The FDA wants to add new Wuhan Virus vaccine testing criteria to emergency use authorization applications—weeks after several pharma companies’ Phase III trials (the last phase requiring substantial data collection before EUA can be requested, the phase whose satisfactory completion is required before general use authorization can be requested) already have begun.
As part of the new guidelines, manufacturers seeking authorization would have to follow trial participants for at least two months after a second vaccine shot.
The new standards would also reportedly ask developers to identify a specific number of severe COVID-19 cases in patients who received a placebo in trials.
These data collection steps would be useful; however, it’s ridiculous to try to make them Critical Items for EUA. The FDA has known the structure of existing tests all along—it approved those tests’ advance into Phase III trials. If the FDA really thought these new “standards” and data collection criteria were important, it would have levied them on the original pharma companies at the time it approved their Phase III trials.
Waiting until this late date to try to add them is suspicious.