Operation Warp Speed

Operation Warp Speed (OWS) is a public–private partnership initiated by the U.S. 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 is headed by co-chair of the COVID-19 Advisory Board, David A. Kessler.[6]

Operation Warp Speed
Official seal of Operation Warp Speed
ActiveMay 15, 2020 – present
(8 months, 3 weeks and 1 day)
CountryUnited States
Allegiance United States
Part ofU.S. Department of Defense
U.S. Department of Health and Human Services
Other various government agencies
EngagementsCoronavirus disease 2019
WebsiteCoronavirus: Operation Warp Speed
Commanders
Chief Operating OfficerGeneral Gustave F. Perna, USA
Chief Scientific AdvisorDavid A. Kessler
Commander in ChiefJoe Biden (2021 – present)
Donald Trump (2020 – 2021)

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The program promotes 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 anticipates 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.[7]

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,[1] is 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]

History

On May 15, 2020, President Donald Trump officially announced the public-private partnership.[4][1][8] The purpose of Operation Warp Speed is to coordinate Health and Human Services-wide efforts, including the NIH ACTIV partnership for vaccine and therapeutic development, the NIH RADx initiative for diagnostic development, and work by BARDA.[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.[2] The name was inspired by terminology for faster-than-light travel used in the Star Trek fictional universe, evoking a sense of rapid progress.[9][10]

The Food and Drug Administration announced on June 30, 2020 that in order to gain approval, the vaccine will need to be at least 50% effective in at least diminishing the severity of COVID-19 symptoms.[11]

In January 2021, White House press secretary Jen Psaki announced that the program is expected to undergo a restructure and rename under the Biden administration.[12][13]

President Donald Trump formally announced Operation Warp Speed on May 15, 2020, in the White House Rose Garden.[14]

Goals

According to the Department of Health and Human Services' fact sheet, the main stated goal of Operation Warp Speed is 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:

  • support pharmaceutical companies for R&D of seven different vaccine candidates simultaneously and certain therapeutic compounds[2]
  • support several vaccine manufacturers for rapid scale-up of manufacturing capacity[2]
  • support organization and facilitate simultaneous FDA review of Phase I-III clinical trials on several of the most promising vaccine candidates[2]
  • 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[2][15]
  • 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[2][16]

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."[17]

Budget and leadership

Operation Warp Speed uses BARDA as the financial interface between the U.S. federal government and the biomedical industry.[18] 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.[19]

Rick Bright, the BARDA Director, was reassigned on or about April 22 following his resistance to (as he phrased it) "efforts to fund potentially dangerous drugs promoted by those with political connections." [20] In May, new leadership was announced. Moncef Slaoui was named Operation Warp Speed's chief adviser.[1][8] 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][21] Retired Lieutenant General Paul A. Ostrowski, who previously served as Director of the Army Acquisition Corps, is the Director of Supply, Production, and Distribution.[22][23]

Companies receiving research funding
See also: COVID-19 vaccine § Vaccines

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.[24][25]

The vaccine developers, different vaccine technologies, and treatments receiving government research funding are:

Name Technology Amount Date announced Vaccine candidate Notes
Johnson & Johnson (Janssen Pharmaceutical)[26][27][28] Non-replicating viral vector $1 billion August 5, 2020 Ad26.COV2-S This is in addition to $456 million the government awarded in March 2020.[29][30]
AstraZeneca–University of Oxford[31] and Vaccitech[32] Modified chimpanzee adenovirus viral vector $1.2 billion May 21, 2020 AZD1222
Moderna[24][25] mRNA $1.53 billion August 11, 2020 mRNA-1273 The government had already given Moderna two grants of $483 million and $472 million.[33] The $1.53 billion announced on August 11 brings the total investment to $2.48 billion.
Novavax[34][35][36] SARS-CoV-2 recombinant spike protein nanoparticle with adjuvant $1.6 billion for advance commercial-scale manufacturing July 7, 2020 NVX‑CoV2373 Funding to demonstrate commercial-scale manufacturing; federal government will own the 100 million doses produced, but will be made available for clinical trials
Merck and IAVI
(two vaccine projects terminated by Merck, January 25, 2021)
[37]		 Antiviral drug research and immune response therapy[37] $38 million April 15, 2020
Sanofi and GlaxoSmithKline[38] Protein (insect cell lines) with adjuvant $2.1 billion July 31, 2020 No name as of October 2020[39] On 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.[40]

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.[44]

Companies not receiving research funding

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.[46] 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.[47]

Pfizer CEO Albert Bourla said that the company decided against taking 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."[48]

On July 22, Operation Warp Speed placed an advance-purchase order of $2 billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine for use in the United States when the vaccine is shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA).[49][50][51] Because it is a two-dose vaccine, this would be enough to vaccinate 50 million Americans. (Pfizer contracted to sell twice that amount of vaccine to the European Union.)[52] 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.[53]

Pfizer initially stated that it was not a participant in Operation Warp Speed because it did not accept taxpayer funds for research and development, but the White House said that the government's advance-order purchase for 100 million doses of vaccine made Pfizer a participant.[54] Company representatives said in November that "the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine",[55] and that "Pfizer is proud to be one of various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine".[56] A spokesperson for Pfizer, however, clarified that they had "not taken federal money for R&D,"[57] but rather its partner, BioNTech, had received substantial funding for accelerated vaccine development and manufacturing from the German government.[47]

Distribution

Vaccine doses purchased by Operation Warp Speed are 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 predicted 100 million available doses by the end of the year.[58] The Trump administration later reduced the goal to 20 million doses, although Operation Warp Speed received praise for its historical accomplishment of producing a vaccine in less than a year. As of January 6, 2021, the CDC was reporting 17,288,950 doses distributed, but only 5,306,797 actually administered to a person.[59] 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.[60])

The distribution effort was criticized for lack of coordination between federal and state governments,[61] and lack of timely federal funding for mass vaccination campaigns.[58] Other reasons cited included the Christmas holiday, employees declining to be vaccinated, a longer than typical time spent on paperwork on answering patient questions, the required observation time, and shortage of trained staff.[62]

Reception
See also: COVID-19_vaccine § Society and culture

Cost

Although initially budgeted by Congress for about $10 billion in May 2020,[1] Operation Warp Speed had spent $12.4 billion by mid-December on vaccine developers for the combined costs of R&D and pre-approval manufacturing for millions of vaccine doses.[63]

Operation Warp Speed anticipates 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.[7] The low prices of coronavirus vaccines have been attributed to the high amount of research funding provided by Operation Warp Speed: despite preliminary data suggesting that the COVID-19 vaccines subsidized by the plan can have much higher effectiveness than flu vaccines, vaccine developers have set initial pricing in line with those of the annual influenza vaccine.[64]

Timeline

The goals of the project, to develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020, had been criticized as being unrealistic, based on decades of experience in developing viral infection vaccines which normally require years or decades for assuring the chosen vaccine will not be toxic and has adequate efficacy.[5][65][66] Most viral infections do not have vaccines because the vaccine technology has failed in early-stage clinical trials.[5][65] Because many vaccines cause side effects, such as pain at the injection site, headaches, and influenza symptoms, safety testing requires years of observation in thousands of clinical trial participants.[65][66]

Similarly, sufficient time – a year or usually many years – is usually needed to be certain a vaccine has durable efficacy while the virus remains pandemic.[21][65][66] Despite extensive previous research attempts to produce safe, effective vaccines against coronaviruses, such as SARS and MERS, all vaccine candidates for coronavirus infections have failed during clinical research, and no vaccine existed to prevent any coronavirus infection.[65] To prepare for manufacturing and distribution, Operation Warp Speed expended resources and financing before the safety and efficacy results of vaccine candidates were known.

Competition

There is potential that the Warp Speed project will expend effort and funding in direct competition with publicly-traded American vaccine companies already fully engaged and financed for development.[5] There is also the possibility that a billion dollars or more of U.S. taxpayer money will be expended on only American efforts or a narrow alternate choice, such as investing in one other vaccine platform – the University of Oxford-AstraZeneca candidate for which the U.S. already paid US$1 billion in May 2020 to receive 300 million doses for American use, if the AstraZeneca vaccine is successful in advancing to proof of safety and efficacy beyond its status as an early-stage Phase I–II trial in May.[67]

Warp Speed did not partner with Chinese vaccine development organizations, or with the World Health Organization (WHO), the Coalition for Epidemic Preparedness Innovations, or the European Commission, which are coordinating and financing international programs for multiple vaccine development, having raised $8 billion together from international partners on May 4 for a Coronavirus Global Response.[4] The U.S. government chose not to include Operation Warp Speed as part of the international Solidarity trial on vaccine development, organized by the WHO.[4]

President Trump displays Executive Order 13962, which requires priority access to COVID-19 vaccines developed in the United States, signed December 8, 2020

On December 8, 2020, President Trump signed an executive order mandating that companies sell vaccine to the US before selling to any other countries (even if they already had contracts with other countries).[68][69]

Vaccine hesitancy

There is concern that the name and intended shortened timeline of Operation Warp Speed could encourage the antivaccine movement, with one expert stating: "I don’t see a path by which you can collect enough efficacy and safety data by the end of the year."[4] Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health concern called vaccine hesitancy,[70] which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020–21.[71] A September 2020 survey found that half of American adults surveyed said they would not accept a vaccination if it was available at that time, and three-quarters expressed concerns about the pace of the process and fears that a vaccine might be confirmed before its safety and effectiveness are fully understood.[72]

Leader neutrality

The leader of the Operation Warp Speed project, Moncef Slaoui, had been a board member of the U.S. vaccine developer, Moderna, and divested his shares in Moderna stock, at a potential personal gain of $10 million, raising questions of his neutrality in judging vaccine candidates.[73] Although Slaoui resigned from the Moderna board when named to head Warp Speed, his share value in Moderna stock increased by $3 million in one day when Moderna announced an advance in vaccine clinical research.[73] At the request of the incoming Biden administration, Slaoui resigned from the project in early January 2021.[74]

Exaggerated claims

Shareholders have sued biotech firm Inovio, claiming the company exaggerated evidence for its coronavirus vaccine's efficacy in order to boost its stock price.[75]

A class action lawsuit has been filed against Vaxart in Northern California U.S. District Court for alleged securities fraud,[76] a concern also reported in the press.[77]

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