The UK Medicines and Healthcare products Regulatory Agency (MHRA) has recently admitted to using circular reasoning and lacking documentation to support its explanation for the high number of Yellow Card reports related to COVID injections. In an article by Stephen Feldman, it was revealed that the MHRA claimed the increase in reports was due to heightened public awareness, leading to more people submitting reports than usual. However, it was discovered that the MHRA used circular reasoning to make this claim, starting with the assumption that the high level of Yellow Card reports was due to the high level of public awareness, and then using the high level of Yellow Card reports as evidence of public awareness.
The Yellow Card scheme is a mechanism through which anyone can voluntarily report any suspected adverse reactions to COVID injections. The purpose of the scheme is to provide early warning signs that the safety of a product may require further investigation. Reports can be made for all medicines, including vaccines, and all medical devices available on the UK market.
The staggering number of Yellow Card reports and the degree of under-reporting are two important aspects to consider. The MHRA previously estimated that they would receive around 1 Yellow Card report per 1,000 doses administered based on past immunization campaigns. However, as of November 2022, they received a total of 474,018 Yellow Card reports for COVID vaccines, with a maximum of 145,104,738 doses administered. This means there were 3 Yellow Card reports per 1,000 doses, indicating a significant increase from their previous estimates.
The MHRA has acknowledged that there is an unknown and variable rate of under-reporting for adverse drug reactions (ADRs). While some studies have estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported, the actual rate is uncertain and influenced by public awareness. The MHRA claims to have implemented a Yellow Card Strategy to promote the scheme and raise awareness among healthcare professionals and the general public. However, they do not have specific documentation to support their claim of high public awareness at the time.
The revelation that the MHRA used circular reasoning to explain the high number of Yellow Card reports raises concerns about the agency's transparency and credibility. The MHRA's excuse that the reported number is high due to public awareness has been debunked, as they have no documentation to support this claim. This raises questions about the accuracy of the reported number of serious adverse reactions and suggests that there may be a much higher number of unreported cases.
Stephen Feldman argues that it is now time to hold the MHRA and its staff accountable for their actions. The lack of documentation to support their claims and their use of circular reasoning undermine public trust in their ability to accurately assess and monitor the safety of COVID vaccines. It is essential for regulatory agencies like the MHRA to be transparent and provide evidence-based explanations for their findings to maintain public confidence in the vaccination process.
