The White House has secured eight experimental coronavirus vaccines through its “Operation Warp Speed” effort, seeking to hedge its bets on different technologies, according to a top adviser to the program.
Moncef Slaoui, the operation’s chief adviser, and Matthew Hepburn, a Department of Defense official, outlined the federal criteria for selecting and securing vaccine candidates in an essay in the New England Journal of Medicine on Wednesday.
Slaoui and Hepburn wrote that that each candidate selected for the Warp Speed portfolio must employ one of four types of vaccine platform technologies believed by the U.S. to likely yield a safe and effective shot. That includes newer technologies such as so-called messenger RNA, as well as older ones using a weakened form of a pathogen to induce an immune response without causing disease.
So far, the government has announced deals for supplying six COVID-19 vaccines candidates. Those shots are being developed by Johnson & Johnson, Moderna Inc., Pfizer Inc. in partnership with BioNTech SE, the University of Oxford in collaboration with AstraZeneca Plc, Sanofi with GlaxoSmithKline Plc, and Novavax Inc.
The final two unidentified candidates will enter trials soon, Slaoui and Hepburn said.
Operations Warp Speed’s other requirements for inclusion in its portfolio are robust pre-clinical or early stage vaccine data, the ability to enter large, late-stage trials in the summer or fall, and the ability to manufacture at scale, with more than 100 million doses ready by mid-2021.
Bloomberg reported in June that Merck & Co. had also been tapped for the operation’s portfolio, though no formal announcement has been made. One of Merck’s two vaccine candidates — based on a measles shot used in Europe — enters the clinic this month. A spokeswoman for Merck declined to comment on whether the company had reached an agreement with the U.S.
Operation Warp Speed is an effort that brings together the Department of Health and Human Services, the Biomedical Advance Research and Development Authority and the Department of Defense, as well as other agencies, to expedite the development, manufacturing and distribution of coronavirus inoculations and treatments.
On Wednesday, Slaoui and Hepburn reiterated that the government wants to have tens of millions of doses of a COVID-19 vaccine approved or authorized for use by the end of 2020, and as many as 300 million doses available and deployed by mid-2021.
Slaoui and Hepburn said the U.S. will ensure that all selected vaccines enroll 30,000 to 50,000 participants in late-stage trials, and that trial endpoints are “harmonized to permit appropriate comparisons.”
The U.S. is working to ensure that “the most vulnerable and at-risk persons will receive vaccine doses once they are ready,” Slaoui and Hepburn said in the New England Journal of Medicine report. But that will also depend on the relative performance of each vaccine in various populations.
© 2020 Bloomberg News
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