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

21:26  09 november  2020
21:26  09 november  2020 Source:   newsweek.com

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Operation Warp Speed is credited with speeding along several other vaccine programs, including one from Moderna Inc. that uses similar technology to Pfizer ’ s and could produce trial data later this month. The Trump administration’ s rapid-vaccine operation , led by the Health and Human Services

Operation Warp Speed ' s goal is to produce and deliver 300 million doses of safe and effective September 16: HHS and DoD released two documents outlining the Trump Administration' s detailed How is Operation Warp Speed being funded ? Congress has directed almost billion to this effort

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.

calendar: Pfizer's global headquarters building is photographed on November 9 in New York City. The pharmaceutical company shared early results of its late-stage COVID-19 vaccine trial on Monday, which indicated the candidate was © KENA BETANCUR/AFP via Getty Images Pfizer's global headquarters building is photographed on November 9 in New York City. The pharmaceutical company shared early results of its late-stage COVID-19 vaccine trial on Monday, which indicated the candidate was "more than 90 percent effective."

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.

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Operation Warp Speed has in some ways lived up to its name: The U. S . government has awarded almost billion to seven different companies to develop vaccines, three of which — Moderna, AstraZeneca and Pfizer — are in late-stage trials. Things are going according to the most aggressive

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"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.

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Operation Warp Speed is pursuing a worthy goal, but it still operates in the shadows. Having already secured 800 million potential doses of six shots, Warp Speed plans to fund at least two more Warp Speed ’ s contracts are clearly preferable to possible alternatives, he says: research delays and dose

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"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."

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Upon receipt of funds and contracts signed, ATI then divvied out this Operation Warp Speed money in the allotted amounts to the aforementioned drug NPR and several partners have attempted in vain to get answers from the Trump administration about what these Operation Warp Speed OTA contracts

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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.

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."

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