Pfizer (PFE) and its partner BioNTech (BNTX) plan to take a first look at the efficacy results from their 44,000 personal vaccine trial as soon as September 27.
But that first look will be after just 32 coronavirus infections have accumulated in the two companies’ 44,000 person trial.
The companies have announced that they will take four opportunities to get a preliminary result before reaching a final goal of 164 virus infections.
You do get to ask whether this very early release of such a small sample and then the structure with four shots at a preliminary result are good science or an effort to beat rivals to vaccine approval.
“I’ve never seen a trial where there were four interim analyses; that may be the Olympic record,” Eric Topol, editor-in-chief of the Medscape website and director of the Scripps Research Translational Institute, told Bloomberg. “It’s obvious why it is being done: so you can just keep looking at the data to try to win a race.”
Drug companies have promised not to compromise the quality of their vaccine trials, but this sure looks like a compromise in standards to me. Besides the small result sample, the Pfizer/BioNTech trials will count patients with mildly symptomatic cases in its effort to reach 42 cases of infection in its trial pool. That means that while Pfizer/BioNTech will reach their case total requirement sooner, the early result of efficacy could be based mostly on mild cases. The U.S. Food & Drug Administration has said that to be approved vaccines should cut the number of symptomatic cases by 50% or more. Yet the drug companies in the vaccine race have different approaches to what symptoms count and when to count them.
That could mean that a vaccine wins approval on its ability to prevent mild symptoms without the FDA having solid numbers on a vaccine’s strong efficacy, it’s ability to prevent serious infections that lead to hospitalizations and deaths.
Pfizer is a member of my Dividend Portfolio. I added the stock to that list on August 28, 2020. It’s down 4.35% since that pick. The shares yield 4.22%. They last went ex-dividend on July 30.
