Asked by: Neale Hanvey (Alba Party - Kirkcaldy and Cowdenbeath)
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.
Asked by: Baroness Hollins (Crossbench - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what progress they have made, if any, in reaching a settlement in cases of individuals who have developed (1) blood clots, and (2) life-changing conditions, such as transverse myelitis, after receiving the COVID-19 AstraZeneca vaccine; and what assessment they have made of the level of payment being awarded under the Vaccine Damage Payment scheme.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
The Government knows there are some extremely rare cases where individuals have sadly experienced harm following vaccination against COVID-19, and recognises how difficult this is for those individuals and their families. It would not be appropriate to comment on individual cases, including where there may be ongoing litigation that may involve the Government.
As part of business-as-usual work, the Government reviews the payment amount of the Vaccine Damage Payment Scheme (VDPS), alongside all routine policy on a regular basis. There are no plans at this time to change the level of payment awarded under the VDPS.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what plans she has to roll out the Covid 19 vaccination programme.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
The Government remains committed to protecting those most vulnerable to COVID-19 through vaccination, as guided by the independent Joint Committee on Vaccination and Immunisation (JCVI). On 7 February 2024, the JCVI published further advice on the United Kingdom’s COVID-19 vaccination programme. The JCVI advice is that a COVID-19 vaccine should be offered in spring 2024 to those at greatest risk of serious disease, and who are therefore most likely to benefit from vaccination. Those eligible are:
- adults aged 75 years old and over;
- residents in a care home for older adults; and
- individuals aged six months old and over who are immunosuppressed, as defined in chapter 14a of the Green Book.
The Government has accepted this advice, with the spring 2024 COVID-19 vaccination programme planned to start in the middle of April. The JCVI will continue to review the optimal timing and frequency of future COVID-19 vaccination beyond spring 2024, and will provide further advice in due course.
Asked by: Lord Strathcarron (Conservative - Excepted Hereditary)
Question to the Department of Health and Social Care:
To ask His Majesty's Government, further to the answer by Lord Evans of Rainow on 11 January (HL Deb col 98), what assessment they have made of whether it is appropriate to describe COVID-19 vaccinations as “very safe” given that the Medicines and Healthcare products Regulatory Agency's Blue Guide, says that "advertising which states or implies that a product is 'safe' is unacceptable"; and whether they intend to publish the evidence base that supports the claim that the COVID-19 vaccinations are “very safe.”
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
All vaccines used in the United Kingdom must be authorised by the UK’s independent medicines’ regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). Each COVID-19 vaccine is only authorised once it has met robust standards of effectiveness, safety, and quality. As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored, and the advice from the MHRA remains that the benefits of vaccination in preventing COVID-19 and serious complications associated with COVID-19 outweigh any currently known side effects in the majority of patients. Information on the characteristics of each vaccine is published by the MHRA on the GOV.UK website. The MHRA’s Blue Guide relates to the advertising and promotion of medicinal products, and in general, debates in Parliament about vaccination are considered to be outside its scope.
Asked by: Lord Framlingham (Conservative - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what steps they are taking to investigate any possible link between COVID-19 vaccinations and increasing numbers of premature deaths from heart and circulatory conditions since 2020.
Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)
There is no evidence linking excess deaths to the COVID-19 vaccine. Analysis from the Office for National Statistics, published on 25 August 2023, shows that people who died between 1 April 2021 and 31 May 2023 and who had a COVID-19 vaccine, had a lower mortality rate than those who had not been vaccinated.
Each COVID-19 vaccine is only authorised once it has met robust standards of effectiveness, safety and quality set by the Medicines and Healthcare Products Regulatory Agency (MHRA). No medicine or vaccine is completely risk-free, but the MHRA continually monitors the safety of the vaccines through a comprehensive vaccine surveillance strategy. This monitoring strategy is proactive and based on a wide range of information sources, with a dedicated team of scientists continually reviewing information to look for safety issues or any unexpected, rare events. Any information indicating a possible new safety concern is thoroughly evaluated, including through a review by the independent expert working group for COVID-19. Updated advice for healthcare professionals and patients is issued where appropriate.
Asked by: Alexander Stafford (Conservative - Rother Valley)
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 23 January 2024 to Question 9963 on Vaccine Damage Payment Scheme: Coronavirus, how many and what proportion of those 163 claimants have received an award in relation to a COVID-19 vaccination specifically.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
Of the 163 claims to the Vaccine Damage Payment Scheme that received an award between 31 December 2020 and 16 January 2024, 160 or 98% were claims related to COVID-19.
Asked by: Fleur Anderson (Labour - Putney)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, how many adverse events were registered with covid-19 vaccines from batch number 4120Z001 via the yellow card scheme; and whether more serious adverse events were registered with covid-19 vaccines from batch number 4120Z001 via the yellow card scheme than other batches of the Oxford-Astra Zeneca 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) continuously monitors the safety of vaccines through a variety of pharmacovigilance approaches including the Yellow Card scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card scheme are assessed and cumulative information reviewed at regular intervals. Our analysis of the Yellow Card reports accounts for product batch number.
The MHRA has received 7112 spontaneous suspected adverse drug reaction (ADR) reports in the United Kingdom relating to the COVID-19 AstraZeneca vaccine with batch number 4120Z001 up to and including 17 January 2024. Our analysis of the Yellow Card reports including review of serious adverse reactions reported has not resulted in any safety concerns with the batch number 4120Z001 for the COVID-19 AstraZeneca vaccine.
Not all batches of the COVID-19 vaccines are the same size, and some batches may have had more wastage than other batches or be distributed more widely outside of the UK. Therefore, we would not expect the number of ADR reports for all batches to be the same as they have been administered to different numbers of patients. Furthermore, different batches would have been used at different stages of the vaccination campaign, and in different patient groups, which could also impact reporting rates.
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, on what date the Oxford–AstraZeneca covid-19 vaccine Vaxzevria was withdrawn from general public administration in the UK; and for what reason.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.
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 covid-19 vaccines are only available through the NHS as of 31 January 2024.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.
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 steps her Department takes to ensure no mRNA vaccines are (a) procured and (b) supplied in breach of a patent.
Answered by Maria Caulfield - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
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.