In this May 4, 2020 photo provided by the University of Maryland School of Medicine, the first patient enrolled in Pfizer’s COVID-19 coronavirus vaccine clinical trial at the University of Maryland School of Medicine in Baltimore, receives an injection.
University of Maryland School of Medicine | AP
Pfizer could have results from its late-stage coronavirus vaccine trial as early as October, CEO Albert Bourla said Thursday.
The pharmaceutical company has already enrolled 23,000 volunteers in the phase three trial that began in late July, Bourla said during a Q&A with the International Federation of Pharmaceutical Manufacturers & Associations, a trade group. It hopes to enroll at least 30,000 participants, he said.
“We expect by the end of October, we should have enough … to say whether the product works or not,” he said.
U.S. health officials have previously said results from late-stage vaccine trials could come in November or sooner.
Pfizer’s potential vaccine is one of three backed by the U.S. that’s currently in late-stage testing. The U.S.-based pharmaceutical giant has been working alongside German drugmaker BioNTech. The companies’ experimental vaccine contains genetic material called messenger RNA, or mRNA. In July, the company released promising data from its early-stage trial.
The phase three trial is expected to include up to 30,000 participants between the ages of 18 and 85 across 120 sites globally, including 39 U.S. states, the company has said. If it is successful, they expect to submit it for final regulatory review as early as October. They plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.
In July, the U.S. government announced it would pay Pfizer and BioNTech $1.95 billion to produce and deliver 100 million doses of their vaccine if it proves safe and effective. The deal was signed as part of Operation Warp Speed, the Trump administration’s effort to accelerate development and production of vaccines and treatments to fight the coronavirus.
The CEO’s remark comes as the Centers for Disease Control and Prevention is asking state governors and local health departments to prepare to distribute a vaccine as soon as November. The deadline is raising concerns among public health experts and scientists that approval of a vaccine will be politically motivated and the White House may be pressuring regulators to get a vaccine to the market ahead of the presidential election on Nov. 3.
Drug company executives, including from Pfizer, have previously insisted they aren’t cutting corners in fast-tracking development of potential vaccines. They have said the Food and Drug Administration hasn’t eased its requirements for proving their vaccines are safe and effective.
While the vaccine may be safe, the executives have said it is “understandable” the public would be concerned, adding they will need to work to gain that trust.
“Vaccine hesitancy is probably one of the greatest challenges for public health that America faces,” John Young, Pfizer’s chief business officer, told Congress on July 21. “All of us need to play a role, should we be successful in this mission, that there’s confidence in the safety and effectiveness of our vaccines based on data, based on confidence the FDA will only approve a vaccine if it’s safe and effective.”
Bourla said Thursday that the company “would never” submit any vaccine for authorization before “we feel it is safe and effective.”
“We will not cut corners,” he said. “Our phase three study will be the only one that will allow us to say if we have a safe and effective vaccine. If we don’t have results from a phase three study, we would not submit.”