Operation Warp Speed
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][2] The first news report of Operation Warp Speed was on April 29, 2020,[3][4][5] and the program was officially announced on May 15, 2020.[1] It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021.[6] At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.[7]
Operation Warp Speed
The program promoted mass production of multiple vaccines, and different types of vaccine technologies, based on preliminary evidence, allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. The plan anticipated that some of these vaccines will not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines.[8]
Operation Warp Speed, initially funded with about $10 billion from the CARES Act (Coronavirus Aid, Relief, and Economic Security) passed by the United States Congress on March 27, 2020,[1] was an interagency program that includes components of the Department of Health and Human Services, including the Centers for Disease Control and Prevention, Food and Drug Administration, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs.[1]
According to the Department of Health and Human Services' fact sheet, the main stated goal of Operation Warp Speed was to "produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics".[2]
Specific targets, as outlined in various media, include:
While coordination was expected with the FDA on technical matters, Commissioner Stephen Hahn noted that the FDA would "provide technical and development assistance to Operation Warp Speed, but the manufacturers decide if they're going to go forward or not" and clarified that the agency had "drawn a very bright line at FDA between us and Operation Warp Speed because we're the independent regulator".[19]
Budget and leadership
Operation Warp Speed used BARDA as the financial interface between the U.S. federal government and the biomedical industry.[20] The program was initially being funded with $10 billion,[1] with additional funds allocated through BARDA.[1] Funding was increased to about $18 billion by October 2020.[21]
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".[22] In May, new leadership was announced. Moncef Slaoui was named Operation Warp Speed's chief adviser.[1][9] Slaoui is a vaccine researcher and, formerly, Chairman of Global Research and Development and Chairman of Global Vaccines at GlaxoSmithKline, where he led the development of five vaccines.[1] General Gustave F. Perna, who served as commanding general of Army Materiel Command, was named Operation Warp Speed chief operating officer.[1][23] Retired Lieutenant General Paul A. Ostrowski, who previously served as director of the Army Acquisition Corps, was the director of supply, production and distribution.[24][25] Army Major General Christopher J. Sharpsten was the deputy director.[26][27]
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.[28][29]
As of August 2020, eight companies were chosen for funding of some $11 billion to expedite development and preparation for manufacturing their respective vaccine candidates.[30][31]
The vaccine developers, different vaccine technologies, and treatments receiving government research funding were:
Indirectly funded companies include:
As of October 2020, Operation Warp Speed had spent less than $1 billion to support the development and manufacturing of three monoclonal antibody treatments, versus almost $10 billion on six vaccines.[52]
Pfizer–BioNTech
The BioNtech project to develop a novel mRNA technology for a COVID-19 vaccine was called "Project Lightspeed", which started in mid-January 2020 at BioNTech's laboratories in Mainz, Germany, just days after the SARS-Cov-2 genetic sequence was first made public.[54] In September 2020, BioNTech received €375 million (US$445 million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine.[55][56][57] On November 9, the Pfizer–BioNTech partnership announced positive early results from its Phase III trial of the BNT162b2 vaccine candidate, and on December 11, the FDA provided emergency use authorization, initiating the distribution of the vaccine.[58] 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".[59]
On July 22, 2020, the U.S. government placed a conditional advance-purchase order of $2 billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine, with an option for 500 million more, for use in the United States if the vaccine was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA).[56][60][61][62] On December 23, 2020, the Trump administration announced that they had ordered another 100 million doses from Pfizer.[63]
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. Pfizer's head of vaccine and research and development, Kathrin Jansen, had said on November 8 that they "were never part of the Warp Speed"; a day later, a company spokeswoman said that the company was "part of Operation Warp Speed as a supplier of a potential coronavirus vaccine".[64][65][66] Experts disagreed whether the U.S. government's conditional advance order "played an important role in expediting Pfizer’s vaccine development process".[56][60]
The United Kingdom was the first country to authorize the vaccine on an emergency basis on December 2, 2020.[67] Emergency use authorization in the United States was issued December 11, 2020.[68]
Distribution
Vaccine doses purchased by Operation Warp Speed were sent from manufacturers via UPS and FedEx to locations specified by state governments. The Federal Pharmacy Partnership delivers doses to CVS and Walgreens locations, which then send pharmacists for mass vaccinations at care facilities like nursing homes.
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.[69] The Trump administration later reduced the goal to twenty million doses. As of January 6, 2021, the CDC was reporting 17,288,950 doses distributed, but only 5,306,797 actually administered to a person.[70] Of those, 3,416,875 were distributed and 511,635 administered through the Federal Pharmacy Partnership. General Gustave Perna said reporting delays cause the administration numbers to lag by 72 to 96 hours.[71] By January 31, 2021, when Operation Warp Speed was being transferred to the Biden Administration, 63.7 million doses had been delivered of a total of 200 million doses that Pfizer and Moderna were contracted to provide by the end of March 2021.[72]
The distribution effort was criticized for lack of coordination between federal and state governments,[73] and lack of timely federal funding for mass vaccination campaigns.[69] Other reasons cited included the Christmas holiday, employees declining to be vaccinated, a longer than typical time spent on paperwork or answering patient questions, the required observation time, and shortage of trained staff.[74]