HPV Vaccine Questioned in English Parliament

House of Lords – Written Answers –  Hansard Monday 5 November 2012

Health: Human Papillomavirus Vaccination


Asked by The Countess of Mar

To ask Her Majesty’s Government whether they will review their policy on the use of the human papillomavirus vaccination (HPV) in the light of the recent research by Tomljenovic and Shaw about the safety of HPV.[HL2911]

[ED: The research abstract is found here: Death after Quadrivalent Human Papillomavirus (HPV) Vaccine: Causal or Coincidental?

and this CHS article: New Research Shows How Gardasil and Cervarix Vaccines Can Silently Kill Your Daughters And Sons]

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To ask Her Majesty’s Government whether they have made any assessment of the data from trials conducted by Merk on the evidence of vasculitis in those using the human papillomavirus vaccination; and, if so, what conclusions they have drawn. [HL2912]

To ask Her Majesty’s Government whether, in the light of recent research by Tomljenovic and Shaw about the safety of the human papillomavirus vaccination (HPV), they will issue guidance to doctors and immunisation nurses about the recording of adverse medical events following the administration of the HPV and the conduct of studies on those receiving the vaccination.[HL2913]

To ask Her Majesty’s Government what criteria they use to assess whether a vaccine should be withdrawn from use; and whether they plan to test the human papillomavirus vaccination against those criteria.[HL2914]

To ask Her Majesty’s Government what assessment they have made of the adequacy of surrogate marker-based extrapolations in demonstrating the efficacy of the human papillomavirus vaccination against cervical cancer.[HL2915]

The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): The Medicines and Healthcare products Regulatory Agency (MHRA), with independent expert advice from the Commission on Human Medicines is responsible for ensuring that the overall balance of risks and benefits of medicines is positive at the time of licensing, and that this remains positive after licensing.

The safety and efficacy of the human papillomavirus (HPV) vaccine Gardasil was evaluated in seven clinical trials (six placebo-controlled trials) prior to licensing with over 10,000 people vaccinated with Gardasil. These trials did not identify an association between Gardasil administration and vasculitis. Tens of millions of people have since been vaccinated with Gardasil HPV vaccine worldwide since licensing and there is no evidence to suggest that Gardasil can cause vasculitis, as suggested by Tomljenovic and Shaw.

The MHRA actively seeks ways to encourage the reporting of suspected adverse reactions by healthcare professionals, carers and patients to all medicines and vaccines through the Yellow Card Scheme. The research by Tomljenovic and Shaw provides no basis to issue any additional specific guidance on reporting suspected side effects to HPV vaccine.

Continuous safety review includes evaluation of suspected adverse reactions collected through the yellow card scheme, as well as the results from any new studies, both published and unpublished. If there is sufficient evidence that a vaccine or medicine is causally associated with a new risk based on the available data, such risks would be characterised and weighed against the known or anticipated benefits. If possible, action would be taken to minimise the risk, which could include restricting use of a product, and communicate the information to healthcare providers, patients and carers. In exceptional cases, where the risks of a product are considered to outweigh its benefits and actions to minimise the risk are not possible, consideration would be given to withdrawing it from use.

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The use of surrogate clinical end points for efficacy of HPV vaccines for prevention of cervical and other HPV related cancers is widely accepted within the scientific community and no robust evidence exists to undermine that concept.

Based on currently available evidence, the known risks of HPV vaccine are greatly outweighed by the expected benefits in preventing deaths from cervical cancer and other morbidities associated with vaccine strains of HPV. The department therefore has no plans to review policy on human papillomavirus (HPV) immunisation or issue advice to the National Health Service in the light of recent research by Tomljenovic and Shaw as it does not materially add to accepted evidence and views about the safety of HPV vaccine.

As with all vaccines and medicines, the MHRA will continue to closely monitor all emerging evidence on the safety of HPV vaccines and action will be taken to minimise risk if supported by the data.

The department will monitor carefully the impact of HPV vaccination, as the early cohorts of vaccinated women will soon be subject to cervical screening surveillance.