Real science is never settled, and anyone who has certainty on such things is not qualified to discuss it.
How can you legitimately give full approval to the Trump vaccines when the placebo control group was broken shortly after the studies began? This process started 6 months before full FDA approval of the Pfizer vaccine. Unprecedented?
Tens of thousands of people who volunteered to be in studies of the Pfizer-BioNTech and Moderna COVID-19 vaccines are still participating in follow-up research. But some key questions won't be easily answered, because many people who had been in the placebo group have now opted to take the vaccine.
...So now Fierro has essentially no comparison group left for the ongoing study.
"It's a loss from a scientific standpoint, but given the circumstances I think it's the right thing to do," he says.
People signing up for these studies were not promised special treatment, but once the FDA authorized the vaccines, their developers decided to offer the shots.
Dr. Steven Goodman, a clinical trials specialist at Stanford University, says losing those control groups makes it more difficult to answer some important questions about COVID-19 vaccines.
"We don't know how long protections lasts," he says. "We don't know efficacy against variants — for which we definitely need a good control arm — and we also don't know if there are any differences in any of these parameters by age or race or infirmity."
WIND: I’m totally 'good' with individuals knowing their status and getting the vaccine—it’s the ethical thing to do. It should be an individual right, every time.
But without a control group, it becomes possible to deny harm from the vaccines much more easily because inferring harm is much harder to do in a statistically valid way.