The MHRA Papers - Part 9

Rats to you

SUMMARY: Having previously drawn reassuring conclusions from animal studies now the EWG think perhaps they are of unknown relevance to human beings

We continue our review of the minutes of the meeting of the MHRA’s ​​Commission On Human Medicines (CHM) COVID-19 Vaccines Benefit Risk Expert Working Group, which took place on 24 December 2020

The secret squirrel's considered evidence from three vaccines: Oxford ASTRA ZENECA’S AZD1222 Deployment Model, Quality assessment AND NON CLINICAL reproductive toxicity focus, PfizerBioNTech’s BNT162b2 dose interval and a non-clinical assessment for Moderna’s vaccine

For the AZ product, The EWG discussed the reproductive toxicity and the precautionary text that should go into the SmPC as the animal data is incomplete and whether the text should be aligned with that for the Pfizer/BioNTech vaccine. 

SmPC stands for Summary of Product Characteristics in EMA speak and it tells you what the product is, how it works and how it should be used.

So, we don't know much about the thorny issue of reproductive toxicity based on rats and nought based on humans. We know the rat stuff isn’t generalisable to Homo Sapiens. There was mix up with doses in the AZ trial, so we are not sure how efficacious the stuff is, but let’s move on - THE EWG was - as per usual - reassured. 

On the BNT162b2 front, we are glad to report that the EWG agreed that the vaccine efficacy reported by Pfizer of 52% is likely to be underestimated since little protection is expected within 14 days of the first dose.

Although this is likely to be an underestimate as 

This is the first and last time we found mention of an independent analysis, although PHE the predecessor to UKHSA can hardly be called “independent”. The non decline in the level of protection is incompatible with persistent lymphopenia. As we have no access to the PHE analysis we cannot comment further.

Note the absence of any absolute measure of effect; it is an omission. However, in a placebo-controlled trial, if you have the data (as any regulator should have), you can quickly get the Risk Difference and, from there, calculate the number needed to vaccinate and the number needed to be vaccinated to harm. This gives a complete picture. This stuff is so easy to calculate that even Tom can do it.

Back to the topic of vaccinating pregnant women or those in the reproductive phase of their lives, 

With the systematic subversion of the precautionary principle underway, that probably means all of this age group. The statement also reinforces the concept of pregnancy as a dangerous disease and not a physiological process (if doctors can keep their hands off pregnancy and labour unless in dire need of an intervention, of course).

However, you’ll be reassured by the conflict  of interest policy for Invited experts

The Invited experts May be invited to all meetings, receive all the papers and presentations and are permitted to participate in discussions when asked by the Chair. However - somehow - the expert “does not contribute to conclusions and recommendations. ” 

This post was written by two old geezers who are reassured that “all is well” based on sketchy rat data and no data on humans.