Human Papillomavirus: Vaccination:Written question - HL1340

Q
Asked on: 05 September 2017
Department of Health
Human Papillomavirus: Vaccination
Lords
To ask Her Majesty's Government what risks associated with the human papilloma virus vaccination have been identified and recorded.
A
Answered by: Lord O'Shaughnessy
Answered on: 13 September 2017

As with all vaccines and medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) closely monitors the safety of 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.

The possible side effects of HPV vaccine are documented in full in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). A copy of the SmPC and PIL are attached. The possible side effects are identified based on evaluation of data from pre-licensure clinical trials and continuous review of safety data accumulated during post-marketing use. The type and frequency of possible side effects of HPV vaccine are broadly similar to those of most types of vaccine routinely offered to adolescents and adults. These are most commonly injection site reactions and sore arm, low grade fever, muscle aches, headaches, tiredness and nausea, which are short lasting. The CHM has advised that available evidence does not support a link between HPV vaccination and chronic illnesses and that the benefits in protecting against cervical cancer and other HPV-related disease outweigh the possible known side effects of the vaccines.

Extensive reviews of HPV vaccine safety have also been undertaken by various independent health bodies/authorities worldwide, such as the US Centre for Disease Control and Prevention and the World Health Organization (WHO). These have similarly concluded that evidence does not support a link between HPV vaccine and the development of a range of chronic illnesses. Most recently, in July 2017, the WHO’s Global Advisory Committee on Vaccine Safety concluded that it has found no new adverse events of concern for HPV vaccine based on many very large, high quality studies.

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