I just did a radio interview on the COVID-19 vaccine booster FDA adcomm. I got all my talking points in and then the the host asked me an interesting question, "How can we trust the clinical trial data since it was paid for by Pfizer?" My initial micro-expression was one of surprise. But it was a good question -- with a good answer: That's the way the system works. But it's more complicated than that. (Isn't that always the case.) As all us Drugwonks know, clinical trials are designed and fielded with significant input from the FDA from the very earliest stages and then the data is scrupulously reviewed by the agency.
I pointed out to the man behind the microphone that Pfizer initially asked their booster be approved for everyone ages 12+ -- but the FDA adcomm didn't see the data that way, voting it down 16-2. Based on the data (paid for and provided by Pfizer), the adcomm recommended (18-0 in favor) that boosters be authorized for vaccinated individuals ages 65+ and (vaccinated) people at serious risk of breakthrough infections (specifically calling out healthcare workers and people who are immuno-compromised).
Assuming the FDA follows the adcomm's recommendations (and I predict they will), this is science at work. It's why the clinical trial process works. What doesn't work is when our political leadership gets out ahead of science-based regulatory decision making. A few weeks BEFORE the adcomm, President Biden announced that booster shots would be available to all Americans ages 12+. That was a mistake. It reeks of the White House trying to put it's thumb on the regulatory scale. Let's hope the same "exuberance" doesn't happen with Pfizer's new announcement about vaccines for our citizens ages 5-11.
The road to hell is paved with good intentions.
I pointed out to the man behind the microphone that Pfizer initially asked their booster be approved for everyone ages 12+ -- but the FDA adcomm didn't see the data that way, voting it down 16-2. Based on the data (paid for and provided by Pfizer), the adcomm recommended (18-0 in favor) that boosters be authorized for vaccinated individuals ages 65+ and (vaccinated) people at serious risk of breakthrough infections (specifically calling out healthcare workers and people who are immuno-compromised).
Assuming the FDA follows the adcomm's recommendations (and I predict they will), this is science at work. It's why the clinical trial process works. What doesn't work is when our political leadership gets out ahead of science-based regulatory decision making. A few weeks BEFORE the adcomm, President Biden announced that booster shots would be available to all Americans ages 12+. That was a mistake. It reeks of the White House trying to put it's thumb on the regulatory scale. Let's hope the same "exuberance" doesn't happen with Pfizer's new announcement about vaccines for our citizens ages 5-11.
The road to hell is paved with good intentions.
