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 - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 - Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)

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 - 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.

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.

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.

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.

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.

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.

Found: .—(1) Section 19 (payments for the review of coronavirus vaccination and testing exemption confirmation

Found: CO RONAVIRUS VACCINATION AND TESTING EXEMPTION CONFIRMATION RE QUE STS PAYMENTS FOR THE REVIEW OF CORONAVIRUS

Found: payment Claims for payment Information needed by the Board to consider a claim PART 6 Review of Coronavirus