Operation Warp Speed (OWS) was a
public–private partnership
A public–private partnership (PPP, 3P, or P3) is a long-term arrangement between a government and private sector institutions.Hodge, G. A and Greve, C. (2007), Public–Private Partnerships: An International Performance Review, Public Administ ...
initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of
COVID-19 vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19).
Prior to the COVID19 pandemic, an e ...
s, therapeutics, and diagnostics.
The first news report of Operation Warp Speed was on April 29, 2020,
and the program was officially announced on May 15, 2020.
[ It was headed by ]Moncef Slaoui
Moncef Mohamed Slaoui (; ; ary, منصف السلاوي, ; born July 22, 1959) is a Moroccan-born Belgian-American researcher who served as the head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021.
Slaoui is t ...
from May 2020 to January 2021 and by David A. Kessler
David Aaron Kessler (born May 13, 1951) is an American pediatrician, attorney, author, and administrator (both academic and governmental) serving as Chief Science Officer of the White House COVID-19 Response Team since 2021. Kessler was the commi ...
from January to February 2021. At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team
The White House COVID-19 Response Team is the task force during the presidency of Joe Biden to respond to the COVID-19 pandemic in the United States. It was set up by Joe Biden on his first day in officeJanuary 20, 2021and replaced President Trum ...
.
The program promoted mass production of multiple vaccines, and different types of vaccine technologies, based on preliminary evidence, allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. The plan anticipated that some of these vaccines will not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines.
Operation Warp Speed, initially funded with about $10billion from the CARES Act
The Coronavirus Aid, Relief, and Economic Security Act, also known as the CARES Act, is a $2.2trillion Stimulus (economics), economic stimulus bill passed by the 116th U.S. Congress and signed into law by President Donald Trump on March 27, ...
(Coronavirus Aid, Relief, and Economic Security) passed by the United States Congress
The United States Congress is the legislature of the federal government of the United States. It is bicameral, composed of a lower body, the House of Representatives, and an upper body, the Senate. It meets in the U.S. Capitol in Washing ...
on March 27, 2020,[ was an interagency program that includes components of the ]Department of Health and Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
, including the Centers for Disease Control and Prevention
The Centers for Disease Control and Prevention (CDC) is the national public health agency of the United States. It is a United States federal agency, under the Department of Health and Human Services, and is headquartered in Atlanta, Georgi ...
, Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
, the National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
, and the Biomedical Advanced Research and Development Authority
The Biomedical Advanced Research and Development Authority (BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, in ...
(BARDA); the Department of Defense Department of Defence or Department of Defense may refer to:
Current departments of defence
* Department of Defence (Australia)
* Department of National Defence (Canada)
* Department of Defence (Ireland)
* Department of National Defense (Philipp ...
; private firms; and other federal agencies, including the Department of Agriculture, the Department of Energy A Ministry of Energy or Department of Energy is a government department in some countries that typically oversees the production of fuel and electricity; in the United States, however, it manages nuclear weapons development and conducts energy-rel ...
, and the Department of Veterans Affairs
The United States Department of Veterans Affairs (VA) is a Cabinet-level executive branch department of the federal government charged with providing life-long healthcare services to eligible military veterans at the 170 VA medical centers an ...
.[
]
History
On May 15, 2020, President Donald Trump
Donald John Trump (born June 14, 1946) is an American politician, media personality, and businessman who served as the 45th president of the United States from 2017 to 2021.
Trump graduated from the Wharton School of the University of Pe ...
officially announced the public-private partnership. The purpose of Operation Warp Speed was to coordinate Health and Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
-wide efforts, including the NIH ACTIV partnership for vaccine and therapeutic development, the NIH RADx initiative for diagnostic development, and work by BARDA.[
Operation Warp Speed was formed to encourage private and public partnerships to enable faster approval and production of vaccines during the COVID-19 pandemic.] The name was inspired by terminology for faster-than-light
Faster-than-light (also FTL, superluminal or supercausal) travel and communication are the conjectural propagation of matter or information faster than the speed of light (). The special theory of relativity implies that only particles with zero ...
travel used in the ''Star Trek
''Star Trek'' is an American science fiction media franchise created by Gene Roddenberry, which began with the eponymous 1960s television series and quickly became a worldwide pop-culture phenomenon. The franchise has expanded into vari ...
'' fictional universe
A fictional universe, or fictional world, is a self-consistent setting with events, and often other elements, that differ from the real world. It may also be called an imagined, constructed, or fictional realm (or world). Fictional universes may ...
, evoking a sense of rapid progress.
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.
In January 2021, White House press secretary Jen Psaki
Jennifer Rene Psaki (; born c. 1978) is an American television political analyst who currently works for MSNBC. Previously, she was a political advisor who served under both the Obama and Biden administrations. Immediately prior to working for ...
announced that the program was expected to undergo a restructure and renaming under the Biden administration
Joe Biden's tenure as the 46th president of the United States began with his inauguration on January 20, 2021. Biden, a Democrat from Delaware who previously served as vice president under Barack Obama, took office following his victory ...
. Also in January 2021, Dr. Moncef Slaoui
Moncef Mohamed Slaoui (; ; ary, منصف السلاوي, ; born July 22, 1959) is a Moroccan-born Belgian-American researcher who served as the head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021.
Slaoui is t ...
, former Operation Warp Speed lead, was told not to use the name Operation Warp Speed anymore. At the end of February 2021, responsibilities of Operation Warp Speed were transferred into the White House COVID-19 Response Team
The White House COVID-19 Response Team is the task force during the presidency of Joe Biden to respond to the COVID-19 pandemic in the United States. It was set up by Joe Biden on his first day in officeJanuary 20, 2021and replaced President Trum ...
.[
]
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, included:
*support pharmaceutical companies for R&D of seven different vaccine candidates simultaneously and certain therapeutic compounds][
*support several vaccine manufacturers for rapid ]scale-up
SCALE-UP, Student-Centered Active Learning Environment with Upside-Down Pedagogies, is a classroom specifically created to facilitate active, collaborative learning in a classroom. The spaces are carefully designed to facilitate interactions betwe ...
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]
*coordinate with the Department of Defense Department of Defence or Department of Defense may refer to:
Current departments of defence
* Department of Defence (Australia)
* Department of National Defence (Canada)
* Department of Defence (Ireland)
* Department of National Defense (Philipp ...
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
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".
Budget and leadership
Operation Warp Speed used BARDA as the financial interface between the U.S. federal government and the biomedical industry. The program was initially being funded with $10billion,[ with additional funds allocated through BARDA.] Funding was increased to about $18billion by October 2020.
Rick Bright, the BARDA director, was reassigned on or about April 22, 2020, following his resistance to (as he phrased it) "efforts to fund potentially dangerous drugs promoted by those with political connections". In May, new leadership was announced. Moncef Slaoui
Moncef Mohamed Slaoui (; ; ary, منصف السلاوي, ; born July 22, 1959) is a Moroccan-born Belgian-American researcher who served as the head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021.
Slaoui is t ...
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
GSK plc, formerly GlaxoSmithKline plc, is a British multinational pharmaceutical and biotechnology company with global headquarters in London, England. Established in 2000 by a merger of Glaxo Wellcome and SmithKline Beecham. GSK is the ten ...
, where he led the development of five vaccines. General Gustave F. Perna
Gustave F. Perna (born 1960) is a retired United States Army four-star general who last served as the chief operating officer of the federal COVID-19 response for vaccine and therapeutics. He previously served as the chief operating officer of O ...
, who served as commanding general of Army Materiel Command, was named Operation Warp Speed chief operating officer
A chief operating officer or chief operations officer, also called a COO, is one of the highest-ranking executive positions in an organization, composing part of the "C-suite". The COO is usually the second-in-command at the firm, especially if t ...
. Retired Lieutenant General Paul A. Ostrowski, who previously served as director of the Army Acquisition Corps, was the director of supply, production and distribution. Army Major General Christopher J. Sharpsten was the deputy director.
Alex Azar
Alex Michael Azar II (; born June 17, 1967) is an American attorney, businessman, lobbyist, and former pharmaceutical executive who served as the United States secretary of health and human services from 2018 to 2021. Azar was nominated to his p ...
, Mark Esper
Mark Thomas Esper (born April 26, 1964) is an American politician and manufacturing executive who served as the 27th United States secretary of defense from 2019 to 2020. A member of the Republican Party, he had previously served as the 23rd ...
, and Deborah Birx
Deborah Leah Birx (born April 4, 1956) is an American physician and diplomat who served as the White House Coronavirus Response Coordinator under President Donald Trump from 2020 to 2021. Birx specializes in HIV/AIDS immunology, vaccine resea ...
were on the board of directors of OWS, while Tony Fauci, Francis Collins
Francis Sellers Collins (born April 14, 1950) is an American physician-geneticist who discovered the genes associated with a number of diseases and led the Human Genome Project. He is the former director of the National Institutes of Health ( ...
, and Robert Redfield
Robert Redfield (December 4, 1897 – October 16, 1958) was an American anthropologist and ethnolinguist, whose ethnographic work in Tepoztlán, Mexico, is considered a landmark of Latin American ethnography. He was associated with the University ...
were nonvoting advisers.
Companies receiving research funding
As of August 2020, eight companies were chosen for funding of some $11billion to expedite development and preparation for manufacturing their respective vaccine candidates.
The vaccine developers, different vaccine technologies, and treatments receiving government research funding were:
Indirectly funded companies include:
*Inovio
Inovio Pharmaceuticals is an American biotechnology company focused on the discovery, development, and commercialization of Synthetic genomics, synthetic DNA products for treating cancers and infectious diseases. In April 2020, Inovio was among so ...
As of October 2020, Operation Warp Speed had spent less than $1billion to support the development and manufacturing of three monoclonal antibody
A monoclonal antibody (mAb, more rarely called moAb) is an antibody produced from a cell Lineage made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to a unique parent cell.
Monoclonal antibodies ca ...
treatments, versus almost $10billion on six vaccines.
*Regeneron
Regeneron Pharmaceuticals, Inc. is an American biotechnology company headquartered in Westchester County, New York. The company was founded in 1988. Originally focused on neurotrophic factors and their regenerative capabilities, giving rise to i ...
was to receive $450million to develop and supply a monoclonal antibody drug, according to a government announcement on July 7, 2020.
Other companies involved in the Warp Speed program
Pfizer–BioNTech
The BioNtech
BioNTech SE ( ; or short for Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develop ...
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
Mainz () is the capital and largest city of Rhineland-Palatinate, Germany.
Mainz is on the left bank of the Rhine, opposite to the place that the Main (river), Main joins the Rhine. Downstream of the confluence, the Rhine flows to the north-we ...
, Germany, just days after the SARS-Cov-2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a ...
genetic sequence
A nucleic acid sequence is a succession of bases signified by a series of a set of five different letters that indicate the order of nucleotides forming alleles within a DNA (using GACT) or RNA (GACU) molecule. By convention, sequences are usua ...
was first made public. In September 2020, BioNTech received €375million (million) from the government of Germany
The Federal Cabinet or Federal Government (german: link=no, Bundeskabinett or ') is the chief executive body of the Federal Republic of Germany. It consists of the Federal Chancellor and cabinet ministers. The fundamentals of the cabinet's or ...
to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine
The Pfizer–BioNTech COVID-19 vaccine ( INN: tozinameran), sold under the brand name Comirnaty, is an mRNA-based COVID-19 vaccine developed by the German biotechnology company BioNTech. For its development, BioNTech collaborated with Amer ...
.
Pfizer CEO Albert Bourla
Albert Bourla ( el, Άλμπερτ Μπουρλά; born ) is a Greek-American veterinarian and the chairman and chief executive officer of Pfizer, an American pharmaceutical company. He joined the company in 1993 and has held several executive ro ...
said that the company decided against taking direct Warp Speed funding for the development of the vaccine out of a desire "to liberate our scientists rom
Rom, or ROM may refer to:
Biomechanics and medicine
* Risk of mortality, a medical classification to estimate the likelihood of death for a patient
* Rupture of membranes, a term used during pregnancy to describe a rupture of the amniotic sac
* ...
any bureaucracy that comes with having to give reports and agree how we are going to spend the money in parallel or together".
But on July 22, 2020, Operation Warp Speed placed an advance-purchase order of $2billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine for use in the United States when the vaccine was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA). On December 23, 2020, the Trump administration announced that they had ordered another 200 million doses from Pfizer. On November 9, the Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
–BioNTech
BioNTech SE ( ; or short for Biopharmaceutical New Technologies) is a German biotechnology company based in Mainz that develops and manufactures active immunotherapies for patient-specific approaches to the treatment of diseases. It develop ...
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
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Act of Congress, Acts of ...
, initiating the distribution of the vaccine.
Pfizer head of vaccine research and development Dr. Kathrin Jansen initially said Pfizer was not a participant in Operation Warp Speed because it did not accept taxpayer funds for research and development, but Pfizer released a statement saying her comments had been "taken out of context" and confirmed that Pfizer was a part of the Warp Speed program. The White House confirmed Pfizer's involvement and the government's initial advance-order purchase for a hundred million doses of vaccine. Company representatives said in November that "the company is part of Operation Warp Speed as a supplier of a potential coronavirus vaccine," and that "Pfizer is proud to be one of various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine."
The United Kingdom was the first country to authorize the vaccine on an emergency basis on December 2, 2020. Emergency use authorization in the United States was issued December 11, 2020.
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
Alex Michael Azar II (; born June 17, 1967) is an American attorney, businessman, lobbyist, and former pharmaceutical executive who served as the United States secretary of health and human services from 2018 to 2021. Azar was nominated to his p ...
, at that time the United States Secretary of Health and Human Services
The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ...
, predicted a hundred million available doses by the end of the year. The Trump administration later reduced the goal to twenty million doses. As of January 6, 2021, the CDC was reporting 17,288,950 doses distributed, but only 5,306,797 actually administered to a person. Of those, 3,416,875 were distributed and 511,635 administered through the Federal Pharmacy Partnership. General Gustave Perna said reporting delays cause the administration numbers to lag by 72 to 96 hours. 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.
The distribution effort was criticized for lack of coordination between federal and state governments, and lack of timely federal funding for mass vaccination campaigns. Other reasons cited included the Christmas holiday, employees declining to be vaccinated, a longer than typical time spent on paperwork or answering patient questions, the required observation time, and shortage of trained staff.
Reception
Cost
Although initially budgeted by Congress for about $10billion in May 2020,[ Operation Warp Speed had spent $12.4billion by mid-December on vaccine developers for the combined costs of R&D and pre-approval manufacturing for millions of vaccine doses.]
Operation Warp Speed anticipated that some of these vaccines would not prove safe or effective, making the program more costly than typical vaccine development, but potentially leading to the availability of a viable vaccine several months earlier than typical timelines. The low prices of coronavirus vaccines were attributed to the high amount of research funding provided by Operation Warp Speed: despite preliminary data suggesting that the COVID-19 vaccines subsidized by the plan had higher effectiveness than flu vaccines, vaccine developers set initial pricing in line with those of the annual influenza vaccine
Influenza vaccines, also known as flu shots, are vaccines that protect against infection by influenza viruses. New versions of the vaccines are developed twice a year, as the influenza virus rapidly changes. While their effectiveness varies fr ...
.
Timeline
The goals of the projectto develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020were initially criticized as being unrealistic, based on decades of experience in developing viral infection vaccines which normally require years or decades for assuring the chosen vaccine will not be toxic and have adequate efficacy.
Most viral infections do not have vaccines because the vaccine technology failed in early-stage clinical trials.[ Because many vaccines cause ]side effect
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
s, such as pain at the injection site, headaches, and influenza
Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses. Symptoms range from mild to severe and often include fever, runny nose, sore throat, muscle pain, headache, coughing, and fatigue. These symptoms ...
symptoms, safety testing requires years of observation in thousands of clinical trial participants.[ Similarly, sufficient timea year or multiple yearsis 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 coronavirus
Coronaviruses are a group of related RNA viruses that cause diseases in mammals and birds. In humans and birds, they cause respiratory tract infections that can range from mild to lethal. Mild illnesses in humans include some cases of the com ...
es, such as SARS
Severe acute respiratory syndrome (SARS) is a viral respiratory disease of zoonotic origin caused by the severe acute respiratory syndrome coronavirus (SARS-CoV or SARS-CoV-1), the first identified strain of the SARS coronavirus species, ''sever ...
and MERS
Middle East respiratory syndrome (MERS) is a viral respiratory infection caused by ''Middle East respiratory syndrome–related coronavirus'' (MERS-CoV). Symptoms may range from none, to mild, to severe. Typical symptoms include fever, cough, ...
, 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, established an exceptionally fast development and approval timeline for vaccines granted emergency marketing. Pfizer joined the Warp Speed program in July 2020, and signed a $1.95 billion contract to be paid out when the vaccine would be FDA approved, and included an initial order of 100 million vaccines. In December 2020, the Trump administration ordered 200 million additional vaccines from Pfizer.
Conclusion
At the end of February 2021, Operation Warp Speed transitioned into the White House COVID-19 Response Team
The White House COVID-19 Response Team is the task force during the presidency of Joe Biden to respond to the COVID-19 pandemic in the United States. It was set up by Joe Biden on his first day in officeJanuary 20, 2021and replaced President Trum ...
under the Biden Administration
Joe Biden's tenure as the 46th president of the United States began with his inauguration on January 20, 2021. Biden, a Democrat from Delaware who previously served as vice president under Barack Obama, took office following his victory ...
.[
]
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 platformthe ]University of Oxford
, mottoeng = The Lord is my light
, established =
, endowment = £6.1 billion (including colleges) (2019)
, budget = £2.145 billion (2019–20)
, chancellor ...
-AstraZeneca
AstraZeneca plc () is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England. It has a portfolio of products for major diseases in areas includin ...
candidate for which the U.S. already paid 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.
Warp Speed did not partner with Chinese vaccine development organizations, or with the World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(WHO), the Coalition for Epidemic Preparedness Innovations
The Coalition for Epidemic Preparedness Innovations (CEPI) is a foundation that takes donations from public, private, philanthropic, and civil society organisations, to finance independent research projects to develop vaccines against emerging ...
, or the European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body o ...
, which are coordinating and financing international programs for multiple vaccine development, having raised $8billion together from international partners on May4 for a Coronavirus Global Response.[ The U.S. government chose not to include Operation Warp Speed as part of the international ]Solidarity trial
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness. The tria ...
on vaccine development, organized by the WHO.[
]
On December 8, 2020, President Trump signed an executive order mandating that companies sell vaccine to the US before selling to any other countries (even if they already had contracts with other countries).
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. Concerns were elevated when the Trump administration withdrew its financial support for the WHO and COVAX
COVID-19 Vaccines Global Access, abbreviated as COVAX, is a worldwide initiative aimed at equitable access to COVID-19 vaccines directed by the GAVI vaccine alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), and the World Hea ...
, and whether the program would participate in international vaccination practices, optimization, and education against vaccine hesitancy
Vaccine hesitancy is a delay in acceptance, or refusal, of vaccines despite the availability of vaccine services and supporting evidence. The term covers refusals to vaccinate, delaying vaccines, accepting vaccines but remaining uncertain abou ...
and misinformation.[ In February 2021 after Operation Warp Speed was transitioned to the ]White House COVID-19 Response Team
The White House COVID-19 Response Team is the task force during the presidency of Joe Biden to respond to the COVID-19 pandemic in the United States. It was set up by Joe Biden on his first day in officeJanuary 20, 2021and replaced President Trum ...
, the United States pledged to donate any vaccine surplus out of concern for vaccine-poor regions, such as Africa.
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.[ Failure of the public to have confidence in a new vaccine and refuse vaccination is a global health concern,] which increases the risk of further viral spreading that could lead to ongoing COVID-19 outbreaks during 2020–21. A September 2020 survey found that half of American adults surveyed said they would not accept a vaccination if it was available at that time, and three-quarters expressed concerns about the pace of the process and fears that a vaccine might be confirmed before its safety and effectiveness are fully understood.
Leader neutrality
The leader of the Operation Warp Speed project, Moncef Slaoui
Moncef Mohamed Slaoui (; ; ary, منصف السلاوي, ; born July 22, 1959) is a Moroccan-born Belgian-American researcher who served as the head of Operation Warp Speed (OPWASP) under President Donald Trump from 2020 to 2021.
Slaoui is t ...
, had been a board member
A board of directors (commonly referred simply as the board) is an executive committee that jointly supervises the activities of an organization, which can be either a for-profit or a nonprofit organization such as a business, nonprofit organi ...
of the U.S. vaccine developer, Moderna
Moderna, Inc. ( ) is an American pharmaceutical and biotechnology company based in Cambridge, Massachusetts that focuses on RNA therapeutics, primarily mRNA vaccines. These vaccines use a copy of a molecule called messenger RNA (mRNA) to produ ...
, and divested his shares
In financial markets, a share is a unit of equity ownership in the capital stock of a corporation, and can refer to units of mutual funds, limited partnerships, and real estate investment trusts. Share capital refers to all of the shares of an ...
in Moderna stock, at a potential personal gain of $10million, raising questions of his neutrality in judging vaccine candidates. Although Slaoui resigned from the Moderna board when named to head Warp Speed, his share value in Moderna stock increased by $3million in one day when Moderna announced an advance in vaccine clinical research.[ At the request of the incoming ]Biden administration
Joe Biden's tenure as the 46th president of the United States began with his inauguration on January 20, 2021. Biden, a Democrat from Delaware who previously served as vice president under Barack Obama, took office following his victory ...
, Slaoui resigned from the project in early January 2021.
Lawsuits and insider trading
Shareholders sued biotech
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...
firm Inovio
Inovio Pharmaceuticals is an American biotechnology company focused on the discovery, development, and commercialization of Synthetic genomics, synthetic DNA products for treating cancers and infectious diseases. In April 2020, Inovio was among so ...
, claiming the company misled the public when it reported how quickly it had designed the blueprint for its vaccine candidate. A class action lawsuit was filed in August 2020 against Vaxart in Northern California U.S. District Court for alleged securities fraud,Himmelberg v. Vaxart, Inc.
, 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. Executives, board members, and investment firms holding shares in vaccine and therapeutic companies, including Moderna, Novavax, and Regeneron, took profits worth some billion (about €
The euro sign () is the currency sign used for the euro, the official currency of the eurozone and unilaterally adopted by Kosovo and Montenegro. The design was presented to the public by the European Commission on 12 December 1996. It consists ...
830 million) on positive news during 2020.[
]
References
Further reading
*
{{Authority control
COVID-19 pandemic in the United States
COVID-19 vaccination in the United States
Federal government of the United States
Warp Speed
The technology in '' Star Trek'' has borrowed many ideas from the scientific world. Episodes often contain technologies named after real-world scientific phenomena, such as tachyon beams, baryon sweeps, quantum slipstream drives, and photon ...
Presidency of Donald Trump
United States Department of Health and Human Services
United States Department of Defense
U.S. federal government response to the COVID-19 pandemic