Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

[1] Operation Warp Speed was formed to encourage private and public partnerships to enable faster approval and production of vaccines during the COVID-19 pandemic.

[11][12] The Food and Drug Administration announced on June 30, 2020, that a vaccine would need to be at least 50% effective for diminishing the severity of COVID-19 symptoms to obtain regulatory and marketing approval.

[13] In January 2021, White House press secretary Jen Psaki announced that the program was expected to undergo a restructure and renaming under the Biden administration.

[22] Rick Bright, the BARDA director, was reassigned on or about April 22, 2020, following his resistance to (as he phrased it) "efforts to fund potentially dangerous drugs promoted by those with political connections".

[27][28] Alex Azar, Mark Esper, Jared Kushner and Adam Boehler were on the board of directors of OWS, while Deborah Birx, Tony Fauci, Francis Collins, and Robert Redfield were nonvoting advisers.

[59] Pfizer CEO Albert Bourla said that the company had not taken Warp Speed funding for the development of the vaccine out of a desire "to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together".

[64] After Pfizer-BioNTech's November 9 announcement, Vice President Mike Pence wrote in a tweet that credit belonged to the "public-private partnership forged by" Trump.

[citation needed] The Federal Pharmacy Partnership delivers doses to CVS and Walgreens locations, which then send pharmacists for mass vaccinations at care facilities like nursing homes.

[citation needed] In October 2020, Alex Azar, at that time the United States Secretary of Health and Human Services, predicted a hundred million available doses by the end of the year.

[5][79] Because many vaccines cause side effects, such as pain at the injection site, headaches, and influenza symptoms, safety testing requires years[citation needed] of observation in thousands of clinical trial participants.

[79] To prepare for manufacturing and distribution, Operation Warp Speed expended resources and financing before the safety and efficacy results of vaccine candidates were known.

[7][15] There was potential that the Warp Speed project would expend effort and funding in direct competition with publicly traded American vaccine companies already fully engaged and financed for development.

[86] In February 2021 after Operation Warp Speed was transitioned to the White House COVID-19 Response Team, the United States pledged to donate any vaccine surplus out of concern for vaccine-poor regions, such as Africa.

[87] There was concern that the name and intended shortened timeline of Operation Warp Speed could encourage vaccine hesitancy, with one expert stating that "some of the language coming out of the White House is very damaging" because one argument of anti-vaccinators is that products are rushed to market without adequate testing.

[92] Shareholders sued biotech firm Inovio, claiming the company misled the public when it reported how quickly it had designed the blueprint for its vaccine candidate.

[95] Executives, board members, and investment firms holding shares in vaccine and therapeutic companies, including Moderna, Novavax, and Regeneron, took profits worth some US$1 billion (about €830 million) on positive news during 2020.