Operation Warp Speed (OWS) was a US government initiative to speed up the development, production, and distribution of COVID-19 vaccines, treatments, and tests. Announced in May 2020, it was led by Moncef Slaoui and later David A. Kessler. The program ended in February 2021, with its responsibilities transferred to the White House COVID-19 Response Team.
BioNTech commenced its mRNA-based COVID-19 vaccine development project, dubbed "Project Lightspeed," in mid-January 2020. This endeavor began shortly after the SARS-CoV-2 genetic sequence was publicly released.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed, allocating approximately $10 billion in funding for Operation Warp Speed.
On or around April 22, 2020, Rick Bright, the director of BARDA, was reassigned following his opposition to funding certain drugs promoted by individuals with political connections. Bright argued that these drugs were potentially dangerous.
On April 29, 2020, the first news report about Operation Warp Speed surfaced, marking the initial public awareness of the program.
In May 2020, Moncef Slaoui, a renowned vaccine researcher, was appointed as the head of Operation Warp Speed.
In May 2020, the US invested US$1 billion in the University of Oxford-AstraZeneca vaccine candidate, securing 300 million doses for American use. This investment aimed to support the development and production of a promising vaccine candidate.
When Operation Warp Speed was initially announced in May 2020, its ambitious goal of developing, manufacturing, and distributing hundreds of millions of COVID-19 vaccine doses by the end of the year was met with skepticism. Critics pointed to the lengthy timelines typically associated with vaccine development, which often span years or even decades.
Operation Warp Speed was officially announced to the public on May 15, 2020, outlining its goals and objectives.
The Food and Drug Administration (FDA) announced on June 30, 2020, that any COVID-19 vaccine seeking regulatory and marketing approval would need to demonstrate at least 50% efficacy in reducing the severity of COVID-19 symptoms.
Pfizer joined Operation Warp Speed in July 2020, signing a $1.95 billion contract to provide 100 million vaccine doses upon FDA approval. This partnership aimed to accelerate the development and distribution of a COVID-19 vaccine.
On July 22, 2020, the U.S. government made a substantial commitment to securing COVID-19 vaccines by placing a conditional advance-purchase order worth $2 billion with Pfizer. This order aimed to procure 100 million doses of their vaccine candidate, with the possibility of acquiring an additional 500 million doses.
In August 2020, Operation Warp Speed chose eight companies to receive a combined funding of approximately $11 billion to expedite the development and manufacturing preparations for their respective COVID-19 vaccine candidates.
In August 2020, a class action lawsuit was filed against Inovio, alleging that the company made misleading statements about the development timeline of its vaccine candidate. This lawsuit highlighted concerns about transparency and potential market manipulation during the vaccine development race.
A September 2020 survey indicated that half of American adults would not take a COVID-19 vaccine if available then. This hesitancy was partly due to concerns about the rapid development pace and potential risks.
In a significant boost to vaccine development efforts, BioNTech secured €375 million (equivalent to US$445 million) in funding from the German government in September 2020. This substantial financial support aimed to accelerate the development and production capacity of the Pfizer-BioNTech COVID-19 vaccine.
In October 2020, then-Health and Human Services Secretary Alex Azar projected that 100 million doses of COVID-19 vaccines would be available by the end of the year. However, the Trump administration later scaled back this goal to 20 million doses. This adjustment reflected the challenges in vaccine production and distribution.
Data from October 2020 revealed that Operation Warp Speed had allocated a significantly larger portion of its funding to vaccines compared to therapeutics. The program had spent less than $1 billion on three monoclonal antibody treatments, while nearly $10 billion had been directed toward six vaccine candidates.
By October 2020, the funding for Operation Warp Speed had been increased to approximately $18 billion, reflecting the program's expanding scope and the need for greater financial resources.
The United Kingdom made a landmark decision on December 2, 2020, by becoming the first country to grant emergency use authorization to the Pfizer-BioNTech COVID-19 vaccine. This decision marked a pivotal step toward making the vaccine available to the public.
On December 8, 2020, President Trump signed an executive order prioritizing the sale of vaccines to the US before other countries, even if those countries had pre-existing contracts. This decision aimed to secure vaccine doses for the American population.
Following the UK's lead, the U.S. Food and Drug Administration (FDA) granted emergency use authorization to the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020. This authorization paved the way for the distribution and administration of the vaccine in the United States.
In December 2020, the FDA issued an emergency use authorization for the Pfizer and Moderna vaccines, marking a significant milestone in the fight against COVID-19. Pfizer joined Operation Warp Speed in July 2020 and had a $1.95 billion contract to supply vaccines upon FDA approval.
The Trump administration further solidified its commitment to securing COVID-19 vaccines by placing an order for an additional 100 million doses from Pfizer on December 23, 2020.
Throughout 2020, Operation Warp Speed's ambitious objectives faced criticism due to the perceived unrealistic timeline for developing, manufacturing, and distributing hundreds of millions of COVID-19 vaccine doses by the end of the year. Critics drew upon decades of experience in viral infection vaccine development, which typically necessitates years or even decades to ensure safety and efficacy.
On January 6, 2021, the Centers for Disease Control and Prevention (CDC) reported a significant discrepancy between the number of COVID-19 vaccine doses distributed and those actually administered. While 17,288,950 doses had been distributed, only 5,306,797 had been administered. This discrepancy highlighted challenges in the vaccine rollout and administration process.
According to a Department of Health and Human Services fact sheet, Operation Warp Speed's primary goal was to produce and distribute 300 million doses of safe and effective COVID-19 vaccines by January 2021.
January 2021 saw a significant shift in Operation Warp Speed's leadership and structure. Moncef Slaoui's tenure ended, and David A. Kessler briefly took over before the program transitioned to the White House COVID-19 Response Team.
Moncef Slaoui, the head of Operation Warp Speed, resigned in early January 2021 at the request of the incoming Biden administration. Slaoui's previous ties to Moderna, a vaccine developer, had raised concerns about potential conflicts of interest.
White House Press Secretary Jen Psaki announced in January 2021 that the Biden administration planned to restructure and rename Operation Warp Speed.
As Operation Warp Speed was being transferred to the Biden administration on January 31, 2021, a total of 63.7 million vaccine doses had been delivered out of the 200 million doses contracted from Pfizer and Moderna. This transition marked a change in leadership and approach to the vaccine rollout.
At the end of February 2021, the Biden administration transitioned Operation Warp Speed into the White House COVID-19 Response Team, reflecting a shift in leadership and approach to the pandemic.
By February 2021, Operation Warp Speed was fully integrated into the White House COVID-19 Response Team, marking the conclusion of its independent operation.
In February 2021, following the transition of Operation Warp Speed to the White House COVID-19 Response Team, the US committed to donating surplus vaccine doses to countries with limited access, addressing concerns about global vaccine equity.
Pfizer and Moderna were contractually obligated to provide a combined total of 200 million COVID-19 vaccine doses by the end of March 2021, as part of their agreements under Operation Warp Speed.