The vaccine candidate, being developed in collaboration with BioNTech (NSDQ:BNTX), is among the top COVID-19 vaccines currently undergoing Phase 3 clinical trials and nearing potential regulatory authorization, should they prove safe and effective. Once the company can do that, it intends to apply for FDA emergency use authorization (EUA).
Bourla, who said the development is “operating at the speed of science,” noted that the company may know whether or not its vaccine is effective by the end of October if it can accumulate a certain number of COVID-19 cases in its trial to compare the effects of the vaccine to a placebo.
However, effectiveness would only check one of three boxes, the executive stressed, with safety and the proof of manufacturing quality and consistency also needing to be provided. The company has earmarked the third week in November for the reaching of its safety milestone, with manufacturing data expected to be ready before then.
All that together means that Pfizer believes it may be able to apply for EUA soon after the safety milestone is reached in late November, should its estimates hold true.
“Assuming positive data, Pfizer will apply for [EUA] in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla wrote. “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.
As the U.S. presidential election nears, there had been rumblings from the Trump administration that a vaccine could be ready to go before the election. Although Pfizer and BioNTech believe they will prove the effectiveness of their vaccine candidate by then, the remaining steps that must be taken rule out any clearance by Nov. 3.
With other vaccine candidates forced to pause trials due to unexplained illnesses, the most recent being Johnson & Johnson, having seen AstraZeneca do so last month, it appears that no vaccine will be able to garner authorization before the election. Previously, the CEOs of nine drug companies pledged that they would not rush their vaccines, but rather ensure that they are safe and effective, despite outside pressures.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease