A briefing paper on constitutional developments in Northern Ireland since the collapse of its devolved institutions in February 2022.
Safety of Covid-19 vaccines
Petition 602171 calls for a Public Inquiry into Covid-19 vaccine safety. The petitioners say:
It is the duty of the Government to ensure that the prescribed medical interventions of its response to Coronavirus are safe. We believe that the recent and increasing volume of data relating to cardiovascular problems since the Covid-19 vaccine rollout began is of enough concern to warrant a full Public Inquiry.
The petition closed on 6 June 2022 and received 107,121 signatures. It will be debated in Westminster Hall on 24 October 2022. The debate will be opened by Elliot Colburn MP (Conservative), on behalf of the Petitions Committee.
Government Response to the petition
The Government responded to the petition on 5 January 2022. It stated that the Government had “commissioned a public inquiry into the Covid-19 pandemic” and had “no plans for a separate inquiry on vaccine safety”. Since the Government issued its Response, the Terms of Reference for the UK Covid-19 public inquiry have been published by the Cabinet Office (June 2022). One of the aims of the Inquiry is to examine “the response of the health and care sector across the UK, including […] the development, delivery and impact of therapeutics and vaccines”.
The role of the Medicines and Healthcare products Regulatory Agency (MHRA) in reviewing the safety, quality and effectiveness of Covid-19 vaccines was also highlighted in the Government Response to the petition. The MHRA is similarly responsible for the ongoing monitoring of the safety of Covid-19 vaccines, particularly through its ‘Yellow Card’ scheme, as the Government Response explains:
The MHRA has authorised COVID-19 vaccine supply following a rigorous review of their safety, quality and efficacy. The clinical trials of the vaccines have shown them to be effective and acceptably safe; however, as part of its statutory functions, the MHRA continually monitors the use of the vaccines to ensure their benefits continue to outweigh any risks. This is a requirement for all authorised medicines and vaccines in the UK. This monitoring strategy is continuous, proactive and based on a wide range of information sources, with a dedicated team of scientists reviewing information daily to look for safety issues or unexpected events.
The MHRA operates the Yellow Card scheme to collect and monitor information on suspected safety concerns or incidents involving vaccines, medicines, medical devices, and e-cigarettes. The scheme relies on the voluntary reporting of suspected adverse incidents by healthcare professionals and members of the public. The scheme is designed to provide an early warning that the safety of a product may require further investigation.
A summary of Yellow Card reporting, in relation to Covid-19 vaccines, has been published weekly by the MHRA and, since August 2022, has been published on a monthly basis at Coronavirus vaccine – summary of Yellow Card reporting.
It was also noted in the Government Response that there has been “the rare occurrence of myocarditis and pericarditis (both inflammatory conditions of the heart) following vaccination against COVID-19”. The following reporting rates for three licenced Covid-19 vaccines, across all age groups, were provided in the Response:
Pfizer/BioNTech Vaccine: For suspected myocarditis (including viral myocarditis) the reporting rate is 12 reports per million doses, and for suspected pericarditis (including viral pericarditis and infective pericarditis) the overall reporting rate is 8 reports per million doses.
Moderna Vaccine: The overall reporting rate for suspected myocarditis is 42 per million doses and for suspected pericarditis is 24 per million doses.
AstraZeneca Vaccine: The overall reporting rate for suspected myocarditis (including viral myocarditis and infectious myocarditis) is 4 per million doses and for suspected pericarditis (including viral pericarditis) is 4 per million doses.
It added that the events reported were “typically mild with individuals usually recovering within a short time with standard treatment and rest” and that “vaccines are the best way to protect people from COVID-19 and have already saved tens of thousands of lives”.
The Commons and Lords Libraries, together with the Parliamentary Office of Science and Technology (POST), have a dedicated webpage on Vaccination and Covid-19, where all its briefings on the matter can be accessed, some of which are also highlighted below:
- Commons Library, The impact of the covid-19 pandemic on people with heart and circulatory diseases, June 2022
- Commons Library, Covid-19: The public inquiries, March 2022
- Commons Library, Coronavirus: Covid-19 vaccine roll-out frequently asked questions (see Section 4 FAQs: vaccine safety), September 2021
- POST, COVID-19 vaccines safety and blood clots, May 2021
- POST, The future of COVID-19 vaccines, March 2022
- NHS, Coronavirus (COVID-19) vaccines side effects and safety, 28 April 2022
- UK Health Security Agency, Myocarditis and pericarditis after COVID-19 vaccination: clinical management guidance for healthcare professionals, updated March 2022
- Ryan Ruiyang Ling et al, Myopericarditis following COVID-19 vaccination and non-COVID-19 vaccination: a systematic review and meta-analysis, The Lancet Respiratory Medicine, 11 April 2022
- British Heart Foundation, Myocarditis and Covid-19 vaccines: should you be worried?, updated October 2022
Government Chief Whips and Deputy Chief Whips in the Commons and Lords since 1945
Briefing on Government and NHS policy on cancer in England and cancer research.