1-20 of 44 results for subject:Moderna
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To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), whether the Medicines and Healthcare products Regulatory Agency has a copy of the Prescription Medicines Code of Practice Authority's audit of Moderna.
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), whether the Medicines and Healthcare products Regulatory Agency has a copy of the Prescription Medicines Code of Practice Authority's audit of Moderna.
The Medicines and Healthcare products Regulatory Agency has conducted searches and does not believe we hold a copy of the report referenced in FOI 903 from the UK Health Security Agency.
The nature of the complaint in the report is outside the scope of what would be investigated by the Agency and as a result we would not expect to hold a copy.
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency, what assessment he has made of the potential impact of the non-sharing of audit documents with government agencies on trust and confidence in the (a) pharmaceutical industry’s self-regulatory...
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency, what assessment he has made of the potential impact of the non-sharing of audit documents with government agencies on trust and confidence in the (a) pharmaceutical industry’s self-regulatory...
The UK Health Security Agency (UKHSA) has requested a copy of the audit report from the Prescription Medicines Code of Practice Authority (PMCPA).
An interim case report is available on the PMCPA website. The PMCPA is a self-regulatory body, which independently administers the Association of the British Pharmaceutical Industry Code of Practice for the Pharmaceutical Industry.
The UKHSA continues discussions with Moderna on their response to the PMCPA’s recommendations. This is being considered and reviewed alongside the management of the Moderna-United Kingdom Strategic Partnership.
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency, whether a copy of the Moderna audit has been requested from the Prescription Medicines Code of Practice Authority.
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency, whether a copy of the Moderna audit has been requested from the Prescription Medicines Code of Practice Authority.
The UK Health Security Agency (UKHSA) has requested a copy of the audit report from the Prescription Medicines Code of Practice Authority (PMCPA).
An interim case report is available on the PMCPA website. The PMCPA is a self-regulatory body, which independently administers the Association of the British Pharmaceutical Industry Code of Practice for the Pharmaceutical Industry.
The UKHSA continues discussions with Moderna on their response to the PMCPA’s recommendations. This is being considered and reviewed alongside the management of the Moderna-United Kingdom Strategic Partnership.
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), whether a copy of the Moderna audit has been requested from the Prescription Medicines Code of Practice Authority (PMCPA).
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), whether a copy of the Moderna audit has been requested from the Prescription Medicines Code of Practice Authority (PMCPA).
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), what assessment he has made of the implications for trust and confidence in the pharmaceutical industry’s self-regulatory system, and in the Moderna-UK Strategic Partnership, if audit documents...
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), what assessment he has made of the implications for trust and confidence in the pharmaceutical industry’s self-regulatory system, and in the Moderna-UK Strategic Partnership, if audit documents...
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), whether the Medicines and Healthcare products Regulatory Agency has a copy of the Prescription Medicines Code of Practice Authority's audit of Moderna.
To ask the Secretary of State for Health and Social Care, with reference to FOI 903 to the UK Health Security Agency (UKHSA), whether the Medicines and Healthcare products Regulatory Agency has a copy of the Prescription Medicines Code of Practice Authority's audit of Moderna.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 June 2025 to Question 59379 on Coronavirus: Research, and with reference to FOI 15/11/25/IR/575, when the UKHSA expects to receive the report from (a) Moderna and (b) PMCPA to review.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 23 June 2025 to Question 59379 on Coronavirus: Research, and with reference to FOI 15/11/25/IR/575, when the UKHSA expects to receive the report from (a) Moderna and (b) PMCPA to review.
The UK Health Security Agency (UKHSA) has yet to receive a copy of the Prescription Medicines Code of Practice Authority (PMCPA) audit report. However, as part of the United Kingdom’s Strategic Partnership with Moderna, the UKHSA is working to understand the scope of the audit's recommendations and how Moderna is addressing them. This includes any corrective actions they are putting in place ahead of a further audit, which the PMCPA have indicated they will carry out in late 2026, early 2027.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 2 June 2025 to Question 53036 on Coronavirus: Research, when he plans to publish the audit; whether he plans to publish his Department's initial assessment of the PMCPA’s ruling; and if has made an...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 2 June 2025 to Question 53036 on Coronavirus: Research, when he plans to publish the audit; whether he plans to publish his Department's initial assessment of the PMCPA’s ruling; and if has made an...
The Prescription Medicines Code of Practice Authority (PMCPA) is a non-governmental, self-regulatory body, which independently administers the Association of the British Pharmaceutical Industry Code of Practice for the Pharmaceutical Industry.
The UK Health Security Agency (UKHSA) will review the PMCPA's audit of Moderna once the report is available. This review will include consideration of the audit findings, any impacts for delivery of the Moderna-UK Strategic Partnership and next steps if required.
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 13 March 2025 to Question 35647 on Coronavirus: Research, if he will make an assessment of the potential impact of the Prescription Medicines Code of Practice Authority case rulings with reference to (a) AUTH/3835/10/23...
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 13 March 2025 to Question 35647 on Coronavirus: Research, if he will make an assessment of the potential impact of the Prescription Medicines Code of Practice Authority case rulings with reference to (a) AUTH/3835/10/23...
In April 2025, the UK Health Security Agency (UKHSA) was made aware that Moderna was to be issued a public reprimand by the Prescription Medicines Code of Practice Authority (PMCPA) appeal board. Moderna would be subject to an audit following two recent cases where they had been ruled to have breached the Association of the British Pharmaceutical Industry Code.
The Government has conducted an initial assessment of the PMCPA’s ruling, and has determined that it will not impact the delivery of the Moderna-United Kingdom Strategic Partnership.
The UKHSA will work with Moderna to ensure any recommendations from the report are duly considered and implemented, and to obtain assurance that these will be upheld for the duration of the partnership.
To ask the Secretary of State for Health and Social Care, with reference to the Prescription Medicines Code of Practice Authority case rulings with reference (a) AUTH/3815/8/23 and (b) 3886/3/24 on Moderna’s NextCOVE trial in children, if he will make an assessment of the potential impact of those rulings on...
To ask the Secretary of State for Health and Social Care, with reference to the Prescription Medicines Code of Practice Authority case rulings with reference (a) AUTH/3815/8/23 and (b) 3886/3/24 on Moderna’s NextCOVE trial in children, if he will make an assessment of the potential impact of those rulings on...
The Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority, and the Research Ethics Committee (REC) review and approve clinical trials on the basis of the benefits and risks, in line with the UK Clinical Trials regulatory (UK CTR) framework.
The safety of those participating in clinical trials is the MHRA’s first priority, and our oversight of trial conduct is informed by the trial’s sponsor efficiently notifying us of safety issues during the conduct of their trial.
Sponsors and investigators involved in the conduct of clinical trials are expected to have robust processes to ensure compliance with The Medicines for Human Use (Clinical Trials) Regulations, which includes compliance with the provision and use of documentation that has been approved for use by a REC.
Where doubts about the safety, conduct, or scientific validity of a clinical trial are identified, the MHRA may take action, in line with the UK CTR, which could include requiring changes to be made to the trial protocol, or suspension or termination of a trial.
To ask the Secretary of State for Health and Social Care, whether any of the vials of (a) Pfizer and (b) Moderna covid-19 vaccines supplied to patients in the United Kingdom contained (i) variable and (ii) excessive levels of residual plasmid DNA.
To ask the Secretary of State for Health and Social Care, whether any of the vials of (a) Pfizer and (b) Moderna covid-19 vaccines supplied to patients in the United Kingdom contained (i) variable and (ii) excessive levels of residual plasmid DNA.
All batches of the Pfizer and Moderna COVID-19 vaccines released in the United Kingdom to date have passed their release specifications for DNA levels. The specifications are set in line with their respective controlled manufacturing process and in accordance with, for example, World Health Organization guidance on the quality, safety, and efficacy of vaccines. No batches that have excessive levels of residual DNA have been released.
To ask the Secretary of State for Health and Social Care, what progress he has made with Moderna on the (a) manufacture of mRNA vaccines in the UK, (b) establishment of a global clinical trials base and (c) investment in UK-based research and development activities.
To ask the Secretary of State for Health and Social Care, what progress he has made with Moderna on the (a) manufacture of mRNA vaccines in the UK, (b) establishment of a global clinical trials base and (c) investment in UK-based research and development activities.
As part of the Moderna-UK Strategic Partnership signed in December 2022, Moderna is building an mRNA vaccine manufacturing facility in Harwell, Oxfordshire. The Moderna Innovation and Technology Centre will support the United Kingdom to be more resilient in the face of future pandemics and health emergencies. It is expected to become operational in 2025.
Moderna is also committed to substantial investment in research and development activities in the UK over the 10-year partnership. This includes running a significant number of clinical trials in the UK and funding grants for UK universities, including PhD places and research programmes.
Since the partnership was established, Moderna has launched 13 trials at over 80 sites in England, Scotland, and Wales, including for Mpox, respiratory syncytial virus, and COVID-19 vaccines. Moderna has funded a PhD at the University of Cambridge and four mRNA Access Partnerships across UK universities. This partnership will also create over 150 skilled jobs in the UK.
His Majesty’s Government (HMG) is committed to protecting people most vulnerable to COVID-19 through vaccination as guided by the independent Joint Committee on Vaccination and Immunisation (JCVI).
On 2 August 2024, the JCVI published advice on the COVID-19 vaccination programme for autumn 2024. Their advice is that a COVID-19 vaccine should...
His Majesty’s Government (HMG) is committed to protecting people most vulnerable to COVID-19 through vaccination as guided by the independent Joint Committee on Vaccination and Immunisation (JCVI).
On 2 August 2024, the JCVI published advice on the COVID-19 vaccination programme for autumn 2024. Their advice is that a COVID-19 vaccine should...
My Hon. Friend the Parliamentary Under-Secretary of State for Public Health and Prevention (Andrew Gwynne MP) has made the following Written Statement:
His Majesty’s Government (HMG) is committed to protecting people most vulnerable to COVID-19 through vaccination as guided by the independent Joint Committee on Vaccination and Immunisation (JCVI).
On 2 August...
My Hon. Friend the Parliamentary Under-Secretary of State for Public Health and Prevention (Andrew Gwynne MP) has made the following Written Statement:
His Majesty’s Government (HMG) is committed to protecting people most vulnerable to COVID-19 through vaccination as guided by the independent Joint Committee on Vaccination and Immunisation (JCVI).
On 2 August...
To ask the Secretary of State for Health and Social Care, whether he has had recent discussions with (a) Moderna and (b) Pfizer on whether they intend to increase the cost of covid-19 booster vaccines in the UK.
To ask the Secretary of State for Health and Social Care, whether he has had recent discussions with (a) Moderna and (b) Pfizer on whether they intend to increase the cost of covid-19 booster vaccines in the UK.
We remain in regular discussion with Moderna and Pfizer/BioNTech on future COVID-19 vaccine supply. We are unable to provide the information requested on costing, as it is commercially sensitive. Moderna and Pfizer/BioNTech continue to negotiate vaccine deals with countries across the world and their ability to negotiate and compete is contingent on pricing information being kept confidential.
To ask the Secretary of State for Health and Social Care, how much public funds his Department has spent on the partnership with Moderna to produce a new Innovation and Technology Centre in the UK.
To ask the Secretary of State for Health and Social Care, how much public funds his Department has spent on the partnership with Moderna to produce a new Innovation and Technology Centre in the UK.
We are unable to provide the information requested on expenditure, as it is commercially sensitive.
Through the partnership, Moderna will, at its own cost, establish a United Kingdom based manufacturing facility and research and development (R&D) centre as well as commit substantial investment in UK based R&D activities over the 10 year period, bringing the UK a step closer to becoming the leading global hub for life sciences.
My Rt Hon Friend the Secretary of State for Health and Social Care (Steve Barclay) has made the following written statement:
The COVID-19 pandemic has shown the importance of having the ability to develop and deploy vaccines rapidly to respond to a health emergency, as well as to mitigate the...
My Rt Hon Friend the Secretary of State for Health and Social Care (Steve Barclay) has made the following written statement:
The COVID-19 pandemic has shown the importance of having the ability to develop and deploy vaccines rapidly to respond to a health emergency, as well as to mitigate the...