Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will include (a) unpaid family carers and (b) household contacts of immuno-suppressed individuals in the covid-19 vaccination programme.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

The primary aim of the autumn 2024 COVID-19 vaccination programme remains the prevention of severe illness, hospitalisations, and deaths, arising from COVID-19. On 2 August 2024 the Government accepted the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI) to offer a COVID-19 vaccination to those aged 65 years old or over, those living in care homes for older adults, and those aged between six months and 64 years old who are in a clinical risk group in England this autumn. Additionally, vaccination will be offered to all frontline health and social care workers, as well as staff in care homes for older adults.

There are no plans to offer a COVID-19 vaccination to unpaid carers, including young carers, or the families and household contacts of people with immunosuppression, during the autumn 2024 campaign in England. Unpaid carers and household contacts of those with immunosuppression have previously been offered vaccination on the basis that it indirectly protected those more vulnerable with whom they are in contact. The JCVI advice for autumn 2024 is that in the era of highly transmissible Omicron sub-variants, any protection offered by the vaccines against transmission of infection from one person to another is expected to be extremely limited. The indirect benefits of vaccination in these groups, vaccinating an individual to reduce the risk of severe disease in other people, are therefore less evident than in previous years.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will make it his policy to extend the covid-19 booster vaccination this autumn to (a) unpaid and (b) young carers.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

The primary aim of the autumn 2024 COVID-19 vaccination programme remains the prevention of severe illness, hospitalisations, and deaths, arising from COVID-19. On 2 August 2024 the Government accepted the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI) to offer a COVID-19 vaccination to those aged 65 years old or over, those living in care homes for older adults, and those aged between six months and 64 years old who are in a clinical risk group in England this autumn. Additionally, vaccination will be offered to all frontline health and social care workers, as well as staff in care homes for older adults.

There are no plans to offer a COVID-19 vaccination to unpaid carers, including young carers, or the families and household contacts of people with immunosuppression, during the autumn 2024 campaign in England. Unpaid carers and household contacts of those with immunosuppression have previously been offered vaccination on the basis that it indirectly protected those more vulnerable with whom they are in contact. The JCVI advice for autumn 2024 is that in the era of highly transmissible Omicron sub-variants, any protection offered by the vaccines against transmission of infection from one person to another is expected to be extremely limited. The indirect benefits of vaccination in these groups, vaccinating an individual to reduce the risk of severe disease in other people, are therefore less evident than in previous years.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he plans to provide covid-19 vaccinations to the (a) families and (b) carers of patients with immunosuppressant diseases.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

The primary aim of the autumn 2024 COVID-19 vaccination programme remains the prevention of severe illness, hospitalisations, and deaths, arising from COVID-19. On 2 August 2024 the Government accepted the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI) to offer a COVID-19 vaccination to those aged 65 years old or over, those living in care homes for older adults, and those aged between six months and 64 years old who are in a clinical risk group in England this autumn. Additionally, vaccination will be offered to all frontline health and social care workers, as well as staff in care homes for older adults.

There are no plans to offer a COVID-19 vaccination to unpaid carers, including young carers, or the families and household contacts of people with immunosuppression, during the autumn 2024 campaign in England. Unpaid carers and household contacts of those with immunosuppression have previously been offered vaccination on the basis that it indirectly protected those more vulnerable with whom they are in contact. The JCVI advice for autumn 2024 is that in the era of highly transmissible Omicron sub-variants, any protection offered by the vaccines against transmission of infection from one person to another is expected to be extremely limited. The indirect benefits of vaccination in these groups, vaccinating an individual to reduce the risk of severe disease in other people, are therefore less evident than in previous years.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, if he will allow contacts of people with immunosuppression to be eligible for the covid-19 vaccination programme in autumn 2024.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

The primary aim of the autumn 2024 COVID-19 vaccination programme remains the prevention of severe illness, hospitalisations, and deaths, arising from COVID-19. On 2 August 2024 the Government accepted the advice of the independent Joint Committee on Vaccination and Immunisation (JCVI) to offer a COVID-19 vaccination to those aged 65 years old or over, those living in care homes for older adults, and those aged between six months and 64 years old who are in a clinical risk group in England this autumn. Additionally, vaccination will be offered to all frontline health and social care workers, as well as staff in care homes for older adults.

There are no plans to offer a COVID-19 vaccination to unpaid carers, including young carers, or the families and household contacts of people with immunosuppression, during the autumn 2024 campaign in England. Unpaid carers and household contacts of those with immunosuppression have previously been offered vaccination on the basis that it indirectly protected those more vulnerable with whom they are in contact. The JCVI advice for autumn 2024 is that in the era of highly transmissible Omicron sub-variants, any protection offered by the vaccines against transmission of infection from one person to another is expected to be extremely limited. The indirect benefits of vaccination in these groups, vaccinating an individual to reduce the risk of severe disease in other people, are therefore less evident than in previous years.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what the evidential basis is for not including household members of people who are clinically vulnerable within the eligibility criteria for covid-19 booster vaccinations.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

As with all United Kingdom vaccination programmes, the decision of which groups are eligible for a particular part of the programme is made following careful consideration of the groups most at risk of illness, severe illness, or death, as a consequence of infection.

As currently available COVID-19 vaccines provide limited protection against transmission and mild or asymptomatic disease, the focus of the programme is on offering vaccination to those most likely to directly benefit, particularly those with underlying health conditions that increase their risk of hospitalisation following infection.

The benefit of vaccinating an individual to reduce the risk of severe disease in other people is much less evident now compared with previous years. For this reason, the Joint Committee on Vaccination and Immunisation did not advise an offer of COVID-19 vaccinations in autumn 2024 for household contacts of people with immunosuppression.

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent assessment his Department has made of the potential risk of people with partial trisomy experiencing heart complications following an mRNA vaccine; and if his Department will take steps to ensure that the decision of Mr Justice Hayden in the Court of Protection is communicated to all health service professionals.

Answered by Andrew Gwynne - Parliamentary Under-Secretary (Department of Health and Social Care)

There has been no formal review of the potential risk of people with partial trisomy experiencing heart complications following an mRNA vaccine, although the safety of vaccines is continually monitored by the independent Medicine and Healthcare products Regulatory Agency (MHRA). The MHRA conducted detailed analysis of all Yellow Card reports of heart inflammation, specifically myocarditis and pericarditis, which occurred following an mRNA vaccine. Details of these analyses were published weekly in the MHRA’s Coronavirus Vaccine - Summary of Yellow Card Reporting, which is available at the following link:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

These analyses did not identify a specific safety concern in relation to patients with congenital conditions, such as trisomy, who received an mRNA vaccine.

In relation to the judgement of the Hon. Mr Justice Hayden, there are currently no plans to communicate the decision from this specific case to all healthcare professionals. As with all vaccines, should any information indicate a possible new safety concern, the system is well placed to rapidly and thoroughly investigate this, with advice for healthcare professionals and patients updated where appropriate.

Question to the Department of Health and Social Care:

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.

Answered by Maria Caulfield

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.

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.

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.

Question to the Department of Health and Social Care:

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.

Answered by Maria Caulfield

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.

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.

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.

Question to the Department of Health and Social Care:

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.

Answered by Maria Caulfield

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).

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.

Question to the Department of Health and Social Care:

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.

Answered by Maria Caulfield

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.

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

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

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

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 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

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

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

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

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.