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.
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 1 March 2023 to Question 152184, Coronavirus: Vaccination, for what reason his Department has not responded to the Regulation 28 report; and when he plans to respond.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
We apologise for the delay in replying to the Coroner. A reply will be sent as a matter of urgency.
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, whether the criteria used by the Medicines and Healthcare products Regulatory Agency to assess the safety of vaccines includes a threshold number or proportion of reports of (a) immune thrombocytopenia and (b) other adverse effects.
Answered by Will Quince
The Medicines and Healthcare products Regulatory Agency (MHRA) continually monitors safety during use of all medicinal products, including vaccines. For COVID-19 vaccines the MHRA implemented a proactive strategy which included prospective safety data collection and use of a range of United Kingdom and international data sources and methodologies. For all products and events each data source is assessed based on its strengths and limitations using appropriate methodologies and statistical thresholds for those data.
The numbers and types of suspected adverse events vary between medicinal products and cannot be used to compare safety profiles as many factors can influence adverse drug reaction reporting such as the extent of use of a product. The MHRA works 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.