Tag: public health

New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

Govind Persad Leave a comment

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

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Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Carmel Shachar Leave a comment

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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Field hospital in NY during COVID-19 pandemic.

Systemic Failures Need Systemic Solutions: COVID-19 and Macromedical Regulation

The Petrie-Flom Center Staff Leave a comment

By Barak D. Richman and Steven L. Schwarcz

Among the many failures to mitigate the harm from COVID-19 in the U.S. has been the failure to meet surging demand for inpatient care. Hospital bed shortages, overwhelmed intensive care nurses, and scarcities of needed medical equipment have been embarrassing but constant features of the American health care landscape. A nation that spends nearly one out of every six dollars on health care should get much, much more for its money.

Though there is much blame to go around — and many insightful commentators have already allocated culpability — we observe that a significant regulatory deficiency has contributed to the nation’s failure to meet population health needs. This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system.

Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry. This existing regulation lacks the capacity to address how those components work together as a system — a system in which deficiencies in one component adversely impact the performance of the other components. We should not view hospitals as individual providers that treat individual patients. Instead, they are part of a larger safety net that needs to expand capacity when emergencies arise. Today’s pandemic destabilized hospital care because hospitals were neither coordinated nor managed systemically in order to meet population demands.

In Macromedical Regulation, 82 Ohio State Law Journal 727 (2021), we address the nation’s systemic failure to contain an infectious contagion, and we offer solutions by deriving lessons from the 2008 financial contagion. We contend that health care regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the health care sector as a system of interconnected parts.

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U.S. Supreme Court

The Supreme Court’s Rulings on COVID-19 Vaccine Mandates, Explained

Kaitlynn Milvert Leave a comment

By Kaitlynn Milvert

In a pair of rulings issued January 13, the Supreme Court put on hold the federal vaccine-or-test requirements for large employers, but allowed federal vaccination requirements for health care workers to take effect while they are litigated in the lower federal courts.

The Court decisions each addressed questions of whether federal agencies — the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid Services (CMS) — have authority to set these vaccination-related requirements.

In doing so, the Court drew new and unprecedented lines between the kinds of risks that agencies operating outside of the health care context — such as OSHA — have power to address through federal regulations. The Court’s decisions on these issues are likely to loom large in future litigation as federal vaccine requirements continue to be litigated in the lower courts.

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Desolate winter scene.

A Timeline of Biden’s Pandemic Response, Part 4: Winter of Death (December 2021 – Present)

Justin Feldman Leave a comment

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first, second, and third parts here.

By Justin Feldman

On December 1, 2021, the CDC issued a press release announcing that it had identified a case of the Omicron variant in the U.S. for the first time.

White House insiders admit that they were unprepared for Omicron, just as they were unprepared for Delta. Vice President Harris recently told an interviewer that the administration was caught flatfooted because their scientific advisors never warned that such variants could crop up (at least two of these advisors, Rick Bright and Celine Gounder, begged to differ).

While vaccination still provides powerful protection against hospitalization and death due to infection from Omicron, protection against symptomatic illness is weaker than before, particularly among those who have not received boosters. And though evidence is mounting that the risk of hospitalization and death is lower for each person infected compared to Delta, Omicron’s extremely high transmissibility means that a large fraction of the population will become infected in a short time period, particularly in the absence of additional public health measures.

On December 21, as the highly contagious variant started to sweep the country, President Biden delivered remarks about the new threat. For the hundred million Americans who remain unvaccinated, the president’s speech warned of the imminent risk of hospitalization and death. For the vaccinated and boosted, Biden’s message was: Keep Calm and Carry On, all will likely be fine. And for Wall Street, the speech was meant to provide a crucial piece of reassurance: There would be no federal support for public health measures that restrict commerce.

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Empty toolbox.

A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

Justin Feldman Leave a comment

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first and second parts here.

By Justin Feldman

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures.

It was initially unclear whether the issue was Delta’s higher transmissibility or waning immunity from vaccines, as the first groups had been vaccinated nearly a year prior. There was noticeable concern from CDC, which acknowledged the “war has changed” in a set of leaked slides from July 29, 2021. Of particular concern were case reports from Massachusetts and internationally of high viral loads observed among those who were vaccinated and infected. In late July, CDC reversed course on its mask guidance and recommended indoor masking for all, including the fully vaccinated, in counties with high transmission. In late September 2021, CDC reversed course on its quarantine guidance, which had previously stated that fully vaccinated people should not quarantine after a known SARS-CoV-2 exposure.

These changing epidemiologic realities could have brought about a course correction and a push for other public health policies to complement vaccination. Instead, the administration mostly adapted by shifting its messaging.

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Traffic light.

The COVID-19 Pandemic, the Failure of the Binary PHEIC Declaration System, and the Need for Reform

The Petrie-Flom Center Staff Leave a comment

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Ilja Richard Pavone

The COVID-19 pandemic has raised unprecedented challenges for the global health framework and its long-term consequences are not yet in full sight. The legal and institutional regime aimed at preventing and controlling the spread of infectious diseases, grounded on the International Health Regulations (IHR) was heavily criticized.

The alarm mechanism based on the declaration of Public Health Emergency of International Concern (PHEIC), in particular, has been severely tested. A PHEIC is an extraordinary event that constitutes a potential public health risk through the international spread of a disease outbreak. The WHO Director-General bases his decision to “ring the bell” upon the technical advice of an Emergency Committee (EC) carrying out “an assessment of the risk to human health, of the risk of international spread, and of the risk of interference with international traffic.”

A PHEIC, then, is declared only when an event is already sufficiently acute and has started to spread internationally. It is not an early warning, but a formal alert, and in the case of COVID-19 it was issued with extreme delay only on 30 January 2020, (one month after notification of early cases by the Chinese government), after Beijing had already adopted quarantine measures around the city of Wuhan, and draconian measures to curb the spread of the disease in the country had been announced.

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Vial and syringe.

A Timeline of Biden’s Pandemic Response, Part 2: A Pandemic of the Unvaccinated (May – Sept. 2021)

Justin Feldman Leave a comment

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first part here.

By Justin Feldman

Framing vaccination as a way to opt out of the pandemic, and understanding the unvaccinated to be political enemies, has helped absolve the Biden administration of its responsibilities to protect the public’s health and facilitated the relentless push to restore “normalcy” (i.e., full economic activity).

The administration knows better: In September 2020, while the vaccines were still being tested, key figures in Biden’s orbit warned that it was unlikely vaccination alone could sufficiently control the pandemic.

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From Shutting Down the Virus to Letting it Rip: A Timeline of Biden’s Pandemic Response

Justin Feldman Leave a comment

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. 

By Justin Feldman

Welcome to our “winter of severe illness and death.”

Hospitals are becoming overwhelmed in various parts of the U.S., and one model predicts more than 120,000 COVID deaths will occur in the first two months of 2022.

How did we get here? How is our Democratic president — who ran, in part, against Trump’s horrid pandemic response — letting the virus rip? How did we get to a point where a key organizer of the Great Barrington Declaration, a right-wing libertarian campaign opposed to public health measures, has stated that Republican and Democratic states alike have adopted policies in line with their philosophy? As hospitals fill up around the country, why are political leaders doing nothing to at least try to “flatten the curve”?

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The Mexican-American border, with some construction still ongoing on the American side.

Pandemics without Borders? Reconsidering Territoriality in Pandemic Preparedness and Response Instruments

The Petrie-Flom Center Staff Leave a comment

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Raphael Oidtmann

The COVID-19 pandemic has (yet again) disclosed that, in contemporary international law, the notion of borders resembles a distinct emanation of legal fiction, i.e., “something assumed in law to be fact irrespective of the truth or accuracy of that assumption.” This characterization of international borders holds particularly true with a view towards managing, containing, and countering the spread of highly contagious pathogens: especially in the context of responding to the global COVID-19 pandemic, it has hence become apparent that the traditional conception of borders as physical frontiers has been rendered somewhat moot. On the contrary, the pandemic experience has proven that a more flexible, fluid, and functional understanding of (international) borders might be warranted, also with a view towards (re-)conceptualizing international health law.

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