Sun. Oct 2nd, 2022
Albert Bourla, chief executive officer of pharmaceutical company Pfizer, strikes a hammer after ringing the closing bell on the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City.
enlarge Albert Bourla, chief executive officer of pharmaceutical company Pfizer, strikes a hammer after ringing the closing bell on the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City.

Pfizer’s chief executive has dashed any lingering hopes that we’ll get a glimpse of COVID-19 vaccine data before next week’s election.

The pharmaceutical giant has the fastest clinical trial design among the frontrunners in the COVID-19 vaccine race. And for weeks, Pfizer CEO Albert Bourla has been raising the possibility that his company could have results by the end of October — a tempting prospect picked up by President Donald Trump, who has pushed for October vaccine news to bolster his reelection bid.

But in a conversation with investors Tuesday, Bourla indicated that an October release is now almost impossible. Researchers conducting the trial involving more than 40,000 people have not yet analyzed the preliminary data, and even if the data were available tomorrow, an outside panel would need at least a week to analyze the results, Bourla said.

“Let’s be very patient,” he said during the phone call, according to The New York Times. “I know how much the stress levels increase. I know how much the vaccine is needed for the world.”

He also tried to put political pressure on vaccine results, saying, “This is not going to be a Republican vaccine or a Democratic vaccine. This will be a vaccine for the citizens of the world. I hope it will have an effect.”

As the Times has previously noted, Pfizer’s trial design is one of the fastest of the handful of trials most advanced, including trials conducted by Moderna, AstraZeneca and Johnson & Johnson. People in Pfizer’s trial get both doses of vaccine in a shorter time frame than in some other studies. Then, the Times writes, after the second dose, researchers begin checking for COVID-19 cases earlier than in other studies. Pfizer’s trial design also offers a first preliminary glimpse — known as an interim analysis — after only 32 volunteers in the study became ill with COVID-19. This is in contrast to the trial of Moderna, which will do an interim analysis after 53 diseases, and that of AstraZeneca, which will do an interim analysis after 75.

Pfizer’s interim analysis of 32 cases is the first of four planned for the trial, which is expected to last until 164 cases emerge. For the initial analysis of 32 cases, researchers will be optimistic about the vaccine’s prospects if 26 or more of those cases occur in people who have only received a placebo.

But for now, it doesn’t appear that the 32-case threshold has been passed to trigger an interim analysis, Bourla suggested in today’s call. This is both good and bad news, as STAT noted. It’s good that the vaccine hasn’t clearly failed yet. But it also suggests the process is slower than expected, even though it has multiple international pilot sites, including the United States, Argentina, Brazil, South Africa, Germany and Turkey.

By akfire1

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