Tag: coronavirus

children wearing masks.

Reconsidering Mask Mandates

Carmel Shachar Leave a comment

By Carmel Shachar

The desire to get back to “normal” is an understandable one. And despite their prevalence for the last two years, masks don’t fit into most people’s concept of normal.

But removing mask requirements means rejecting yet another public health tool to control the pandemic and protect our health care system.

First, some context: most states haven’t had indoor mask mandates in place for many months. As of February 10th, only Washington, Oregon, California, New Mexico, Hawaii, Illinois, and Delaware had statewide indoor mask mandates. These remaining few states are now taking steps to end mask policies. Some states have narrower mask mandates that apply to schools, and are similarly moving to end such policies.

But the decision to end these mandates is not made in a vacuum. We should be thinking about what other public health initiatives and components should be in place before we lift these protections.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

The Petrie-Flom Center Staff Leave a comment

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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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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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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