Back to School: How biopharma can reboot drug development. Access exclusive analysis here

BioCentury is providing this content for free given the urgent need for information about the coronavirus crisis. Further analysis can be found in our COVID-19 Resource Center. For more, sign up for our daily email.
1006 bourla hahn
BioCentury & Getty Images

Politics, Policy & Law

Pfizer’s Bourla, FDA’s Hahn say science, not politics, should drive COVID vaccine decisions

Oct 6, 2020 | 5:52 PM GMT

Albert Bourla pushed back Tuesday on President Donald Trump’s assertions that vaccine developers have complained to him about FDA’s COVID-19 guidance.

The chairman and CEO of Pfizer Inc. (NYSE:PFE) also disagreed with Trump’s claims that the White House should have the final word on FDA guidance documents, suggesting that the president is undermining confidence in the agency’s decisions.

FDA Commissioner Stephen Hahn asserted the agency’s independence Tuesday by stating explicitly that nothing other than science will influence its regulation of COVID-19 vaccines, and that career scientists will make authorization or approval decisions.

In the Sept. 29 debate with former Vice President Joe Biden, Trump suggested that CDC and Operation Warp Speed officials were underestimating the speed of COVID-19 vaccine development when they estimated that authorization could occur in December or early 2021. “I've spoken to the companies, and we can have it a lot sooner,” Trump said.

The president has also suggested that vaccine developers have complained to the White House about FDA’s unreleased guidance on emergency use authorization (EUA) of COVID-19 vaccines.

Bourla tweeted Tuesday: “Pfizer has never discussed @US_FDA’s #COVID19 vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.”

He added: “@US_FDA’s public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The Pfizer CEO concluded: “In fact we believe @US_FDA’s independence is today more important than ever as public trust in #COVID19 vaccine development has been eroded by the politicization of the process.”

FDA released elements of its COVID-19 EUA guidance Tuesday in advisory committee documents.

Hahn responded to concerns that pressure from the White House could cause the agency to green-light a vaccine prematurely.

“FDA will not authorize or approve any COVID-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness. In this effort, science will guide our decisions. FDA will not allow any pressure, from anybody, to change that,” Hahn said in an address to the Food and Drug Law Institute annual meeting.

Trial Subscription

Get a two-week free trial subscription to BioCentury


Article Purchase

This article may not be distributed to non-subscribers