During most of today I watched
a meeting of the Food and Drug Administration Vaccines and Related Biological
Products Advisory Committee Meeting as they considered the COVID-19 vaccine
developed by Pfizer and BioNTech. These experts have spent the day weighing the
benefits and risks of this new vaccine with an eye towards approval of the drug
for “emergency use” (as opposed to a full and final approval) in the U.S.,
which would make it the first available here for immunization against the
disease.
The key question they
sought to answer was: Is the vaccine safe and effective enough to given to
millions of Americans? They were also quite keen on dealing with questions
about what happens to patients enrolled in the ongoing trial, half of whom have
received a placebo. There are complicated ethical issues here. No one questions
the value of “double-blind” studies, where neither the patients nor the
treating physicians know which drug each participant is receiving. But because
there are no other drugs approved for the treatment of this far-too-frequently fatal
infection, it seems a moral imperative to make the active compound available to
all the participants. It is really a difficult decision to make, because it
compromises what can be learned about longer term efficacy and safety.
But something else came to me this morning when I first logged in to the meeting, which is all being conducted virtually, and saw the introductions of the members of the FDA Advisory Committee. Lo and behold, the statistician on that committee was someone familiar to me from a Pfizer project some years ago, although I could not recall which one. I found an e-mail address for her and sent a message, figuring she might see it in a few days. I was quite surprised when I heard from her not long after I sent the note, and she remembers me, too. At the time, she was with an academic group consulting with us on our studies of voriconazole (Vfend) in the primary treatment of acute invasive aspergillosis. I was moved off that project to head the group of statisticians working on oncology and pain and inflammation before the New Drug Application for voriconazole was submitted, but I still remember celebrating that approval with the team. .
All in all, it was an extremely fascinating day, with a group of very bright people raising critical questions. At the end, I suspect that the FDA will allow this to go forward, so let’s all get ready to roll up our sleeves.
Meanwhile, stay safe and well.
Love,
Rebecca
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