MHRA Caught Not Doing Its Promised Vaccine Safety Monitoring (Again)

We all know, I hope, about the significant and sustained number of excess deaths since May 2022. Most recently, you probably saw Esther McVey MP asking if the Department of Health would commit to an urgent and thorough investigation.

Maria Caulfield MP, one of the health ministers, replied saying that it’s also happening elsewhere and there is a range of factors. Implicitly, she was refusing to investigate. Outrageous.

However, it actually reminded me that way back in February 2021, MHRA promised to do a whole range of routine population-level data analysis “to quickly detect a potential safety signal” for the Covid vaccines. It announced it here under the section “Rapid Cycle Analysis and Ecological Analysis“. It explains what it involves as follows:

[A]s COVID-19 vaccination records (i.e., those given outside of GP surgeries) begin to get updated within GP systems, the MHRA will implement a form of active surveillance known as ‘Rapid Cycle Analysis’. This method involves proactive, weekly analysis of a range of pre-defined events (theoretical side effects) to quickly identify safety signals – it again involves ‘observed vs expected’ analyses (i.e. comparing rates after vaccination to rates in unvaccinated comparator groups) but doesn’t rely on people directly reporting any concerns through the Yellow Card scheme. It is also a more robust way to quickly determine if rates are likely to be consistent with a coincidental association. It also uses the MaxSPRT approach with adjustments made for the expected delays in the recording of events presenting to and diagnosed in secondary care settings. The list of pre-defined events of special interest is not fixed and can be expanded at any time.

The MHRA will also use the CPRD data to conduct ‘ecological analyses’. This involves monitoring trends in the rates of pre-defined events within given population cohorts, based on prioritisation groups for vaccine roll out, to see if they are occurring to a greater extent amongst those targeted for vaccination after it is deployed compared to historical rates from the pre-deployment period. Comparisons can also be made to trends seen in groups not targeted for vaccination at the same time. This approach is most useful when we see high vaccine uptake and is another way to quickly detect a potential safety signal.

So I had a poke around MHRA’s website to see how it is getting on with this. Not very well, it turns out.

One of MHRA’s five divisions is called Clinical Practice and Research Datalink (CPRD) and it maintains a bibliography of peer-reviewed research and reports which have used data provided by MHRA from NHS datasets for things like ICU, A&E, inpatients, outpatients, cancer registration and pregnancy. When I looked, the bibliography had been updated as recently as January 9th 2023. So well and truly up-to-date. So far, so good.

Imagine my surprise when I could only find two population-level studies relating to the Covid vaccines, both relating to thrombocytopenia (low blood platelet count), one from February 2022 and one from October. So just one type of adverse event has been put through MHRA’s promised ecological analysis in the last two years. It doesn’t say much for MHRA’s commitment to use population-level data “to quickly detect a potential safety signal”.

Imagine my further surprise that none of the datasets which MHRA’s CPRD Division provides for research contains data after June 2021.

So in conclusion, all about as useless as the other strand of Covid vaccine surveillance it promised, Targeted Active Monitoring, which I noted in a recent article it quietly dropped 15 months ago.

For me, there are only two possible conclusions: either the MHRA is not doing the Covid vaccine surveillance it promised, or it is doing it and not making the results publicly available. Either way, it’s high time that MPs, the Covid Inquiry and the media started asking MHRA some searching questions.

Until Nick retired a few years ago, he was a Senior Civil Servant in a Government Department.