Esther McVey, the Conservative former minister, has called for the mandatory reporting of vaccine side-effects, as she criticised the “gross underreporting” of unintended impacts and highlighted a need for “substantial reform” at the Medicines and Healthcare products Regulatory Agency (MHRA). The MP for Tatton emphasised the importance of improving transparency in the healthcare system, claiming that the current voluntary reporting scheme, known as the “yellow card” system, fails to capture the full scale of adverse reactions.
The yellow card system allows patients, doctors, and members of the public to report side-effects of vaccines and other medical treatments to the MHRA. These reports are then reviewed by the agency, which can take action by withdrawing a product from the market or issuing new safety guidance. However, Ms McVey pointed out that this system is voluntary, leading to significant underreporting of serious reactions.
Speaking in the House of Commons, McVey echoed the concerns of the Sling The Mesh campaign and others, suggesting that the UK should follow the example of Denmark and Sweden, where healthcare professionals are legally required to report suspected adverse reactions. “This reporting scheme should be a valuable source of information about possible harms and act as an early warning system,” McVey said. “But we know that there is a gross underreporting to the scheme.”
The former minister further argued that underreporting presents a major challenge in identifying safety signals and establishing causation. As a result, she warned that this gap in reporting could lead to unnecessary harm, including deaths, with side-effects from treatments going unnoticed for extended periods, sometimes even years or decades.
Estimates suggest that only 10% of serious reactions are reported to the MHRA, a figure McVey described as alarming. Additionally, hospital admissions caused by adverse reactions to medication are thought to cost the NHS £2.2 billion annually. The former minister also raised concerns over the MHRA’s handling of reports of deaths potentially linked to Covid vaccines, noting that only 54% of such cases were followed up by the agency.
In addition to issues surrounding reporting, McVey criticised the level of transparency at the MHRA. She referred to statistics showing that between 2008 and 2017, only 41% of Freedom of Information (FOI) requests made to the MHRA were answered. While the rate improved to 76% in 2021, McVey argued that the agency’s lack of openness undermines public trust.
“MHRA’s behaviour around the commission on human medicine meetings for Covid-19 Vaccine Benefit Risk working group shows beyond any doubt that a culture of delay and secrecy has emerged,” McVey remarked. She specifically pointed to the delayed release of meeting minutes, which were published four years after the event, with many sections redacted. She questioned the reasons behind such delays and the extensive redactions, particularly as the meetings continually described vaccines as “safe and effective” despite emerging concerns.
Conservative MP Sir Christopher Chope also voiced concerns about the lack of openness, suggesting that it has contributed to declining trust in vaccines. He pointed to the example of the MMR vaccine, noting that lower uptake of this vaccine was partly due to the public’s lack of trust in the regulatory system.
McVey responded, “If people lose trust in vaccines, if they lose trust in the pharmaceutical industry, if they lose trust in the regulatory agency, this is precisely what happens.” She stressed the importance of ensuring that new vaccines and medicines are thoroughly tested, with continuous monitoring to ensure their safety. “We just want to make sure that new vaccines, new medicines coming to use, are thoroughly tested, and along the way we keep an overall watch that they are working correctly.”
The issue was also raised by Conservative shadow health minister Dr Luke Evans, who questioned whether the government believes the yellow card system is effective. He urged for a review of the system to ensure it is fit for purpose, adding that a trusted regulatory system is essential for public confidence and for fostering innovation in healthcare.
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Health minister Karin Smyth responded by acknowledging that the MHRA recognises the need for constant improvement in its monitoring systems. She highlighted the recent introduction of a new IT system, Safety Connect, which is designed to enhance the efficiency of reporting and processing yellow card reports. Smyth also outlined new regulations introduced last November, which require manufacturers to proactively monitor and report on medical devices once they are on the market. She assured that further reforms are planned to improve traceability and increase scrutiny of medical devices throughout their lifecycle.
In conclusion, while the government has taken steps to improve the reporting system, McVey and others argue that mandatory reporting and increased transparency are essential to restore public trust and ensure the safety of vaccines and other medical treatments.
