This is a really good point, Alan. I think history will regard all this as madness and the imposition of experimental products on misinformed and terrorised populace.
I am not a medic, but I think I understand enough of the issues to find the contrast between paragraph 3.7.and 3.19 quite astonishing:
“3.7 The EWG asked about the EMA’s rolling review of BNT162b2 and how it differs from the MHRA’s review process for regulation 174 (temporary authorisation of the supply of an unlicensed vaccine). The EWG heard that the outcome of the EMA’s assessment, if positive, is grant of a Marketing Authorisation (MA), either conditional or full MA. The MHRA’s current review of BNT162b2 in line with regulation 174 is a risk-based evaluation in the context of emergency use and does not result in a MA for the product but a separate form of authorisation to supply. The emergency use review process seeks to confirm the absence of major issues or gaps in the data that could represent safety concerns, prior to the vaccine’s deployment.
3.19 The EWG noted that the data indicate a highly reactogenic vaccine with levels of reactogenicity similar to those observed with the typhoid vaccine. The EWG heard the extent of data to support the reactogenicity profile is in line with WHO requirements. The EWG noted product information and communications will need to inform recipients of what to expect from the vaccine. The EWG heard that systemic reactions are more frequent and more severe after dose 2, and in younger recipients.”
Given the “more frequent and more severe” reactions indicated in 3.19 what is a “risk-based evaluation” supposed to mean? You can’t divorce risk from benefit. So how was it possible to confirm the absence of “safety concerns” in younger recipients for whom the risk was extremely low? Were the recipients really told “what to expect from the vaccine”?
Love your work. How often is the highlighting of missing information, just as important (or more so) than the examination of evidence that IS presented.
This is a really good point, Alan. I think history will regard all this as madness and the imposition of experimental products on misinformed and terrorised populace.
An old geezer
Yes, the best body swerves in the business.
An old geezer
I am not a medic, but I think I understand enough of the issues to find the contrast between paragraph 3.7.and 3.19 quite astonishing:
“3.7 The EWG asked about the EMA’s rolling review of BNT162b2 and how it differs from the MHRA’s review process for regulation 174 (temporary authorisation of the supply of an unlicensed vaccine). The EWG heard that the outcome of the EMA’s assessment, if positive, is grant of a Marketing Authorisation (MA), either conditional or full MA. The MHRA’s current review of BNT162b2 in line with regulation 174 is a risk-based evaluation in the context of emergency use and does not result in a MA for the product but a separate form of authorisation to supply. The emergency use review process seeks to confirm the absence of major issues or gaps in the data that could represent safety concerns, prior to the vaccine’s deployment.
3.19 The EWG noted that the data indicate a highly reactogenic vaccine with levels of reactogenicity similar to those observed with the typhoid vaccine. The EWG heard the extent of data to support the reactogenicity profile is in line with WHO requirements. The EWG noted product information and communications will need to inform recipients of what to expect from the vaccine. The EWG heard that systemic reactions are more frequent and more severe after dose 2, and in younger recipients.”
Given the “more frequent and more severe” reactions indicated in 3.19 what is a “risk-based evaluation” supposed to mean? You can’t divorce risk from benefit. So how was it possible to confirm the absence of “safety concerns” in younger recipients for whom the risk was extremely low? Were the recipients really told “what to expect from the vaccine”?
With side-stepping like that I'd like to hire the MHRA to coach the Welsh rugby team.
Love your work. How often is the highlighting of missing information, just as important (or more so) than the examination of evidence that IS presented.