Feds rebuff Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials: reports

Ever since Pfizer was pegged to participate in the U.S. government’s Warp Speed effort to get COVID-19 vaccines to market, the company has made it quite clear it did not need to take any federal money to develop the vaccine.

But did that refusal of R&D funding contribute to Pfizer’s inability to manufacture more doses of its mRNA vaccine for the U.S. market?

Pfizer could provide more than the 100 million doses it promised in its original contract with the U.S. government in the first half of next year—but only if Trump administration officials demand that suppliers of raw materials quickly fulfill the company’s orders. And CEO Albert Bourla, Ph.D., is calling on the government to use the Defense Production Act to do just that.

The Trump administration hasn't done so yet because they’ve focused on providing those materials to vaccine makers that did take federal R&D funding, like Moderna, according to unnamed sources who spoke to The New York Times.

A spokesperson for Pfizer declined to comment, citing the confidentiality of discussions with the U.S. government. But Bourla said during a CNBC interview that the company is in negotiations to sell an additional 100 million doses of Pfizer’s COVID-19 vaccine to the U.S. government.

“We can provide a lot of that in the third quarter. The U.S. government wants it in the second quarter,” Bourla said in the Monday interview. “We are working very collaboratively to try to find a solution and be able to allocate those 100 million [doses] in the second quarter if possible, or a lot of them.”

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Pfizer requested early on that the government award it “favored status” with suppliers of raw materials, but officials were afraid that would damage competing vaccine programs that did take federal R&D money, according to the Times report. Among those companies is Moderna, which is expected to win emergency use authorization from the FDA for its mRNA vaccine this week—and last Friday, inked a deal to add 100 million more doses to its initial U.S. order.

One option to speed up Pfizer’s vaccine output now would be for the government to deploy the Defense Production Act to expand the supply of raw materials needed to make COVID-19 vaccines. In fact, Department of Health and Human Services (HHS) Secretary Alex Azar said earlier this week he had suggested that solution after the government restarted negotiations with Pfizer in October.

Bourla said during the CNBC interview that he hopes the feds invoke the Defense Production Act “very soon” because “we are running at critical supply limitations.”

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A rather public tiff between Pfizer and the U.S. government broke out last week, when Pfizer board member and former FDA Commissioner Scott Gottlieb, M.D., told CNBC that Pfizer has made multiple offers to provide additional doses of its COVID-19 vaccine. Gottlieb said earlier this week that the government even turned down an offer for more doses in November after the company released interim data from a phase 3 trial showing the vaccine was 95% effective.

HHS was none too happy about Gottlieb’s remarks, posting a five-part response on Twitter. “At no time did [Warp Speed] turn down an offer from Pfizer for any number of millions of doses having a firm delivery date and quantity, and it's a shame that someone is misinforming the American public,” HHS said. The agency added that it continues to negotiate with Pfizer for additional doses.

Moderna, meanwhile, snagged an expansion of its original supply contract with the U.S. government last Friday. The government said it would pay the company $1.68 billion for 100 million additional doses to be delivered in the second quarter of next year. Moderna expects to ship its first 20 million doses this month, and 80 million in the first quarter, for which the U.S. has vowed $1.525 billion.

All in all, the U.S. government has invested $4.1 billion to develop and purchase Moderna’s mRNA COVID-19 vaccine, HHS estimated.