| Corporate earnings calls tend to be dry affairs filled with mind-numbing questions about obscure revenue numbers. But Pfizer's third-quarter earnings call last week was all about the vaccine.
Analysts peppered CEO Albert Bourla with question after question on exactly when the company's long-awaited Covid-19 vaccine data might arrive. Had the company conducted an interim efficacy analysis of its giant final-stage trial? Had there been any changes to Pfizer's aggressive plan for looking at the data? Scientists overseeing the trial "haven't seen any unblinded data yet and they haven't performed any interim analysis yet," Bourla said, essentially conceding that a long-promised October readout was unlikely. "I just ask everybody to be a little bit patient."  Albert Bourla Photographer: Zach Gibson/Bloomberg Once Pfizer and its German partner BioNTech get the results, Bourla said it might take 5 to 7 days to vet the data before the company makes a statement. Here's how the Pfizer trial works: Volunteers get two shots of Pfizer's vaccine or two shots of a placebo; then doctors wait for a certain number of Covid-19 cases to occur. A data monitoring board overseeing the trial will look at the efficacy data for the first time after 32 cases have occurred, a number that hadn't been reached as of Tuesday.
Then there are three possibilities: The shot can be declared effective, it can be deemed a failure—or the monitoring board could decide the results aren't yet conclusive. Pfizer has promised an announcement if the vaccine is deemed effective or futile, but it doesn't plan on saying anything if the monitoring board decides to continue the trial with no verdict. There is a high bar for declaring success after just 32 cases. According to the trial plan, the shot must be at least 76.9% effective at this early point. This would occur if 6 volunteers or fewer who received the vaccine got Covid, while at least 26 people who got the placebo got sick. Pfizer has scheduled other analyses after 62 cases, 92 cases, 120 cases, and 164 cases, with progressively lower thresholds for declaring the vaccine effective.
Moderna has a generally similar trial with a more conservative data analysis plan. Its monitoring board will first look at the efficacy data after 53 cases have occurred, a threshold likely to be reached by late November. Moderna says it will announce whatever happens at that first analysis, even if the decision is merely to continue the trial with no verdict.
Despite the fever-pitch excitement, nobody knows what is going to happen. It's a new virus and Pfizer and Moderna are using new technology. As Bourla told analysts: "You never know until you have a study readout."—Robert Langreth | 
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