Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
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.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.
Asked by: Desmond Swayne (Conservative - New Forest West)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment her Department made of the potential risks of discontinuing routine covid-19 testing of hospital patients prior to their discharge to care homes before.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The public health advice is that now is an appropriate point to end routine asymptomatic discharge testing for COVID-19, and move to a risk-based approach. A reduction in the severity of illness associated with the omicron variant, coupled with a high uptake of the vaccine among residents during the autumn COVID-19 vaccination booster, continued provision of infection prevention and control guidance, and the upcoming increased eligibility for COVID-19 treatments, demonstrates a reduced level of risk from COVID-19 in adult social care settings. In addition, epidemiological studies, and consensus reports from the early phases of the pandemic, suggest that hospital discharge was not dominant in the ingress of COVID-19 into care home settings.
The UK Health Security Agency’s (UKHSA) guidance on safe discharge and management of individuals with symptoms of an acute respiratory infection remains in place, and this will be kept under regular review. National Health Service trusts will have local discretion to re-introduce discharge or other forms of testing where clinically appropriate, following a risk assessment involving local authority public health teams, UKHSA Health Protection Teams, and care providers, as necessary in the decision making.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
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.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
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.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.
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.
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.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
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.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.
Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many of the reports in relation to (a) fatal outcomes and (b) adverse reactions in patients who have received a COVID-19 vaccine received by the Medicines and Healthcare products Regulatory Agency under its statutory function to operate a system of post marketing surveillance were judged as (i) likely, (ii) possibly and (iii) unlikely to have been caused by Covid-19 vaccine; and how many such reports lacked sufficient information to make a judgement.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
While the Medicines and Healthcare products Regulatory Agency carefully assesses Yellow Card reports of suspected adverse reactions, including those with a fatal outcome, to determine whether additional information is required to facilitate assessment of the link between a medicine and the reported adverse event, they do not assign causality at the level of individual reports.
Cumulatively, Yellow Card data is thoroughly analysed 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.
Asked by: Ellie Reeves (Labour - Lewisham West and Penge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether her Department has undertaken an impact assessment on the impact that long covid has had on the NHS workforce.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
No assessment has been made of the potential merits of collecting data on the prevalence of long COVID. On 25 April 2024, the Office for National Statistics will be publishing additional analysis from the fortnightly Winter Coronavirus (COVID-19) Infection Study, including data on trends in ongoing symptoms of COVID-19. This article will expand on the existing analysis published in the Winter Coronavirus (COVID-19) Infection Study’s data tables, to look more in depth at trends in self-reported symptoms of COVID-19, including ongoing symptoms and associated risk factors. No assessment has been made of the impact that long COVID has had on the National Health Service workforce.
Asked by: Ellie Reeves (Labour - Lewisham West and Penge)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, whether she has made an assessment of the potential merits of collecting data on the prevalence of long covid.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
No assessment has been made of the potential merits of collecting data on the prevalence of long COVID. On 25 April 2024, the Office for National Statistics will be publishing additional analysis from the fortnightly Winter Coronavirus (COVID-19) Infection Study, including data on trends in ongoing symptoms of COVID-19. This article will expand on the existing analysis published in the Winter Coronavirus (COVID-19) Infection Study’s data tables, to look more in depth at trends in self-reported symptoms of COVID-19, including ongoing symptoms and associated risk factors. No assessment has been made of the impact that long COVID has had on the National Health Service workforce.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Hessle)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, with reference to page 13 of the the National Audit Office report entitled Resilience to flooding, published on 15 November 2023, how many (a) projects have been cancelled and (b) homes will no longer be better protected; and where those homes are located, by local authority area.
Answered by Robbie Moore - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
In March 2020, the Government doubled its investment in flood defences to a record £5.2 billion between 2021 and 2027 to better protect communities across England from flooding and coastal erosion. Since April 2021, over £1.5 billion has been invested in over 200 flood protection schemes, better protecting over 71,000 properties.
The capital investment programme is annually reviewed and updated to accommodate changes, including the introduction of new schemes or urgent works.
The Government is aware of the challenges and delays caused by inflation and the availability of skills and labour across the sector. The start of the programme was also impacted by the coronavirus pandemic, which resulted in fewer people to develop projects and delayed mobilisation of construction activity.
As stated in the NAO report, the Environment Agency forecast that 1,500 projects will provide better protection to 200,000 properties by the end of the programme in March 2027.
Delivery is the Government’s key priority, and we are working with the Environment Agency to review the programme in the light of the impacts of inflation and the pandemic. More information will be available in due course.
Asked by: Baroness Hollins (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress they have made, if any, in reaching a settlement in cases of individuals who have developed (1) blood clots, and (2) life-changing conditions, such as transverse myelitis, after receiving the COVID-19 AstraZeneca vaccine; and what assessment they have made of the level of payment being awarded under the Vaccine Damage Payment scheme.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government knows there are some extremely rare cases where individuals have sadly experienced harm following vaccination against COVID-19, and recognises how difficult this is for those individuals and their families. It would not be appropriate to comment on individual cases, including where there may be ongoing litigation that may involve the Government.
As part of business-as-usual work, the Government reviews the payment amount of the Vaccine Damage Payment Scheme (VDPS), alongside all routine policy on a regular basis. There are no plans at this time to change the level of payment awarded under the VDPS.