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

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

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

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

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

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

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

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 the Secretary of State for Health and Social Care, what steps she plans to take to ensure that online pharmacies that provide medicines to patients in the UK adhere to the NHS clinical guideline on puberty-suppressing hormones or the treatment of children and adolescents who have gender (a) incongruence and (b) dysphoria.

Answered by Andrea Leadsom

All community pharmacists, whether working on a high street or online, have a duty of care to their patients. We would expect pharmacists to take reasonable steps to ensure that all the medicines they dispense are against legally valid prescriptions, and appropriate for the patient under the authority of the prescriber. This includes both National Health Service prescriptions and private prescriptions. Registered pharmacy professionals and premises are independently regulated by the General Pharmaceutical Council (GPhC), and guidance has been issued for those providing services at a distance, including online pharmacies.

While pharmacists are responsible for a final clinical check, ultimately the responsibility for the product prescribed rests with the prescriber. We are looking closely at what can be done to address any loopholes in prescribing practices, including work with the GPhC to define the dispensing responsibilities of pharmacists providing private prescriptions, as recommended by the Cass Report.

Remembering Fergie MacDonald

Women Against State Pension Inequality (WASPI)