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 t…