Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the Regulation 28 Report to Prevent Future Deaths sent to his Department on 13 October 2022, which states that from the 25th February 2022 the MHRA investigated the potential signal of immune thrombocytopenia and identified three cases of cerebral venous sinus thrombosis which could possibly be associated with the Astra Zeneca covid-19 vaccine, if he will make an assessment of the reasons for which the MHRA did not receive all of the necessary clinical information to allow them fully to consider these cases; and whether sufficient information has now been provided to the MHRA to allow them to make a full consideration.
Answered by Will Quince
Prevention of Future Death reports play a valuable role in drawing matters of concern to the attention of the Government, its agencies and others to determine if action should be taken. The Department ensures that relevant regulators and other bodies are aware of matters of concern brought to its attention so that the system can respond as appropriate, and the Medicines and Healthcare products Regulatory Agency has provided input into the Department's response to this Regulation 28 Report.
The Department is finalising its response to this Regulation 28 report. It is within the Chief Coroner’s discretion to publish the report, together with the Department’s response.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, for what reason reforming the Vaccine Damage Payment Scheme would require the processing of all current claims to be paused and clinical contracts to be renegotiated; and if he will make a statement.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Should any reforms be made to the Vaccine Damage Payment Scheme (VDPS), particularly legislative, it would likely be necessary to pause the processing of cases to allow for the reforms to be implemented in a way which limited unequal treatment between cases. An assessment of the impacts of any specific reform would be required before a decision was taken to pause the processing of cases. The Department is focused on continuing to process claims made through the VDPS, working to ensure that those who qualify receive payments as quickly as possible.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many Yellow Card reports citing (a) immune thrombocytopenia and (b) low platelet counts as possible adverse effects from covid-19 vaccinations were received by the Medicines and Healthcare products Regulatory Agency in (a) January, (b) February and (c) March 2021.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Immune thrombocytopenia (ITP) is an adverse event of special interest for COVID-19 vaccines and was under enhanced monitoring from the start of the United Kingdom immunisation programme. The Medicines and Healthcare products Regulatory Agency first received a report of suspected ITP following COVID-19 vaccination in late December 2020.
No spontaneous suspected adverse reaction reports were received through the Yellow Card scheme for ITP or Thrombocytopenic purpura in January 2021, 26 reports were received in February 2021 and 62 reports were received in March 2021.
9 spontaneous suspected adverse reaction reports were received through the Yellow Card scheme for Thrombocytopenia in January 2021, 15 reports were received in February 2021 and 124 reports were received in March 2021.
No spontaneous suspected adverse reaction reports were received through the Yellow Card scheme for decreased Platelet count in January 2021, 9 reports were received in February 2021 and 56 reports were received in March 2021.
It should be noted that the sum of suspected adverse reactions above will not equal the number of Yellow Card reports, due to some reports containing more than one adverse reaction.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when the Medicines and Healthcare products Regulatory Agency first received clinical evidence on immune thrombocytopenia as a possible adverse effect of a covid-19 vaccination.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Immune thrombocytopenia (ITP) is an adverse event of special interest for COVID-19 vaccines and was under enhanced monitoring from the start of the United Kingdom immunisation programme. The Medicines and Healthcare products Regulatory Agency (MHRA) first received a report of suspected immune thrombocytopenia following COVID-19 vaccination in late December 2020. No cases of ITP where reported from the clinical trials for the COVID-19 vaccines used in the UK immunisation programme from December 2020.
A series of MHRA reviews of ITP and thrombocytopenia were presented to the Commission on Human Medicine (CHM)’s Expert Working Group on COVID-19 vaccine Benefit Risk from February 2021 onwards. Warnings about a very rare risk of thrombosis and thrombocytopenia were added to the product information for the AstraZeneca vaccine in early April 2021. A warning about a very rare risk of thrombocytopenia without thrombosis, including ITP, has also since been added to the AstraZeneca vaccine product information. The CHM advised that the benefits of the vaccine continue to outweigh any known risks.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many applications have been (a) received and (b) decided for mandatory reversals of Vaccine Damage Payment Scheme decisions relating to covid-19 vaccinations; and what the maximum time period is for those applications to be decided upon.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
127 applications for mandatory reversals have been received as of 20 April 2023. The number of decisions reached on these applications is under five and therefore cannot be provided as the exact number may make individual claimants identifiable in the public domain. Whilst there is no maximum time period for the assessment of mandatory reversals, they usually take around six months, due to the need to gather updated medical records. This can vary from case to case, however, depending on the individual circumstances of each claim.
There is no limit on the number of times a reversal can be requested and no time limit on making such a request.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many people are employed in the NHS Business Services Authority's quality assurance processes for reviewing Vaccine Damage Payment Scheme claims relating to covid-19 vaccinations; and how many claims initially recommended for acceptance have been overturned as a result of those processes.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
NHS Business Services Authority (NHSBSA) employs a number of clinical specialists to quality audit a sample of vaccine damage payment scheme assessment reports prepared by the independent medical assessment supplier. We are not able to disclose the exact number of clinicians currently employed by the NHSBSA to carry out these assessments, because the total number falls below five and clinicians could be identified when combined with other information that may be in the public domain or reasonably available.
The purpose of the quality audit undertaken by NHSBSA’s clinical specialists is to check that the independent medical assessor has followed guidance and available scientific evidence in a way that is consistent and fair. The clinicians may request that the independent medical assessor provides clarification of points raised within a report before a claim outcome is finalised. However, the NHSBSA does not overturn decisions.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many cases of covid-19 vaccine-induced thrombosis and thrombocytopenia were reported to Public Health England using the reporting link contained within the 7 April 2021 Guidance from the Expert Haematology Panel; and how many of these reports related to events that took place before April 2021.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
This data collection was established to support the work of the Medicines and Healthcare products Regulatory Agency. Whilst information on reported cases of COVID-19 vaccine induced thrombosis and thrombocytopaenia was collected by Public Health England, reporting was not mandatory or part of an official surveillance system and the data are not centrally validated.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what account his Department takes of (a) actual and (b) potential changes in the level of disability when deciding whether the 60 per cent disablement threshold has been met for the purposes of Vaccine Damage Payment Scheme.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
There is no minimum or maximum period after the administration of any vaccine at which the level of disability caused by that vaccine can be assessed for the purposes of a payment under the vaccine damage payment scheme (VDPS), although claims must be made on or before the date on which the disabled person turns 21 years old, or six years on from the date of the vaccination, whichever is later. The VDPS assessment of disablement looks across the whole period during which the claimant has suffered and is expected to suffer, based on all the medical evidence available, not just disablement at a particular point in time. This means that in some cases, even where there have been serious short-term symptoms, over the whole assessment period it may be that the disablement does not meet the 60% threshold.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what the (a) minimum and (b) maximum period is after the administration of a covid-19 vaccine at which the level of disability caused by that vaccine can be assessed for the purposes of a payment under the Vaccine Damage Payment Scheme.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
There is no minimum or maximum period after the administration of any vaccine at which the level of disability caused by that vaccine can be assessed for the purposes of a payment under the vaccine damage payment scheme (VDPS), although claims must be made on or before the date on which the disabled person turns 21 years old, or six years on from the date of the vaccination, whichever is later. The VDPS assessment of disablement looks across the whole period during which the claimant has suffered and is expected to suffer, based on all the medical evidence available, not just disablement at a particular point in time. This means that in some cases, even where there have been serious short-term symptoms, over the whole assessment period it may be that the disablement does not meet the 60% threshold.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 17 April 2023 to Question 176541 on Vaccine Damage Payment Scheme: Coronavirus, which safety concerns relating to covid-19 vaccines have been the subject of advice for (a) healthcare professionals and (b) patients since January 2021.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The United Kingdom Health Security Agency (UKHSA) publishes a range of resources to support healthcare professionals delivering the COVID-19 vaccination programme. Information on vaccine safety is available in the green book (chapter 14a), the primary professional source of guidance for front line immunisers, available at the following link:
https://www.gov.uk/government/publications/covid-19-the-green-book-chapter-14ai
Information on adverse events is available at the following links:
https://www.gov.uk/government/collections/covid-19-vaccination-and-rare-side-effects
UKHSA also produces patient information leaflets, which include information on rare side effects following vaccination. ‘What to expect after your COVID-19 vaccine’ is available at the following link:
https://www.gov.uk/government/publications/covid-19-vaccination-what-to-expect-after-vaccination
Vaccine safety remains at the forefront of the COVID-19 vaccine programme. The Medicines and Healthcare products Regulatory Agency is responsible for monitoring the safety of all COVID-19 vaccines approved in the United Kingdom.