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Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether her Department has taken recent steps to help increase the supply of free lateral flow tests to people who are at risk of becoming seriously ill if they contract covid-19.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

This year, the National Health Service will offer free COVID-19 lateral flow tests and treatments to an additional 1.4 million people at the highest risk of severe illness, on top of the 3.9 million people already eligible for free COVID-19 lateral flow tests and treatments.

Those who are at highest risk of becoming seriously ill, who are eligible for COVID-19 treatments, can continue to access free COVID-19 lateral flow tests from their local pharmacy. This cohort of people are encouraged to test regularly, to gain timely access to treatments. A full list of those who are eligible, as well as information on how to access the tests, is available at the following link:

https://www.nhs.uk/conditions/covid-19/treatments-for-covid-19/

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, whether the Health and Safety Executive pursued prosecution of (a) public and (b) private sector employers for failure to abide by health and safety legislation during the Covid 19 pandemic.

Answered by Paul Maynard - Parliamentary Under-Secretary (Department for Work and Pensions)

The Health and Safety at Work etc Act (HSWA) 1974 is the primary piece of legislation covering occupational health and safety in Great Britain. It sets out the general duties which employers have towards employees and members of the public, employees have to themselves and to each other and certain self-employed have towards themselves and others.

HSWA applies equally across all workplaces in all industry sectors and does not distinguish between either public or private sector duty-holders. As such, the Health and Safety Executive (HSE) would not routinely differentiate or record this information.

The prosecution data below is for the time period of the 1^st April 2020 and the 31^st March 2022, this being the timeframe of the pandemic prior to HSE returning to business as usual. The figures are for all prosecutions taken under health and safety legislation which were published in the HSE Annual Report 2020/21 and 2021/22 respectively and are not Covid specific.

HSE pursued 206 prosecutions in 2020/21, with a 94% conviction rate, and 290 prosecutions in 2021/22, with a 96% conviction rate. A total of 496 prosecutions across the period referred to.

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, whether the Health and Safety Executive is investigating (a) public and (b) private sector employers for failure to abide by health and safety legislation during the Covid 19 pandemic.

Answered by Paul Maynard - Parliamentary Under-Secretary (Department for Work and Pensions)

The Health and Safety at Work etc Act (HSWA) 1974 is the primary piece of legislation covering occupational health and safety in Great Britain. It sets out the general duties which employers have towards employees and members of the public, employees have to themselves and to each other and certain self-employed have towards themselves and others.

HSWA applies equally across all workplaces in all industry sectors and does not distinguish between either public or private sector duty-holders. As such, the Health and Safety Executive (HSE) would not routinely differentiate or record this information.

Question to the Department for Work and Pensions:

To ask the Secretary of State for Work and Pensions, whether any (a) public and (b) private sector employer has been reported to the Health and Safety Executive for failure to abide by health and safety legislation during the Covid 19 pandemic.

Answered by Paul Maynard - Parliamentary Under-Secretary (Department for Work and Pensions)

The Health and Safety at Work etc Act (HSWA) 1974 is the primary piece of legislation covering occupational health and safety in Great Britain. It sets out the general duties which employers have towards employees and members of the public, employees have to themselves and to each other and certain self-employed have towards themselves and others.

HSWA applies equally across all workplaces in all industry sectors and does not distinguish between either public or private sector duty-holders. As such, the Health and Safety Executive (HSE) would not routinely differentiate or record this information.

Reports received by HSE are generally in the form of a ‘concern’. These can be in relation to any health and safety issue in the workplace and can be submitted via HSE’s online reporting portal.

Between the 1^st April 2020 and the 31st March 2022, this being the timeframe of the pandemic prior to HSE returning to business as usual, HSE handled over 70,000 concerns about health and safety in the workplace.

However, not all of these concerns were in relation to a failure to abide by health and safety legislation, some were requests for general health and safety advice, support, and guidance. This data has been published in the HSE Annual Report 2020/21 and 2021/22 respectively and is not Covid specific.

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 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.

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 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.

Question to the Department of Health and Social Care:

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.

Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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.

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.

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.

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.

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.

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.

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.

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