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Bourla, speaking on a call with reporters on Tuesday, also reiterated confidence in Pfizer (NYSE:PFE)’s ability to deliver its mRNA vaccine, developed with German partner BioNTech, even though it must be stored at minus 70 degrees Celsius.
He added the companies are working on a “new formulation” capable of withstanding higher temperatures.
His comments came after the U.S. Food and Drug Administration (FDA) released documents raising no new safety or efficacy issues with Pfizer’s vaccine, setting the stage for Thursday’s meeting with outside experts to the FDA who will discuss recommending the shot.
“We have answers to every question they will ask,” Bourla said. “I think they will vote ‘yes’ given the strength of the data.”
His vaccine, already being delivered in limited quantities in Britain after its emergency approval there, has raised concerns due to the Antarctic temperatures it must be stored at, though Pfizer and BioNTech have sought to reassure that it can survive at 2 and 8 degrees for a limited time.
Bourla said he was “very comfortable” with the companies’ ability to distribute the vaccine at minus 70 degrees by using special storage boxes developed by their mechanics.
“You can transport (it) in a normal car, for example, we have GPS and thermometers inside those boxes, so at any point in time, we know where each box is, and the temperature,” Bourla said.
“We’ve started already in the UK and things are going very well,” he said. “I think everybody will see pretty soon that this is not a challenge, at least in countries where there is basic infrastructure, like a road or a place to store things.”
Bourla said the companies are pursuing changes to make the vaccine potentially more suitable for developing countries including Africa where such infrastructure may not be in place.
“Yes, we are working also on a new formulation that will be able to avoid the minus 70 and can be stored in simple refrigeration,” he said.
