Pharmaceutical giant Pfizer is pushing back on claims that it may have delayed trial data on Monday, as the company announced promising early results from its clinical trials for a coronavirus relief drug just days after the presidential election.
President Trump had repeatedly said he expected to have the results by the end of October – ahead of the November election.
In a statement on Monday, Pfizer Chairman and CEO Albert Bourla revealed that, following a discussion with the FDA, it decided to drop a 32-case interim analysis – and instead conduct the first analysis at a minimum of 62 cases.
The first interim efficacy analysis was conducted on Nov. 8, at which time the company said there were 94 cases in trial.
Critics, including Trump’s son Don Jr., questioned whether that “delay” was intentional and whether the company would have otherwise been able to detail the results prior to the election, as the president – and Bourla – had initially predicted.
A spokesperson for the company emphasized that Pfizer said it “may” know the results of its study by the end of October.
In an Oct. 16 open letter, Bourla said the company was “operating at the speed of science.”
It is unclear at what point the company reached the 32-case milestone, though the spokesperson pointed out that Pfizer said on its Oct. 27 earnings call it had not yet reached the 32 cases to trigger the first interim analysis.
During an interview with Axios, Bourla said he would have released the results sooner – before the election – had they been available.
He said the data came in on Thursday or Friday – and the committee met on Sunday.
“Sunday we knew that the data are in. So the data came in on Thursday or Friday,” Bourla told the publication. “And on — but you know, from the time that the data comes in, before the committee meets, some people need to prepare for each case a very big and accurate narrative. And the physician should sign it. So there's a lot of work that needs to be done. But we did it with the speed of light.”
The early data indicates the vaccine could be more than 90% effective.
Dr. Nicole Saphier told FOX Business on Monday that this number far exceeded expectations, and she noted that Moderna’s vaccine is likely to have encouraging results in the near future as well.
However, there is still more testing to be done before the Pfizer vaccine gets approval. The company estimates that it will likely have acquired the necessary median of two months’ worth of safety data following the second (and final) dose of the vaccine candidate by the third week of November.
Pfizer is predicting that it will be able to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.