Pfizer late-stage testing may produce results as early as October, according to the announcement of CEO Albert Bourla on Thursday.
There are already 23,000 volunteers for the Pfizer late-stage testing that started in late July, Bourla said during an interview with the International Federation of Pharmaceutical Manufacturers & Associations, a trade group. The CEO of the pharmaceutical company said they plan to enroll at least 30,000 participants.
“We expect by the end of October, we should have enough ... to say whether the product works or not,” he said.
US health officials have previously announced that findings from late-stage testing could be available in November or sooner.
Pfizer’s potential Covid-19 vaccine is one of three supposed by the US that is currently in late-stage testing. Pfizer has been working on its candidate vaccine with German drugmaker BioNTech. Their potential vaccine involves the use of a genetic material called messenger RNA, or mRNA. In July, the company announced promising data from its early-stage trial.
The Pfizer late-stage testing is expected to have 30,000 participants between the ages of 18 and 85 across 120 sites from different parts of the world, including 39 US states, according to the company.
Once the testing has becomed successful, the company will submit it for final regulatory review as early as October. They will release 100 million doses by the end of 2020 and around 1.3 billion doses by the end of 2021.
In July, the White House said it would pay Pfizer and BioNTech $1.95 billion to develop and distribute 100 million doses of their Covid-19 vaccine if it is proven effective and safety. The agreement was sealed as part of Operation Warp Speed, the Trump administration’s program that aims to speed up the development and manufacturing of vaccines and treatments to kill the coronavirus.
The CEO’s statement comes as the Centers for Disease Control and Prevention calls on state governors and local health departments to set up their distribution zones for a Covid-19 vaccine as soon as November. With this, health experts are concerned that the deadline will be politically motivated and that regulators are being pressured by the White House to come up with a vaccine ahead of the presidential election on November 3.
Cutting corners
Meanwhile, drug company executives, including from Pfizer, stressed they are not cutting corners to develop vaccines. They noted that the Food and Drug Administration has not relaxed its requirements for evaluating the safety and effectiveness of their vaccines.
According to executives, it is “understandable” that the public has concerns, stressing that they will need to work to establish trust.
“Vaccine hesitancy is probably one of the greatest challenges for public health that America faces,” John Young, Pfizer’s chief business officer, said at the 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 mentioned on 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.”
