FDA made it very clear what its standards were for COVID vaccines. FDA repeatedly told its advisory committee, the public and vaccine manufacturers what it required in order to issue an EUA for a COVID vaccine. I have copied 4 of the FDA's power-points below so we can all agree on what, precisely, those standards are.
Meryl, it seems the 50% is not only just a guidance, it is also an arbitrary level. So I think they can easily change it to approve a vaccine. There is no science to the 50%. The person who came up with that likely had 5 fingers/hand. If they had a finger missing, the guidance would have been 40% ...
The statute, 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies, comes with 238 links attached, respectively. Allow for a generous amount of time to gain a comprehensive understanding of the statute.
Innovation in Clinical Trial Design - A white paper by the EFPIA Clinical Design Taskforce on behalf of the EFPIA Clinical Research Expert Group. March 2020
"Only we can stop them from issuing that EUA" Please, tell us how to go about doing this...it seems we are running out of time..... :(
Meryl, it seems the 50% is not only just a guidance, it is also an arbitrary level. So I think they can easily change it to approve a vaccine. There is no science to the 50%. The person who came up with that likely had 5 fingers/hand. If they had a finger missing, the guidance would have been 40% ...
The statute, 21 U.S. Code § 360bbb–3 - Authorization for medical products for use in emergencies, comes with 238 links attached, respectively. Allow for a generous amount of time to gain a comprehensive understanding of the statute.
Innovation in Clinical Trial Design - A white paper by the EFPIA Clinical Design Taskforce on behalf of the EFPIA Clinical Research Expert Group. March 2020
https://www.efpia.eu/media/547507/efpia-position-paper-innovation-in-clinical-trial-design-white-paper.pdf
Whats labs got to do with it - April 2021
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjN_I3WoND2AhVWDkQIHQ29CqUQFnoECBYQAQ&url=https%3A%2F%2Fwww.cdc.gov%2Fcliac%2Fdocs%2Fapril-2021%2F2_cliac-april-2021-meeting-transcript.pdf&usg=AOvVaw0S5XXMOG37eNrWBOLu4SHF
A dozen pages of footnotes - May 2020
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi2-eaEwOT2AhUeD0QIHfGZBTkQFnoECBEQAQ&url=https%3A%2F%2Fdpmc.govt.nz%2Fsites%2Fdefault%2Ffiles%2F2021-12%2FPMCSA-20-09_COVID-19-vaccines-07-09-2020-v2.pdf&usg=AOvVaw13TDn1u6BEehfF_QBSQmmJ