Operation Warp Speed
{{Short description|US program to accelerate COVID-19 vaccine efforts}}
{{pp-semi-indef|small=yes}}
{{Infobox military unit
| unit_name = Operation Warp Speed
| image = Operation Warp Speed.png
| image_size = 120px
| caption = Official seal of Operation Warp Speed
| dates = May 15, 2020 – February 24, 2021
({{ayd|2020|5|15|2021|2|24}})
| country = United States
| allegiance = {{flag|United States}}
| size =
| command_structure = {{nowrap|U.S. Department of Defense}}
{{nowrap|U.S. Department of Health and Human Services}}
Other various government agencies
| garrison =
| garrison_label = Headquarters
| motto =
| battles = Coronavirus disease 2019
| anniversaries =
| decorations =
| disbanded = Transitioned to White House COVID-19 Response Team
| website = {{url|https://www.defense.gov/Spotlights/Coronavirus-DOD-Response/|Coronavirus: Operation Warp Speed}}
| commander1 = Moncef Slaoui
| commander1_label = Head
| commander2 = General Gustave F. Perna
| commander2_label = Chief Operating Officer
| commander3 = Donald Trump
| commander3_label = Commander in Chief
| notable_commanders =
| identification_symbol =
| identification_symbol_label = Flag
| identification_symbol_2 =
| identification_symbol_2_label = Variant flag
}}
{{Use mdy dates|date=December 2021}}
{{COVID-19 pandemic sidebar|expanded=medical}}
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.{{Cite web|title=Trump Administration Announces Framework and Leadership for 'Operation Warp Speed'|url=https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html|date=May 15, 2020|website=U.S. Department of Health and Human Services|access-date=May 15, 2020|quote=Among its other objectives, Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.|archive-date=December 16, 2020|archive-url=https://web.archive.org/web/20201216233803/https://www.hhs.gov/about/news/2020/05/15/trump-administration-announces-framework-and-leadership-for-operation-warp-speed.html|url-status=dead}}{{Cite web|title=Fact Sheet: Explaining Operation Warp Speed|newspaper=HHS.gov |url=https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html|publisher=US Department of Health and Human Services|date=November 10, 2020|access-date=November 24, 2020|archive-date=December 19, 2020|archive-url=https://web.archive.org/web/20201219231756/https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html|url-status=live}} The first news report of Operation Warp Speed was on April 29, 2020,{{Cite news|last1=Jacobs|first1=Jennifer|last2=Armstrong|first2=Drew|date=April 29, 2020|title=Trump's 'Operation Warp Speed' aims to rush coronavirus vaccine|work=Bloomberg News|url=https://www.bloomberg.com/news/articles/2020-04-29/trump-s-operation-warp-speed-aims-to-rush-coronavirus-vaccine|access-date=May 15, 2020|archive-date=December 17, 2020|archive-url=https://web.archive.org/web/20201217221515/https://www.bloomberg.com/news/articles/2020-04-29/trump-s-operation-warp-speed-aims-to-rush-coronavirus-vaccine|url-status=live}}{{cite journal|url=https://www.science.org/content/article/unveiling-warp-speed-white-house-s-america-first-push-coronavirus-vaccine|newspaper=Science|title=Unveiling 'Warp Speed,' the White House's America-first push for a coronavirus vaccine|date=May 12, 2020|first=Jon|last=Cohen|s2cid=219432336|doi=10.1126/science.abc7056|access-date=May 16, 2020|archive-date=November 29, 2020|archive-url=https://web.archive.org/web/20201129213136/https://www.sciencemag.org/news/2020/05/unveiling-warp-speed-white-house-s-america-first-push-coronavirus-vaccine|url-status=live|url-access=subscription}}{{Cite news|last=Sanger|first=David E.|date=April 29, 2020|title=Trump seeks push to speed vaccine, despite safety concerns|work=The New York Times|url=https://www.nytimes.com/2020/04/29/us/politics/trump-coronavirus-vaccine-operation-warp-speed.html|access-date=May 15, 2020|archive-date=December 9, 2020|archive-url=https://web.archive.org/web/20201209015250/https://www.nytimes.com/2020/04/29/us/politics/trump-coronavirus-vaccine-operation-warp-speed.html|url-status=live}} 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.{{Cite news|last=Kaplan|first=Sheila|date=January 15, 2021|title=Biden Picks Former F.D.A. Chief to Lead Federal Vaccine Efforts|work=The New York Times|url=https://www.nytimes.com/2021/01/15/health/covid-vaccine-kessler.html|access-date=January 15, 2021|archive-date=January 15, 2021|archive-url=https://web.archive.org/web/20210115173332/https://www.nytimes.com/2021/01/15/health/covid-vaccine-kessler.html?action=click&module=Top+Stories&pgtype=Homepage|url-status=live}} At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.{{Cite news|last=Zraick|first=Karen|date=February 24, 2021|title=Meet the key members of Biden's Covid-19 response team.|language=en-US|work=The New York Times|url=https://www.nytimes.com/2021/02/24/us/bidens-covid-19-response-team.html|access-date=March 7, 2021|issn=0362-4331}}
The program promoted mass production of multiple vaccines, and different types of vaccine technologies, based on preliminary evidence. Then there were clinical trials. The plan anticipated that some of these vaccines would not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines.{{Cite news|last1=Jacobs|first1=Jennifer|last2=Armstrong|first2=Drew|date=April 29, 2020|title=Trump's 'Operation Warp Speed' Aims to Rush Coronavirus Vaccine|work=Bloomberg News|url=https://www.bloomberg.com/news/articles/2020-04-29/trump-s-operation-warp-speed-aims-to-rush-coronavirus-vaccine|access-date=May 15, 2020|archive-date=December 17, 2020|archive-url=https://web.archive.org/web/20201217221515/https://www.bloomberg.com/news/articles/2020-04-29/trump-s-operation-warp-speed-aims-to-rush-coronavirus-vaccine|url-status=live}}
Operation Warp Speed, initially funded with about $10{{nbs}}billion from the CARES Act (Coronavirus Aid, Relief, and Economic Security) passed by the United States Congress on March 27, 2020, was an interagency program that includes components of the Department of Health and Human Services, including the Centers for Disease Control and Prevention, Food and Drug Administration, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA); the Department of Defense; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs.
History
File:President Trump Delivers an Update on Vaccine Development (49899015697).jpg 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. The purpose of Operation Warp Speed was to coordinate Health and Human Services-wide efforts, including the NIH ACTIV[https://www.nih.gov/research-training/medical-research-initiatives/activ ACCELERATING COVID-19 THERAPEUTIC INTERVENTIONS AND VACCINES (ACTIV)] partnership for vaccine and therapeutic development, the NIH RADx[https://www.nih.gov/research-training/medical-research-initiatives/radx RAPID ACCELERATION OF DIAGNOSTICS (RADX)] initiative for diagnostic development, and work by BARDA.
Operation Warp Speed was formed to encourage private and public partnerships to enable faster approval and production of vaccines during the COVID-19 pandemic. The name was inspired by terminology for faster-than-light travel used in the Star Trek fictional universe, evoking a sense of rapid progress.{{Cite web| last1 = LaFraniere| first1 = Sharon| last2 = Thomas| first2 = Katie| last3 = Weiland| first3 = Noah| last4 = Baker| first4 = Peter| last5 = Karni| first5 = Annie| title = Scientists Worry About Political Influence Over Coronavirus Vaccine Project| work = The New York Times| access-date = December 17, 2020| date = August 2, 2020| url = https://www.nytimes.com/2020/08/02/us/politics/coronavirus-vaccine.html| archive-date = December 19, 2020| archive-url = https://web.archive.org/web/20201219124811/https://www.nytimes.com/2020/08/02/us/politics/coronavirus-vaccine.html| url-status = live}}{{Cite news|last=McGinley|first=Laurie|title=Meet the most important federal official you probably don't know – the man who holds the fate of the coronavirus vaccine in his hands|language=en-US|newspaper=The Washington Post|url=https://www.washingtonpost.com/health/coronavirus-vaccine-approval-decider/2020/08/11/7c6fb7a0-d8f1-11ea-930e-d88518c57dcc_story.html|access-date=December 17, 2020|date=August 11, 2020|archive-date=December 14, 2020|archive-url=https://web.archive.org/web/20201214053939/https://www.washingtonpost.com/health/coronavirus-vaccine-approval-decider/2020/08/11/7c6fb7a0-d8f1-11ea-930e-d88518c57dcc_story.html|url-status=live}}
The Food and Drug Administration announced on June 30, 2020, that a vaccine would need to be at least 50% effective for diminishing the severity of COVID-19 symptoms to obtain regulatory and marketing approval.{{cite news| url=https://www.usatoday.com/story/news/2020/06/30/fda-coronavirus-vaccine-would-have-least-50-effective/5349964002/| author=Elizabeth Weise| title=FDA says a coronavirus vaccine would have to be at least 50% effective to be approved| publisher=USA Today| date=June 30, 2020| access-date=July 1, 2020| archive-date=December 12, 2020| archive-url=https://web.archive.org/web/20201212125641/https://www.usatoday.com/story/news/2020/06/30/fda-coronavirus-vaccine-would-have-least-50-effective/5349964002/| url-status=live}}
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.{{Cite news|last=Kennedy|first=Merrit|date=January 15, 2021|title=Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures'|work=NPR|url=https://www.npr.org/sections/coronavirus-live-updates/2021/01/15/957261530/biden-administration-will-rename-operation-warp-speed-citing-trump-failures|url-status=live|access-date=January 29, 2021|archive-date=January 29, 2021|archive-url=https://web.archive.org/web/20210129083309/https://www.npr.org/sections/coronavirus-live-updates/2021/01/15/957261530/biden-administration-will-rename-operation-warp-speed-citing-trump-failures}}{{Cite news|last1=Kaplan|first1=Sheila|last2=Stolberg|first2=Sheryl Gay|date=January 15, 2021|title=Biden picks a former F.D.A. chief to lead federal vaccine efforts, which will drop the name Operation Warp Speed.|language=en-US|work=The New York Times|url=https://www.nytimes.com/2021/01/15/world/biden-picks-a-former-fda-chief-to-lead-federal-vaccine-efforts-which-will-drop-the-name-operation-warp-speed.html|access-date=January 29, 2021|issn=0362-4331|archive-date=January 27, 2021|archive-url=https://web.archive.org/web/20210127055331/https://www.nytimes.com/2021/01/15/world/biden-picks-a-former-fda-chief-to-lead-federal-vaccine-efforts-which-will-drop-the-name-operation-warp-speed.html|url-status=live}} Also in January 2021, Dr. Moncef Slaoui, former Operation Warp Speed lead, was told not to use the name Operation Warp Speed anymore.{{Cite journal|last=Cohen|first=Jon|title=Ex-vaccine chief reflects on triumphs, failures, and Trump|journal=Science|date=January 29, 2021|volume=371|issue=6528|pages=449–450|doi=10.1126/science.371.6528.449|pmid=33510005|bibcode=2021Sci...371..449C|doi-access=free}} At the end of February 2021, responsibilities of Operation Warp Speed were transferred into the White House COVID-19 Response Team.{{Cite web|last=Vergun|first=David|date=February 25, 2021|title=DOD Officials Provide COVID-19 Response Update|url=https://www.defense.gov/News/News-Stories/Article/Article/2515684/dod-officials-provide-covid-19-response-update/|access-date=March 7, 2021|website=U.S. Department of Defense|language=en-US}}
Goals
According to the Department of Health and Human Services' fact sheet, the main stated goal of Operation Warp Speed was to "produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics".
Specific targets, as outlined in various media, include:
- support pharmaceutical companies for R&D of seven different vaccine candidates simultaneously and certain therapeutic compounds
- support several vaccine manufacturers for rapid scale-up of manufacturing capacity
- support organization and facilitate simultaneous FDA review of Phase I-III clinical trials on several of the most promising vaccine candidates
- facilitate manufacturing vaccine candidates while they remain pre-approved during prefinal clinical research to prepare for rapid deployment, if proven to be safe and effective{{cite web |author1=David Wallace-Wells |title=We had the vaccine the whole time |url=https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html |publisher=Intelligencer, New York Magazine, Vox Media Network, Inc |access-date=December 8, 2020 |date=December 7, 2020 |archive-date=December 8, 2020 |archive-url=https://web.archive.org/web/20201208184538/https://nymag.com/intelligencer/2020/12/moderna-covid-19-vaccine-design.html |url-status=live }}
- 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{{cite web |author1=C. Todd Lopez |title=In Warp Speed Effort, Knowing Where Vaccines Are Is Key to Distribution Strategy |url=https://www.defense.gov/News/News-Stories/Article/Article/2395789/in-warp-speed-effort-knowing-where-vaccines-are-is-key-to-distribution-strategy/ |publisher=US Department of Defense |access-date=December 8, 2020 |date=October 28, 2020 |archive-date=December 5, 2020 |archive-url=https://web.archive.org/web/20201205060606/https://www.defense.gov/Explore/News/Article/Article/2395789/in-warp-speed-effort-knowing-where-vaccines-are-is-key-to-distribution-strategy/ |url-status=live }}
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".{{cite web |title=AMA, FDA video update: The critical role of health care professionals during COVID-19 |url=https://www.ama-assn.org/delivering-care/public-health/ama-fda-video-update-critical-role-health-care-professionals-during |website=AMA-Assn.org |date=August 14, 2020 |publisher=American Medical Association |access-date=December 17, 2020 |archive-date=December 18, 2020 |archive-url=https://web.archive.org/web/20201218230948/https://www.ama-assn.org/delivering-care/public-health/ama-fda-video-update-critical-role-health-care-professionals-during |url-status=live }}
Budget and leadership
Operation Warp Speed used BARDA as the financial interface between the U.S. federal government and the biomedical industry.{{Cite web | publisher=Marketplace, Minnesota Public Radio | date=October 30, 2014 | access-date=November 24, 2020 | title=BARDA: The venture capital firm buried in the US government | url=https://www.marketplace.org/2014/10/30/barda-venture-capital-firm-buried-us-government/ | author=Dan Gorenstein | archive-date=June 13, 2020 | archive-url=https://web.archive.org/web/20200613113313/https://www.marketplace.org/2014/10/30/barda-venture-capital-firm-buried-us-government/ | url-status=live }} The program was initially being funded with $10{{nbs}}billion, with additional funds allocated through BARDA. Funding was increased to about $18{{nbs}}billion by October 2020.{{cite news |author1=Stephanie Baker |author2=Cynthia Koons |title=Inside Operation Warp Speed's $18 Billion Sprint for a Vaccine |url=https://www.bloomberg.com/news/features/2020-10-29/inside-operation-warp-speed-s-18-billion-sprint-for-a-vaccine |access-date=November 24, 2020 |work=Bloomberg Businessweek |date=October 29, 2020 |archive-date=December 8, 2020 |archive-url=https://web.archive.org/web/20201208044030/https://www.bloomberg.com/news/features/2020-10-29/inside-operation-warp-speed-s-18-billion-sprint-for-a-vaccine |url-status=live }}
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".{{cite news |last1=Collins |first1=Kaitlan |last2=Diamond |first2=Jeremy |last3=Klein |first3=Betsy |title=Director of key federal vaccine agency says his departure was retaliation |url=https://edition.cnn.com/2020/04/22/politics/rick-bright-barda-trump-coronavirus/index.html |publisher=CNN |date=April 22, 2020 |access-date=August 30, 2020 |archive-date=November 1, 2020 |archive-url=https://web.archive.org/web/20201101082959/https://edition.cnn.com/2020/04/22/politics/rick-bright-barda-trump-coronavirus/index.html |url-status=live }} 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.{{Cite web|title=Trump launches 'operation warp speed' effort to develop coronavirus vaccine by year's end|url=https://www.newsweek.com/trump-launches-operation-warp-speed-effort-develop-coronavirus-vaccine-years-end-1504458|last=Crisp|first=Elizabeth|date=May 15, 2020|website=Newsweek|language=en|access-date=May 15, 2020|quote=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{{snd}}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.|archive-date=May 19, 2020|archive-url=https://web.archive.org/web/20200519121257/https://www.newsweek.com/trump-launches-operation-warp-speed-effort-develop-coronavirus-vaccine-years-end-1504458|url-status=live}} Retired Lieutenant General Paul A. Ostrowski, who previously served as director of the Army Acquisition Corps, was the director of supply, production and distribution.{{Cite news|last=Guckert|first=Ross|date=June 4, 2020|title=PEO Perspective: June 2020|url=https://www.eis.army.mil/newsroom/news/peo-eis-wide/peo-perspective-june-2020|access-date=December 8, 2020|website=PEO EIS|language=en|archive-date=December 20, 2020|archive-url=https://web.archive.org/web/20201220193343/https://www.eis.army.mil/newsroom/news/peo-eis-wide/peo-perspective-june-2020|url-status=live}}{{cite web |title=LTG Paul Ostrowski, USA (Ret) |url=https://www.ndia.org/events/2020/10/2/2020-virtual-solic/speakers/paul-ostrowski |publisher=National Defense Industrial Association |access-date=November 27, 2020 |archive-date=December 20, 2020 |archive-url=https://web.archive.org/web/20201220163401/https://www.ndia.org/events/2020/10/2/2020-virtual-solic/speakers/paul-ostrowski |url-status=live }} Army Major General Christopher J. Sharpsten was the deputy director.{{cite news |url=https://www.digitech-insight.com/cxo-viewpoint/operation-warp-speed-raises-many-questions-from-the-supply-chain-industry-some-with-answers-that-have-yet-to-emerge-nid-588.html |title=Operation Warp Speed Raises Many Questions from The Supply Chain Industry Some with Answers That Have Yet to Emerge |first=Amy |last=Thorn |magazine=DigiTech Insight |access-date=July 21, 2021}}{{cite press release |url=https://www.prweb.com/releases/operation-warp-speed-leader-joins-international-stability-operations-association-for-an-online-discussion-on-the-covid-19-vaccine-862981370.html |title=Operation Warp Speed Leader Joins ISOA for an Online Discussion on the COVID-19 Vaccine |date=December 11, 2020 |publisher=International Stability Operations Association |access-date=July 21, 2021}}
Alex Azar, Mark Esper, Jared Kushner and Adam Boehler were on the board of directors of OWS, while Deborah Birx, Tony Fauci, Francis Collins, and Robert Redfield were nonvoting advisers.{{Cite book|last=Borrell|first=Brendan Jonathan|title=The first shots: the epic rivalries and heroic science behind the race to the coronavirus vaccine|date=2021|isbn=978-0-358-56984-8|location=New York|pages=139–143|oclc=1275436164}}{{cite web|url=https://www.esquire.com/entertainment/books/a37990781/covid-vaccine-development-race/|title=Inside the Messy Race to Develop a COVID Vaccine|website=esquire.com|access-date=14 November 2023|date=Oct 19, 2021}}
Companies receiving research funding
{{See also|COVID-19 vaccine clinical research#Trial and authorization status}}
As of August 2020, eight companies were chosen for funding of some $11{{nbs}}billion to expedite development and preparation for manufacturing their respective vaccine candidates.{{cite journal | last1=Slaoui | first1=Moncef | last2=Hepburn | first2=Matthew | title=Developing safe and effective covid vaccines – Operation Warp Speed's strategy and approach | journal=New England Journal of Medicine | date=August 26, 2020 | volume=383 | issue=18 | pages=1701–1703 | issn=0028-4793 | doi=10.1056/nejmp2027405 | pmid=32846056 | s2cid=221347918 | quote=advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021{{nbs}}... 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 progressed to clinical trials. | doi-access=free }}{{cite news |author1=Noah Higgins-Dunn |title=The U.S. has already invested billions in potential coronavirus vaccines. Here's where the deals stand |url=https://www.cnbc.com/2020/08/14/the-us-has-already-invested-billions-on-potential-coronavirus-vaccines-heres-where-the-deals-stand.html |access-date=September 24, 2020 |work=CNBC |date=August 14, 2020 |archive-date=December 8, 2020 |archive-url=https://web.archive.org/web/20201208220048/https://www.cnbc.com/2020/08/14/the-us-has-already-invested-billions-on-potential-coronavirus-vaccines-heres-where-the-deals-stand.html |url-status=live }}
The vaccine developers, different vaccine technologies, and treatments receiving government research funding were:
Indirectly funded companies include:
- Inovio{{cite web | title=INOVIO Reports Positive Interim Phase I Data for COVID-19 DNA Vaccine, Joins 'Warp Speed' Primate Study | publisher=Genetic Engineering and Biotechnology News | date=June 30, 2020 | url=https://www.genengnews.com/news/inovio-reports-positive-interim-phase-i-data-for-covid-19-dna-vaccine-joins-warp-speed-primate-study/ | access-date=July 1, 2020 | archive-date=October 1, 2020 | archive-url=https://web.archive.org/web/20201001233159/https://www.genengnews.com/news/inovio-reports-positive-interim-phase-i-data-for-covid-19-dna-vaccine-joins-warp-speed-primate-study/ | url-status=live }}{{Cite news|last1=Gelles|first1=David|last2=Murphy|first2=Heather|date=August 11, 2020|title=This Company Boasted to Trump About Its Covid-19 Vaccine. Experts Are Skeptical.|language=en-US|work=The New York Times|url=https://www.nytimes.com/2020/08/09/business/coronavirus-vaccine-inovio.html|access-date=September 25, 2020|issn=0362-4331|quote=And while the company has said that it is part of Operation Warp Speed{{snd}}the flagship federal effort to quickly produce treatments and vaccines for the coronavirus{{snd}}Inovio is not on the list of companies selected to receive financial support to mass-produce vaccines.|archive-date=November 25, 2020|archive-url=https://web.archive.org/web/20201125001621/https://www.nytimes.com/2020/08/09/business/coronavirus-vaccine-inovio.html|url-status=live}}
As of October 2020, Operation Warp Speed had spent less than $1{{nbs}}billion to support the development and manufacturing of three monoclonal antibody treatments, versus almost $10{{nbs}}billion on six vaccines.{{Cite web|last=Brennan|first=Zachary|date=October 2, 2020|title=Warp Speed's focus on vaccines may have shortchanged antibody treatments|url=https://www.politico.com/news/2020/10/02/warp-speed-covid-antibody-treatments-425649|access-date=October 8, 2020|website=Politico|language=en|archive-date=December 8, 2020|archive-url=https://web.archive.org/web/20201208113636/https://www.politico.com/news/2020/10/02/warp-speed-covid-antibody-treatments-425649|url-status=live}}
- Regeneron was to receive $450{{nbs}}million to develop and supply a monoclonal antibody drug, according to a government announcement on July 7, 2020.{{Cite press release|date=July 7, 2020|title=HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing Demonstration Project of COVID-19 Investigational Therapeutic Treatment|url=https://www.hhs.gov/about/news/2020/07/07/hhs-dod-collaborate-regeneron-large-scale-manufacturing-demonstration-project-covid-19-investigational-therapeutic-treatment.html|access-date=October 8, 2020|website=HHS.gov|language=en|archive-date=December 18, 2020|archive-url=https://web.archive.org/web/20201218071923/https://www.hhs.gov/about/news/2020/07/07/hhs-dod-collaborate-regeneron-large-scale-manufacturing-demonstration-project-covid-19-investigational-therapeutic-treatment.html|url-status=live}}
Pfizer–BioNTech
The BioNtech project to develop a novel mRNA technology for a COVID-19 vaccine was called "Project Lightspeed", which started in mid-January 2020 at BioNTech's laboratories in Mainz, Germany, just days after the SARS-Cov-2 genetic sequence was first made public.{{cite web|url=https://biontech.de/covid-19 |title=Aiming to address the global coronavirus pandemic: Project Lightspeed|publisher=BioNTech |date=2020|access-date=December 13, 2020 |archive-url= https://web.archive.org/web/20201218102549/https://biontech.de/covid-19 |archive-date=December 18, 2020 |url-status=live}} In September 2020, BioNTech received €375{{nbs}}million ({{US$|445}}{{nbs}}million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine.{{cite news |title=BioNTech wins $445 million German grant for COVID-19 vaccine |url=https://www.reuters.com/article/health-coronavirus-germany-vaccine-idUSKBN2661KP |access-date=January 7, 2021 |work=Reuters |date=September 15, 2020 |archive-date=January 25, 2021 |archive-url=https://web.archive.org/web/20210125114023/https://www.reuters.com/article/health-coronavirus-germany-vaccine-idUSKBN2661KP |url-status=live }}{{cite news |last1=Griffin |first1=Riley |last2=Armstrong |first2=Drew |url=https://www.bloomberg.com/news/articles/2020-11-09/pfizer-vaccine-s-funding-came-from-berlin-not-washington |title=Pfizer Vaccine's Funding Came From Berlin, Not Washington |work=Bloomberg News |date=November 9, 2020 |archive-url=https://web.archive.org/web/20201109190822/https://www.bloomberg.com/news/articles/2020-11-09/pfizer-vaccine-s-funding-came-from-berlin-not-washington |archive-date=November 9, 2020 |url-status=live |access-date=February 8, 2024}}{{Cite web|date=September 15, 2020|title=BioNTech erhält BMBF-Förderung von bis zu 375 Millionen Euro für COVID-19-Impfstoffprogramm BNT162|trans-title=BioNTech receives BMBF funding of up to 375 million euros for COVID-19 vaccine program BNT162|url=https://investors.biontech.de/de/news-releases/news-release-details/biontech-erhaelt-bmbf-foerderung-von-bis-zu-375-millionen-euro/|access-date=August 30, 2021|website=investors.biontech.de|language=de}} 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.{{Cite web|last=Maxouris|first=Christina |date=December 12, 2020|title=FDA's Covid-19 vaccine authorization is a 'monumental moment,' expert says. It came on the deadliest day of the pandemic|url=https://www.cnn.com/2020/12/12/health/us-coronavirus-saturday/index.html |url-status=live|archive-url= https://web.archive.org/web/20201217065901/https://www.cnn.com/2020/12/12/health/us-coronavirus-saturday/index.html |archive-date=December 17, 2020 |access-date=December 12, 2020|work=CNN}} Pfizer CEO Albert Bourla said that the company had not taken Warp Speed funding for the development of the vaccine out of a desire "to liberate our scientists [from] any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together".{{Cite web|last=Axios|date=November 9, 2020|title=Pfizer CEO says he would've released vaccine data before election if possible|url= https://www.axios.com/pfizer-ceo-says-he-wouldve-released-vaccine-data-before-election-if-possible-a4f0c822-bf49-4a04-ac7f-5275c8d895b4.html |url-status=live|archive-url= https://web.archive.org/web/20201210091527/https://www.axios.com/pfizer-ceo-says-he-wouldve-released-vaccine-data-before-election-if-possible-a4f0c822-bf49-4a04-ac7f-5275c8d895b4.html |archive-date= December 10, 2020 |access-date=November 11, 2020|website=Axios}}
On July 22, 2020, the U.S. government placed a conditional advance-purchase order of $2{{nbs}}billion with Pfizer to manufacture 100{{nbs}}million doses of a COVID-19 vaccine, with an option for 500{{nbs}}million more, for use in the United States if the vaccine was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA).{{cite news |author1=Alexander Nazaryan |title=So is Pfizer part of Operation Warp Speed or not? Yes and no |url=https://ca.news.yahoo.com/so-is-pfizer-part-of-operation-warp-speed-or-not-well-its-a-little-complicated-175429888.html |access-date=November 9, 2020 |work=Yahoo Financial News |date=November 9, 2020 |archive-url= https://web.archive.org/web/20201211070300/https://ca.news.yahoo.com/so-is-pfizer-part-of-operation-warp-speed-or-not-well-its-a-little-complicated-175429888.html |archive-date=December 11, 2020 |url-status=live}}{{cite web|date=July 22, 2020|title=U.S. Government Engages Pfizer to Produce Millions of Doses of COVID-19 Vaccine|url=https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html |access-date=July 23, 2020|work=US Department of Health and Human Services |archive-url=https://web.archive.org/web/20201217220648/https://www.hhs.gov/about/news/2020/07/22/us-government-engages-pfizer-produce-millions-doses-covid-19-vaccine.html |archive-date=December 17, 2020}} On December 23, 2020, the Trump administration announced that they had ordered another 100{{nbs}}million doses from Pfizer.{{Cite news|last1=Gumbrecht |first1=Jamie |last2=Holmes |first2=Kristen |url=https://edition.cnn.com/2020/12/23/health/pfizer-vaccine-purchase-100-million-doses/index.html |title=Trump administration to purchase additional 100 million Pfizer vaccine doses |work=CNN |date=December 23, 2020 |access-date=February 8, 2024}}
After Pfizer-BioNTech's November 9 announcement, Vice President Mike Pence wrote in a tweet that credit belonged to the "public-private partnership forged by" Trump. Pfizer's head of vaccine and research and development, Kathrin Jansen, had said on November 8 that they "were never part of the Warp Speed"; a day later, a company spokeswoman said that the company was "part of Operation Warp Speed as a supplier of a potential coronavirus vaccine".{{Cite news |date=November 9, 2020|author=Katie Thomas |author2=David Gelles |author3=Carl Zimmer |title=Pfizer's early data shows vaccine is more than 90% effective|url=https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html |work=The New York Times|quote=On Monday, a spokeswoman for Pfizer clarified that the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine|access-date=November 9, 2020 |archive-url=https://web.archive.org/web/20201218025538/https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html |archive-date=December 18, 2020 |url-status=live}}{{cite news|url=https://www.nytimes.com/2020/11/10/health/was-the-pfizer-vaccine-part-of-the-governments-operation-warp-speed.html |title=Was the Pfizer vaccine part of the government's Operation Warp Speed?|date=November 10, 2020|work=The New York Times|access-date=November 14, 2020 |archive-url=https://web.archive.org/web/20201216182631/https://www.nytimes.com/2020/11/10/health/was-the-pfizer-vaccine-part-of-the-governments-operation-warp-speed.html |archive-date=December 16, 2020 |url-status=live}}{{cite news|title=Pfizer Avoided R&D Funding From Trump's Operation Warp Speed Because of Bureaucracy, Politics|work=Newsweek |url=https://www.newsweek.com/pfizer-avoided-rd-funding-trumps-operation-warp-speed-because-bureaucracy-politics-1546110 |first=Emily |last=Czachor |date=November 9, 2020|access-date=November 9, 2020 |archive-url= https://web.archive.org/web/20201209210229/https://www.newsweek.com/pfizer-avoided-rd-funding-trumps-operation-warp-speed-because-bureaucracy-politics-1546110 |archive-date=December 9, 2020 |url-status=live}} As reported by Peter Baker in his book on Trump, Albert Bourla of Pfizer stated: "He (Bourla) had launched his own company's Project Lightspeed nearly two months before Operation Warp Speed got underway and he was not about to allow his vaccine to be politicized... Bourla rallied his counterparts at eight other drug companies to issue a joint public pledge in 14 newspapers on September 8 vowing to 'only submit for approval' any new vaccines 'after demonstrating safety and efficacy'. They would not be rushed by a president seeking to salvage his flailing election hopes".{{cite book |title=The Divider: Trump in the White House, 2017-2021 |last=Baker |first=Peter |authorlink=Peter Baker (journalist) |publisher=Doubleday |year=2022 |title-link=The Divider: Trump in the White House, 2017–2021 |isbn=978-0385546539}} page 527
Experts disagreed whether the U.S. government's conditional advance order "played an important role in expediting Pfizer’s vaccine development process".{{cite news |last=Dale |first=Daniel |title=Fact-checking the battle for credit over Pfizer's vaccine announcement |url=https://edition.cnn.com/2020/11/10/politics/fact-check-pfizer-warp-speed-pence/ |work=CNN |date=November 10, 2020 |access-date=February 8, 2024 |archive-url=https://web.archive.org/web/20201116124140/https://edition.cnn.com/2020/11/10/politics/fact-check-pfizer-warp-speed-pence/ |archive-date=November 16, 2020 |url-status=live}} The United Kingdom was the first country to authorize the vaccine on an emergency basis on December 2, 2020.{{cite web |work=NBC News|url=https://www.nbcnews.com/news/world/u-k-becomes-first-country-approve-pfizer-biontech-covid-19-n1249651|title=U.K. becomes first country to approve Pfizer-BioNTech Covid-19 vaccine|date=December 2, 2020|access-date=March 24, 2021}} Emergency use authorization in the United States was issued December 11, 2020.{{cite press release|title=Pfizer-BioNTech COVID-19 Vaccine|website=US Food & Drug Administration|date=February 28, 2021|url=https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccine|access-date=March 24, 2021}}
Distribution
Vaccine doses purchased by Operation Warp Speed were sent from manufacturers via UPS and FedEx to locations specified by state governments.{{fact|date=November 2024}} The Federal Pharmacy Partnership delivers doses to CVS and Walgreens locations, which then send pharmacists for mass vaccinations at care facilities like nursing homes.{{fact|date=November 2024}}
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.{{Cite web |url=https://www.politico.com/news/2020/12/30/coronavirus-vaccine-target-trump-452558 |title=Trump misses 20 million Covid shot target |website=Politico |date=December 30, 2020 |access-date=January 7, 2021 |archive-date=January 4, 2021 |archive-url=https://web.archive.org/web/20210104220344/https://www.politico.com/news/2020/12/30/coronavirus-vaccine-target-trump-452558 |url-status=live }} 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.{{cite web |url=https://covid.cdc.gov/covid-data-tracker/#vaccinations |access-date=January 6, 2021 |title=CDC COVID Data Tracker |date=March 28, 2020 |archive-date=January 25, 2021 |archive-url=https://web.archive.org/web/20210125031037/https://covid.cdc.gov/covid-data-tracker/#vaccinations |url-status=live }} 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.{{Cite web |url=https://www.cnbc.com/2020/12/30/covid-vaccine-operation-warp-speed-chief-says-distribution-should-be-better-.html |title=Operation Warp Speed chief says Covid vaccine distribution 'should be better' as U.S. misses goal |website=CNBC |date=December 30, 2020 |access-date=January 7, 2021 |archive-date=January 4, 2021 |archive-url=https://web.archive.org/web/20210104053706/https://www.cnbc.com/2020/12/30/covid-vaccine-operation-warp-speed-chief-says-distribution-should-be-better-.html |url-status=live }} By January 31, 2021, when Operation Warp Speed was being transferred to the Biden Administration, 63.7 million doses had been delivered of a total of 200 million doses that Pfizer and Moderna were contracted to provide by the end of March 2021.{{cite web |title=Operation Warp Speed: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges |url=https://www.gao.gov/products/gao-21-319 |publisher=US Government Accountability Office |access-date=6 May 2022 |date=11 February 2021}}
The distribution effort was criticized for lack of coordination between federal and state governments,{{Cite web |url=https://www.wbur.org/commonhealth/2021/01/05/baker-communication-key-to-smooth-vaccine-distribution |title=Baker Says More Communication From Feds Is Key To Smooth Vaccine Distribution |date=January 5, 2021 |access-date=January 7, 2021 |archive-date=February 14, 2021 |archive-url=https://web.archive.org/web/20210214231149/https://www.wbur.org/commonhealth/2021/01/05/baker-communication-key-to-smooth-vaccine-distribution |url-status=live }} 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.{{Cite web |url=https://www.wbur.org/commonhealth/2021/01/04/coronavirus-vaccinations-massachusetts |title=Pace Of Coronavirus Vaccination Lags Supply In Mass. |date=January 4, 2021 |access-date=January 7, 2021 |archive-date=January 7, 2021 |archive-url=https://web.archive.org/web/20210107082323/https://www.wbur.org/commonhealth/2021/01/04/coronavirus-vaccinations-massachusetts |url-status=live }}
Reception
{{See also|COVID-19 vaccine#Society and culture}}
=Cost=
Although initially budgeted by Congress for about $10{{nbs}}billion in May 2020, Operation Warp Speed had spent $12.4{{nbs}}billion by mid-December on vaccine developers for the combined costs of R&D and pre-approval manufacturing for millions of vaccine doses.{{cite web |author1=Emily Barone |title=The Trump Administration's 'Operation Warp Speed' Has Spent $12.4 Billion on Vaccines. How Much Is That, Really? |url=https://time.com/5921360/operation-warp-speed-vaccine-spending/ |publisher=Time Magazine |access-date=January 30, 2021 |date=December 14, 2020 |archive-date=January 25, 2021 |archive-url=https://web.archive.org/web/20210125131810/https://time.com/5921360/operation-warp-speed-vaccine-spending/ |url-status=live }}
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. Government subsidies allowed the COVID-19 vaccines to be distributed with initial pricing similar to that of the annual influenza vaccine.{{Cite web|last=Jennings|first=Katie|date=November 17, 2020|title=How Much Will A Covid-19 Vaccine Cost?|url=https://www.forbes.com/sites/katiejennings/2020/11/17/how-much-will-a-covid-19-vaccine-cost/|access-date=December 6, 2020|website=Forbes|language=en|archive-date=December 13, 2020|archive-url=https://web.archive.org/web/20201213011422/https://www.forbes.com/sites/katiejennings/2020/11/17/how-much-will-a-covid-19-vaccine-cost/|url-status=live}}
=Timeline=
The goals of the project{{snd}}to develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020{{snd}}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.{{Cite journal|title=The challenges of vaccine development against a new virus during a pandemic|first1=Michael S|last1=Diamond|first2=Theodore C|last2=Pierson|date=May 13, 2020|journal=Cell Host and Microbe|volume=27|issue=5|pages=699–703|doi=10.1016/j.chom.2020.04.021|pmc=7219397|pmid=32407708}}{{Cite news|last=Nisen|first=Max|date=April 30, 2020|title=Operation Warp Speed needs to waste money on vaccines|work=Bloomberg News|publisher=The Washington Post|url=https://www.washingtonpost.com/business/operation-warp-speed-needs-to-waste-money-on-vaccines/2020/04/30/d65f3cee-8b04-11ea-80df-d24b35a568ae_story.html|access-date=May 28, 2020|archive-date=June 11, 2020|archive-url=https://web.archive.org/web/20200611191026/https://www.washingtonpost.com/business/operation-warp-speed-needs-to-waste-money-on-vaccines/2020/04/30/d65f3cee-8b04-11ea-80df-d24b35a568ae_story.html}}
Most viral infections do not have vaccines because the vaccine technology failed in early-stage clinical trials. Because many vaccines cause side effects, such as pain at the injection site, headaches, and influenza symptoms, safety testing requires years{{Citation needed|reason=Vaccinologists like Paul Offitt say negative effects show up within days or weeks, not years. If there's contrary information it would be good to link to it.|date=August 2021}} of observation in thousands of clinical trial participants. Similarly, sufficient time{{snd}}a year or multiple years{{snd}}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.
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.{{cite news |date=August 23, 2021 |title=FDA Approves First COVID-19 Vaccine |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine |agency=Food and Drug Administration |access-date=May 25, 2025}} Pfizer joined the Warp Speed program in July 2020,{{cite press release |date=July 22, 2020 |title=Pfizer and BioNTech Announce an Agreement with U.S. Government for up to 600 Million Doses of mRNA-based Vaccine Candidate Against SARS-CoV-2 |url=https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-agreement-us-government-600 |publisher=Pfizer |access-date=May 25, 2025}} 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.{{Cite web|last=Lovelace|first=Berkeley Jr.|date=November 18, 2020|title=Watch live: U.S. officials speak on Operation Warp Speed after Pfizer releases positive vaccine data|url=https://www.cnbc.com/2020/11/18/watch-live-officials-speak-on-warp-speed-after-pfizer-releases-covid-vaccine-data.html|access-date=July 1, 2021|website=CNBC|language=en}} In December 2020, the Trump administration ordered 200 million additional vaccines from Pfizer.{{Cite web|author=Victoria Knight|title=Biden's criticism of Trump administration vaccine contracts too broad to be accurate|url=https://www.politifact.com/factchecks/2021/mar/05/joe-biden/bidens-criticism-trump-administration-vaccine-cont/ |date=March 5, 2021|access-date=February 23, 2025|website=PolitiFact}}
==Conclusion==
At the end of February 2021, Operation Warp Speed transitioned into the White House COVID-19 Response Team under the Biden Administration.
=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. 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{{snd}}the University of Oxford-AstraZeneca candidate for which the U.S. already paid {{USD|1}}{{nbs}}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.{{Cite web|title=AstraZeneca receives $1 billion in U.S. funding for Oxford University coronavirus vaccine|url=https://www.cnbc.com/2020/05/21/coronavirus-us-gives-astrazenena-1-billion-for-oxford-vaccine.html|last=McKeever|first=Vicky|date=May 21, 2020|website=CNBC|language=en|access-date=May 28, 2020|archive-date=May 28, 2020|archive-url=https://web.archive.org/web/20200528104123/https://www.cnbc.com/2020/05/21/coronavirus-us-gives-astrazenena-1-billion-for-oxford-vaccine.html|url-status=live}}
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{{nbs}}billion together from international partners on May{{nbs}}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.
File:Operation Warp Speed Vaccine Event (50705630873) (cropped).jpg
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).{{Cite web|last1=Christensen|first1=Jen|last2=Acosta|first2=Jim|last3=Carvajal|first3=Nikki|last4=Vazquez|first4=Maegan|date=December 8, 2020|title=Trump to sign order aimed at prioritizing Covid-19 vaccine shipment to Americans|url=https://www.cnn.com/2020/12/07/politics/operation-warp-speed-vaccine-distribution-executive-order/index.html|access-date=December 8, 2020|website=CNN|archive-date=December 8, 2020|archive-url=https://web.archive.org/web/20201208193103/https://www.cnn.com/2020/12/07/politics/operation-warp-speed-vaccine-distribution-executive-order/index.html|url-status=live}}{{cite web |last1=Trump |first1=Donald |title=Executive Order on Ensuring Access to United States Government COVID-19 Vaccines |url=https://trumpwhitehouse.archives.gov/presidential-actions/executive-order-ensuring-access-united-states-government-covid-19-vaccines/ |access-date=December 12, 2020 |archive-date=January 20, 2021 |archive-url=https://web.archive.org/web/20210120202057/https://trumpwhitehouse.archives.gov/presidential-actions/executive-order-ensuring-access-united-states-government-covid-19-vaccines/ |via=National Archives |work=whitehouse.gov |url-status=live }}
=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.{{cite journal | last1=Kim | first1=Jerome H | last2=Hotez | first2=Peter | last3=Batista | first3=Carolina | last4=Ergonul | first4=Onder | last5=Figueroa | first5=J Peter | last6=Gilbert | first6=Sarah | last7=Gursel | first7=Mayda | last8=Hassanain | first8=Mazen | last9=Kang | first9=Gagandeep | last10=Lall | first10=Bhavna | last11=Larson | first11=Heidi | last12=Naniche | first12=Denise | last13=Sheahan | first13=Timothy | last14=Shoham | first14=Shmuel | last15=Wilder-Smith | first15=Annelies | last16=Strub-Wourgaft | first16=Nathalie | last17=Yadav | first17=Prashant | last18=Bottazzi | first18=Maria Elena | title=Operation Warp Speed: implications for global vaccine security | journal=The Lancet Global Health | date=March 26, 2021 | volume=9 | issue=7 | pages=e1017–e1021 | issn=2214-109X | doi=10.1016/S2214-109X(21)00140-6 | pmid=33780663 | pmc=7997645 | doi-access=free }} 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.{{cite news |author1=Carl O'Donnell |author2=Andrea Shalal |title=Biden to pledge $4 billion to COVAX vaccine program at G7 meeting Friday |url=https://www.reuters.com/article/us-usa-biden-covax/biden-to-pledge-4-billion-to-covax-vaccine-program-at-g7-meeting-friday-idUSKBN2AI2YP |access-date=April 1, 2021 |work=Reuters |date=February 18, 2021}}
=Vaccine hesitancy=
{{Main|COVID-19 vaccine misinformation and 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. Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health concern,{{Cite web |url=https://www.who.int/emergencies/ten-threats-to-global-health-in-2019 |title=Ten health issues WHO will tackle this year |publisher=World Health Organization |access-date=May 26, 2020 |year=2019 |archive-date=November 11, 2019 |archive-url=https://web.archive.org/web/20191111212640/https://www.who.int/emergencies/ten-threats-to-global-health-in-2019 }} which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020–21.{{Cite journal |last1=Dubé|first1=Eve|last2=Laberge|first2=Caroline|last3=Guay|first3=Maryse|last4=Bramadat|first4=Paul|last5=Roy|first5=Réal|last6=Bettinger|first6=Julie|date=August 1, 2013|title=Vaccine hesitancy: an overview|journal=Human Vaccines & Immunotherapeutics|volume=9|issue=8|pages=1763–1773|doi=10.4161/hv.24657|issn=2164-554X|pmc=3906279|pmid=23584253}} 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.{{cite news|url=https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/|title=U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine|date=September 17, 2020|work=Pew Research|access-date=October 15, 2020|archive-date=October 15, 2020|archive-url=https://web.archive.org/web/20201015005522/https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/|url-status=live}}
=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{{nbs}}million, raising questions of his neutrality in judging vaccine candidates.{{Cite news|title=Head of Trump's Covid-19 vaccine program to divest more than $10M in Moderna shares after criticism|url=https://medcitynews.com/2020/05/head-of-trumps-covid-19-vaccine-program-to-divest-more-than-10m-in-moderna-shares-after-criticism/|date=May 19, 2020|author=Alaric Dearment|work=MedCity News|access-date=May 28, 2020}} Although Slaoui resigned from the Moderna board when named to head Warp Speed, his share value in Moderna stock increased by $3{{nbs}}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.{{cite news|url=https://edition.cnn.com/2021/01/13/politics/moncef-slaoui-operation-warp-speed-resigns-biden-administration/index.html|author1=Kristen Holmes |author2=Sarah Mucha |author3=Gregory Lemos |title=Head of US vaccine effort resigns at request of incoming Biden administration but will stay through transition|work=CNN|date=January 13, 2021|access-date=January 30, 2021|archive-date=February 1, 2021|archive-url=https://web.archive.org/web/20210201063106/https://edition.cnn.com/2021/01/13/politics/moncef-slaoui-operation-warp-speed-resigns-biden-administration/index.html|url-status=live}}
=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.{{Cite news|last1=Gelles|first1=David|last2=Murphy|first2=Heather|date=August 11, 2020|title=This Company Boasted to Trump About Its Covid-19 Vaccine. Experts Are Skeptical|language=en-US|work=The New York Times|url=https://www.nytimes.com/2020/08/09/business/coronavirus-vaccine-inovio.html|access-date=September 25, 2020|issn=0362-4331|archive-date=November 25, 2020|archive-url=https://web.archive.org/web/20201125001621/https://www.nytimes.com/2020/08/09/business/coronavirus-vaccine-inovio.html|url-status=live}} A class action lawsuit was filed in August 2020 against Vaxart in Northern California U.S. District Court for alleged securities fraud,[http://securities.stanford.edu/filings-documents/1075/VI2400_20/2020824_f01c_20CV05949.pdf Himmelberg v. Vaxart, Inc.] {{Webarchive|url=https://web.archive.org/web/20201011063520/http://securities.stanford.edu/filings-documents/1075/VI2400_20/2020824_f01c_20CV05949.pdf |date=October 11, 2020 }}, No. 20-cv-05949 (N.D. Cal. August 24, 2020) a concern related to Vaxart executives enriching themselves by selling shares timed to positive news on vaccine development during mid-2020.{{Cite news|last1=Gelles|first1=David|last2=Drucker|first2=Jesse|date=July 25, 2020|title=Corporate Insiders Pocket $1 Billion in Rush for Coronavirus Vaccine|language=en-US|work=The New York Times|url=https://www.nytimes.com/2020/07/25/business/coronavirus-vaccine-profits-vaxart.html|access-date=September 25, 2020|issn=0362-4331|archive-date=September 24, 2020|archive-url=https://web.archive.org/web/20200924124530/https://www.nytimes.com/2020/07/25/business/coronavirus-vaccine-profits-vaxart.html|url-status=live}} Executives, board members, and investment firms holding shares in vaccine and therapeutic companies, including Moderna, Novavax, and Regeneron, took profits worth some {{US$|1}} billion (about €830 million) on positive news during 2020.
See also
{{Donald Trump series}}
References
{{Reflist}}
Further reading
{{Scholia}}
- {{cite book |title=The First Shots: The Epic Rivalries and Heroic Science Behind the Race to the Coronavirus Vaccine |year=2021 |author=Brendan Borrell |publisher=Mariner Books |isbn=978-0-358-56984-8}}
- David Oshinsky, "Vaccines at Warp Speed" (review of Thomas R. Cech, The Catalyst: RNA and the Quest to Unlock Life's Deepest Secrets, Norton, 2024, 292 pp.), The New York Review of Books, vol. LXXII, no. 5 (27 March 2025), pp. 48–50. In order to create Covid-19 vaccines "[t]here was no need, as with earlier vaccines, to grow, attenuate, and purify large amounts of virus – in this case SARS-CoV-2 – ... because the vaccine no longer contains it. Instead, synthetic mRNA instructs the cells to create a harmless fragment of SARS-CoV-2 that will trigger the immune system to recognize and destroy the virus... [T]he body becomes the factory." (p. 49.) The success of the Covid-19 vaccines "recast the importance of RNA.... [I]t is almost a given, as [the book's author] Cech makes clear, that RNA will power the next generation of pharmaceuticals, which will move beyond infectious diseases to those caused by a 'missing or mutated protein,' such as muscular dystrophy, and numerous cancers caused by 'normal cellular processes gone awry.'... [The question arises, however:] Will this growing focus on 'disease-driven research' overshadow the more traditional 'curiosity-driven' research so vital to scientific advancement?" (p. 50.)
{{COVID-19 pandemic in the United States}}
{{COVID-19 pandemic}}
{{Vaccine safety}}
{{Authority control}}
Category:COVID-19 pandemic in the United States
Category:COVID-19 vaccination in the United States
Category:Federal government of the United States
Category:First presidency of Donald Trump
Category:United States Department of Health and Human Services
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Category:U.S. federal government response to the COVID-19 pandemic
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