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1141380

	registered interest
	date	23/07/2019
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	MMR Vaccine: Safety
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what steps he is taking to maintain and improve pharmacovigilance in relation to the MMR vaccine.
	tabling member constituency	Gravesham
	tabling member printed	Adam Holloway
	uin	280998
	answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>As with all vaccines and medicines, the safety of the Measles, Mumps and Rubella (MMR) vaccine remains under continual review by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA uses all available sources of evidence in pharmacovigilance, including regular review of suspected adverse reactions submitted through the Yellow Card Scheme, data from clinical and epidemiological studies, the medical literature and information from pharmaceutical companies and other worldwide regulatory authorities. The MHRA’s processes and data analysis systems are regularly evaluated to ensure optimal performance in monitoring the safety of vaccines and medicines.</p><p>The balance of benefits and risks of MMR vaccine remains overwhelmingly favourable.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 25/07/2019 16:35:38 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	1522 label Biography information for Adam Holloway

1141381

	registered interest
	date	23/07/2019
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	MMR Vaccine
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what steps he is taking to help ensure (a) transparency and (b) accountability in the process of manufacturing the MMR vaccine.
	tabling member constituency	Gravesham
	tabling member printed	Adam Holloway
	uin	280999
	answer	answer is ministerial correction date of answer 25/07/2019 answer text <p>Two Measles, Mumps and Rubella (MMR) vaccines are licensed for use in the United Kingdom: M-M-RVaxPro and Priorix. Both vaccines are on the National Health Service’s routine immunisation schedule. The quality, safety and efficacy of both M-M-RVaxPro and Priorix have been evaluated before they were given a Marketing Authorisation in Europe, and the Marketing Authorisation Holder for each vaccines is legally required to submit periodic safety update reports to the regulator, which are documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The sites at which the products are manufactured are also required to undergo periodic inspections to ensure that they comply with Good Manufacturing Practices. Each batch of vaccines is tested by an official medicines control laboratory (OMCL). OMCL testing is independent of and in addition to the manufacturer’s testing. These procedures ensure that the MMR vaccines available in the UK are safe and efficacious and that the manufacturers/Marketing Authorisation holders are held accountable for their products.</p><p>A European Public Assessment Report (EPAR) for M-M-RVaxPro is available at the following link:</p><p><a href="https://www.ema.europa.eu/en/documents/scientific-discussion/m-m-rvaxpro-epar-scientific-discussion_en.pdf" target="_blank">https://www.ema.europa.eu/en/documents/scientific-discussion/m-m-rvaxpro-epar-scientific-discussion_en.pdf</a></p><p>Priorix was approved before public assessment reports were a requirement. The EPAR for M-M-RVaxPro contains a general summary of the manufacturing information that was provided during the assessment process; however, the specific details of the manufacturing process are confidential.</p> answering member constituency Thurrock answering member printed Jackie Doyle-Price question first answered 25/07/2019 16:38:57 answering member 4065 label Biography information for Dame Jackie Doyle-Price
	tabling member	1522 label Biography information for Adam Holloway