In a marathon session, an FDA committee learned the truth about the upcoming COVID-19 vaccines: They are only designed to address mild cases of the coronavirus.
That means they may not prevent the worst cases, including those leading to death. "We could have a vaccine that seems to do well ... and it's effective in avoiding mild cases, but actually does very little to address what we really care about, which is serious disease and death," said Shelden Toubman, a consumer representative lawyer on the committee.
What this amounts to is that the world is betting the farm on vaccines to stop the pandemic’s death toll — but the vaccines are not designed to do what the world expects, said Peter Doshi, an associate professor at the University of Maryland School of Pharmacy, in a commentary in The BMJ.
“None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” Doshi said.