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With AZ deal, Operation Warp Speed takes first step to train guns on coronavirus

Initiative unveils first investment: up to $1.2B in a COVID-19 vaccine AstraZeneca has licensed from Oxford

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Operation Warp Speed, along with its promises and dangers, is coming into sharp focus. Its investment of up to $1.2 billion in a COVID-19 vaccine candidate is testimony to the risks it is prepared to take. Its biggest weapon is the U.S. military expertise that it is bringing to the fight.

In a deal announced May 21, Operation Warp Speed -- the Trump administration’s program to accelerate COVID-19 countermeasures -- gains access to the vaccine AZD1222 (formerly ChAdOx1 nCoV-19) that AstraZeneca plc (LSE:AZN; NYSE:AZN) licensed from the University of Oxford.

The deal brings together multiple U.S. government agencies and is predicated on taking substantial financial risks, especially by committing to manufacture a vaccine that hasn’t been tested.

In addition to financial risk, the U.S. government’s statements that it could make the vaccine, AZD1222, available on an emergency use basis as early as the fall and more widely in early 2021, suggests a willingness to bet on large-scale use of a vaccine with very little safety data.

Under the arrangement, BARDA could “provide up to $1.2 billion to support, in parallel, advanced clinical studies, vaccine manufacturing technology transfer, process development, scaled-up manufacturing, and other development activities. Emergency use authorization or licensure of this vaccine from the U.S. Food and Drug Administration (FDA) would be required to make the vaccine available,” HHS said.

As AZ advances the vaccine candidate into late-stage trials, the U.S. government will begin manufacturing it at one of BARDA’s Centers for Innovation and Advanced Development in Manufacturing (CIADM) operated by Emergent BioSolutions Inc. (NYSE:EBS).

The deal, and the U.S. government’s messaging about it, reinforces the America-first nature of the initiative. The U.S. is requiring domestic manufacturing of projects it finances and its goals are expressed in terms of producing vaccine quantities for the U.S. population.

However, the U.S. will not have exclusive access to the Oxford vaccine.

AZ also has joined forces with the U.K. government, and will supply the U.K. starting in September. A May 17 statement from U.K. Business Secretary Alok Sharma said that AZ would make 30 million doses available by September as part of an agreement to deliver over 100 million doses in total. “The U.K. will be first to get access,” said Sharma.

In addition, AZ has deals with Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine Alliance and the World Health Organisation (WHO) “for the fair allocation and distribution of the vaccine around the world,” according to the press release, and is in discussions with the Serum Institute of India and other potential partners to increase production and distribution.

Bringing the military into the fight

Operation Warp Speed is turning to the military to help solve manufacturing problems, aid with logistics, and supplement private sector vaccine developers and NIH with Department of Defense capabilities for testing and developing countermeasures.

The goals of Operation Warp Speed, according HHS include making 300 million doses of a safe and effective COVID-19 vaccine available for Americans by January 2021.

The program was created in part to bypass the factionalism that has stymied the government response to COVID-19. Beyond recruiting DoD, it is already making progress in integrating the activities of HHS agencies in ways that have often been promised but never achieved.

Whether Operation Warp Speed will succeed is hard to assess. Its budget and lines of authority, key attributes for any government entity, have not been determined, officials involved with the operation told BioCentury.

Rapid distribution and deployment of vaccines for the entire American population are challenges that only the military is equipped to meet.

In addition, its role vis-a-vis other collaborations is not yet clear. It sits alongside at least three other large-scale consortia with overlapping memberships and missions that are already working in parallel (see “Collaborating to Clobber COVID-R&D”).

Operation Warp Speed will not supplant or direct the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership that is being led by NIH and managed by the Foundation for the NIH (FNIH), leaders of both organizations told BioCentury.

Similarly, ACTIV did not replace and is not directing the activities of COVID R&D, a collaboration of biopharmaceutical company R&D leaders (see “Pharmas Align Behind Crowdsourcing Solution”).

The COVID-19 Therapeutics Accelerator, launched by the Bill & Melinda Gates Foundation, the Wellcome Trust and Novartis AG (NYSE:NVS; SIX:NOVN) is working more closely with European governments and international organizations than with Operation Warp Speed or ACTIV.

Even as it is scrambling to find its footing, in its first few days of operation Operation Warp Speed has surprised veteran government employees who told BioCentury that it is the first time they have seen NIH, FDA, CDC, BARDA and other HHS agencies working in a truly integrated fashion. The agencies usually operate autonomously, with collaboration being more rhetorical than real.

Operation Warp Speed is co-ordinating the federal agencies to ensure they complement one another, and that companies developing countermeasures don’t have to navigate through different and sometimes conflicting demands from six or seven agencies.

Even more unusual is the close integration of the DoD with HHS. DoD has made important contributions to pandemic preparedness, such as the investments by Defense Research Advanced Projects Agency (DARPA) in antibody therapies and nucleic acid vaccine platforms, but it is unusual for DoD to collaborate closely with civilian agencies on public health missions (see “DARPA’s Gambles Might Have Created the Best Hopes for Stopping COVID-19”).

Origins of Warp Speed

Individuals involved in planning the initiative told BioCentury it was created because White House officials, including VP Mike Pence and Jared Kushner, were frustrated by the absence of strong leadership and coordination across government and the private sector to create COVID-19 countermeasures and get them deployed as quickly as possible.

Operation Warp Speed reflects President Donald Trump’s and his inner circle’s disillusionment with Alex Azar. As HHS secretary and a former president of the Lilly USA unit of Eli Lilly and Co. (NYSE:LLY), Azar would have been an obvious choice to take control of the U.S. government’s drive to accelerate COVID-19 countermeasure development.

From his first days in office, however, Azar has been mired in personal disputes and turf battles with HHS agency heads who must work together seamlessly to make this operation succeed. The controversy surrounding his firing of Rick Bright as director of BARDA, long-running feuds with CMS Administrator Seema Verma and other administration officials, and downplaying the threat of COVID-19 in January and February, led the White House to sideline Azar.

Focus on vaccines, military contributions

The selection of Moncef Slaoui as chief adviser to Operation Warp Speed reflects the initiative’s focus on vaccines, though its scope extends to diagnostics and therapeutics.

Slaoui, a partner at venture firm Medicxi, was chairman of the vaccines division at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and head of its pharmaceutical R&D.

Speaking at the White House announcement of the initiative on May 15, Slaoui expressed confidence “that we will be able to deliver a few hundred million doses” of an undisclosed COVID-19 vaccine by year-end.

Achieving that goal will require more than getting the science right.

Attention has focused on Slaoui, but the key to the operation’s success is more likely to rest in the hands of his COO counterpart, General Gustave Perna, who heads the U.S. Army’s Materiel Command, which is responsible for the Army’s global supply chain and installation and materiel readiness.

No other entity has the mission, budget and power to envision and implement all of the steps required to manufacture and distribute vaccines, drugs and diagnostics to entire populations.

Perna and his staff bring logistics and acquisition expertise that will be needed to figure out solutions to challenges such as arranging a cold chain and securing and distributing specialized tens of millions of glass vials, and needles to inject 300 million or more doses of vaccines.

Ramping up manufacturing and organizing the logistics for rapid distribution and deployment of vaccines for the entire American population are challenges that only the military is equipped to meet.

Just as Perna is paired with Slaoui, there is a military counterpart for each of the Operation Warp Speed HHS leaders of the vaccines, therapeutics and diagnostics teams.

Bruce Tromberg, director of NIH’s National Institute of Biomedical Imaging and Bioengineering, is heading the initiative’s diagnostics team. His DoD support is Major General Lee Payne, assistant director for combat support at DHA.

Vaccines are being led by Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.

Marks is being supported by Matthew Hepburn, an infectious diseases physician with 24 years of DoD experience in vaccines and public health. Hepburn has served as director of medical preparedness on the White House National Security Staff, a DARPA project director, and most recently as the leader of a DoD initiative focused on rapid development of vaccines and treatments for pandemics.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, is leading the Operation Warp Speed therapeutics team.

Woodcock’s DoD support is Sean Biggerstaff, acting director for R&D at the Defense Health Agency. DHA supports the Army, Navy, Air Force and Marine Corps medical services, and the TRICARE system that provides healthcare to over 9.5 million service members, retirees and their families.

Because of their roles in developing vaccines and therapies, Marks and Woodcock have been recused from any involvement in reviewing COVID-19 countermeasures at FDA.

Multiple collaborations

In addition to their roles in Operation Warp Speed, Woodcock and Marks serve on the ACTIV executive committee.

There is overlap in turn among members of ACTIV, the COVID R&D consortium of biopharma R&D leaders, and the COVID-19 Therapeutics Accelerator.

Members of these collaborations are in constant communication, but there still is some uncertainty about who is in charge of critical aspects such as designing and running trials.

The HHS press release states that the federal government will design and run clinical trials of countermeasures that are being developed with federal funding. “The protocols for the trials will be overseen and set by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols.”

The press release does not say whether Operation Warp Speed or ACTIV will be responsible for designing trials.

NIH Director Francis Collins did not mention Operation Warp Speed on a May 19 live-streamed JAMA interview in which he discussed plans for developing and testing COVID-19 drugs and vaccines (see "NIH-led ACTIV Partnership Close to Selecting Repurposed Therapies").

Collins said the ACTIV executive committee will consider a slate of about six repurposed agents that could be tested in one or more master protocols starting less than six weeks after the selections are finalized.

ACTIV members told BioCentury the consortium is finalizing plans for harmonized trials of countermeasures and will not be taking direction from Operation Warp Speed.

ACTIV is likely to design and run a vaccine master protocol. At the same time, some companies will test COVID-19 vaccine candidates on their own. The hope, according to ACTIV leaders, is that all of the trials will have identical or similar endpoints and will use the same assays to assess vaccine performance.

The COVID R&D consortium isn’t waiting for either of the other consortia, though it is in discussion with ACTIV and shares several members.

COVID R&D is writing its own master protocol, and has already launched an adaptive trial to evaluate 10-20 agents within a year to treat ARDS, the late-stage respiratory failure that can lead to death in COVID-19 (see “COVID R&D Consortium Launches I-SPY Adaptive Trial”).

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