|Operation Warp Speed|
|Active||May 15, 2020 – February 24, 2021|
|Disbanded||Transitioned to White House COVID-19 Response Team|
|Part of|| U.S. Department of Defense |
U.S. Department of Health and Human Services
Other various government agencies
|Engagements||Coronavirus disease 2019|
|Website||Coronavirus: Operation Warp Speed|
|Chief Operating Officer||General Gustave F. Perna|
|Commander in Chief|| Donald Trump |
|Part of a series on the|
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, 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.
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, 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.
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 ACTIV partnership for vaccine and therapeutic development, the NIH 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 30 June 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.
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, included:
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".
Operation Warp Speed used BARDA as the financial interface between the U.S. federal government and the biomedical industry. billion, with additional funds allocated through BARDA. Funding was increased to about $18 billion by October 2020.The program was initially being funded with $10
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.
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.
The vaccine developers, different vaccine technologies, and treatments receiving government research funding were:
|Name||Technology||Amount||Date announced||Vaccine candidate||Date FDA authorized||Notes|
|Johnson & Johnson (Janssen Pharmaceutical)||Non-replicating viral vector||$1 billion||August 5, 2020||Ad26.COV2-S||February 28, 2021||This funding is in addition to $456 million the government awarded in March 2020. FDA authorized emergency use only.|
|AstraZeneca–University of Oxford and Vaccitech||Modified chimpanzee adenovirus viral vector||$1.2 billion||May 21, 2020||AZD1222||No 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.|
|Moderna||mRNA||$1.53 billion||August 11, 2020||mRNA-1273||18 December 2020||The government had already given Moderna two grants of $483 million and $472 million. The $1.53 billion announced on August 11 brought the total investment to $2.48 billion. FDA authorized emergency use only.|
|Novavax||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||Antiviral drug research and immune response therapy||$38 million||April 15, 2020||two vaccine projects terminated by Merck, January 25, 2021|
|Sanofi and GlaxoSmithKline||Protein (insect cell lines) with adjuvant||$2.1 billion||July 31, 2020||VAT00008||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.|
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.
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. million (US$445 million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine.In September 2020, BioNTech received €375
Pfizer CEO Albert Bourla said that the company decided against taking direct 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".
But 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 was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA). On December 23, the Trump administration announced that they had ordered another 200 million doses from Pfizer. 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 head of vaccine research and development Dr. Kathrin Jansen initially said Pfizer was not a participant in Operation Warp Speed because it did not accept taxpayer funds for research and development, but Pfizer released a statement saying her comments had been "taken out of context" and confirmed that Pfizer was a part of the Warp Speed program.The White House confirmed Pfizer's involvement and the government's initial advance-order purchase for a hundred million doses of vaccine. Company representatives said in November that "the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine," 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."
The United Kingdom was the first country to authorize the vaccine on an emergency basis on December 2, 2020.Emergency use authorization in the United States was issued December 11, 2020.
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.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. 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. )
The distribution effort was criticized for lack of coordination between federal and state governments,and lack of timely federal funding for mass vaccination campaigns. 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.
Although initially budgeted by Congress for about $10 billion in May 2020, 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.
Operation Warp Speed 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.The low prices of coronavirus vaccines were 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 had higher effectiveness than flu vaccines, vaccine developers set initial pricing in line with those of the annual influenza vaccine.
The goals of the project –to develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020 –were initially 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 have adequate efficacy.
Most viral infections do not have vaccines because the vaccine technology failed in early-stage clinical trials. [ citation needed ] of observation in thousands of clinical trial participants. Similarly, sufficient time –a year or multiple years –is usually needed to be certain a vaccine has durable efficacy while the virus remains pandemic. 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. To prepare for manufacturing and distribution, Operation Warp Speed expended resources and financing before the safety and efficacy results of vaccine candidates were known.Because many vaccines cause side effects, such as pain at the injection site, headaches, and influenza symptoms, safety testing requires years
In the case of Operation Warp Speed, effective vaccines made by BioNTech in Germany and Pfizer and Moderna were given an emergency use authorization by the FDA in December 2020, established an exceptionally fast development and approval timeline for vaccines granted emergency marketing. Pfizer joined the Warp Speed program in July 2020, and signed a $1.95 billion contract to be paid out when the vaccine would be FDA approved, and included an initial order of 100 million vaccines.In December 2020, the Trump admin ordered additional 200 million vaccines from Pfizer.
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. –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, when the AstraZeneca vaccine was successful in advancing to proof of safety and efficacy beyond its status as an early-stage Phase I–II trial in May.There was also the possibility that a billion dollars or more of U.S. taxpayer money would be expended on only American efforts or a narrow alternate choice, such as investing in one other vaccine platform
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. 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.
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).
The focus of Operation Warp Speed to deploy approved COVID-19 vaccines first for the American people raised ethical and logistical concerns that access to vaccines outside of the United States may be restricted during 2021, leaving low-to-middle-income countries with no or minimal supply.Concerns were elevated when the Trump administration withdrew its financial support for the WHO and COVAX, and whether the program would participate in international vaccination practices, optimization, and education against vaccine hesitancy and misinformation. 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.
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.Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health concern, which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020–21. 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.
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. 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. At the request of the incoming Biden administration, Slaoui resigned from the project in early January 2021.
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. US$1 billion (about €830 million) on positive news during 2020.A class action lawsuit was filed in August 2020 against Vaxart in Northern California U.S. District Court for alleged securities fraud, a concern related to Vaxart executives enriching themselves by selling shares timed to positive news on vaccine development during mid-2020. Executives, board members, and investment firms holding shares in vaccine and therapeutic companies, including Moderna, Novavax, and Regeneron, took profits worth some
Pfizer Inc. is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German immigrants, Charles Pfizer (1824-1906) and his cousin Charles F. Erhart (1821-1891).
Moderna, Inc is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts. It focuses on vaccine technologies based on messenger RNA (mRNA). Moderna's vaccine platform inserts synthetic nucleoside-modified messenger RNA (modRNA) into human cells using a coating of lipid nanoparticles. This mRNA then reprograms the cells to prompt immune responses. Moderna develops mRNA therapeutic vaccines that are delivered in lipid nanoparticles, using mRNA with pseudouridine nucleosides. Candidates are designed to have improved folding and translation efficiency via insertional mutagenesis.
The COVID-19 pandemic in the United States is part of the worldwide pandemic of coronavirus disease 2019. More than 40.3 million confirmed cases have been reported since January 2020, with more than 651,000 deaths, the most of any country, and the twenty-fourth-highest per capita worldwide. As many infections have gone undetected, the Centers for Disease Control and Prevention (CDC) estimated that, as of May 2021, there could be a total 120.2 million infections in the United States, or more than a third of the total population. The US has about one-fifth of the world's confirmed cases and deaths. COVID-19 was the third-leading cause of death in the US in 2020, behind heart disease and cancer. US life expectancy dropped by 3 years for Hispanic Americans, 2.9 years for African Americans, and 1.2 years for white Americans from 2019 to 2020.
A COVID‑19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 (COVID‑19). Prior to the COVID‑19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. On 10 January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by 19 March, the global pharmaceutical industry announced a major commitment to address COVID-19. The COVID‑19 vaccines are widely credited for their role in reducing the spread, severity, and death caused by COVID-19.
The Moderna COVID‑19 vaccine, codenamed mRNA-1273 and sold under the brand name Spikevax, is a COVID-19 vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). It is authorized for use in people aged twelve years and older in some jurisdictions and for people eighteen years and older in other jurisdictions to provide protection against COVID-19 which is caused by infection by the SARS-CoV-2 virus. It is designed to be administered as two or three 0.5 mL doses given by intramuscular injection at an interval of at least 28 days apart.
Moncef Mohamed Slaoui is a Moroccan-born Belgian-American researcher who served as the Head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021.
BioNTech SE is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develops pharmaceutical candidates based on messenger ribonucleic acid (mRNA) for use as individualized cancer immunotherapies, as vaccines against infectious diseases and as protein replacement therapies for rare diseases, and also engineered cell therapy, novel antibodies and small molecule immunomodulators as treatment options for cancer.
COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Health Organization (WHO). It is one of the three pillars of the Access to COVID-19 Tools Accelerator, an initiative begun in April 2020 by the WHO, the European Commission, and the government of France as a response to the COVID-19 pandemic. COVAX coordinates international resources to enable low-to-middle-income countries equitable access to COVID-19 tests, therapies, and vaccines. By 15 July 2020, 165 countries – representing 60% of the human population – had joined COVAX.
The Pfizer–BioNTech COVID-19 vaccine, sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. It is authorized for use in people aged twelve years and older in some jurisdictions and for people sixteen years and older in other jurisdictions, to provide protection against COVID-19, caused by infection with the SARS-CoV-2 virus. For its development BioNTech collaborated with Pfizer, an American company, for support with clinical trials, logistics, and manufacturing. The vaccine is given by intramuscular injection. It is composed of nucleoside-modified mRNA (modRNA) encoding a mutated form of the full-length spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles. Initial advice indicated that vaccination required two doses given 21 days apart, but the interval was later extended to up to 42 days in the US, and up to four months in Canada.
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Drew Weissman is a physician-scientist best known for his contributions to RNA biology. His work helped enable development of effective mRNA vaccines, the best known of which are those for COVID-19 produced by BioNTech/Pfizer and Moderna. Weissman is a professor of medicine at the Perelman School of Medicine at the University of Pennsylvania.
The COVID-19 vaccination campaign in Italy is a mass immunization campaign that was put in place by the Italian government in order to respond to the ongoing COVID-19 pandemic. It started on 27 December 2020, together with most countries in the European Union.
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COVID-19's caused virus, SARS-CoV-2, was isolated in late 2019. Its genetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive COVID-19 vaccine. Since 2020, vaccine development has been expedited via unprecedented collaboration in the multinational pharmaceutical industry and between governments. By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection. According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.
The COVID-19 vaccination program in Canada is an ongoing, intergovernmental effort coordinated between the bodies responsible in the Government of Canada to acquire and distribute vaccines to individual provincial and territorial governments who in turn administer approved COVID-19 vaccines during the COVID-19 pandemic in Canada. Some provinces have asked local municipal governments, hospital systems, family doctors and independently owned pharmacies to aid in part, or in full with vaccination rollout. The vaccination effort in full is the largest such immunization effort in the nation's history; it started in mid-December 2020 and is currently ongoing.
The CureVac COVID-19 vaccine is a COVID-19 vaccine candidate developed by CureVac N.V. and the Coalition for Epidemic Preparedness Innovations (CEPI). The vaccine showed inadequate results in its Phase III trials with only 47% efficacy.
The COVID-19 vaccination campaign in the United States is an ongoing mass immunization campaign for the COVID-19 pandemic in the United States. The FDA granted emergency use authorization to the Pfizer–BioNTech vaccine on December 10, 2020; mass vaccinations began on December 14, 2020. The Moderna vaccine was granted emergency use authorization on December 17, 2020, and the Janssen vaccine was granted emergency use authorization on February 27, 2021. By April 19, 2021, all U.S. states had opened vaccine eligibility to residents aged 16 and over. On May 10, 2021, the FDA approved the Pfizer vaccine for adolescents aged 12 to 15. On August 23, 2021, the FDA granted full approval to the Pfizer–BioNTech vaccine for individuals aged 16 and over.
COVID-19 vaccine clinical research is the clinical research on COVID-19 vaccines, including their efficacy, effectiveness and safety. There are 22 vaccines authorized for use by national governments, with six vaccines being approved for emergency or full use by at least one WHO-recognised stringent regulatory authority; and five of them are in Phase IV. 204 vaccines under clinical trials that have not yet been authorized. There are also nine clinical trials on heterologous vaccination courses.
Among its other objectives, Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.
[President] Trump described the administration's plan as 'a massive scientific industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project' of World War II, with the intent to rapidly develop and distribute a vaccine with help from the U.S. military and world-renowned doctors and scientists.
The project will cost billions of dollars, one of the people said. And it will almost certainly result in significant waste by making inoculations at scale before knowing if they'll be safe and effective –meaning that vaccines that fail will be useless. But it could mean having doses of vaccine available for the American public by the end of this year, instead of by next summer.
advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021 ... Of the eight vaccines in OWS’s portfolio, six have been announced and partnerships executed with the companies: Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein). These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.
And while the company has said that it is part of Operation Warp Speed –the flagship federal effort to quickly produce treatments and vaccines for the coronavirus –Inovio is not on the list of companies selected to receive financial support to mass-produce vaccines.
On Monday, a spokeswoman for Pfizer clarified that the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccineCS1 maint: uses authors parameter (link)
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