Operation Warp Speed
January 2020
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. In September 2020, BioNTech received €375 million (US$445 million) from the government of Germany to accelerate the development and production capacity of the Pfizer–BioNTech COVID-19 vaccine.
March 27, 2020
Operation Warp Speed, initially funded with about $10 billion from the CARES Act (Coronavirus Aid, Relief, and Economic Security) passed by the United States Congress on March 27, 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, 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.
April 22, 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 was named Operation Warp Speed's chief adviser. Slaoui is a vaccine researcher and, formerly, Chairman of Global Research and Development and Chairman of Global Vaccines at GlaxoSmithKline, where he led the development of five vaccines. General Gustave F. Perna, who served as commanding general of Army Materiel Command, was named Operation Warp Speed chief operating officer. Retired Lieutenant General Paul A. Ostrowski, who previously served as director of the Army Acquisition Corps, was the director of supply, production and distribution. Army Major General Christopher J. Sharpsten was the deputy director.
April 29, 2020
Operation Warp Speed (OWS) was a public–private partnership initiated by the United States government to facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The first news report of Operation Warp Speed was on April 29, 2020, and the program was officially announced on May 15, 2020. It was headed by Moncef Slaoui from May 2020 to January 2021 and by David A. Kessler from January to February 2021. At the end of February 2021, Operation Warp Speed was transferred into the responsibilities of the White House COVID-19 Response Team.
May 2020
Although initially budgeted by Congress for about $10 billion in May 2020, Operation Warp Speed had spent $12.4 billion by mid-December on vaccine developers for the combined costs of R&D and pre-approval manufacturing for millions of vaccine doses.
May 2020
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 – the University of Oxford-AstraZeneca candidate for which the U.S. already paid US$1 billion in May 2020 to receive 300 million doses for American use, when the AstraZeneca vaccine was successful in advancing to proof of safety and efficacy beyond its status as an early-stage Phase I–II trial in May.
May 15, 2020
On May 15, 2020, President Donald Trump officially announced the public-private partnership. The purpose of Operation Warp Speed was to coordinate Health and Human Services-wide efforts, including the NIH ACTIV partnership for vaccine and therapeutic development, the NIH RADx initiative for diagnostic development, and work by BARDA.
June 30, 2020
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.
July 2020
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.
July 22, 2020
But on July 22, 2020, Operation Warp Speed placed an advance-purchase order of $2 billion with Pfizer to manufacture 100 million doses of a COVID-19 vaccine for use in the United States when the vaccine was shown to be safe, effective, licensed, and authorized by the Food and Drug Administration (FDA). On December 23, 2020, the Trump administration announced that they had ordered another 200 million doses from Pfizer. On November 9, the Pfizer–BioNTech partnership announced positive early results from its Phase III trial of the BNT162b2 vaccine candidate, and on December 11, the FDA provided emergency use authorization, initiating the distribution of the vaccine.
August 2020
As of August 2020, eight companies were chosen for funding of some $11 billion to expedite development and preparation for manufacturing their respective vaccine candidates.
August 2020
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. A class action lawsuit was filed in August 2020 against Vaxart in Northern California U.S. District Court for alleged securities fraud, a concern related to Vaxart executives enriching themselves by selling shares timed to positive news on vaccine development during mid-2020. Executives, board members, and investment firms holding shares in vaccine and therapeutic companies, including Moderna, Novavax, and Regeneron, took profits worth some US$1 billion (about €830 million) on positive news during 2020.
September 2020
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.
October 2020
As of October 2020, Operation Warp Speed had spent less than $1 billion to support the development and manufacturing of three monoclonal antibody treatments, versus almost $10 billion on six vaccines.
October 2020
In October 2020, Alex Azar, at that time the United States Secretary of Health and Human Services, predicted a hundred million available doses by the end of the year. The Trump administration later reduced the goal to twenty million doses. As of January 6, 2021, the CDC was reporting 17,288,950 doses distributed, but only 5,306,797 actually administered to a person. Of those, 3,416,875 were distributed and 511,635 administered through the Federal Pharmacy Partnership. General Gustave Perna said reporting delays cause the administration numbers to lag by 72 to 96 hours. 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.
October 2020
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 $10 billion, with additional funds allocated through BARDA. Funding was increased to about $18 billion by October 2020.
December 02, 2020
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.
December 08, 2020
On December 8, 2020, President Trump signed an executive order mandating that companies sell vaccine to the US before selling to any other countries (even if they already had contracts with other countries).
January 2021
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".
January 2021
In January 2021, White House press secretary Jen Psaki announced that the program was expected to undergo a restructure and renaming under the Biden administration. Also in January 2021, Dr. Moncef Slaoui, former Operation Warp Speed lead, was told not to use the name Operation Warp Speed anymore. At the end of February 2021, responsibilities of Operation Warp Speed were transferred into the White House COVID-19 Response Team.
January 2021
The leader of the Operation Warp Speed project, Moncef Slaoui, had been a board member of the U.S. vaccine developer, Moderna, and divested his shares in Moderna stock, at a potential personal gain of $10 million, raising questions of his neutrality in judging vaccine candidates. Although Slaoui resigned from the Moderna board when named to head Warp Speed, his share value in Moderna stock increased by $3 million in one day when Moderna announced an advance in vaccine clinical research. At the request of the incoming Biden administration, Slaoui resigned from the project in early January 2021.
February 2021
At the end of February 2021, Operation Warp Speed transitioned into the White House COVID-19 Response Team under the Biden Administration.
February 2021
The focus of Operation Warp Speed to deploy approved COVID-19 vaccines first for the American people raised ethical and logistical concerns that access to vaccines outside of the United States may be restricted during 2021, leaving low-to-middle-income countries with no or minimal supply. Concerns were elevated when the Trump administration withdrew its financial support for the WHO and COVAX, and whether the program would participate in international vaccination practices, optimization, and education against vaccine hesitancy and misinformation. In February 2021 after Operation Warp Speed was transitioned to the White House COVID-19 Response Team, the United States pledged to donate any vaccine surplus out of concern for vaccine-poor regions, such as Africa.
