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.

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.

All routine policy, including the Vaccine Damage Payment Scheme (VDPS), is reviewed on a regular basis. My Rt hon. Friend, the Secretary of State for Health and Social Care is currently looking into aspects of the scheme, following recent meetings with interested stakeholders.

Separately, work is underway with the scheme’s administrator, the NHS Business Service Authority, to review processes and make administrative changes, to improve the scheme within the current legislative framework. Formal consideration of whether any reforms to the VDPS are necessary will form part of Module 4 of the COVID-19 Inquiry, chaired by the Rt Hon Baroness Heather Carol Hallett DBE.

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.

The South West Complaints Team transferred from NHS England to the NHS Somerset Integrated Care Board (ICB), who now host the NHS South West Collaborative Commissioning Hub, on 1 July 2023. This followed the delegation of pharmacy, optometry, and dentistry associated complaints on 1 April 2023. The following table shows the number of complaints the South West Complaints Team received, and the proportion that were investigated for NHS Dorset ICB, each month from October 2023 to March 2024:

Of the 1,051 total complaints, 86 have been outstanding for more than two months. Of the 182 complaints from NHS Dorset ICB, 14 have been outstanding for more than two months.

The NHS Business Services Authority (NHSBSA) administers the Vaccine Damage Payment Scheme, on behalf of the Department. Administration costs for the scheme were £600,000, £8.8 million, and £16.1 million for April 2021 to March 2022, April 2022 to March 2023, and April 2023 to March 2024, respectively. Payments made by the NHSBSA for the provision of medical records totalled £1,200, £72,000, and £73,100, for the same periods. The figures are provided to the nearest decimal place.

The NHS England National Patient Safety Team and the Medicines and Healthcare products Regulatory Agency (MHRA) routinely work closely on both system development, and a number of safety issues. The NHS England National Patient Safety Team have a data sharing agreement with the MHRA, and provide regular sharing of patient safety incidents reported to NHS England, that are classified as medication incidents or medical device incidents. In addition, the MHRA are able to request focussed searches of reported incidents if they are working on a specific issue.

However, the MHRA does not have the legal powers to compel healthcare professionals to provide additional information after an initial report of a suspected adverse reaction. The MHRA has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and potentially to enable faster access to information, where considered necessary for an assessment. This work remains ongoing.

Adverse events of special interest (AESI) are medical events or conditions that have been identified as possible vaccine safety concerns, based mainly on previous experience with other vaccines and immune-mediated events which theoretically may occur, as vaccines stimulate an immune response. AESIs for COVID-19 vaccines were subject to enhanced surveillance by the Medicines and Healthcare products Regulatory Agency (MHRA) and many other regulators from the start of the United Kingdom’s immunisation programme.

Specifically in relation to AESIs, the MHRA has received 22880 UK spontaneous suspected adverse reaction (ADR) reports across all COVID-19 vaccines. Over 157 million doses of COVID-19 vaccines have been given in the UK. It is important to note that Yellow Card reports are not proof of a side effect occurring, and the incidence of a reaction occurring cannot be determined by these reports. The MHRA considers that the benefits of the COVID-19 vaccines continue to outweigh the risks for the majority of people.

The MHRA acknowledges receipt of every Yellow Card report received, and a team of safety experts follow up for additional information as necessary, including consideration of reports with a fatal outcome, based on the completeness, severity, and clinical details provided in the report. Responses to follow-up requests for ADR reports are recorded and stored with the original report on our ADR database. The information is then passed downstream for use in signal detection and the identification of safety concerns.

The data is available for its core purpose of assessment and signal detection, however, the systems were not designed to quantify follow-up metrics requested in this parliamentary question. As such it is not possible to automatically generate metrics on the proportion of follow-up requests sent. The MHRA has provided information on follow up rates under Freedom of Information, within the 20 day statutory timeframes based on manual review of reports, and is committed to publishing high level data on its website.

AstraZeneca completed its COVID-19 vaccine supply agreement with the Government in 2022. Since the beginning of the COVID-19 vaccine booster programme in September 2021, in line with advice from the Joint Committee on Vaccination and Immunisation, the vaccines deployed in the national programme have primarily been mRNA vaccines that were considered to provide a strong booster response.

In 2021 there were 27 claims related to measles, mumps or rubella (MMR) received by the Vaccine Damage Payment Scheme (VDPS), one of which is still awaiting a decision as of 1 February 2024. Additionally in 2021, 616 claims were received relating to COVID-19, with 42 still awaiting an outcome as of 1 February 2024. 43 claims were received for all other diseases covered by the Vaccine Damage Payment Act (VDPA) 1979, and in this category, seven applications were awaiting an outcome as of 1 February 2024.

In 2022 there were 19 claims related to MMR received by the VDPS, one of which is still awaiting a decision as of 1 February 2024. Furthermore in 2022, 2723 claims were received relating to COVID-19 with 266 still awaiting an outcome as of 1 February 2024. 86 claims were received for all other diseases covered by the VDPA 1979, and of these, 12 applications were still awaiting an outcome as of 1 February 2024.

In 2023 there were five claims related to MMR received by the VDPS, one of which is still awaiting a decision as of 1 February 2024. In this same year, 5383 claims were received relating to COVID-19 with 3519 still awaiting an outcome on 1 February 2024. 222 claims were received for all other diseases covered by the VDPA 1979, and of these, 139 applications were still awaiting an outcome as of 1 February 2024.

The Government has signed contracts for the supply of COVID-19 mRNA vaccines, under which suppliers are required to warrant that the receipt and use of their vaccines will not infringe on any intellectual property rights.

As of 31 January 2024, the Vaccine Damage Payment Scheme (VDPS) has received 9172 COVID-19 related claims. Within these claims, 163 have received an award and 4421 have been rejected. Of these rejected claims: 300 claims were rejected for not meeting the 60% disability threshold; 339 claims were found invalid, either outside the scope of the VDPS or a duplicate claim; and 4249 claims are awaiting resolution.

The Government is committed to protecting those most at risk from COVID-19 through vaccination, as guided by the independent Joint Committee on Vaccination and Immunisation. Those eligible receive vaccination for free through the National Health Service. Whether and when a private market for COVID-19 vaccines emerges is a matter for private companies, and the Government has no formal role in this. However, the Government is supportive of the emergence of a private market for COVID-19 vaccines, to increase choice for consumers.

As of 31 January 2024, of the 163 COVID-19 related applications to the Vaccine Damage Payment Scheme that have received an award, 69 cases were related to cerebral venous sinus thrombosis, 49 were related to Guillain-Barré syndrome and 45 cases were related to other medical conditions.

Of the 300 cases where causation was accepted but the individual did not meet the 60% threshold, 50 cases were related to cerebral venous sinus thrombosis, 63 were related to Guillain-Barré syndrome and 187 cases were related to other medical conditions.

As of 5 January 2024, of the 8778 COVID-19 related applications to the Vaccine Damage Payment Scheme, 4658 applications or 53.06% related to a first vaccination received between January and March 2021; 2028 applications or 23.10% related to a first vaccination received between April and June 2021; and 516 applications or 5.88% related to a first vaccination received between July and September 2021.

As of 5 January 2024, of the claims submitted to the Vaccine Damage Payment Scheme relating to COVID-19, 157 claims have been outstanding for more than 18 months; 341 claims have been outstanding for over 12 months and 1854 claims have been outstanding for over six months.

Of these claims, no mandatory reversals have been submitted that have been outstanding for over 18 months; 18 mandatory reversal applications have been outstanding for over 12 months, and 124 mandatory reversal applications have been outstanding for over six months.

All services within the National Health Service across the United Kingdom are available to members of the Armed Forces, veterans and their families. In England, NHS England commissions additional services for veterans with service-related injuries. Veterans can and are encouraged to use these services whenever they need support.

Op RESTORE, formerly known as the Veterans’ Trauma Network, delivers comprehensive medical care to veterans with physical service-related health problems. Veterans are supported by Defence Medical Welfare Service, and other key charities form part of the Multi-Disciplinary Team and support process which helps veterans to “wait well” whilst waiting for treatment.

For medical conditions arising as a direct result of time spent serving in the Armed Forces, general practitioners can refer directly into the OP RESTORE service.

From 1 October 2021 to 1 September 2023, the NHS Business Services Authority has received 6,809 claims relating to COVID-19 vaccinations, and 251 claims relating to vaccines for other illnesses.

Of these claims, 3,933 are currently awaiting a final decision; of which, 3,796 are related to vaccines for COVID-19 and 137 are related to vaccines for other illnesses. These 137 are broken down per vaccine as follows:

- 35 are adult flu

- 33 are unidentified/unclear due to multiple types of vaccinations

- 17 are diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b (DTaP/IPV/Hib)

- 15 are measles, mumps and rubella (MMR)

- 9 are human papillomavirus (HPV)

The following vaccines have received fewer than five claims and the exact amount cannot be disclosed as this information may make individuals personally identifiable in the public domain:

- Influenza

- Swine flu (Pandemic influenza A (H1N1) 2009)

- Polio (Poliomyelitis - orally administered)

- Unidentified/unclear

- Haemophilus influenzae type b, meningococcal group C (Hib/Men C)

- Haemophilus influenzae type b (Hib)

- Meningococcal group C (Men C, Men ACWY)

- Pneumococcal (PCV)

- Tuberculosis (TB)

- Tetanus

- Mumps

- Meningococcal group B (Men B)

- Diphtheria, tetanus, pertussis and polio (DTaP/IPV)

- Rubella (German measles)

Of the 221 COVID-19 related claims rejected due to not meeting the 60% disability threshold, as of 1 September 2023, only nine, or 4%, potentially would have met a disability threshold of 50%; 34, or 15%, potentially would have met a disability threshold of 40%; 73, or 33%, potentially would have met a disability threshold of 30%; and 116, or 53%, potentially would have met a disability threshold of 20%. The data for lower thresholds is cumulative and includes claims that would meet a higher threshold.

As of 1 September, of the 1,784 COVID-19 related claims that have been waiting for the provision of medical records for over three months, 314 claims have had subject access requests (SARs) submitted, with a total of 492 SARs between them. Claims usually have an average of two to three healthcare providers listed on their claim form, which results in multiple SARs being submitted for one claim. 1,470 claims have not had any SARs submitted. Due to previous SARs not receiving the desired outcome, steps are being taken to identify other avenues to engage with healthcare providers to gather medical records as quickly as possible and improve processing times.

Of the 492 SARs submitted, 62 (12%) have been outstanding more than six months, 276 (56%) have been outstanding more than three months, 280 (57%) have been outstanding more than one month, and two have been outstanding for less than a month. 210 (43%) of these SARs have resulted in the records being received.