Bill of Health - Globe and vaccine, covid vaccine

Reclaiming Global Public Health

By Zain Rizvi

By December 2020, the world had astonishingly powerful tools against COVID-19. New mRNA vaccines, underpinned by decades of public investment, had been authorized by global regulators. Yet the promise of the vaccines was unevenly realized: deep fault lines emerged between those who were able to secure vaccines and those left behind, or what South Africa’s president Cyril Ramaphosa called “vaccine apartheid.”

Dose shortages elevated the role of pharmaceutical executives. Fielding calls from heads of state, they decided what vaccine deliveries to prioritize, shaping which countries could protect lives and livelihoods. The answer to one of the most important public health questions of our time — who gets access to vaccines? — was mostly determined neither by political representatives nor scientists, but by corporate executives.

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Vial and syringe.

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

By Victoria Kalumbi

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated, and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19.[1]

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials.

In this post, I argue that young people should have the opportunity to consent to vaccines. I focus on the specific case of children in foster care and the juvenile justice system, as they are particularly vulnerable amid the ongoing pandemic. However, the legal and political avenues explored in this piece to ensure that young people have a stake in their health and vaccine status are broadly generalizable to all children.

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Vaccines.

COVID-19, Patents, and Trade Secrets

By David Gindler & Jasper L. Tran

Has the worldwide distribution of COVID-19 vaccines been impacted by patent rights? David Gindler, head of IP at Milbank LA, and Jasper L. Tran, senior associate at Milbank LA, argue that the story is much more complicated — making vaccines involves much more than waiving patents, they explain.

The following article, which is adapted from the authors’ conversation with Vanderbilt Law Review podcast editor Jacob Goodman on Hot Topics in Intellectual Property Law, provides an overview of the complicated intellectual property landscape associated with COVID-19 vaccines and therapeutics.

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Bill of Health - Globe and vaccine, covid vaccine

COVID ‘Compromise’ on International IP Underscores Need for New Approach

By Cynthia M. Ho

The leaked compromise regarding a “waiver” of international intellectual property (IP) obligations under the TRIPS Agreement for World Trade Organization (WTO) members has met harsh criticism as a shadow of the original proposal to waive international obligations regarding patent, trade secret, and copyright obligations relating to any COVID vaccine, treatment, diagnostic, or personal protective equipment (PPE).

The compromise excludes diagnostics, treatments, and PPE. It only narrowly modifies compulsory licenses of patents covering COVID vaccines. Moreover, it imposes additional restrictions on use of compulsory licenses. But still, multinational pharmaceutical manufacturers have protested even these modest changes from the status quo, arguing that there is no IP problem that needs to be fixed.

Clearly there is a problem. It has taken 18 months since the original Indian and South African proposal to get to this limited compromise, while gross vaccine inequity between wealthy and poor countries continues. In addition, the leaked compromise between four WTO members is still being debated — and even if agreement can be reached, it needs agreement of over 100 other WTO members. We need a new approach.

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American Soldiers Salute. US Army.

Vaccine Mandates in the Military: Litigation Over Religious Exemptions

By Kaitlynn Milvert

In August 2021, the U.S. Department of Defense (DoD) put in place requirements for service members to receive the COVID-19 vaccine. Litigation has since ensued over the military branches’ restrictive approach to religious exemptions to vaccination.

On March 25, the U.S. Supreme Court weighed into one such case: the Court granted the government’s request for a partial stay to allow the Navy to continue to use vaccination status in making deployment and assignment decisions while the litigation proceeds.

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close up of hands signing contract.

Using Contracts to Lessen Inequities in Access to Medicines in Pandemics and Epidemics

By Sapna Kumar and Ana Santos Rutschman

Research funding contracts can help to safeguard against profound inequities in global allocation and distribution of lifesaving diagnostics, drugs, and vaccines.

During large transnational public health crises, global demand soars for diagnostics, drugs, and vaccines. Although some of these products can be developed within compressed timelines, global production capacity remains limited. Against a backdrop of product scarcity, wealthier countries can out-bid their lower-income counterparts and capture most of the supply during the early stages of pandemics and epidemics. This leaves the vulnerable low-income populations waiting months, or even years, for their turn.

This predictable, inequitable pattern can be held off before the next pandemic. At the research and development (R&D) stage, government funders can bind producers to equity goals through targeted contractual provisions, as we explain in a recently-published Nature Biotechnology article. We summarize our proposals in the following sections. Read More

Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Private Employer Vaccine Mandates in the Courts

By Kaitlynn Milvert

After the Occupational Safety and Health Administration (OSHA) COVID-19 vaccine mandate for large employers was withdrawn last month, many pronounced private employers to be “on their own” to make decisions about vaccine requirements for their employees.

Until one outlier Fifth Circuit decision last week, federal courts have largely agreed. In lawsuits challenging private employers’ COVID-19 vaccine mandates, federal district courts have routinely denied requests for preliminary injunctions to halt private employers’ vaccination policies from taking effect.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

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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Baby held in someone's arms.

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

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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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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