Thanks Figgs. Interesting article. (Especially
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Posted On: 12/05/2020 7:56:22 PM
Thanks Figgs.
Interesting article. (Especially with the two different messages coming from the administration and BP on their respective ideas of what funding and partnership had occurred.) Some of the comments were, arguably, even more interesting. A good one below. This same commentor also (IMO correctly) mentions that the author of the piece skips over the independent advisory committee (DSMC) part of the process– that may account for some of what he considers the lengthy 2-week delay.
While the FDA needs to address and be accountable for the speed and efficiency of the EAU and approval processes (and what seem to be incredible opportunities that were missed in supporting and expediting clinical trials)- they need to balance that with real safety/length of efficacy considerations as well as be very mindful of a large percentage of Americans that are reasonably concerned about a ‘rushed’ vaccine- in particular for pregnant women, children and communities of color.
Admittedly- am a total newbie to biotech stocks. As far as leronlimab goes- I am trying to balance my eagerness/panic/frustration in watching the worldwide suffering with the evidence that, while not expecting warp speed, it is much faster than turtle speed.
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“This NEJM (document) explains the special policies taken to expedite Covid vaccines as best as possible within an admittedly heavily regulated area:https://www.nejm.org/doi/full/10.1056/NEJMp2031373 and this is the Federal Register notice https://www.fda.gov/regulatory-information/se...t-covid-19 and the actual document here https://www.fda.gov/media/142749/download I would highly recommend reading the document, especially Section III, it explains a lot about how this all works given the emergency declaration by the HHS secretary. I'd also recommend Section V which describes the evidentiary standards.
Importantly, the guidance says the following "Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect." --- This time frame is the minimal amount of time we would need to see the effectiveness and durability of the immunity, particularly because mRNA vaccines induce significant innate immunity which is not the main strategy of vaccination.
This particular guidance, by many immunologist's/virologist's standards, is too short a time frame.”
Interesting article. (Especially with the two different messages coming from the administration and BP on their respective ideas of what funding and partnership had occurred.) Some of the comments were, arguably, even more interesting. A good one below. This same commentor also (IMO correctly) mentions that the author of the piece skips over the independent advisory committee (DSMC) part of the process– that may account for some of what he considers the lengthy 2-week delay.
While the FDA needs to address and be accountable for the speed and efficiency of the EAU and approval processes (and what seem to be incredible opportunities that were missed in supporting and expediting clinical trials)- they need to balance that with real safety/length of efficacy considerations as well as be very mindful of a large percentage of Americans that are reasonably concerned about a ‘rushed’ vaccine- in particular for pregnant women, children and communities of color.
Admittedly- am a total newbie to biotech stocks. As far as leronlimab goes- I am trying to balance my eagerness/panic/frustration in watching the worldwide suffering with the evidence that, while not expecting warp speed, it is much faster than turtle speed.
_______________________________
“This NEJM (document) explains the special policies taken to expedite Covid vaccines as best as possible within an admittedly heavily regulated area:https://www.nejm.org/doi/full/10.1056/NEJMp2031373 and this is the Federal Register notice https://www.fda.gov/regulatory-information/se...t-covid-19 and the actual document here https://www.fda.gov/media/142749/download I would highly recommend reading the document, especially Section III, it explains a lot about how this all works given the emergency declaration by the HHS secretary. I'd also recommend Section V which describes the evidentiary standards.
Importantly, the guidance says the following "Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events; cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine would be responsible for a protective effect." --- This time frame is the minimal amount of time we would need to see the effectiveness and durability of the immunity, particularly because mRNA vaccines induce significant innate immunity which is not the main strategy of vaccination.
This particular guidance, by many immunologist's/virologist's standards, is too short a time frame.”
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