answer text <p>As with all vaccines and medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) closely monitors the safety of the 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>The MHRA takes account of all available sources of safety data, including reports of suspected side effects submitted through the Yellow Card Scheme. 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. Such reports are kept under continual review.</p><p> </p><p>Since 2008, at least three million girls have been vaccinated with HPV vaccine across the United Kingdom. Through the Yellow Card Scheme, 341 reports included a suspected psychiatric event. The detailed medical history is not always provided in Yellow Card reports. Evaluation of such reports does not indicate a causal association with the HPV vaccine. In July 2015, the CHM thoroughly reviewed the safety of HPV vaccines and concluded that the evidence does not support a link between HPV vaccination and the development of chronic illnesses.</p> answering member printed Lord O'Shaughnessy question first answered 31/10/2017 12:34:43 answering member 4545 label Biography information for Lord O'Shaughnessy
tabling member	1861 label Biography information for The Countess of Mar