Operation Warp Speed

Operation Warp Speed is a public–private partnership, initiated by the federal government of the United States, to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. It was introduced by the Trump administration in early April 2020.[2][3][4] Operation Warp Speed will promote mass production of multiple vaccines 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.[5] Congress has allocated nearly $10 billion for Operation Warp Speed with $6.5 billion designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.[6]

President Donald Trump formally announced Operation Warp Speed on May 15, 2020 in the White House Rose Garden.[1]

Operation Warp Speed is an interagency program that includes components of the Department of Health and Human Services, including the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), 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.

History

President Trump officially announced the public-private partnership in mid-May 2020.[7] Operation Warp Speed will coordinate existing 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.[8]

The Food and Drug Administration announced on June 30, 2020 that the vaccine will need to be at least 50% effective to gain approval, in at least diminishing the severity of COVID-19 symptoms.[9]

Leadership and budget

In May 2020, Moncef Slaoui was named by the Trump administration as Operation Warp Speed chief adviser.[10] 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 major novel vaccines.[11] General Gustave F. Perna, Commanding General, Army Materiel Command, was named Operation Warp Speed chief operating officer.[11][12] The project has other scientists, physicians, and military officers involved in management of the key focus areas of development, manufacturing, and distribution.[11] The project has a budget of $10 billion, with additional funds allocated through BARDA.[11]

Funded companies
See also: COVID-19_vaccine § Vaccine candidates

As of July, eight companies had been chosen for funding to expedite development and preparation for manufacturing their respective vaccine candidates: Johnson & Johnson (Janssen Pharmaceutical), AstraZeneca-University of Oxford, Pfizer-BioNTech, Moderna, Merck, Vaxart, Inovio, and Novavax.[13][14][15] In June agreements of $1.2 billion for successful vaccine were signed with AstraZeneca and $483 million with Moderna.[13][16]

In July, Operation Warp Speed agreed to pay $1.6 billion to Novavax if clinical trials are successful to produce 100 million doses of its candidate vaccine.[17] Novavax is a company with no history of marketed products.[15] Also in July, Pfizer and BioNTech received an order of $2 billion to manufacture 100 million doses of a COVID-19 vaccine when it is shown to be safe and effective, and is licensed.[18][19][20] On July 31st, Sanofi and GSK were funded for $2.1 billion.[21]

Criticism
See also: COVID-19_vaccine § Potential limitations

Timeline

The goals of the project to develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020 have 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.[4][22][23] Most viral infections do not have vaccines because the vaccine technology has failed in early-stage clinical trials.[4][22] 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.[22][23] Similarly, sufficient time – a year or usually many years – is needed to be certain a vaccine has durable efficacy while the virus remains pandemic.[12][22][23] For these reasons, 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 exists to prevent any coronavirus infection.[22] To prepare for manufacturing and distribution, Operation Warp Speed will expend resources and financing before the safety and efficacy results of vaccine candidates are known, possibly wasting vaccine doses and their costs.[4][12] The government is intentionally accepting likely losses that a private company normally would not, because doing so means any successful vaccine would become available much sooner, limiting the massive health and economic impacts of the COVID-19 pandemic.

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.[4] There is also the possibility that a billion dollars or more of US 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 US 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.[24]

Warp Speed will not partner with Chinese vaccine development organizations – which have more vaccines in clinical development, as of May 2020 – 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 4 May for a Coronavirus Global Response.[3] The US government chose not to include Operation Warp Speed as part of the international Solidarity trial on vaccine development, organized by the WHO.[3]

Vaccine hesitancy

The proposed haste of Operation Warp Speed to have one or more vaccines sufficiently studied for safety and efficacy, approved internationally, and manufactured in hundreds of millions of doses by the end of 2020 is a potential barrier to public acceptance about safety and need to vaccinate against COVID-19, possibly harming vaccine acceptance.[3] Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health threat called "vaccine hesitancy",[25] which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020-21.[26]

Leader neutrality

The leader of the Operation Warp Speed project, Moncef Slaoui, had been a board member of the US 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.[27] 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.[27]

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References
  1. "Remarks by President Trump on Vaccine Development". White House. 15 May 2020.
  2. Jacobs, Jennifer; Armstrong, Drew (29 April 2020). "Trump's 'Operation Warp Speed' aims to rush coronavirus vaccine". Bloomberg News. Retrieved 15 May 2020.
  3. Cohen, Jon (12 May 2020). "Unveiling 'Warp Speed,' the White House's America-first push for a coronavirus vaccine". Science. doi:10.1126/science.abc7056. S2CID 219432336.
  4. Sanger, David E. (29 April 2020). "Trump seeks push to speed vaccine, despite safety concerns". New York Times. Retrieved 15 May 2020.
  5. Jacobs, Jennifer; Armstrong, Drew (29 April 2020). "Trump's 'Operation Warp Speed' Aims to Rush Coronavirus Vaccine". Bloomberg News. Retrieved 15 May 2020.
  6. Division, News (2020-05-15). "Trump Administration Announces Framework and Leadership for 'Operation Warp Speed'". HHS.gov. Retrieved 2020-07-22.
  7. Conklin, Audrey (15 May 2020). "Trump launches 'Operation Warp Speed' for coronavirus vaccine". Fox Business. Retrieved 15 May 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.
  8. "Trump Administration Announces Framework and Leadership for 'Operation Warp Speed'". U.S. Department of Health and Human Services. 15 May 2020. Retrieved 15 May 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.
  9. Elizabeth Weise (June 30, 2020). "FDA says a coronavirus vaccine would have to be at least 50% effective to be approved". USA Today.
  10. Conklin, Audrey (2020-05-15). "Trump launches 'Operation Warp Speed' for coronavirus vaccine". FOXBusiness. Retrieved 2020-07-22.
  11. "Trump Administration Announces Framework and Leadership for 'Operation Warp Speed'". Department of Health and Human Services, US Government. 2020-05-15. Retrieved 2020-05-28.
  12. Crisp, Elizabeth (2020-05-15). "Trump launches "operation warp speed" effort to develop coronavirus vaccine by year's end". Newsweek. Retrieved 2020-05-15. 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.
  13. "Vaxart oral COVID-19 vaccine joins Trump's "Warp Speed," ramps up manufacturing capacity". Genetic Engineering and Biotechnology News. 2020-06-29. Retrieved 2020-07-01.
  14. "INOVIO Reports Positive Interim Phase I Data for COVID-19 DNA Vaccine, Joins "Warp Speed" Primate Study". Genetic Engineering and Biotechnology News. 2020-06-30. Retrieved 2020-07-01.
  15. Katie Thomas (2020-07-07). "U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine". The New York Times. Retrieved 2020-07-07.
  16. Division, News (2020-05-21). "Trump Administration's Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October". HHS.gov. Retrieved 2020-07-22.
  17. Division, News (2020-07-06). "HHS, DOD Collaborate with Novavax to Produce Millions of COVID-19 Investigational Vaccine Doses in Commercial-Scale Manufacturing Demonstration Projects". HHS.gov. Retrieved 2020-07-22.
  18. Erman, Michael; Banerjee, Ankur (2020-07-22). "U.S. to pay Pfizer, BioNTech $1.95 bln for millions of COVID-19 vaccine doses". Reuters. Retrieved 2020-07-22.
  19. Moreno, J. Edward (2020-07-22). "US negotiates 100 million doses of coronavirus vaccine from Pfizer that will be free to Americans". The Hill. Retrieved 2020-07-22.
  20. "U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine". US Department of Health and Human Services. 22 July 2020. Retrieved 23 July 2020.
  21. https://www.fiercepharma.com/pharma/sanofi-gsk-win-hefty-2-1b-operation-warp-speed-funding-for-covid-19-vaccine
  22. Diamond, Michael S; Pierson, Theodore C (2020-05-13). "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.
  23. Nisen, Max (2020-04-30). "Operation Warp Speed needs to waste money on vaccines". Bloomberg News. The Washington Post. Retrieved 2020-05-28.
  24. McKeever, Vicky (2020-05-21). "AstraZeneca receives $1 billion in U.S. funding for Oxford University coronavirus vaccine". CNBC. Retrieved 2020-05-28.
  25. "Ten health issues WHO will tackle this year". World Health Organization. 2019. Retrieved 2020-05-26.
  26. Dubé, Eve; Laberge, Caroline; Guay, Maryse; Bramadat, Paul; Roy, Réal; Bettinger, Julie (2013-08-01). "Vaccine hesitancy: an overview". Human Vaccines and Immunotherapeutics. 9 (8): 1763–1773. doi:10.4161/hv.24657. ISSN 2164-554X. PMC 3906279. PMID 23584253.
  27. Alaric Dearment (2020-05-19). "Head of Trump's Covid-19 vaccine program to divest more than $10M in Moderna shares after criticism". MedCity News. Retrieved 2020-05-28.
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