Human Papillomavirus: Vaccination

Department of Health written question – answered at on 13 June 2016.

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Photo of Andrew Gwynne Andrew Gwynne Shadow Minister (Health)

To ask the Secretary of State for Health, whether the Medicines and Healthcare Products Regulatory Agency holds any clinical trial data for HPV vaccines which is not in the public domain.

Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

An error has been identified in the written answer given on 07 June 2016.

The correct answer should have been:

There are two three human papilloma virus vaccines licensed in the European Union: Cervarix, and Gardasil and Gardasil 9. These products are licensed centrally throughout Europe by the European Commission via the European Medicines Agency (EMA). Applicants for centrally authorised products are required to submit all relevant supporting clinical trials data, whether published or not, to the EMA directly and not to the Medicines and Healthcare products Regulatory Agency.

Under current medicines legislation, the EMA database registers all EU-approved clinical trials of investigational medicinal products. Since March 2011 this information has been publicly accessible through the EU Clinical Trials Register (except adult Phase 1 trials). The EU Clinical Trials Register includes all EU-conducted trials since May 2004 when the Clinical Trials Directive was implemented and can be found here:

https://www.clinicaltrialsregister.eu/ctr-search/search

Furthermore since July 2014 clinical trial sponsors have been required to provide a summary of their trial results uploaded onto the EU Clinical Trials Register within one year of their trial completing. There is a two year programme of back-loading underway to provide summaries of trial results for all trials on the Register back to when the EudraCT database was initiated in May 2004.

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Photo of George Freeman George Freeman The Parliamentary Under-Secretary of State for Business, Innovation and Skills, The Parliamentary Under-Secretary of State for Health

There are two three human papilloma virus vaccines licensed in the European Union: Cervarix, and Gardasil and Gardasil 9. These products are licensed centrally throughout Europe by the European Commission via the European Medicines Agency (EMA). Applicants for centrally authorised products are required to submit all relevant supporting clinical trials data, whether published or not, to the EMA directly and not to the Medicines and Healthcare products Regulatory Agency.

Under current medicines legislation, the EMA database registers all EU-approved clinical trials of investigational medicinal products. Since March 2011 this information has been publicly accessible through the EU Clinical Trials Register (except adult Phase 1 trials). The EU Clinical Trials Register includes all EU-conducted trials since May 2004 when the Clinical Trials Directive was implemented and can be found here:

https://www.clinicaltrialsregister.eu/ctr-search/search

Furthermore since July 2014 clinical trial sponsors have been required to provide a summary of their trial results uploaded onto the EU Clinical Trials Register within one year of their trial completing. There is a two year programme of back-loading underway to provide summaries of trial results for all trials on the Register back to when the EudraCT database was initiated in May 2004.

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No0 people think not

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Annotations

Steve Hinks
Posted on 9 Jun 2016 5:59 am (Report this annotation)

The European Medicines Agency EMA) recently reviewed safety of HPV vaccines. It concluded that 'they are safe' and stated that 'reported adverse reactions did not show a consistent pattern regarding time-to-onset following vaccination! They appear to have totally ignored the evidence provided by the UK Association of HPV Injured Daughters (AHVID) which reported that a questionnaire completed by 94 member families indicated that:
• 27 girls (31% ) had adverse reactions on the same day as the vaccination, many of them suffrering immediately, within minutes.
• 12 girls (14%) had adverse reactions after just 1 dose
• 19 girls (22%) had adverse reactions after just 2 doses (some of these had reactions also to the 1st dose
• 14 girls had adverse reactions after the 3rd dose (and some of these had earlier reactions)
• At least 4 girls (4%) had adverse reactions after each of 3 doses. Health professionals had indicated that the vaccine is safe and the adverse reactions suffered were not recognised as side effects of the vaccine. Initial symptoms were often ‘generally unwell, flu-like, tired, aches and pains’. With each dose the severity increased and day-by-day the severity increased. With some it was eventually several weeks before these symptoms developed into collapse with total fatigue and sleeping up to 23 hours each day.