With one COVID-19 vaccine authorized in the U.S. and another candidate speeding toward an OK this week, Operation Warp Speed is hustling to lock down hundreds of millions of shots for a massive U.S. immunization campaign. So far, it's striking out in expanding an order from Pfizer—but it managed to score an additional 100 million doses from archrival Moderna.
The U.S. government on Friday tapped its option to buy additional doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, snapping up 100 million more doses for around $1.68 billion. The deal raises the U.S. order to 200 million doses, enough to vaccinate 100 million people. The shot is up for review at an FDA advisory panel meeting Thursday.
The latest slate of Moderna shots are set for delivery in the second quarter of 2021. Ahead of that, Moderna plans to ship out some 20 million doses this month and deliver 80 million more in the first quarter, the company said—provided it wins an emergency FDA authorization as expected.
The extra doses should “give Americans greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021,” Alex Azar, secretary of the Department of Health and Human Services, said in a release. The U.S. has an option to purchase another 300 million doses of Moderna’s vaccine down the line.
Under a deal struck in August, the U.S will shell out $1.525 billion for the first 100 million doses. The supply agreement comes on top of $955 million in federal funding Moderna snared from the U.S. Biomedical Advanced Research and Development Authority (BARDA). Together with the new order, the U.S. has laid out $4.1 billion to develop and buy Moderna's vaccine, according to the Department of Health and Human Services.
There’s a lot of pressure on those extra Moderna doses—and for the shot to succeed when it goes before the FDA advisory committee this Thursday—particularly after media reports claiming Operation Warp Speed failed to lock down more doses of Pfizer and BioNTech’s vaccine hopeful when it had the chance.
Pfizer’s original $1.95 billion, 100 million-dose deal with the U.S. included an option for the government to purchase an extra 100 million to 500 million doses, and Pfizer itself urged the government to start with 200 million—enough to vaccinate 100 million people.
But officials reportedly rebuffed Pfizer on the grounds that its shot had not yet proven itself, and the drugmaker’s initial supplies are now spoken for, thanks to a slew of purchase agreements around the globe. The U.S. will need to strike a separate contract with Pfizer for any additional COVID-19 shots, a Pfizer spokesperson told Fierce Pharma last week.
Besides the U.S. deal for 200 million, Moderna pledged to supply up to 160 million doses to the European Union, and it has inked deals with Canada, Japan, Switzerland, the United Kingdom, Israel and Qatar.
Moderna’s vaccine has so far proven 94.1% effective in phase 3. Early- to mid-stage immunogenicity data showed patients’ antibody levels stayed elevated in the 90 days after they received a second dose of the vaccine, raising hopes that it could offer longer-term protection against COVID-19.
And last week, Moderna dosed the first adolescents in a phase 2/3 trial that could position its shot for an OK in teenagers ahead of the 2021-22 school year.
Last Friday, just over 24 hours after an FDA panel recommended emergency use of Pfizer and BioNTech’s vaccine, the FDA made it official, authorizing the first coronavirus shot for use in the U.S.