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. The first news report of Operation Warp Speed was on April 29, 2020, and the program was officially announced on May 15, 2020. It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021. At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.
The program promoted mass production of multiple vaccines, and different types of vaccine technologies, based on preliminary evidence. Then there were clinical trials. The plan anticipated that some of these vaccines would 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.
Operation Warp Speed, initially funded with about $10billion from the CARES Act (Coronavirus Aid, Relief, and Economic Security) passed by the United States Congress on March 27, 2020, 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 (NIH), 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.
History
In April 2020, Robert Kadlec, Assistant Secretary for Preparedness and Response, worked with Peter Marks (physician), director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) to develop OWS. Kadlec and Marks wrote a proposal for then Secretary of the Department of Health and Human Services (HHS) Alex Azar detailing how Operation Warp Speed would screen potential vaccine candidates and eventually distribute final product to all Americans.Abutaleb, Yasmeen et al. "How the ‘deep state’ scientists vilified by Trump helped him deliver an unprecedented achievement", Washington Post (December 14, 2020).
A memo circulated by Kadlec and Marks to Azar on April 12 was the first detailed accounting of OWS’ goals: Inside the Messy Race to Develop a COVID Vaccine, Esquire (October 19, 2021).
"Project Warp Speed Maximally expediting a safe, effective vaccine A safe, effective, broadly administered vaccine is the single most important solution to the Covid-19 pandemic MISSION: Maximally expedite the development of a safe and effective vaccine with sufficient scale to inoculate all Americans who need it DEADLINE: Enable broad access to the public by October 2020 PLAN: Modeled after the Manhattan Project approach, a multi-disciplinary, multi-sector team that brings the numerous in-flight efforts under a single authority to drive relentless coordination, barrier elimination, and accountability for mission success"
Kadlec was responsible for setting the aggressive deadline of October 2020 to complete simultaneous clinical trials and roll out the vaccine to the American public. Recognizing the national security importance of OWS, Azar and Kadlec also worked to enlist the Department of Defense (DoD) as a key partner in both the science and the logistics.
On May 15, 2020, President Donald Trump officially announced the public-private partnership. The purpose of Operation Warp Speed was to coordinate Health and Human Services-wide efforts, including the NIH ACTIVACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV) partnership for vaccine and therapeutic development, the NIH RADxRAPID ACCELERATION OF DIAGNOSTICS (RADX) initiative for diagnostic development, and work by BARDA.
Operation Warp Speed was formed to encourage private and public partnerships to enable faster approval and production of vaccines during the COVID-19 pandemic. The name was inspired by terminology for faster-than-light travel used in the Star Trek fictional universe, evoking a sense of rapid progress.
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.
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. Also in January 2021, Dr. Moncef Slaoui, former Operation Warp Speed lead, was told not to use the name Operation Warp Speed anymore. At the end of February 2021, responsibilities of Operation Warp Speed were transferred into the White House COVID-19 Response Team.
Goals 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".
Specific targets, as outlined in various media, include: support pharmaceutical companies for R&D of seven different vaccine candidates simultaneously and certain therapeutic compounds support several vaccine manufacturers for rapid scale-up of manufacturing capacity support organization and facilitate simultaneous FDA review of Phase I-III clinical trials on several of the most promising vaccine candidates facilitate manufacturing vaccine candidates while they remain pre-approved during prefinal clinical research to prepare for rapid deployment, if proven to be safe and effective coordinate with the Department of Defense for vaccine supply, production, and deployment around the United States, and track every vaccine vial and the injection schedule for each American receiving a vaccination
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".
Budget and leadership Operation Warp Speed used BARDA as the financial interface between the U.S. federal government and the biomedical industry. The program was initially being funded with $10billion, with additional funds allocated through BARDA. Funding was increased to about $18billion by October 2020.
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". In May, new leadership was announced. Moncef Slaoui was named Operation Warp Speed's chief adviser. 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. General Gustave F. Perna, who served as commanding general of Army Materiel Command, was named Operation Warp Speed chief operating officer. Retired Lieutenant General Paul A. Ostrowski, who previously served as director of the Army Acquisition Corps, was the director of supply, production and distribution. Army Major General Christopher J. Sharpsten was the deputy director.
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.
Companies receiving funding
As of August 2020, eight companies were chosen for funding of some $11billion to expedite development and preparation for manufacturing their respective vaccine candidates.
The vaccine developers, different vaccine technologies, and treatments receiving government research funding were: +NameTechnologyAmountDate announcedVaccine candidateDate FDA authorizedNotesJohnson & Johnson (Janssen Pharmaceutical)Non-replicating viral vector$1billionAugust 5, 2020Ad26.COV2-SFebruary 28, 2021This funding is in addition to $456million the government awarded in March 2020. FDA authorized emergency use only.AstraZeneca–University of Oxford and VaccitechModified chimpanzee adenovirus viral vectorUp to $1.2billionMay 21, 2020AZD1222No FDA authorization.First authorized December 20, 2020, in the United Kingdom. In March 2021, a number of countries paused use of the vaccine out of fears it may be implicated in cases of blood clotting observed in vaccine recipients.ModernamRNA$1.53billionAugust 11, 2020mRNA-1273December 18, 2020The government had already given Moderna two grants of $483million and $472million. The $1.53billion announced on August 11 brought the total investment to $2.48billion. FDA authorized emergency use only.NovavaxSARS-CoV-2 recombinant spike protein nanoparticle with adjuvant$1.6billion for advance commercial-scale manufacturingJuly 7, 2020NVX‑CoV2373Funding to demonstrate commercial-scale manufacturing; federal government will own the 100 million doses produced, but will be made available for clinical trialsMerck and IAVIAntiviral drug research and immune response therapy$38millionApril 15, 2020 Two vaccine projects terminated by Merck, January 25, 2021Sanofi and GlaxoSmithKlineProtein (insect cell lines) with adjuvant$2.1billionJuly 31, 2020VAT00008On December 11, 2020, the companies announced that they would delay the vaccine's release until late 2021 because it produced "insufficient immune response" in elderly people. Indirectly funded companies include:
Inovio
As of October 2020, Operation Warp Speed had spent less than $1billion to support the development and manufacturing of three monoclonal antibody treatments, versus almost $10billion on six vaccines.
Regeneron was to receive $450million to develop and supply a monoclonal antibody drug, according to a government announcement on July 7, 2020.
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. In September 2020, BioNTech received €375million (million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine. 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. 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".
On July 22, 2020, the U.S. government placed a conditional advance-purchase order of $2billion with Pfizer to manufacture 100million doses of a COVID-19 vaccine, with an option for 500million 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). On December 23, 2020, the Trump administration announced that they had ordered another 100million doses from Pfizer.