Pfizer clarified its relationship with Operation Warp Speed on Monday afternoon after earlier comments from the pharmaceutical company’s R&D director seemed to indicate that it had no connection with the White House program. Donald Trump’s government launched the initiative just before the outbreak of the coronavirus pandemic. It was designed with the intention of producing and distributing 300 million doses of safe, effective COVID-19 vaccines by January, in coordination with contractors.
Although Pfizer has agreed to distribute at least 100 million doses of its vaccine, if it proves safe and effective, to the U.S. government as part of Operation Warp Speed for nearly $2 billion, company employees have indicated that it has independently funded research and development.
“Pfizer is proud to be one of several vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID 19 vaccine,” said a Pfizer spokesperson in a statement sent to Washington on Monday afternoon. “Although Pfizer has an up-front 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 turned down R&D funding to “free” scientists from bureaucratic restrictions while they worked on the development of a COVID 19 vaccine, the pharmaceutical company’s CEO, Dr. Albert Bourla, said in a September interview with Margaret Brennan of CBS News.
“If [Pfizer’s vaccine program] fails, the money will go in our pocket,” said Bourla, responding to a question from Brennan, “why did the company take the risk of shouldering the financial burden of R&D when it could have obtained BARDA funding through Operation Warp Speed.
“At the end of the day it’s just money. It won’t break the company, although it will be painful because we are investing at least one and a half billion in COVID right now,” the CEO added. “But the reason why I did this was to free our scientists from all bureaucracy”.
Later, Bourla told Brennan that he wanted to ensure that the researchers could focus exclusively on “scientific challenges” and allow the company to pursue a potential vaccine candidate without the need for outside pressure that comes with outside intervention or oversight.
“When you get money from someone who always comes with strings attached You want to see how we will move forward, what kind of steps you will take. They want reports,” he concluded, “and I also wanted to keep Pfizer out of politics, by the way.
Bourla’s September comments were circulated in the social media on Monday after Pfizer announced the results of an early investigation into its vaccine program, which was developed in coordination with German biotechnology company BioNTech. According to Pfizer’s latest update, preliminary study data indicate that the vaccine candidate was “more than 90 percent effective” against COVID-19.
There are three critical areas where we need to demonstrate success before we can submit an EUA application for our #COVID19 vaccine
â¶ï¸ Proof of effectiveness in most vaccinated patients
â¶ï¸ proof of safety with data from thousands of patients
â¶ï¸ Consistently after the highest quality standards manufactured
– Pfizer Inc. (@pfizer) November 9, 2020
The report had not yet been published in a peer-reviewed publication at the time of Pfizer’s announcement, which, after its publication on Monday, triggered a wave of questions from scientists. The company announced that it plans to file for regulatory approval with the U.S. Food and Drug Administration in the third week of November, once additional data has been collected.
The announcement was greeted with ceremonial messages from Trump and Vice President Mike Pence, who tweeted “the public-private partnerships forged by President @realDonaldTrump” in response to the Pfizer update.
Kathrin Jansen, Pfizer’s Director of Vaccine Research and Development, then commented to the New York Times, distancing the vaccine program from Operation Warp Speed.
“We were never part of Warp Speed,” she told the newspaper. “We never took money from the U.S. government or from anyone.”
In the follow-up statement from Pfizer, the company said Jansen “emphasized” the fact that “all investment in research and