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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Globe and 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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Melbourne, Australia - 1st November 2021: A person wearing full PPE holds a vial of sotrovimab medicine covid-19 virus treatment. It is under an emergency use authorization to treat covid in Australia.

Litigation Challenges Prioritization of Race or Ethnicity in Allocating COVID-19 Therapies

By James Lytle

Recent guidance from the U.S. Food & Drug Administration (FDA) encouraged several states to adopt policies that prioritized race or ethnicity in the allocation of monoclonal antibody treatments and oral antivirals for the treatment of SARS-CoV-2.

The guidance proved to be highly controversial, prompting two states, Utah and Minnesota, to withdraw their guidance, and leading a third state, New York, to become the subject of two federal lawsuits that challenge the guidance’s legality: one (Jacobson v. Bassett) brought by a white, non-Hispanic Cornell Law Professor, William Jacobson, in the Northern District of New York (“Jacobson”) and a second (Roberts v. Bassett) initiated by Jonathan Roberts and Charles Vavruska, two white, non-Hispanic residents of New York City in the Eastern District (“Roberts”).

Public health and policy experts have published commentaries on the challenging issues underlying New York’s COVID treatment guidelines and others have offered more detailed guidance, including on this blog, on what criteria should be used in allocating scarce COVID treatments. What follows is focused on the litigation pending in New York and its potential impact on the broader issues at the intersection of the pandemic response and racial equity.

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

How to Fairly Allocate Scarce COVID-19 Therapies

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

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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Vaccines.

Promote Trust, Avoid Fraud: Lessons in Public Health Messaging from the Booster Roll Out

By Carmel Shachar

Even in September 2021, it was fairly clear that boosters for all adults, regardless of risk factors or which vaccines they initially received, would be coming soon.

Indeed, within two months, the U.S. Centers for Disease Control and Prevention (CDC) revised its recommendations to say that all vaccinated adults should receive a COVID-19 booster.

Unfortunately, the discrepancy between past messaging, which restricted access to boosters to select groups, and the current, broad recommendation has spawned two, related public health communications problems.

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Vial and syringe.

Causes of COVID Vaccine Hesitancy

By Jasper L. Tran

Vaccinated individuals — like Tolstoy’s happy families — are all alike; each unvaccinated individual is hesitant for her own reason.

Prior research conducted in developed countries reveals five main individual-level determinants of pre-COVID vaccine hesitancy (commonly referred to as the 5 C model drivers of vaccine hesitancy): (1) Confidence (trust in vaccine’s effectiveness and safety, vaccine administrators and their motives); (2) Complacency (perceiving infection risks as low and vaccination as unnecessary); (3) Convenience / Constraints (structural or psychological barriers to converting vaccination intentions into vaccine uptake); (4) Risk Calculation (perceiving higher risks related to vaccination than the infection itself); and (5) Collective Responsibility (willingness to vaccinate to protect others through herd immunity).

COVID-19 vaccines see these five hesitancy determinants again, only further exacerbated by waves of misinformation promulgated on social media, including through “bot” accounts, that prey on the concerns and insecurities of an already vulnerable public.

On the one hand, irrational and unreasonable conspiracy theories about COVID-19 and its vaccine abound among the anti-vaxxers — a subgroup of science deniers. These conspiracy theories include:

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Globe and vaccine.

Decolonizing the Pandemic Treaty Through Vaccine Equity

By Tlaleng Mofokeng, Daniel Wainstock, and Renzo Guinto

In recent years, there have been growing calls to “decolonize” the field of global health. Global health traces its roots back to colonial medicine when old empires sought to address tropical diseases which, if not controlled, could be brought by colonizers back home.

Today, many countries in the Global South may have already been liberated from their colonizers, but the colonial behavior of global health continues to manifest in policies, funding, research, and operations.

Unlike the tropical diseases of the past, SARS-CoV-2 has affected rich and poor countries alike, but the tools for putting this pandemic under control — most notably vaccines — remain unevenly distributed across the world. As of October 27, 2021, 63.5% of individuals in high-income countries have been vaccinated with at least one shot of the COVID-19 vaccine. Meanwhile, in low-income countries, only 4.8% of the population has been vaccinated with at least one dose.

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Vial and syringe.

The Pandemic Treaty and Intellectual Property Sharing: Making Vaccine Knowledge a Public Good 

By Ellen ‘t Hoen

The COVID-19 pandemic has laid bare the lack of regulation for the sharing of intellectual property (IP) and technology needed for an effective and equitable response to the crisis.

The Pandemic Treaty (or other legal instrument) scheduled for discussion at the World Health Assembly in the fall of 2021 should focus on establishing the norm that the IP and knowledge needed to develop and produce essential pandemic health technologies become global public goods. It should also ensure predictable and sufficient financing for the development of such public goods.

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