U.S. officials took aim at Pfizer’s COVID-19 vaccine manufacturing process at a press conference Wednesday, suggesting the drugmaker had, at last, divulged production hiccups that could scupper efforts to get millions of shots into patients’ arms by year-end.
But Pfizer sees things very differently—and it made those thoughts clear in a Thursday statement.
“Pfizer is not having any production issues with our COVID-19 vaccine, and no shipments containing the vaccine are on hold or delayed," the drugmaker said. In fact, it said, millions of doses are sitting in warehouses, ready for shipment whenever the government calls for them.
And Pfizer board member and ex-FDA chief Scott Gottlieb, M.D., pitched his take Friday morning, speculating the government may have “throttled” Pfizer’s orders to make way for a looming Moderna rollout.
The statements mark the latest in an increasingly testy point-counterpoint between Pfizer and the federal government. Tensions started flaring in October when Pfizer chose to delay its FDA submission until late November, dashing President Donald Trump's hopes of a pre-election vaccine approval. The company has also been vocal about its rejection of federal R&D funding for its vaccine program, which may have led officials at Wednesday's conference to knock the company's transparency.
Meanwhile, Gottlieb touched off a public feud with the Department of Health and Human Services last week when he alleged in a CNBC interview that the government had repeatedly turned down offers to purchase more Pfizer doses, even as recently as November.
As for transparency, Pfizer said government officials have had more than enough opportunity to follow its manufacturing and distribution process.
“We have continuously shared with Operation Warp Speed and the U.S. Department of Health and Human Services through weekly meetings every aspect of our production and distribution capabilities,” the statement continued. “They have visited our facilities, walked the production lines and been updated on our production planning as information has become available.”
In another wrinkle, less than a week after Pfizer's emergency authorization—and just as an FDA advisory panel was reviewing a rival mRNA shot from Moderna—officials in multiple states said they were alerted that next week’s shipments of Pfizer vaccines had been reduced, The Washington Post reported.
One administration official said those dose adjustments stemmed from states requesting an expedited timeline to secure future shipments, giving federal authorities less time to inspect and sign off on available supply, The Post reported. But coming after the feds' suggestion of manufacturing shortfalls, the news from state officials seemed to suggest Pfizer wasn't providing enough doses.
That's funny, Pfizer said—we could ship millions more now.
"This week, we successfully shipped all 2.9 million doses that we were asked to ship by the U.S. Government to the locations specified by them," the statement read. "We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses."
Meanwhile, Gottlieb threw another curveball Friday morning, suggesting on CNBC's Squawk Box that the government may have dialed back its Pfizer shipments to make room for Moderna's shot—the next candidate due for an emergency nod.
“They’re throttling it,” former FDA commissioner and Pfizer director @ScottGottliebMD says of govt’s plans for shipping Pfizer vaccine. Suggests govt may think 7M doses is all system can handle next wk & wants to leave room for Moderna’s 5M. “There’s many more doses available.” https://t.co/DhGkpdd50f— Meg Tirrell (@megtirrell) December 18, 2020
"They don't think that the channel can distribute more than, let's say, 7 million doses next week. They want to leave room for Moderna to deliver their 5 million, so they've titrated back what Pfizer's shipping," Gottlieb said. "They're throttling it."
"I think they should be taking some risk and leaning forward trying to get more doses in people's arms—both Moderna and Pfizer," he said, adding that Pfizer does indeed have extra doses available with more on the way.
"Pfizer does not have vaccine shipments that are on hold or delayed," a Pfizer spokeswoman said over the phone. "We continue to dispatch orders from the government as they come in."
During Wednesday's press conference, Department of Health and Human Services Secretary Alex Azar drew a clear distinction between the government’s relationship with Pfizer and shot developers like Moderna, which accepted federal funding for R&D.
Those other companies “are more intimately engaged in the support of the development and manufacturing of their product on an ongoing basis, whereas the relationship that Pfizer wanted with Operation Warp Speed was the guaranteed purchase of vaccine,” he said.
Pfizer, for its part, is working with the government to double its original order for 100 million doses and provide them in the first half of next year, CEO Albert Bourla told CNBC Monday. But the company is “running at critical supply limitations,” and it will need the government to leverage the Defense Production Act to free up raw materials for additional doses, Bourla said.
“Pfizer is manufacturing and readying for release millions of doses each day, and that volume will grow over the coming weeks,” Pfizer said in its statement. The company maintains confidence it can deliver up to 50 million doses globally this year, with capacity for up to 1.3 billion doses in 2021.
While Pfizer's statement seems to point the finger at the feds, an HHS spokesperson told The Post the government was still on track to deploy enough doses for 20 million people by year-end, denying any order adjustments to "numbers locked in with states."