Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

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Medical Hospital: Neurologist and Neurosurgeon Talk, Use Computer, Analyse Patient MRI Scan, Diagnose Brain. Brain Surgery Health Clinic Lab: Two Professional Physicians Look at CT Scan. Close-up.

Creating Brain-Forward Policies Amid a ‘Mass Deterioration Event’

By Emily R.D. Murphy

COVID-19 will be with us — in our society and in our brains — for the foreseeable future. Especially as death and severe illness rates have dropped since the introduction of vaccines and therapeutics, widespread and potentially lasting brain effects of COVID have become a significant source of discussion, fear, and even pernicious rumors about the privileged deliberately seeking competitive economic advantages by avoiding COVID (by continuing to work from home and use other peoples’ labor to avoid exposures) and its consequent brain damage.

This symposium contribution focuses specifically on COVID’s lasting effects in our brains, about which much is still unknown. It is critical to focus on this — notwithstanding the uncertainty about what happens, to how many, and for how long — for two reasons. First, brain problems (and mental health) are largely invisible and thus overlooked and deprioritized. And second, our current disability laws and policies that might be thought to deal with the problem are not up to the looming task. Instead, we should affirmatively consider what brain-forward policies and governance could look like, building on lessons from past pandemics and towards a future of more universal support and structural accommodation of diminishment as well as disability.

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Emergency room.

Hospitals in Poor Rural Counties Face the Greatest Financial Threat from COVID

By Robert I. Field and Anthony W. Orlando

The latest wave of COVID cases and hospitalizations has raised concerns about the financial resilience of many hospitals in the United States. Throughout the pandemic, we have witnessed shortages of medical supplies, exhaustion of frontline workers, and the overflow of patients beyond the physical capacity of hospital beds and buildings. Now, after nearly two years of repeated COVID surges, there is a real danger that some institutions might run so low on funding that they will need to downsize or close altogether.

Large hospitals in metropolitan areas have, for the most part, weathered the storm. Ample financial resources enabled them to survive with fewer lucrative elective procedures and sudden overwhelming demand for less profitable intensive care for COVID patients. But in many parts of the country, especially rural regions, smaller hospitals lack such financial cushions. For them, COVID could be an existential threat.

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Medicine law concept. Gavel and stethoscope on book close up

Transdisciplinary Integration: The Only Way Forward for Public Health

By Scott Burris

As we look toward National Public Health Week amid two long years of a pandemic, reflection for us at the Center for Public Health Law Research has focused on how we move forward in a mostly broken public health system. We see public health law as a central component of a strong future for public health, where transdisciplinary partnership leads the way.

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Supreme Court of the United States.

The Bind We’re in — And How the Supreme Court Put Us There

By Jennifer Bard

As the COVID-19 pandemic rages into its third year of global death and destruction, the Supreme Court of the United States has effectively thwarted every measure by federal or state government to implement the public health tools that for hundreds of years have been used to stop the spread of contagious disease. They have done so by operationalizing what were previously fringe and relatively harmless academic views in ways that extend their powers beyond any previous boundaries. These include, but are not limited to, extending the protection for religious exercise past any previously imagined, and limiting Congressional authority to respond to emergencies by imposing impossible standards of specificity on its delegation of authority to the agencies which it creates, funds, and directly oversees.

In so doing, the Court has not only undermined the health of the nation, and pushed millions of people into unnecessary long-term disability, which our fragmented health care and social security system is unequipped to handle. It has also threatened our national security by infecting what is already more than half of the children in the country with a virus that has the potential to damage every organ in their bodies, from heart to brain.

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Person filling syringe from vial.

The Beginning of the End of Federalism

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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Gloved hand grabs beaker with rolled currency.

Leverage COVID-19 Frameworks to Prepare for the Next Pandemic

By Matthew Bauer

How should scientists, policy makers, and governments balance efforts to address the current pandemic with initiatives to prevent the next one?

We have seen this play out before during the 2003 SARS crisis. A burst of research funding and resources were thrown at tackling the health emergency that spread to 29 different countries. Ultimately, enormous efforts across the globe were able to halt the crisis, but as scientific research continued post-outbreak, it became difficult to sustain funding.

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