How Operation Warp Speed clashed with Pfizer in the early days of the pandemic

 Operation Warp Speed, perhaps the brightest spot in former President Donald Trump’s Covid-19 legacy, helped hurry the development and distribution of Pfizer and Moderna’s lifesaving Covid-19 vaccines at a pace never before imagined.

One of the central figures in and around the now-defunct OWS was Paul Mango, former deputy chief of staff at HHS who led the media calls around Covid-19 and worked closely with former HHS Secretary Alex Azar.

Mango has penned a new book on his time at OWS leading up to the vaccines, which hits the shelves on May 18.

An advance copy of the book, known as Warp Speed: Inside the Operation That Beat COVID, the Critics, and the Odds, delivers several surprising behind-the-scenes struggles between Warp Speed and Pfizer, a company that insists it never took any government support for its Covid-19 vaccine.

But Mango’s book explains more of the details on how Pfizer’s vaccine struggled at the beginning, what Pfizer did take from OWS, and how the Big Pharma was reliant on the federal government for several key tasks.

In outlining the central issues for Warp Speed, Mango points to Pfizer, which sold 100 million doses of its vaccine for $1.95 billion to the US, as one of three main sources of tension.

When the vaccines first began rolling out, Mango explains how Pfizer pledged in September 2020 that it would likely deliver 50 million doses to the US before year’s end.

“As the autumn wore on, however, Pfizer began reducing the numbers of doses we could expect to receive,” Mango writes.

The doses were eventually delivered in a trickle in early December, Mango says, but Pfizer shifted its promise to 22 million doses, and ended up only providing 18 million.

“Needless to say, in those early weeks, when it came to Pfizer’s manufacturing process, we had little confidence at all,” Mango writes.

Pfizer has since distributed more Covid-19 doses than just about any other company and hauled in more than $20 billion in vaccine sales last year worldwide. Pfizer CEO Albert Bourla is also writing his own book that may explain some of this situation more. But still, Mango insists that Pfizer was the toughest to deal with.

“Of all the companies in which we invested, Pfizer was both the least transparent and least collaborative. It would not let us observe its manufacturing processes for months and then failed to deliver the contracted amounts of doses it promised in November and December of 2020. This eroded the credibility of the GEN [Gustave] Perna’s distribution team in the eyes of many governors,” Mango writes.

Similarly, Mango, a West Point graduate who also served as chief of staff at CMS, noted the “only problem” Warp Speed encountered among 18 uses of the Defense Production Act to prioritize certain supplies, was with Pfizer.

“It is hard to know for sure, but politics may have been at least partially behind Pfizer’s generally difficult stance toward OWS, even while depending heavily on our assistance with packaging, distributing, and administering its doses,” Mango writes, adding:

For a long time, Pfizer declined to answer these questions yet voiced frustration with not receiving a priority rating under the DPA. We speculated that the company intended to use the DPA to help it manufacture vaccines that would be shipped overseas, which, in many cases, the DPA prohibited. In the late fall, Pfizer began to encounter serious raw material and spare parts constraints. Only then did it comply with the DPA’s requirements and receive (in December) a priority rating.

Pfizer did not respond to a request for comment.

The GAO also noted in a report from last April that the Department of Defense worked with all of the companies but Pfizer to negotiate additional government rights requiring vaccine developers to license their IP so that a contract manufacturer may produce the vaccine for exclusive sale to the government.

“According to DOD officials, DOD was unable to negotiate with Pfizer to include third party manufacture as a remedy in its agreement due to the government’s lack of involvement in the Pfizer vaccine’s development. Pfizer officials noted that Pfizer’s agreement does not allow the government to ‘march-in,’ as that term is defined in 35 U.S.C. § 203, and according to their agreement, government funding was limited to payment for doses,” the GAO report says.

Mango also reflects on the tension between Moncef Slaoui, Warp Speed’s disgraced chief scientific advisor who has since been let go from several biotechs and boards due to sexual harassment, and Deborah Birx, the White House coronavirus task force coordinator.

Whereas Slaoui insisted on advancing six vaccine candidates across three different tech platforms, Birx told the team to focus “on only one of these three platforms, a tried-and-tested technology referred to as ‘protein sub-unit’ being utilized by two of our vaccine candidate companies Novovax and Sanofi,” according to Mango.

Hindsight is 20/20, but neither the Novovax nor the Sanofi Covid-19 vaccines have received an EUA yet.

And whereas Warp Speed helped NIH build Moderna’s Covid-19 vaccine from the ground up, making the EUA a momentous occasion, Mango notes that the Pfizer EUA:

Did not have the same emotional impact on our team. It wasn’t even really a Pfizer vaccine. Distributed by Pfizer, BioNTech, a small company in Germany, actually developed it. While heavily supported by Operation Warp Speed in many ways, including a $2 billion advanced purchase order for 100 million doses, Pfizer consistently chose to operate at arm’s length. So, we did not feel nearly the personal ownership of Pfizer’s success as we did of Moderna’s.

https://endpts.com/how-operation-warp-speed-clashed-with-pfizer-in-the-early-days-of-the-pandemic/