When I see statements like this about an EUA for a Covid vaccine, I want to understand what exactly is being suggested. “Trials are complete”? Benefits outweigh the risk”?
My reactions to this interview. 1/7
My reactions to this interview. 1/7
The language around vaccine EUAs is vague. “Benefits outweigh the risks.” Risks vary across populations. The interview seems to hint at an EUA for a high-risk population, rather than the general population? Maybe healthcare workers? (I am speculating.) 2/7
fiercepharma.com/vaccines/even-…
fiercepharma.com/vaccines/even-…
But remember that the risk profile has not changed since the FDA issued their June guidance, and published many op-eds stating their plan. 3/7
washingtonpost.com/opinions/fda-c…
washingtonpost.com/opinions/fda-c…
The stated plan is to only approve vaccines on the basis of compelling safety and efficacy data. At least for these early vaccines (before we have an immune correlate), efficacy data must be collected from randomized controlled trials. 4/7
nytimes.com/2020/08/03/opi…
nytimes.com/2020/08/03/opi…
What does it mean to issue an EUA before “completing” a trial? An EUA could be issued following an interim analysis demonstrating compelling efficacy and safety data. Technically the trial is not “complete” until participants have been followed for 12-24 mos. 5/7
This is very different from issuing an EUA on the basis of immune response data (we simply don’t know what level of neutralizing antibodies is protective), or a signal of efficacy from a very underpowered trial. The vaccine should rule out a 30% lower bound for efficacy. 6/7
Premature issuance of an EUA could jeopardize the conduct of randomized trials (why get a placebo?) and would backfire if the vaccine is not efficacious or has safety problems. Critically, we need the process to be transparent and trustworthy. 7/END
