In a statement posted to Pfizer's website Friday, chief executive Dr. Albert Bourla ruled out that a COVID-19 vaccine would be ready before Election Day on Nov. 3. President Donald J. Trump once called Bourla a "great guy," but the jury is out now on what he'll say with this new development.
"As I’ve said before, we are operating at the speed of science. This means we may know whether or not our vaccine is effective by the end of October," Bourla said. "To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates."
His statement continued, "So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency ... For 171 years Pfizer has been known for our high-quality standards. Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine."
The world is waiting for a safe and effective #COVID19 vaccine. Today our Chairman & CEO penned an open letter to h… https://t.co/MQYrT6m7aj— Pfizer Inc. (@Pfizer Inc.) 1602843272.0
“This is good, really good,” said Dr. Eric Topol, a clinical trial expert at Scripps Research in San Diego who was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging it not to rush its vaccine.
The New York Times reported Friday that, "Dr. Bourla’s statement arrived soon after the F.D.A. published new guidelines detailing how the agency would evaluate a vaccine for emergency authorization, a document published after weeks of stalling by the White House."
