Pfizer Chairman and CEO Updates Timeline for COVID-19 VaccineBy
Albert Bourla, Chairman and CEO of Pfizer, issued an open letter on October 16, 2020 to update the development timelines of its lead COVID-19 vaccine candidate, which the company is developing with its partner, BioNTech, a Mainz, Germany-based immunotherapy company.
He specified that the vaccine may be ready for submission for emergency use authorization (EUA) to the US Food and Drug Administration (FDA) in the third week of November (November 2020). For the EUA, the FDA requires that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on the company’s current trial enrollment and dosing pace, Pfizer estimates that it will reach this milestone in the third week of November.
“Assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November,” said Bourla in his statement. “All the data contained in our US 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. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.”
Bourla said the company may know whether or not its vaccine is effective by the end of October based on reaching certain data thresholds. “[W]e 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,” he said in his statement. “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.”
He added that the efficacy data for the vaccine will be reviewed independently. “As Pfizer is blinded to who received the vaccine versus the placebo, a committee of independent scientists will review the complete data and they will inform us if the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial,” said Bourla in his statement. “Pfizer will continue running the trial through its final analysis point even if it is declared effective at an earlier stage. In the spirit of candor, we will share any conclusive readout (positive or negative) with the public as soon as practical, usually a few days after the independent scientists notify us.”
Bourla also outlined the timing of manufacturing data for an EUA submission. “If we achieve a positive efficacy readout and a robust safety profile, the last requirement will be the submission of manufacturing data that demonstrates the quality and consistency of the vaccine that will be produced,” he said in his statement. “Pfizer has been investing at risk since the early days of the pandemic to perfect our manufacturing processes and rapidly build up capacity. We expect to have our manufacturing data ready for submission before the safety milestone is reached.”
The company’s lead COVID-19 vaccine candidate is based on BioNTech’s proprietary messenger ribonucleic acid (mRNA) technology and is supported by Pfizer’s global vaccine development and manufacturing capabilities. The vaccine candidate is currently being evaluated in an ongoing global Phase III study at more than 120 clinical sites worldwide, including the US, Brazil, South Africa, and Argentina. The companies reported last month (September 2020) that if authorization or approval is obtained, the companies aim to supply globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.