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1718366

registered interest
date	15/05/2024
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	Coronavirus: Vaccination
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 NHS England took to ensure that informed consent was given by recipients of the Oxford-AstraZeneca covid-19 vaccine.
tabling member constituency	Christchurch
tabling member printed	Sir Christopher Chope
uin	26323
answer	answer is ministerial correction date of answer 24/05/2024 answer text <p>To ensure informed consent was given by patients who received the AstraZeneca COVID-19 vaccine, all vaccination sites were instructed to follow consent guidance in line with the recommendations set out in chapter two of the UK Health Security Agency Green Book on vaccinations and immunisations.</p><p>Healthcare organisations administering any COVID-19 vaccinations are responsible for drawing up their own policies for obtaining informed consent, and health professionals overseeing or administering COVID-19 vaccines are responsible for ensuring that valid consent has been obtained. This would normally involve a discussion with the clinician prior to the administration of the vaccine, and individuals will also have had access to guides and patient information leaflets which provided details about the vaccine, how it is administered, possible side effects, and other warnings and precautions to take.</p><p>Regarding the very rare adverse events of concurrent thrombosis and thrombocytopenia associated with the AstraZeneca COVID-19 vaccine, NHS England notified healthcare organisations administering the COVID-19 vaccinations immediately following the updated advice from the independent Joint Committee on Vaccination and Immunisation published on 7 April 2021, and then again following updated advice on 7 May 2021. In these updates, sent via system letters, NHS England set out the next steps for healthcare organisations and clinicians, including on the consent process.</p> answering member constituency Lewes answering member printed Maria Caulfield grouped question UIN 26324 question first answered 24/05/2024 08:24:20 answering member 4492 label Biography information for Maria Caulfield previous answer version 35277 answering member constituency Faversham and Mid Kent answering member printed Helen Whately answering member 4527
tabling member	242 label Biography information for Sir Christopher Chope

1718367

registered interest
date	15/05/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, on what date NHS England informed patients receiving the Oxford-AstraZeneca Covid-19 vaccine that there were safety risks of vaccine-induced thrombosis with thrombocytopenia associated with the vaccine.
tabling member constituency	Christchurch
tabling member printed	Sir Christopher Chope
uin	26324
answer	answer is ministerial correction date of answer 24/05/2024 answer text <p>To ensure informed consent was given by patients who received the AstraZeneca COVID-19 vaccine, all vaccination sites were instructed to follow consent guidance in line with the recommendations set out in chapter two of the UK Health Security Agency Green Book on vaccinations and immunisations.</p><p>Healthcare organisations administering any COVID-19 vaccinations are responsible for drawing up their own policies for obtaining informed consent, and health professionals overseeing or administering COVID-19 vaccines are responsible for ensuring that valid consent has been obtained. This would normally involve a discussion with the clinician prior to the administration of the vaccine, and individuals will also have had access to guides and patient information leaflets which provided details about the vaccine, how it is administered, possible side effects, and other warnings and precautions to take.</p><p>Regarding the very rare adverse events of concurrent thrombosis and thrombocytopenia associated with the AstraZeneca COVID-19 vaccine, NHS England notified healthcare organisations administering the COVID-19 vaccinations immediately following the updated advice from the independent Joint Committee on Vaccination and Immunisation published on 7 April 2021, and then again following updated advice on 7 May 2021. In these updates, sent via system letters, NHS England set out the next steps for healthcare organisations and clinicians, including on the consent process.</p> answering member constituency Lewes answering member printed Maria Caulfield grouped question UIN 26323 question first answered 24/05/2024 08:24:21 answering member 4492 label Biography information for Maria Caulfield previous answer version 35278 answering member constituency Faversham and Mid Kent answering member printed Helen Whately answering member 4527
tabling member	242 label Biography information for Sir Christopher Chope

1715634

registered interest
date	02/05/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether (a) his Department and (b) the Medicines and Healthcare products Regulatory Agency has received data from Astra Zeneca on the potential serious adverse effects of its covid-19 vaccine for a small number of recipients.
tabling member constituency	Christchurch
tabling member printed	Sir Christopher Chope
uin	24607
answer	answer is ministerial correction date of answer 15/05/2024 answer text <p>The Department has not directly received data from AstraZeneca regarding potential adverse effects of their COVID-19 vaccine Vaxzevria, as it is not the appropriate body to receive this information. It instead relies on the expert advice of the Medicines and Healthcare products Regulatory Agency (MHRA).</p><p>All vaccine manufacturers have a legal responsibility to mitigate risk and monitor the safety and performance of vaccines throughout the product lifecycle. This includes a legal responsibility to transmit reports of suspected adverse reactions received directly to the MHRA. Following the MHRA’s receipt of the first Yellow Card reports of suspected thrombosis and associated thrombocytopaenia associated with the Vaxzevria vaccine in February 2021, AstraZeneca provided the Commission on Human Medicines’ Vaccine Benefit Risk Expert Working Group an analysis of the age stratified risk of thrombosis with thrombocytopenia associated with the AstraZeneca vaccine. This was assessed by the Commission on Human Medicines, with the Patient Information updated to state the risks of these events.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/05/2024 10:08:51 answering member 4492 label Biography information for Maria Caulfield previous answer version 32814 answering member constituency Lewes answering member printed Maria Caulfield answering member 4492 label Biography information for Maria Caulfield
tabling member	242 label Biography information for Sir Christopher Chope

1715270

registered interest
date	01/05/2024
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	Coronavirus: Vaccination
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 her Department is taking to help increase the provision of covid-19 booster vaccinations to community pharmacies.
tabling member constituency	South Staffordshire
tabling member printed	Sir Gavin Williamson
uin	24457
answer	answer is ministerial correction date of answer 08/05/2024 answer text <p>Community pharmacies have been taking part in the COVID-19 vaccination programme since January 2021. NHS England has recently changed the model for procuring COVID-19 vaccination services to an opt-in model. All community pharmacies who applied, and met the minimum requirements, received a contract to deliver COVID-19 vaccinations. This enabled more pharmacies to support the autumn 2023/24 booster campaign, administering COVID-19 vaccinations alongside flu vaccinations, which are also increasingly being administered in these settings.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 08/05/2024 11:46:48 answering member 4492 label Biography information for Maria Caulfield
tabling member	4108 label Biography information for Sir Gavin Williamson

1699110

registered interest
date	26/03/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, what processes the Medicines and Healthcare products Regulatory Agency uses to determine whether a covid-19 vaccine may have caused (a) fatal outcomes and (b) adverse reactions in patients.
tabling member constituency	Kirkcaldy and Cowdenbeath
tabling member printed	Neale Hanvey
uin	20788
answer	answer is ministerial correction date of answer 15/04/2024 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) does not assign causality at the level of individual reports, as this is not the responsibility of the MHRA, and as such a process is not held. The MHRA holds processes for cumulative analysis of Yellow Card data, as well as assessment of data from other sources, for patterns or evidence which might suggest a causal link between the vaccination and the reported reaction, alongside other relevant data. In relation to fatal reports, it is the role of a Coroner to determine the likely cause of death for an individual. The MHRA’s approach to post authorisation surveillance of COVID-19 vaccines is outlined in the published Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/04/2024 08:27:52 answering member 4492 label Biography information for Maria Caulfield
tabling member	4782 label Biography information for Neale Hanvey

1699111

registered interest
date	26/03/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency has (a) requested and (b) reviewed data from the expert review panel set up by the Norwegian government into the cause of death in relation to patients who have received a Covid 19 vaccine.
tabling member constituency	Kirkcaldy and Cowdenbeath
tabling member printed	Neale Hanvey
uin	20789
answer	answer is ministerial correction date of answer 15/04/2024 answer text <p>Following the initial roll out of the COVID-19 vaccination programme in December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) had a comprehensive surveillance strategy in place, enabling continual close monitoring of emerging safety evidence, including relevant safety information from international regulators. This included engagement with the European Medicines Agency to discuss data emerging from European Member States and countries in the European Economic Area, such as Norway. The MHRA communicates safety advice based upon consideration of the totality of evidence from all relevant information sources, rather than the strengths and limitations of individual data sources.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/04/2024 08:46:30 answering member 4492 label Biography information for Maria Caulfield
tabling member	4782 label Biography information for Neale Hanvey

1698645

registered interest
date	25/03/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether she has had recent discussions with the (a) Chair and (b) Chief Executive of the Medicines and Healthcare products Regulatory Agency on its statutory function to operate a system of post marketing surveillance in the UK for (i) fatal outcomes and (ii) adverse reactions in patients who have received a covid-19 vaccine.
tabling member constituency	Kirkcaldy and Cowdenbeath
tabling member printed	Neale Hanvey
uin	20439
answer	answer is ministerial correction date of answer 15/04/2024 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) fulfils the requirements set out in the Human Medicines Regulation Part 11, in respect of obligations on the licensing authority to conduct surveillance of all medicinal products, including COVID-19 vaccines.</p><p>For COVID-19 vaccines, the MHRA implemented a proactive strategy, which included prospective safety data collection, and use of a range of domestic and international data sources and methodologies. For all products, events and outcomes, each data source is assessed based on its strengths and limitations, using appropriate methodologies and, where appropriate, statistical thresholds for those data. The MHRA also work closely with public health partners in reviewing the effectiveness and impact of the vaccines, to ensure the benefits continue to outweigh any possible side effects.</p><p>The MHRA keep all available evidence under review including studies, published literature, and data arising from the widespread use of COVID-19 vaccines in the United Kingdom and globally. Ministers routinely engage with officials from the MHRA on a number of issues.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/04/2024 08:39:19 answering member 4492 label Biography information for Maria Caulfield
tabling member	4782 label Biography information for Neale Hanvey

1698646

registered interest
date	25/03/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, how many reports have been received by the Medicines and Healthcare products Regulatory Agency on (i) fatal outcomes and (ii) adverse reactions in patients who have received a covid-19 vaccine.
tabling member constituency	Kirkcaldy and Cowdenbeath
tabling member printed	Neale Hanvey
uin	20440
answer	answer is ministerial correction date of answer 15/04/2024 answer text <p>The Medicines and Healthcare products Regulatory Agency has received 489,004 spontaneous suspected adverse drug reaction reports relating to a COVID-19 vaccine up to and including 28 February 2024, within the United Kingdom. 2,734 of the reports were associated with a fatal outcome. Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the vaccine may have caused the adverse reaction. The existence of an adverse reaction report does not necessarily mean that the vaccine has caused the reaction. Reporting rates can be influenced by many factors, including the seriousness of the adverse reactions, their ease of recognition, and the extent of the use of a particular vaccine.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/04/2024 08:38:36 answering member 4492 label Biography information for Maria Caulfield
tabling member	4782 label Biography information for Neale Hanvey

1698647

registered interest
date	25/03/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, if the Medicines and Healthcare products Regulatory Agency will establish an expert review panel to investigate the cause of death for reports of suspected (i) fatal outcomes and (ii) adverse reactions in patients who have received a covid-19 vaccine.
tabling member constituency	Kirkcaldy and Cowdenbeath
tabling member printed	Neale Hanvey
uin	20441
answer	answer is ministerial correction date of answer 15/04/2024 answer text <p>The Medicines and Healthcare products Regulatory Agency’s (MHRA) role is to ensure that the benefits associated with a medicinal product outweigh the known risks, at the time of first authorisation and thereafter. Whilst the MHRA seeks expert advice from the Commission on Human Medicines and its expert advisory groups on the likelihood of an association between a COVID-19 vaccine and a safety concern, this is based on the totality of evidence from Yellow Card data, and relevant information from other sources. Should a new link between a medicine and a safety concern be confirmed, the MHRA will take necessary regulatory action, such as updating product information to include a warning for patients and healthcare professionals.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/04/2024 08:30:48 answering member 4492 label Biography information for Maria Caulfield
tabling member	4782 label Biography information for Neale Hanvey

1698659

registered interest
date	25/03/2024
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	Coronavirus: Vaccination
house id	1
legislature	25259 pref label House of Commons
question text	To ask the Secretary of State for Health and Social Care, whether she has made an assessment of the potential implications for her policies of the article in the British Medical Journal entitled Pfizer-BioNTech vaccine is “likely” responsible for deaths of some elderly patients, Norwegian review finds, published on 27 May 2021; and if she will have discussions with the Medicines and Healthcare products Regulatory Agency on the contents of the report.
tabling member constituency	Kirkcaldy and Cowdenbeath
tabling member printed	Neale Hanvey
uin	20442
answer	answer is ministerial correction date of answer 15/04/2024 answer text <p>Following the initial roll out of the COVID-19 vaccination programme in December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) had a comprehensive surveillance strategy in place, enabling continual close monitoring of emerging safety evidence including studies, published literature, and data arising from the widespread use in the United Kingdom and globally. This included the article and Norwegian reports highlighted. The MHRA communicates safety advice based upon consideration of the totality of evidence from all relevant information sources, rather than the strengths and limitations of individual data sources.</p> answering member constituency Lewes answering member printed Maria Caulfield question first answered 15/04/2024 08:30:24 answering member 4492 label Biography information for Maria Caulfield
tabling member	4782 label Biography information for Neale Hanvey