In this photo from the University of Maryland School of Medicine dated May 4, 2020, the first patient enrolled in Pfizer's COVID-19 coronavirus vaccine clinical trial at the University of Maryland's School of Medicine, Baltimore, receives an injection.
University of Maryland School of Medicine | AP
Pfizer could get results from its late-stage coronavirus vaccine study as early as October, CEO Albert Bourla said Thursday.
The pharmaceutical company has already enrolled 23,000 volunteers in the Phase 3 study, which began in late July, Bourla said during a Q&A with the International Federation of Pharmaceutical Manufacturers & Associations, a trading group. It hoped to enroll at least 30,000 participants, he said.
"We expect to have enough by the end of October … to say whether the product is working or not," he said.
U.S. health officials previously said results from late-stage vaccination trials could be in November or earlier.
Pfizer's potential vaccine is one of three vaccines supported by the US and is currently in late-stage testing. The US-based pharmaceutical company works with the German drug manufacturer BioNTech. The companies' experimental vaccine contains genetic material known as messenger RNA or mRNA. In July, the company released promising data from its early study.
The Phase 3 study is expected to enroll up to 30,000 participants between the ages of 18 and 85 in 120 locations worldwide, including 39 US states. If it's successful, they expect to submit it for final regulatory review as early as October. They plan to deliver up to 100 million cans by the end of 2020 and around 1.3 billion cans by the end of 2021.
In July, the US government announced that it would pay Pfizer and BioNTech $ 1.95 billion to manufacture and supply 100 million doses of their vaccine if it proves safe and effective. The contract was signed as part of Operation Warp Speed, the Trump administration's efforts to accelerate the development and production of vaccines and treatments to fight the coronavirus.
The CEO's comment comes as the Centers for Disease Control and Prevention urge governors and local health departments to prepare to distribute a vaccine as early as November. The deadline raises concerns among public health experts and scientists that getting a vaccine approved will be politically motivated and the White House may be pressuring regulators to get a vaccine on the market before the November 3rd presidential election.
Pharmaceutical company executives, including Pfizer, have previously insisted they don't compromise on the rapid development of potential vaccines. You said the Food and Drug Administration has not relaxed its requirements for demonstrating the safety and effectiveness of its vaccines.
While the vaccine may be safe, executives said it was "understandable" that the public would be concerned, adding that they must work to gain that trust.
"The hesitation about vaccines is probably one of the greatest public health challenges in America," Pfizer chief business officer John Young told Congress on July 21. "We all have a role to play if we are to be successful on this mission." that there is confidence in the safety and effectiveness of our vaccines based on data based on the confidence that the FDA will only approve a vaccine if it is safe and effective. "
Bourla said Thursday that the company "would never" submit a vaccine for approval until "we believe it is safe and effective".
"We're not going to cut corners," he said. "Our phase three study will be the only one that will allow us to tell if we have a safe and effective vaccine. If we didn't have results from a phase three study, we wouldn't submit them."