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Pfizer’s chief executive has dashed any lingering hope that we’ll glimpse COVID-19 vaccine data before next week’s election.
The pharmaceutical giant has the speediest clinical-trial design among the frontrunners in the COVID-19 vaccine race. And for weeks, Pfizer CEO Albert Bourla has dangled the possibility that his company would have results by the end of October—an enticing prospect picked up by President Donald Trump, who has pushed for October vaccine news to bolster his re-election bid.
But in a call with investors Tuesday, Bourla indicated an October release was nearly impossible now. Researchers conducting the over 40,000-person trial have not yet analyzed preliminary data and, even if the data were available tomorrow, an outside panel would need at least a week to analyze any results, Bourla said.
“Let’s be very patient,” he said on the call, according to The New York Times. “I know how much the stress levels are growing. I know how much the vaccine is needed for the world.”
He also tried to release political pressure on the vaccine results, saying: “This is not going to be a Republican vaccine or a Democratic vaccine. This is going to be a vaccine for the citizens of the world. I hope that it is going to be effective.”
As the Times has previously noted, Pfizer’s trial design is one of the fastest among the handful of trials furthest along—including trials conducted by Moderna, AstraZeneca, and Johnson & Johnson. People in Pfizer’s trial receive both doses of vaccine in a shorter timeframe than some other trials. Then, the Times writes, researchers begin monitoring for COVID-19 cases earlier after the second dose than in other trials. Pfizer’s trial design also allows for a first preliminary glimpse—aka an interim analysis—after just 32 volunteers in the trial become ill with COVID-19. That’s in contrast to Moderna’s trial, which will conduct an interim analysis after 53 illnesses, and AstraZeneca’s, which will conduct an interim analysis after 75.
Pfizer’s 32-case interim analysis is the first of four planned for the trial, which is expected to run until 164 cases occur. For the first 32-case analysis, researchers will be optimistic about the vaccine’s prospects if 26 or more of those cases are in people who only got a placebo.
But for now, it doesn’t appear that the 32-case threshold has been met to trigger an interim analysis, Bourla suggested in the call today. This is both good and bad news, as STAT pointed out. It’s good that the vaccine hasn’t clearly failed yet. But it also suggests that the trial is moving more slowly than expected, even though it has multiple international trial sites, including the United States, Argentina, Brazil, South Africa, Germany, and Turkey.