Pfizer Avoided R&D Funding From Trump's Operation Warp Speed Because of Bureaucracy, Politics

Pfizer clarified its relationship with Operation Warp Speed on Monday afternoon, after earlier comments from the pharmaceutical company's research-and-development chief seemed to indicate it did not have ties to the White House program. Donald Trump's administration launched the initiative near the onset of the coronavirus pandemic. It was designed with intentions to produce and distribute 300 million doses of safe, effective COVID-19 vaccines by January, in coordination with contracted companies.

Although Pfizer did agree to distribute at least 100 million doses of its vaccine, if proven safe and effective, to the U.S. government for nearly $2 billion under Operation Warp Speed, company personnel have made a point to note that it financed research and development independently.

"Pfizer is proud to be one of various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine," a Pfizer spokesperson said in a statement sent to Newsweek Monday afternoon. "While Pfizer did reach an advanced purchase agreement with the U.S. government, the company did not accept BARDA [Biomedical Advanced Research and Development Authority] funding for the research and development process," the statement continued.

Pfizer declined the R&D funding in order to "liberate" scientists from bureaucratic limitations as they worked to develop a COVID-19 vaccine, the pharmaceutical company's CEO, Dr. Albert Bourla, said in a September interview with CBS News' Margaret Brennan.

"If [Pfizer's vaccine program] fails, it goes to our pocket," Bourla said, responding to a question from Brennan about why the company risked shouldering the financial burden of research and development when it could have received BARDA funding through Operation Warp Speed.

"At the end of the day, it's only money. That will not break the company, although it is going to be painful because we are investing one billion and a half at least in COVID right now," the CEO added. "But the reason why I did it was because I wanted to liberate our scientists from any bureaucracy."

Later, Bourla told Brennan he wanted to ensure researchers were able to focus on "scientific challenges" exclusively, and allow the company to pursue a potential vaccine candidate without pressures that accompany outside intervention or oversight.

"When you get money from someone that always comes with strings. They want to see how we are going to progress, what type of moves you are going to do. They want reports," he finished. "And also, I wanted to keep Pfizer out of politics, by the way."

Bourla's September comments circulated on social media Monday, after Pfizer shared results of an early examination into its vaccine program, developed in coordination with German biotechnology company BioNTech. According to Pfizer's latest update, preliminary trial data indicated the immunization candidate was "more than 90 percent effective" in protecting against COVID-19.

There are 3 critical areas where we must demonstrate success before filing for EUA of our #COVID19 vaccine

▶️ Evidence of efficacy in most vaccinated patients

▶️ Evidence of safety w/ data from thousands of patients

▶️ Manufactured consistently at the highest quality standards

— Pfizer Inc. (@pfizer) November 9, 2020

The report was not yet published by a peer-reviewed publication at the time of Pfizer's announcement, which ushered in a wave of questions from scientists upon release Monday. The company said it plans to apply for regulatory approval from the U.S. Food and Drug Administration during the third week of November, once additional data is collected.

The announcement was met with celebratory messages from Trump and Vice President Mike Pence, who credited "the public-private partnership forged by President @realDonaldTrump" in a tweet responding to Pfizer's update.

Kathrin Jansen, the head of vaccine research and development at Pfizer, subsequently distanced the immunization program from Operation Warp Speed in comments to The New York Times.

"We were never part of the Warp Speed," she told the newspaper. "We have never taken any money from the U.S. government or from anyone."

In Pfizer's follow-up statement, the company said Jansen "was emphasizing" the fact that "all the investment for R&D was made by Pfizer at risk."

Pfizer's headquarters on November 9 in New York City. The pharmaceutical company, which declined R&D funding from the Trump administration's Operation Warp Speed, shared early results of its late-stage COVID-19 vaccine trial on Monday, which indicated the candidate was "more than 90 percent effective." KENA BETANCUR/AFP via Getty Images