On the heels of early positive COVID-19 vaccine data, the CEOs at BioNTech and Pfizer are gearing up for a late-stage trial and talking up potential approvals later this year.
In separate interviews this week, Pfizer CEO Albert Bourla and BioNTech CEO Ugur Sahin said their mRNA vaccine candidate could be ready to submit to regulators in the fall or winter, respectively, pending success in a massive pivotal study yet to kick off.
Speaking with Time, Pfizer’s Bourla said the company “should be able in the September time frame to have enough data to say if the vaccine works or not.” That would enable an FDA submission and a “potential approval in October, if we are lucky,” he told the publication.
After the partners posted promising early data, “plus many other data that we haven’t published yet,” Bourla is thinking about “when” the partners will have a COVID-19 vaccine, rather than “if,” he told the publication. But if the project fails, the companies “will just have to write it off and call it a day,” he added.
For his part, Sahin told the Wall Street Journal the study should be completed by the end of the year, at which point the partners could seek approvals. Still, Sahin offered a word of caution about anyone expecting a quick return to normalcy. He predicts it’ll be 10 years before humanity can beat back the virus entirely.
A Pfizer spokeswoman said the partners are “working together on an expedited timeline to bring a safe and efficacious vaccine to the people who need it the most as early as October. There is no change to our timeline.”
Pfizer and BioNTech earlier this month reported phase 1/2 trial data showing that all trial participants who received 10 micrograms (mcg) or 30 mcg of an mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections. Despite mild and moderate side effects, the safety and tolerability were “consistent with what is expected,” Jefferies analyst Michael Yee wrote at the time.
That study tested only one out of four candidates the partners are investigating. With the results and others, Pfizer and BioNTech plan to advance to phase 3 later this month.
If approved, Pfizer plans to price for a profit, Bourla told Time. At the same time, he’s encouraging governments to distribute doses to people most in need first. The company is already in discussions with governments over supply agreements, he added.
Pfizer and BioNTech are part of an industrywide effort to advance COVID-19 vaccines at record speeds. Including their vaccine, 21 candidates are in human testing, according to the World Health Organization.