• MHRA has no procedure for following up Yellow Card reports
• MHRA reassures evaluation of reports for causation
• No process for assessing causation or records of Covid vaccine Yellow Card assessments
The MHRA does not have a formal procedure for following up Yellow Card reports, and is unaware of how many they have actually followed up. Furthermore, in 2022 they assured that they “carefully evaluate reports of serious suspected side-effects,” however this recently came to light as being false. They do not have a process for assessing causation, nor do they hold any information about how many Covid vaccine Yellow Card reports they have assessed for possible causation. This suggests that either the MHRA is lying about assessing causation of Yellow Card reports, or they do not record the assessment and are therefore unable to do anything as a result.
Nick, a former Senior Civil Servant in the Ministry of Defence, has written a report on the MHRA which raises questions about their processes and procedures.
This lack of procedure and information raises concerns about the MHRA’s commitment to safety and their ability to effectively evaluate Yellow Card reports.
We already know that MHRA does not have a procedure for following up Yellow Card reports, even just the fatal and serious ones or those involving children or pregnancy. Nor does it know how many it has actually followed up to obtain any missing information one would think was critical to investigating reported deaths and serious side-effects of medicines – information like the age of the subject, his or her medical records, time between administration and death or injury, medicine batch data and so on, which are missing from many Yellow Card reports. No, it has no idea.
But even if it doesn’t investigate individual Yellow Card reports, at least it reassured me in 2022 that “the MHRA carefully evaluates reports of serious suspected side-effects as soon as they are received to consider whether the medicine or vaccine may have caused the event, or whether the event was likely to be purely coincidental”. It’s not ideal to be assessing causation without some key information, but it’s better than nothing. Or is it ?
Imagine my surprise when I recently discovered that even that reassurance is hollow. The MHRA just admitted that it doesn’t have a process for assessing causation (consisting of things like: who does the assessment, what medical qualifications he or she must have, his or her seniority, does anyone have to sign it off, what data are required, what categories of probability to use, what to do with the assessment etc.) Worse still, it doesn’t hold any information about how many Covid vaccine Yellow Cards it has assessed for possible causation.
Assuming that it isn’t lying about not holding that information, there are only two possibilities. Either it lied about assessing causation of Yellow Card reports or it doesn’t record the assessment and therefore can’t do anything as a result.
The word ‘negligent’ springs to mind.
Until Nick retired a few years ago, he was a Senior Civil Servant in the Ministry of Defence responsible for the safety and effectiveness of ammunition used by the Armed Forces. He is co-author of the Perseus Group report on U.K. medicines regulator the MHRA.
