Deborah Nason 
courtesy of Pfizer
Albert Bourla’s gamble to forgo federal help to develop Pfizer-BioNTech’s coronavirus vaccine paid off when the Food and Drug Administration granted full approval for the shots on Monday.
Pfizer’s CEO recalled his decision to go it alone and how the company is applying what it learned to future drug development, in an exclusive interview today with Crain’s.
“I know that bureaucracy and innovation are like water and oil,” said Bourla, who is also chairman of the Manhanttan-based drug company. “I wanted to protect this team from both internal and external bureaucracy. We knew that if we accepted governmental funds, we would have to answer to them. When I told the team we wouldn’t be accepting any government money, they cheered.”
The Pfizer vaccine, which has been found to be 91% effective, is still under emergency-use authorization for anyone between the ages of 12 and 15.
The shots will be marketed under the name Comirnaty. It is the first vaccination to be approved by the federal government.
“For us, it’s an additional confirmation of the efficacy and safety and the work of our people,” Bourla said. “And looking at polls, [the lack of approval] has been one of the major reasons for people to not get vaccinated. I expect to see the needle moving now.”
The joint effort between the two pharmaceutical companies happened at warp speed compared to the usual timeline for a vaccine from development to approval.
“It’s true I pushed the timelines, but they tend to give me too much credit and not enough to the team,” Bourla said. “The most important thing was that at a certain point, we believed we could do it. And we felt that if we wouldn’t be successful, no one else would be able to deliver. Failure was not an option.”
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To combat internal bureaucracy, Bourla said he flattened the organization and streamlined execution, including all the managers on the team on one video call, and himself as the main decision-maker. “Everyone was able to have a say and decisions could be made much more quickly,” he said.
“Now we know how miraculous this process was,” Bourla said. “It can’t work for all projects, but for some, I am the main decision-maker. We are duplicating the process so that other leaders will serve as the main decision-makers.”
An earlier version of this story said the Pfizer vaccine remains under emergency authorization for individuals under 12; the emergency-use authorization applies to those between the ages of 12 and 15. This story has been corrected.
Source link : https://www.modernhealthcare.com/politics-policy/pfizer-ceo-albert-bourla-recalls-his-decision-go-it-alone-vaccination-effort
