Operation Warp Speed

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Operation Warp Speed
120px
Official seal of Operation Warp Speed
Active May 15, 2020 – February 24, 2021
(285 days)
Country United States
Allegiance  United States
Part of U.S. Department of Defense
U.S. Department of Health and Human Services
Other various government agencies
Engagements Coronavirus disease 2019
Disbanded Transitioned to White House COVID-19 Response Team
Website Coronavirus: Operation Warp Speed
Commanders
Head Moncef Slaoui
Chief Operating Officer General Gustave F. Perna
Commander in Chief Donald Trump
Joe Biden

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]

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,[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]

History

File:President Trump Delivers an Update on Vaccine Development (49899015697).jpg
President Donald Trump formally announced Operation Warp Speed on May 15, 2020, in the White House Rose Garden.

On May 15, 2020, President Donald Trump officially announced the public-private partnership.[4][1][9] 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.[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.[10][11]

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.[12]

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.[13][14] Also in January 2021, Dr. Moncef Slaoui, former Operation Warp Speed lead, was told not to use the name Operation Warp Speed anymore.[15] At the end of February 2021, responsibilities of Operation Warp Speed were transferred into the White House COVID-19 Response Team.[7][16]

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".[2]

Specific targets, as outlined in various media, included:

  • 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][17]
  • 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][18]

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 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, is the director of supply, production, and distribution.[24][25]

Companies receiving research funding

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.[26][27]

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)[28][29][30] 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.[31][32] FDA authorized emergency use only.[33]
AstraZenecaUniversity of Oxford[34] and Vaccitech[35] Modified chimpanzee adenovirus viral vector $1.2 billion May 21, 2020 AZD1222 No FDA authorization. First authorized December 20, 2020, in the United Kingdom.[36] 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.[37]
Moderna[26][27] 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.[38] The $1.53 billion announced on August 11 brought the total investment to $2.48 billion. FDA authorized emergency use only.[39]
Novavax[40][41][42] 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)
[43]
Antiviral drug research and immune response therapy[43] $38 million April 15, 2020
Sanofi and GlaxoSmithKline[44] Protein (insect cell lines) with adjuvant $2.1 billion July 31, 2020 VAT00002 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.[45]

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.[49]

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.[51] 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.[52]

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".[53]

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).[54][55][56] Because it is a two-dose vaccine, this would be enough to vaccinate fifty million Americans. (Pfizer contracted to sell twice that amount of vaccine to the European Union.)[57] On November 9, the PfizerBioNTech 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 initially said 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 the government's advance-order purchase for a hundred million doses of vaccine made Pfizer a participant.[59] Company representatives said in November that "the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine,"[60] 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."[61] A spokesperson for Pfizer, however, clarified that they had "not taken federal money for R&D",[62] but rather its partner, BioNTech, had received substantial funding for accelerated vaccine development and manufacturing from the German government.[52]

The United Kingdom was the first country to authorize the vaccine on an emergency basis on December 2, 2020.[63] Emergency use authorization in the United States was issued December 11, 2020.[64]

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 predicted a hundred million available doses by the end of the year.[65] 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.[66] 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.[67])

The distribution effort was criticized for lack of coordination between federal and state governments,[68] and lack of timely federal funding for mass vaccination campaigns.[65] 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.[69]

Reception

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.[70]

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.[8] 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.[71]

Timeline

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.[5][72][73]

Most viral infections do not have vaccines because the vaccine technology failed in early-stage clinical trials.[5][72] 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.[72][73] Similarly, sufficient time – a year or multiple years – is usually needed to be certain a vaccine has durable efficacy while the virus remains pandemic.[23][72][73] 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.[72] To prepare for manufacturing and distribution, Operation Warp Speed expended resources and financing before the safety and efficacy results of vaccine candidates were known.

In the case of Operation Warp Speed, effective vaccines made by BioNTech in Germany and Pfizer (a partnership not funded by Operation Warp Speed) 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.

Competition

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.[5] 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 – 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.[74]

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]

File:Operation Warp Speed Vaccine Event (50705630873) (cropped).jpg
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).[75][76]

Concern for equitable access

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.[77] 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.[77] 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.[78]

Vaccine hesitancy

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.[4] Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health concern,[79] which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020–21.[80] 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.[81]

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.[82] 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.[82] At the request of the incoming Biden administration, Slaoui resigned from the project in early January 2021.[83]

Lawsuits and insider trading

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.[84] A class action lawsuit was filed in August 2020 against Vaxart in Northern California U.S. District Court for alleged securities fraud,[85] a concern related to Vaxart executives enriching themselves by selling shares timed to positive news on vaccine development during mid-2020.[86] 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.[86]

References

  1. 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 "Trump Administration Announces Framework and Leadership for 'Operation Warp Speed'". U.S. Department of Health and Human Services. May 15, 2020. Archived from the original on December 16, 2020. Retrieved May 15, 2020. Among its other objectives, Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 "Fact Sheet: Explaining Operation Warp Speed". US Department of Health and Human Services. November 10, 2020. Archived from the original on December 19, 2020. Retrieved November 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  3. Jacobs, Jennifer; Armstrong, Drew (April 29, 2020). "Trump's 'Operation Warp Speed' aims to rush coronavirus vaccine". Bloomberg News. Archived from the original on December 17, 2020. Retrieved May 15, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  4. 4.0 4.1 4.2 4.3 4.4 Cohen, Jon (May 12, 2020). "Unveiling 'Warp Speed,' the White House's America-first push for a coronavirus vaccine". Science. doi:10.1126/science.abc7056. S2CID 219432336. Archived from the original on November 29, 2020. Retrieved May 16, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  5. 5.0 5.1 5.2 5.3 Sanger, David E. (April 29, 2020). "Trump seeks push to speed vaccine, despite safety concerns". The New York Times. Archived from the original on December 9, 2020. Retrieved May 15, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  6. Kaplan, Sheila (January 15, 2021). "Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts". The New York Times. Archived from the original on January 15, 2021. Retrieved January 15, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  7. 7.0 7.1 Zraick, Karen (February 24, 2021). "Meet the key members of Biden's Covid-19 response team". The New York Times. ISSN 0362-4331. Retrieved March 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  8. 8.0 8.1 Jacobs, Jennifer; Armstrong, Drew (April 29, 2020). "Trump's 'Operation Warp Speed' Aims to Rush Coronavirus Vaccine". Bloomberg News. Archived from the original on December 17, 2020. Retrieved May 15, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  9. 9.0 9.1 Conklin, Audrey (May 15, 2020). "Trump launches 'Operation Warp Speed' for coronavirus vaccine". Fox Business. Archived from the original on December 20, 2020. Retrieved May 15, 2020. [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.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  10. LaFraniere, Sharon; Thomas, Katie; Weiland, Noah; Baker, Peter; Karni, Annie (August 2, 2020). "Scientists Worry About Political Influence Over Coronavirus Vaccine Project". The New York Times. Archived from the original on December 19, 2020. Retrieved December 17, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  11. McGinley, Laurie (August 11, 2020). "Meet the most important federal official you probably don't know – the man who holds the fate of the coronavirus vaccine in his hands". The Washington Post. Archived from the original on December 14, 2020. Retrieved December 17, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  12. Elizabeth Weise (June 30, 2020). "FDA says a coronavirus vaccine would have to be at least 50% effective to be approved". USA Today. Archived from the original on December 12, 2020. Retrieved July 1, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  13. Kennedy, Merrit (January 15, 2021). "Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures'". NPR. Archived from the original on January 29, 2021. Retrieved January 29, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  14. Kaplan, Sheila; Stolberg, Sheryl Gay (January 15, 2021). "Biden picks a former F.D.A. chief to lead federal vaccine efforts, which will drop the name Operation Warp Speed". The New York Times. ISSN 0362-4331. Archived from the original on January 27, 2021. Retrieved January 29, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  15. Cohen, Jon (January 29, 2021). "Ex-vaccine chief reflects on triumphs, failures, and Trump". Science. 371 (6528): 449–450. doi:10.1126/science.371.6528.449. PMID 33510005 Check |pmid= value (help). Archived from the original on February 8, 2021. Retrieved February 12, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  16. Vergun, David (February 25, 2021). "DOD Officials Provide COVID-19 Response Update". U.S. Department of Defense. Retrieved March 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  17. David Wallace-Wells (December 7, 2020). "We had the vaccine the whole time". Intelligencer, New York Magazine, Vox Media Network, Inc. Archived from the original on December 8, 2020. Retrieved December 8, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  18. C. Todd Lopez (October 28, 2020). "In Warp Speed Effort, Knowing Where Vaccines Are Is Key to Distribution Strategy". US Department of Defense. Archived from the original on December 5, 2020. Retrieved December 8, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  19. "AMA, FDA video update: The critical role of health care professionals during COVID-19". AMA-Assn.org. American Medical Association. Archived from the original on December 18, 2020. Retrieved December 17, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  20. Dan Gorenstein (October 30, 2014). "BARDA: The venture capital firm buried in the US government". Marketplace, Minnesota Public Radio. Archived from the original on June 13, 2020. Retrieved November 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  21. Stephanie Baker; Cynthia Koons (October 29, 2020). "Inside Operation Warp Speed's $18 Billion Sprint for a Vaccine". Bloomberg Businessweek. Archived from the original on December 8, 2020. Retrieved November 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  22. Collins, Kaitlan; Diamond, Jeremy; Klein, Betsy (April 22, 2020). "Director of key federal vaccine agency says his departure was retaliation". CNN. Archived from the original on November 1, 2020. Retrieved August 30, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  23. 23.0 23.1 Crisp, Elizabeth (May 15, 2020). "Trump launches 'operation warp speed' effort to develop coronavirus vaccine by year's end". Newsweek. Archived from the original on May 19, 2020. Retrieved May 15, 2020. 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.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  24. Guckert, Ross (June 4, 2020). "PEO Perspective: June 2020". PEO EIS. Archived from the original on December 20, 2020. Retrieved December 8, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  25. "LTG Paul Ostrowski, USA (Ret)". National Defense Industrial Association. Archived from the original on December 20, 2020. Retrieved November 27, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  26. 26.0 26.1 Slaoui, Moncef; Hepburn, Matthew (August 26, 2020). "Developing safe and effective covid vaccines – Operation Warp Speed's strategy and approach". New England Journal of Medicine. 383 (18): 1701–1703. doi:10.1056/nejmp2027405. ISSN 0028-4793. PMID 32846056. S2CID 221347918. Archived from the original on December 16, 2020. Retrieved September 24, 2020. 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.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  27. 27.0 27.1 Noah Higgins-Dunn (August 14, 2020). "The U.S. has already invested billions in potential coronavirus vaccines. Here's where the deals stand". CNBC. Archived from the original on December 8, 2020. Retrieved September 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  28. Rivers, Brenda Marie (August 6, 2020). "Johnson & Johnson Secures $1B in Federal Vaccine Production Funding". GovCon Wire. Archived from the original on October 27, 2020. Retrieved November 19, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  29. "HHS, DOD Collaborate With Johnson & Johnson to Produce Millions of COVID-19 Investigational Vaccine Doses". August 5, 2020. Archived from the original on December 12, 2020. Retrieved November 19, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  30. Higgins-Dunn, Noah (August 5, 2020). "Johnson & Johnson reaches deal with U.S. for 100 million doses of coronavirus vaccine at more than $1 billion". CNBC. Archived from the original on December 9, 2020. Retrieved November 19, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  31. "Experimental Johnson & Johnson vaccine protects monkeys in a single dose, study finds". CNBC. Reuters. July 30, 2020. Archived from the original on October 25, 2020. Retrieved November 19, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  32. Erman, Michael (August 7, 2020). "U.S. to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate". Reuters. Archived from the original on December 12, 2020. Retrieved November 19, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  33. "Media Statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices' Recommendation to Use Janssen's COVID-19 Vaccine in People 18 and Older". Centers for Disease Control and Prevention (CDC) (Press release). February 28, 2021. Retrieved March 24, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  34. "Trump Administration's Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October". HHS.gov (Press release). May 21, 2020. Archived from the original on December 20, 2020. Retrieved July 22, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  35. "Vaxart oral COVID-19 vaccine joins Trump's 'Warp Speed,' ramps up manufacturing capacity". Genetic Engineering and Biotechnology News. June 29, 2020. Archived from the original on September 29, 2020. Retrieved July 1, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  36. "Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK". BBC News Online. December 30, 2020. Retrieved March 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  37. Sam Meredith (March 15, 2021). "Germany, France, Spain and Italy become latest countries to suspend AstraZeneca vaccine over blood clot fears". CNBC. Retrieved March 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  38. Adams, Ben (July 27, 2020). "Moderna nabs a BARDA billion as its kick-starts late-stage pandemic vaccine test". FierceBiotech. Archived from the original on December 9, 2020. Retrieved November 20, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  39. "Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine". US National Institutes of Health. December 18, 2020. Retrieved March 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  40. Katie Thomas (July 7, 2020). "U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine". The New York Times. Archived from the original on December 17, 2020. Retrieved July 7, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  41. "HHS, DOD Collaborate with Novavax to Produce Millions of COVID-19 Investigational Vaccine Doses in Commercial-Scale Manufacturing Demonstration Projects". HHS.gov (Press release). July 6, 2020. Archived from the original on December 21, 2020. Retrieved December 20, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  42. "Novavax Announces $1.6 Billion Funding from Operation Warp Speed". Novavax. July 7, 2020. Archived from the original on December 17, 2020. Retrieved December 20, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  43. 43.0 43.1 Matthew Herper; Helen Branswell (January 26, 2021). "In a major setback, Merck to stop developing its two Covid-19 vaccines and focus on therapies". STAT. Archived from the original on February 6, 2021. Retrieved February 5, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  44. Angus Liu (July 31, 2020). "Top vaccine players Sanofi, GSK win $2.1B Warp Speed funding for COVID-19 shot". FiercePharma. Archived from the original on November 28, 2020. Retrieved September 24, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  45. Hollingsworth, Julia (December 11, 2020). "GlaxoSmithKline and Sanofi Pasteur vaccine delayed until late 2021". CNN. Archived from the original on December 11, 2020. Retrieved December 11, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  46. "HHS Adds $628 Million to Contract with Emergent BioSolutions to Secure CDMO Manufacturing Capacity for Operation Warp Speed". HHS.gov. U.S. Department of Health and Human Services (press release). May 31, 2020. Archived from the original on December 10, 2020. Retrieved September 25, 2020. Before this task order announcement, Emergent had begun collaborating on development and manufacturing with Johnson & Johnson, Novavax, and Vaxart on their COVID-19 vaccine candidates.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  47. "INOVIO Reports Positive Interim Phase I Data for COVID-19 DNA Vaccine, Joins 'Warp Speed' Primate Study". Genetic Engineering and Biotechnology News. June 30, 2020. Archived from the original on October 1, 2020. Retrieved July 1, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  48. Gelles, David; Murphy, Heather (August 11, 2020). "This Company Boasted to Trump About Its Covid-19 Vaccine. Experts Are Skeptical". The New York Times. ISSN 0362-4331. Archived from the original on November 25, 2020. Retrieved September 25, 2020. 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.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  49. Brennan, Zachary (October 2, 2020). "Warp Speed's focus on vaccines may have shortchanged antibody treatments". Politico. Archived from the original on December 8, 2020. Retrieved October 8, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  50. "HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing Demonstration Project of COVID-19 Investigational Therapeutic Treatment". HHS.gov (Press release). July 7, 2020. Archived from the original on December 18, 2020. Retrieved October 8, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  51. "Aiming to address the global coronavirus pandemic: Project Lightspeed". BioNTech. 2020. Archived from the original on December 18, 2020. Retrieved December 13, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  52. 52.0 52.1 "BioNTech wins $445 million German grant for COVID-19 vaccine". Reuters. September 15, 2020. Archived from the original on January 25, 2021. Retrieved January 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  53. Axios (November 9, 2020). "Pfizer CEO says he would've released vaccine data before election if possible". Axios. Archived from the original on December 10, 2020. Retrieved November 11, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  54. Alexander Nazaryan (November 9, 2020). "So is Pfizer part of Operation Warp Speed or not? Yes and no". Yahoo Financial News. Archived from the original on December 11, 2020. Retrieved November 9, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  55. "U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine". US Department of Health and Human Services. July 22, 2020. Archived from the original on December 17, 2020. Retrieved July 23, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  56. "Was the Pfizer vaccine part of the government's Operation Warp Speed?". The New York Times. November 10, 2020. Archived from the original on December 16, 2020. Retrieved November 14, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  57. Goodman, J. David; Delkic, Melina (December 7, 2020). "Covid-19 Live Updates: Trump Officials Passed When Pfizer Offered to Sell More Vaccine Doses in Late Summer". The New York Times. ISSN 0362-4331. Archived from the original on December 16, 2020. Retrieved December 7, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  58. Maxouris, Christina (December 12, 2020). "FDA's Covid-19 vaccine authorization is a 'monumental moment,' expert says. It came on the deadliest day of the pandemic". CNN. Archived from the original on December 17, 2020. Retrieved December 12, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  59. Dale, Daniel (November 10, 2020). "Fact-checking the battle for credit over Pfizer's vaccine announcement". cnn.com. CNN. Archived from the original on November 16, 2020. Retrieved November 15, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  60. Katie Thomas, David Gelles, Carl Zimmer (November 9, 2020). "Pfizer's early data shows vaccine is more than 90% effective". The New York Times. Archived from the original on December 18, 2020. Retrieved November 9, 2020. 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)<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  61. Emily Czachor (November 9, 2020). "Pfizer Avoided R&D Funding From Trump's Operation Warp Speed Because of Bureaucracy, Politics". Newsweek. Archived from the original on December 9, 2020. Retrieved November 9, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  62. Jacob Jarvis (November 9, 2020). "Pfizer Research Head Distances COVID-19 Vaccine From Trump's Operation Warp Speed". Newsweek. Archived from the original on December 12, 2020. Retrieved November 9, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  63. "U.K. becomes first country to approve Pfizer-BioNTech Covid-19 vaccine". NBC News. December 2, 2020. Retrieved March 24, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  64. "Pfizer-BioNTech COVID-19 Vaccine". US Food & Drug Administration (Press release). February 28, 2021. Retrieved March 24, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  65. 65.0 65.1 "Trump misses 20 million Covid shot target". Archived from the original on January 4, 2021. Retrieved January 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  66. "CDC COVID Data Tracker". Archived from the original on January 25, 2021. Retrieved January 6, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  67. "Operation Warp Speed chief says Covid vaccine distribution 'should be better' as U.S. misses goal". Archived from the original on January 4, 2021. Retrieved January 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  68. "Baker Says More Communication From Feds Is Key To Smooth Vaccine Distribution". Archived from the original on February 14, 2021. Retrieved January 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  69. "Pace Of Coronavirus Vaccination Lags Supply In Mass". Archived from the original on January 7, 2021. Retrieved January 7, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  70. Emily Barone (December 14, 2020). "The Trump Administration's 'Operation Warp Speed' Has Spent $12.4 Billion on Vaccines. How Much Is That, Really?". Time Magazine. Archived from the original on January 25, 2021. Retrieved January 30, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  71. Jennings, Katie (November 17, 2020). "How Much Will A Covid-19 Vaccine Cost?". Forbes. Archived from the original on December 13, 2020. Retrieved December 6, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  72. 72.0 72.1 72.2 72.3 72.4 Diamond, Michael S; Pierson, Theodore C (May 13, 2020). "The challenges of vaccine development against a new virus during a pandemic". Cell Host and Microbe. 27 (5): 699–703. doi:10.1016/j.chom.2020.04.021. PMC 7219397. PMID 32407708.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  73. 73.0 73.1 73.2 Nisen, Max (April 30, 2020). "Operation Warp Speed needs to waste money on vaccines". Bloomberg News. The Washington Post. Archived from the original on June 11, 2020. Retrieved May 28, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  74. McKeever, Vicky (May 21, 2020). "AstraZeneca receives $1 billion in U.S. funding for Oxford University coronavirus vaccine". CNBC. Archived from the original on May 28, 2020. Retrieved May 28, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  75. Christensen, Jen; Acosta, Jim; Carvajal, Nikki; Vazquez, Maegan (December 8, 2020). "Trump to sign order aimed at prioritizing Covid-19 vaccine shipment to Americans". CNN. Archived from the original on December 8, 2020. Retrieved December 8, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  76. Trump, Donald. "Executive Order on Ensuring Access to United States Government COVID-19 Vaccines". whitehouse.gov. Archived from the original on January 20, 2021. Retrieved December 12, 2020 – via National Archives.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  77. 77.0 77.1 Kim, Jerome H; Hotez, Peter; Batista, Carolina; Ergonul, Onder; Figueroa, J Peter; Gilbert, Sarah; Gursel, Mayda; Hassanain, Mazen; Kang, Gagandeep; Lall, Bhavna; Larson, Heidi; Naniche, Denise; Sheahan, Timothy; Shoham, Shmuel; Wilder-Smith, Annelies; Strub-Wourgaft, Nathalie; Yadav, Prashant; Bottazzi, Maria Elena (March 26, 2021). "Operation Warp Speed: implications for global vaccine security". The Lancet Global Health. 0. doi:10.1016/S2214-109X(21)00140-6. ISSN 2214-109X. PMC 7997645 Check |pmc= value (help). PMID 33780663 Check |pmid= value (help).<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  78. Carl O’Donnell; Andrea Shalal (February 18, 2021). "Biden to pledge $4 billion to COVAX vaccine program at G7 meeting Friday". Reuters. Retrieved April 1, 2021.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  79. "Ten health issues WHO will tackle this year". World Health Organization. 2019. Archived from the original on November 11, 2019. Retrieved May 26, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  80. Dubé, Eve; Laberge, Caroline; Guay, Maryse; Bramadat, Paul; Roy, Réal; Bettinger, Julie (August 1, 2013). "Vaccine hesitancy: an overview". Human Vaccines and Immunotherapeutics. 9 (8): 1763–1773. doi:10.4161/hv.24657. ISSN 2164-554X. PMC 3906279. PMID 23584253.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  81. "U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine". Pew Research. September 17, 2020. Archived from the original on October 15, 2020. Retrieved October 15, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  82. 82.0 82.1 Alaric Dearment (May 19, 2020). "Head of Trump's Covid-19 vaccine program to divest more than $10M in Moderna shares after criticism". MedCity News. Retrieved May 28, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  83. Kristen Holmes, Sarah Mucha and Gregory Lemos (January 13, 2021). "Head of US vaccine effort resigns at request of incoming Biden administration but will stay through transition". CNN. Archived from the original on February 1, 2021. Retrieved January 30, 2021.CS1 maint: uses authors parameter (link)<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  84. Gelles, David; Murphy, Heather (August 11, 2020). "This Company Boasted to Trump About Its Covid-19 Vaccine. Experts Are Skeptical". The New York Times. ISSN 0362-4331. Archived from the original on November 25, 2020. Retrieved September 25, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>
  85. Himmelberg v. Vaxart, Inc. 11, 2020/https://web.archive.org/web/20201011063520/http://securities.stanford.edu/filings-documents/1075/VI2400_20/2020824_f01c_20CV05949.pdf Archived October 11, 2020 at the Wayback Machine, No. 20-cv-05949 (N.D. Cal. August 24, 2020)
  86. 86.0 86.1 Gelles, David; Drucker, Jesse (July 25, 2020). "Corporate Insiders Pocket $1 Billion in Rush for Coronavirus Vaccine". The New York Times. ISSN 0362-4331. Archived from the original on September 24, 2020. Retrieved September 25, 2020.<templatestyles src="Module:Citation/CS1/styles.css"></templatestyles>

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