What does ending the COVID-19 pandemic mean from a legal perspective?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

The COVID-19 pandemic isn’t over. The United States is averaging around 100,000 new cases per day and recently marked 1 million total deaths, and global deaths associated with the pandemic are estimated at nearly 15 million. But the U.S. legal response to the pandemic appears to be winding down, with mask mandates disappearing, an uncertain congressional response, COVID relief money running out, the end of most emergency orders at the state level, and calls for an end to federal emergency declarations. In this post, we examine COVID-related public health emergency declarations, what ending those would mean from a legal perspective, and what impact that would have on pandemic innovation policy, including access to existing COVID innovations and incentives to develop new ones.

What are the major COVID-19 emergency declarations?

Broadly speaking, public health emergency declarations give governments the power to “activate funds, personnel, and material and change the legal landscape to aid in the response to a public health threat,” generally in a manner legally different from typical law- or rule-making processes. Because public health measures often are (and need to be) wide-ranging, federal, state, tribal, and local governments all have the power to issue such declarations. And even within a given government authority, individual agencies often possess complementary but different powers to issue their own public health emergency declarations. COVID-19 has consequently prompted a large number of distinct emergency declarations, each with different legal effects.

How do we encourage innovation on “long COVID”?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Since the pandemic began, numerous recovered COVID-19 patients have reported having “long COVID”: COVID-19 symptoms persisting well beyond the underlying viral infection period. Whether such a condition is specific to COVID-19, or more generally a form of “post-acute sequelae”—or even a discernable condition—has bedeviled scientists and clinicians alike. The fact remains, though, that likely millions of people in the U.S. alone will continue to report a variety of challenging symptoms more than 6 months after they’re infected. Despite this magnitude of reports, confusion regarding defining the condition and identifying its etiological basis has presented significant challenges to innovating treatments for it. In this post, we explore some of the current evidence surrounding “long COVID,” some of the difficulties in developing long COVID treatments, and how policymakers can move things along.

How does pregnancy factor into COVID-19 innovation?

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

Pregnant people are at increased risk of severe illness from COVID-19, but they have been largely excluded from clinical trials, the process of testing vaccines’ and treatments’ safety and efficacy. They’re consequently left in a bind: there’s not great evidence about the safety and efficacy of products they can take to be safe from COVID-19. This lack of information might be part of the explanation for low vaccine uptake among pregnant people, particularly women of color. And while this lack of data isn’t particularly novel with respect to drug development, generally—we’re historically bad at generating robust safety data for pregnant people—failing to do so for COVID-19 seems to have outsized public health consequences. What’s behind this ongoing exclusion? And how should policymakers consider including pregnant people in COVID-19 clinical trials and beyond?

How would the proposed American Pandemic Preparedness Plan help address underinvestment in pandemic-related innovation?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Historically, the United States’ preparedness for a pandemic is like Charles Dudley Warner’s aphorism on the weather: everybody talks about it but no one ever does anything. Before COVID-19 struck, it was clear that the threat of a pandemic was real and that the world was not ready. As one of many examples, a September 2019 report from the Global Preparedness Monitoring Board (GPMB)—an expert group convened by the World Bank and WHO—concluded that “there is a very real threat of a rapidly moving, highly lethal pandemic of a respiratory pathogen killing 50 to 80 million people and wiping out nearly 5% of the world’s economy.” Perhaps the tragedy of the current crisis will provide sufficient motivation to better prepare for next time.

As a step in this direction, earlier this month the Biden administration released a twenty-seven page American Pandemic Preparedness Plan—with a $65 billion price tag—to provide the United States with “broad and deep protection against biological threats, ranging from the ongoing and increasing risk of pandemic disease, to the possibility of laboratory accidents and the deliberate use of bioweapons.” These include, of course, several innovation policy commitments to encourage the development of pandemic-related tools for COVID-19 and beyond. What are those commitments? How do they work—or would have worked—for COVID-19? And what does this say about innovation policy more generally?

How does the CDC’s Advisory Committee on Immunization Practices impact innovation and access to COVID-19 vaccines?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

In previous blog posts in this series, we have explored the roles different federal agencies, including the NIH, FDA, and CMS, play in the development and distribution of new healthcare technologies in the fight against COVID-19. But we have devoted much less attention to the CDC and its Advisory Committee on Immunization Practices (ACIP), which has a key role to play in the distribution of vaccines, including those against COVID-19. In this post, we explain the role played by ACIP, discuss several important COVID-19 vaccine decisions ACIP has been involved in, and consider what ACIP’s processes might teach policymakers more generally about innovation and access to health technologies.

What’s happening with proposals for a WTO waiver of COVID-related IP?

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

If COVID-19 were a pandemic movie, we’d be very close to the end since we’ve identified several excellent vaccines; the conventional biomedical innovation narrative often ends with the product being fully developed. But we’ve still got a long way to go with COVID-19, and the biggest challenge is getting the vaccines to billions more people (and getting them to take the vaccines, but that’s a separate topic). Only 0.3% of global doses have been administered in low-income countries, many of which are confronting severe outbreaks. A staggering 1 million infections were reported in Africa in just one month, with few vaccines in sight. By some estimates, much of the world’s population won’t be vaccinated until well into 2023. Amid pledges of sharing vaccines, perhaps the most prominent policy debate today is about waiving intellectual property rights to COVID-19 technologies, including vaccines. In this post we explain what’s being proposed, what’s happening with the waiver negotiations, and what impact these negotiations might have.

Why do differences in clinical trial design make it hard to compare COVID-19 vaccines?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult—even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

What’s the difference between vaccine approval (BLA) and authorization (EUA)?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Recently, Pfizer and BioNTech and Moderna announced that they are seeking full FDA approval for their mRNA COVID-19 vaccines—filing, in FDA parlance, a Biologics License Application (BLA). Johnson & Johnson plans to file its own BLA later this year. But currently, all three vaccines are being distributed under a different FDA mechanism, the Emergency Use Authorization (EUA). What’s the difference, under the hood, between these two mechanisms? Why would these companies want to go through the BLA process? And what tools can policymakers use to make the EUA to BLA shift better?

How are COVID-19 vaccine developers and regulators responding to variants?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

The remarkable news of record-breaking COVID-19 vaccine development has been clouded by the increasing emergence of new variants of the SARS-CoV-2 virus. Like other viruses, SARS-CoV-2 mutates over time, due to random errors in copying its genetic sequence. When one of these mutations helps the virus survive and reproduce—such as by making the virus more transmissible—that variant will spread more rapidly than the original virus through natural selection. The global effort to control the pandemic has thus been framed as a race between the vaccines and the variants: can the world be vaccinated before the virus evolves to evade the vaccines? In this post, we examine how COVID-19 vaccine developers are responding to the spread of variants, how the FDA plans to regulate updates to the vaccines, and other innovation policies governments should consider to combat the variant spread.

Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? (No!)

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? A number of recent commentaries have suggested as much, and have advocated for either weakening or strengthening patents covering various aspects of COVID-19 vaccines. Turning to patent law to address innovation problems may seem natural, as legal scholars conventionally view patent law as “our primary policy tool to promote innovation.” But there is a reason we have written over thirty posts on COVID-19 innovation issues without a single post focused on patent law (until now): many other legal institutions have turned out to be far more important. This is particularly true for vaccines. In this post, we explain why either eliminating or strengthening patents would have little effect on the rollout of vaccines for this pandemic, and why non-patent institutions will play a far more important role than patent law in incentivizing innovation for the next pandemic.

How can policymakers overcome the hurdles to scaling up antibody manufacturing?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

In our last post, we introduced some of the clinical evidence supporting the use of therapeutic antibodies against COVID-19—including Regeneron’s casirivimab and imdevimab and Eli Lilly’s bamlanivimab—and analyzed the existing problems in the distribution and administration of those therapies. Even in just the last few weeks, further clinical evidence has supported the use of these technologies, leading the FDA to issue an additional emergency use authorization for Lilly’s bamlanivimab and etesevimab cocktail. In the near future, though, problems in administering our existing supply of these new drugs may give way to problems producing enough of them—a challenge that is also affecting the vaccine rollout. In this post, we consider the difficult manufacturing issues involved in the therapeutic antibody context (a subject we’ve previously explored regarding vaccines), and what might be done to address them.

Why aren’t therapeutic antibodies being used more to treat COVID-19?

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

When former President Donald Trump contracted COVID-19 in fall 2020, he was treated with monoclonal antibodies, touted as potentially miraculous treatments. Unlike other treatments so touted, there is some rigorous evidence to support these assertions: antibody drugs look like the best treatments currently available to prevent COVID cases from progressing to hospitalization. But months later, the drugs are in limited use and seem to be only a moderately important part of the COVID-19 response. Why aren’t antibodies making more of a difference for ordinary Americans?

Irene Calboli: Trademarking COVID

Irene Calboli, professor of law at Texas A&M University School of Law, has written a new empirical article reporting that "the COVID-19 pandemic has led to a veritable tsunami of trademark applications" for COVID, QUARANTINE, SOCIAL DISTANCING, and other pandemic-related terms.  Indeed, Calboli concludes that trademarking of COVID-related terms is unusually rampant, even when compared to past tragedies and disasters such as 9/11, Hurricane Katrina, and Ebola. "Ultimately," Calboli writes, "probably only the HIV/AIDS pandemic can be compared with COVID-19 in terms public awareness, societal fears, and strong emotions," and even "the beginning of the HIV/AIDS pandemic did not see a similar rush to trademark filings" that we have seen with COVID. While several practitioners have also noted the large number of applications filed for these terms in the past month, Calboli's paper is the first to survey these applications comprehensively and in detail. 

The full article, Trademarks and the COVID-19 Pandemic: An Empirical Analysis of Trademark Applications Including the Terms “COVID,” “Coronavirus,” “Quarantine,” “Social Distancing”, “Six Feet Apart,” and “Shelter in Place, can be downloaded on SSRN.  The data are included as an appendix to the paper.  The article will be published in the Akron Law Review's IP Symposium Issue as part of the Annual Akron Law IP Scholars Conference. (The other scholars publishing in this year's IP issue are Margaret Chon, Robert Merges, Kristen Osenga, and Sharon Sandeen.) 

I interviewed Professor Calboli on her findings. The interview is transcribed in this post.  To follow along, here is one of the many beautiful tables and informational graphics in the article, included with Calboli's permission.

What can policymakers learn from the disastrously slow COVID-19 vaccine rollout?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good news to the fight against the pandemic: the FDA’s emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines and the ensuing nationwide rollouts. The record-breaking vaccine development timeline and the videos of healthcare workers receiving early vaccines are worth celebrating. But the subsequent distribution has been tragically slow—echoing distribution challenges for COVID-related goods ranging from PPE to diagnostics. On Dec. 29, Dr. Leana Wen noted that at the initial vaccination rate, it would take 10 years to vaccinate the roughly 80% of Americans needed to achieve herd immunity. According to Bloomberg’s vaccine tracker, as of today, fewer than 10 million vaccines have been administered in the United States. States are still sitting on nearly two-thirds of the doses they have received, and the federal government is holding half the U.S. supply in reserve. In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.

How can policymakers encourage COVID-19 vaccine trials for children?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

The past two weeks have been full of exciting COVID-19 vaccine news, including the FDA’s emergency use authorizations (EUAs) for the Pfizer–BioNTech and Moderna vaccines and the nationwide rollout of Pfizer’s vaccine. Choosing how to allocate access to vaccine doses has been left to individual states, leaving policymakers with difficult decisions about how to prioritize their populations, complicated in part by the federal government’s reduction in some vaccine shipments. 

With a limited supply of doses, who should get the first shots? Some commentators have suggested prioritizing children early for a host of reasons, including hope about children returning to school. Last month a New York Times column asserted that “saving the most lives could mean prioritizing the vaccination of children and young adults.” But there is an important reason that kids can’t be part of the vaccine line yet: we don’t know whether these vaccines work for them. In this post, we explain why COVID-19 vaccines are only just starting to be tested in children and what policymakers can do to spur pediatric vaccine trials.

What administrative actions might we expect on COVID-19 in President-elect Biden’s administration?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

When President-elect Joe Biden is inaugurated in January, his administration will face the ongoing public health and economic challenges created by COVID-19. Even if Biden takes office without control of Congress, we can expect his administration to take important actions regarding COVID-19 innovation in response to the pandemic. In this post, we consider three main pillars of his administration’s likely response (as articulated by the Biden-Harris transition website) and explain the legal foundations behind them.

What role is AI playing in the COVID-19 pandemic?

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

Promising results for the Pfizer/BioNTech and Moderna vaccines have been the most exciting COVID-19 innovation news in the past few weeks. But while vaccines are a crucial step toward controlling this virus, it is important not to overlook the many other technological developments spurred by the pandemic. In this week’s post, we explore how the COVID-19 pandemic is proving a fertile ground for the use of artificial intelligence and machine learning in medicine. AI offers the tantalizing possibility of solutions and recommendations when scientists don’t understand what’s going on—and that is sometimes exactly what society needs in the pandemic. The lack of oversight and wide deployment without much in the way of validation, however, raise concerns about whether researchers are actually getting it right. 

What did we learn from last week’s FDA vaccine advisory committee meeting?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

On October 22, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss the development, authorization, and licensure of COVID-19 vaccines. The meeting was not focused on any particular vaccine candidate; rather, it gave the FDA an opportunity to seek more general guidance about the process from outside experts. In this post, we explain what advisory committees like VRBPAC do, what happened at the meeting last week, and what this means for the COVID-19 vaccine timeline.

What is—and should be—the military’s role in COVID-19 research?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

A recent STAT News report found that Operation Warp Speed—the government’s Manhattan Project-style effort to quickly develop a COVID-19 vaccine—has substantial military involvement. Although it might initially seem counterintuitive to think of the virus as a military issue, the military’s involvement is part of a long history of government military spending on public health aims. What has been the role of military involvement and spending on preventing and treating diseases with pandemic potential? What’s different, if anything, for COVID? And what should policymakers and scholars be focused on going forward?

How are COVID-19 vaccine manufacturers aiming to encourage trust in the FDA’s approval process?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?