Office of Preparedness and Response

In January 2018, Kadlec testified to the U.S. Congress that the US was dangerously unprepared for a pandemic.^[8] Prior to the COVID-19 pandemic, Kadlec had heavily focused the office on preparing for a response to bioterror attacks, a choice that was later scrutinized.^[9] From January through March 2020, Kadlec and his team focused on evacuating U.S. nationals from cruise ships and countries hard-hit by the pandemic; Kadlec's defenders said that this focus was necessary to protect Americans, while detractors criticized him for missing opportunities to prepare for pandemic COVID-19 in the United States.

In April 2020, Kadlec demoted federal scientist Rick Bright, removing him from his position as head of the Biomedical Advanced Research and Development Authority (BARDA) and reassigning him to a lower post at the National Institutes of Health. The following month, Bright filed a wide-ranging whistleblower complaint against Kadlec and several Trump administration officials.^[10][9] Bright asserted that Kadlec ousted him in retaliation for his "insistence" that the federal government focus resources on "safe and scientifically vetted solutions" against the COVID-19 pandemic rather than "technologies that lack scientific merit" such as the use of hydroxychloroquine, which had been pushed by the Trump administration.^[9] Bright also alleged that in January 2020, Kadlec had delayed acting to obtain face masks, testing swabs, and other materials for which there was later a shortage.^[9] Supporters of Bright and supporters of Kadlec each accused the other "of preferential treatment for favored contractors and inappropriate spending decisions."^[9] HHS denied that Bright had been retaliated against, but the Office of Special Counsel recommended Bright's reinstatement as BARDA chief,^[9][10] finding a "substantial likelihood of wrongdoing" in his ouster.^[10]

Creation of Operation Warp Speed

Kadlec is responsible for creating the COVID-19 vaccine development program named Operation Warp Speed (OWS). In April 2020, Kadlec worked with Peter Marks (physician), director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) to develop OWS. Kadlec and Marks wrote a proposal for then Secretary of the Department of Health and Human Services (HHS) Alex Azar detailing how Operation Warp Speed would screen potential vaccine candidates and eventually distribute final product to all Americans. ^[11]

A memo circulated by Kadlec and Marks to Azar on April 12 was the first detailed accounting of OWS’ goals: ^[12]

"Project Warp Speed

Maximally expediting a safe, effective vaccine

A safe, effective, broadly administered vaccine is the single most important solution to the Covid-19 pandemic

MISSION: Maximally expedite the development of a safe and effective vaccine with sufficient scale to inoculate all Americans who need it

DEADLINE: Enable broad access to the public by October 2020

PLAN: Modeled after the Manhattan Project approach, a multi-disciplinary, multi-sector team that brings the numerous in-flight efforts under a single authority to drive relentless coordination, barrier elimination, and accountability for mission success"

Kadlec was responsible for setting the aggressive deadline of October 2020 to complete simultaneous clinical trials and roll out the vaccine to the American public.^[12] Recognizing the national security importance of OWS, Azar and Kadlec also worked to enlist the Department of Defense (DoD) as a key partner in both the science and the logistics.^[12]

While OWS was initially named “Project Warp Speed,” Kadlec would later rename it to “Operation Warp Speed” to better reflect the role DoD would play.^[12] On April 24, 2020, Kadlec approved the first communications between FDA and companies who would eventually partner with the government to successfully develop and distribute COVID-19 vaccines.^[12] OWS was announced to the public on May 15, 2020.^[13]

Emergent BioSolutions controversies

Before being appointed by Trump as Assistant Secretary for Preparedness and Response in 2017, Kadlec previously was a consultant for Emergent BioSolutions, a U.S. biotechnology company, and was part-owner of a consulting company related to its founder; he did not disclose these facts in Senate nomination forms during his 2017 confirmation process.^[14] According to HHS, Kadlec may not have realized that his involvement in the start-up could be characterized as one of employment. Kadlec's company RPK Consulting had provided consulting services to Emergent until 2015.^[15] Soon after taking office, Kadlec pushed to increase the government's stockpile of smallpox vaccine from Emergent BioSolutions, and HHS ultimately awarded a 10-year, $2.8 billion single-source contract to the company to purchase its smallpox vaccines at twice the previous price.^[14][16] While renewal of the contract was initially sought on modest terms, Kadlec's office finalized the deal with double the term length (10 years instead of 5 years) and double the number of doses per year (to 18 million). This raised concerns about a potential conflict of interest.^[9][14]

After 15 million Janssen COVID-19 vaccines were ruined due to an error by Emergent BioSolutions (who held a contract to manufacture the vaccines at a Baltimore production facility), a congressional investigation was launched "into whether Emergent used ties to the Trump administration to get billions of dollars in federal contracts despite a history of failing to complete contracts" as well as concerns about "inadequate staff training, persistent quality-control issues, and the company's 'unjustified' 800% price increase for an anthrax vaccine" purchased by the government.^[17][15] The inquiry, launched by the Democratic chairs of the House Committee on Oversight and Reform and Select Oversight Subcommittee on the Coronavirus Crisis, focused in part on Kadlec's role; in a letter, the chairs of the committee wrote that Kadlec "appears to have pushed for" the $628 million award to Emergent to develop the factory "despite indications that Emergent did not have the ability to reliably fulfill the contract."^[17][15] The inquiry was not pursued any further.