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Bioethics in a Pandemic: Operation Warp Speed

References to Operation Warp Speed (OWS) have been present throughout our coverage of the ethical questions related to the development and distribution of a COVID-19 vaccine. In fact, OWS is part of a broader public-private effort to accelerate COVID-19 countermeasures, such as the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. OWS has ambitious goals. It intends to deliver 300 million doses of a safe and effective vaccine for COVID-19 by January 19, 2021. Here, we provide a brief overview of OWS, its current progress, and relevant ethical considerations.

What is Operation Warp Speed?

OWS is a public-private partnership that engages private firms to coordinate existing government COVID-19 efforts. Companies provide to the U.S. government an allocation of countermeasures developed in exchange for receiving support from OWS. The intent is to make the countermeasures affordable for the American people.

Leading the OWS efforts are:

OWS is broken down into three main components:

  • Development. OWS aims to provide protocols for the demonstration of safety and efficacy to allow clinical trials to proceed more quickly. Such protocols describe how a clinical trial will be conducted and ensure the safety of the trial subjects and integrity of the data collected. Traditionally, the private company developing a new product develops the protocol. Under OWS, protocols are a coordinated effort between private companies and government support and oversight.

  • Manufacturing. The federal government is investing in necessary manufacturing. This investment enables private companies to aggressively advance the development and distribution components of the eventual vaccine. Traditionally, drug product manufacturing takes place after FDA approves or authorizes the product. Under OWS, manufacturing capacity for selected candidates will advance while the candidates are still in development.

  • Distribution. The government and its private partners are developing a plan to deliver safe and effective product as quickly as possible. OWS will build the necessary plans and infrastructure for distribution prior to FDA approval or authorization of the product. OWS will expand domestic manufacturing and supplies necessary for distribution. DoD’s involvement will enable faster distribution and administration of the eventual vaccine more so than would have been possible without the Agency’s involvement.

To accomplish these goals, Congress has directed almost $10 billion to this effort through supplemental funding, including the Coronavirus Aid, Relief and Economic Security (CARES) Act. Specifically, more than $6.5 billion has been directed towards countermeasure development through BARDA and $3 billion for NIH research.

How are Operation Warp Speed Countermeasures Measuring Up?

In July 2020, senior officials working on OWS held a briefing that provided an update on the countermeasures. According to Paul Mango, the Deputy Chief of Staff for Policy at HHS, the project is on track to meet its timeline goals; HHS is “maximizing” the probability of having tens of millions of vaccines by January 2021; and the regulatory standard against which a vaccine will be judged will not be affected by the accelerated timeline.

By now, most people know that vaccines take years to develop. Fast-tracking the vaccine development to about a year would make it the fastest developed vaccine in the history of the U.S. It is unclear whether this methodology will forever change the vaccine landscape and timeline, but most vaccines do not and will not benefit from the collaboration and funding provided by OWS. That said, OWS has chosen fourteen (14) independent coronavirus vaccine candidates, at least nine of which are in the late stages (Phase III) of human clinical trials, with awards split amongst pharmaceutical companies and clinical-stage biotech companies. The OWS agencies’ intend to narrow that to seven candidates for early-stage clinical trials.

The July briefing also discussed the challenges associated with vaccine distribution. First, some candidate vaccines are single-dose, while others require multiple doses, and each methodology has different storage and transport requirements. There is also the question of reimbursement: Who will pay for the vaccine?  According to HHS officials, the federal government will pay for the procurement and distribution of the vaccine within the U.S. Further, Medicare and Medicaid beneficiaries will be able to receive the vaccine at no cost to the beneficiary. And along these lines, several commercial insurers have pledged to have no copays for the administration of the vaccine.

While OWS has made significant progress related to vaccine countermeasures, there has only been a modest impact on therapeutics and diagnostics. Therapeutics have the ability to reduce disease severity and prevent disease, which would each have a windfall effect on lessening the burden on the health care system. However, to date, very little attention or investment has been provided to the development and manufacturing of therapeutics. Similarly, diagnostics have had a limited role in OWS’s focus. Instead, other initiatives, such as NIH’s Rapid Acceleration of Diagnostics, which has its own funding, are picking up the slack in this area.

The Ethical Considerations of Operation Warp Speed

The pace and scope of OWS efforts to fast-track a vaccine are unprecedented. Aside from the ethics related to vaccine clinical trials, there are several potential risks associated with the accelerated timelines and countermeasures. For instance, the politicization of an accelerated timeline may undermine the public’s confidence in FDA’s commitment to rigorous scientific standards needed for vaccine development. FDA has already sparked controversy when it issued emergency use authorizations (EUAs) for drugs heavily touted by President Trump on the basis of little evidence. One EUA, hydroxychloroquine, had to be withdrawn when it became clear that it was ineffective against COVID-19 and caused serious side effects.

Such politicization and speed of development has many Americans concerned about an eventual vaccine. From a public health perspective, the fear is that a large portion of the population will not trust the COVID-19 vaccine. The argument becomes: If not enough people trust a vaccine, what is the point of having one? And, as we discussed early this month, the public’s confidence and trust in a vaccine will be vital to its success.

Aside from development problems, OWS aims to start manufacturing the vaccine at the industrial scale well before the establishment of vaccine safety and efficacy. This strategy is a significant shift from the traditional manufacturing of drug products. According to HHS, this will increase the federal government’s financial risks, but it will not impact the safety and efficacy of an end product. However, how this plays out remains to be seen.

Adding to that challenge is the actual distribution of the eventual vaccine. Penn Medicine bioethicist Harald Schmidt researched how to set priorities in the distribution of health care. He notes,

Many take it for granted that you start from a utilitarian framework . . . that it's about saving the most lives or the most life-years. But in a society such as ours, you can't take that kind of ahistorical perspective. We have highly unequal access to health care, vast differences in how easy it is for people to live healthily, and, for example, in Philadelphia, a difference of 30 years in life expectancy between economically better and worse off zip codes. These are horrific facts that have to do with social determinants of health, with structural racism. That's why to me it's absolutely imperative that any allocation system doesn't proceed in colorblind fashion.

Schmidt emphasizes the need to prioritize COVID-19 vaccine distribution for residents of neighborhoods that rank low on measures of housing quality, employment, income, and more. While these issues are discussed and considered in the Draft Framework, the federal government currently intends to target high risk populations, such as the chronically ill and elderly. We expected to gain clarity on this in the coming weeks as the Draft Framework is finalized.

We also have the consideration of international public health. OWS funding aids American companies for domestic use. However, multiple other countries have teamed up with the private companies funded under OWS as clinical trial sites. The Trump Administration has noted that any vaccine developed under OWS would be shared “fairly” around the world once U.S. needs are met. This reassurance does not seem to comfort the skeptics, and there are ongoing concerns that other countries agreeing to assist in vaccine development may be left without directly benefiting from the final product. We will continue to track these issues as OWS progresses towards its goals.

©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.National Law Review, Volume X, Number 267
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About this Author

Bridgette A. Keller, health system administration LAWYER, Mintz
Associate

Bridgette applies her experience in health system administration and ethics in health care to her health law practice. Bridgette advises health care providers, ACOs, health plans, PBMs, and laboratories on a variety of regulatory, fraud and abuse, and business planning matters.

With a background in health care operations, Bridgette is able to provide clients with practical insight that includes a focus on the business implications of health care enforcement defense activities, internal investigations, regulatory compliance, and fraud and abuse...

202-434-7435
Elizabeth K. Conti Associate Mintz DC FDA Regulatory Health Care Enforcement & Investigations Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Consumer Product Safety
Associate

Elizabeth focuses her practice on regulatory compliance and enforcement defense matters for companies in the pharmaceuticals, medical device, dietary supplement, cosmetics, and food industries as well as pharmacies and distributors.

She advises clients on FDA regulations related to labeling, advertising, importing and exporting, and manufacturing practices. Her practice also encompasses administrative matters and civil litigation related to DEA requirements. On the enforcement defense side of her practice, Elizabeth counsels clients on fraud and abuse compliance and litigation involving the False Claims Act, the Stark law, and the federal anti-kickback statute.

Prior to joining Mintz, Elizabeth was a health law associate in the Washington office of a Wisconsin-based national law firm, where she assisted clients with a wide range of FDA, DEA, and health care fraud and abuse enforcement matters. Earlier, she was a winter associate at that firm.

While earning her law degree, Elizabeth also completed a clerkship at the White House Council on Environmental Quality and internships with the Environmental Protection Agency’s Office of the General Counsel and Office of Enforcement and Compliance Assurance. At law school, she served as a note & comment editor of the Catholic University Law Review.

202-434-7317
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