Vial and syringe.

4 Things to Know About Intellectual Property, Patent Pledges, and COVID-19 Vaccines

By Chloe Reichel

High-profile commentators have argued recently that vaccine scarcity needn’t exist. If vaccine manufacturers simply shared their patents with other pharmaceutical companies, supply would quickly ramp up. 

Others have pointed out that numerous bottlenecks exist in the manufacturing process, from the glass vials that hold the vaccine, to the lipids that encase the vaccine’s active ingredient, mRNA.

And even if these bottlenecks didn’t exist, the intellectual property argument may be a straw man.    

In fact, this past October, Moderna made a gesture toward opening access to its intellectual property, by pledging that it would not enforce its patents against “those making vaccines intended to combat the pandemic.” That month, Jorge L. Contreras, a Presidential Scholar and Professor of Law at the University of Utah, covered the patent pledge and its potential implications for Bill of Health.

We checked in with Contreras to ask about the implications of Moderna’s patent pledge now that its vaccine has been proven safe and effective. Here are the highlights from the conversation:

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Patient receives Covid-19 vaccine.

Can Employers Mandate a Vaccine Under Emergency Use Authorization?

By Dorit Rubinstein Reiss

Several months ago, I wrote a post asking whether employers can mandate the uptake of a vaccine under an Emergency Use Authorization (EUA). My view then was that there was substantial legal uncertainty, but that the balance indicated that at the least, they may be possible, at the discretion of the Secretary of the Department of Health and Human Services (HHS).

Much of that discussion is still relevant, but developments and new points brought to my attention since have changed my view.

At this point, while there is still legal uncertainty, my view is that the balance of factors supports the ability of employers (or states) to require EUA vaccines. Courts vary, but my current assessment is that most courts would be inclined to uphold an employer mandate for an EUA COVID-19 vaccine.

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Person receiving vaccine.

Complex Regulations Push Employers Toward Voluntary Vaccination Programs, Not Mandates

By Lauren Hammer Breslow, JD, MPH

As COVID-19 vaccines become increasingly available, employers have been thrust into the spotlight on the public health question of whether or not to mandate vaccination for employees.

Despite strong evidence that mandatory vaccines best serve public health, a rubric of laws making mandatory programs complicated to deploy is leading many employers to favor vaccine encouragement policies.

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COVID-19 fake news concept illustration.

COVID-19 Vaccine Misinformation and the Anti-Vaccine Movement

By Dorit Rubinstein Reiss

The anti-vaccine movement is aggressively working to promote misinformation about COVID-19 vaccines, up to and including promoting fake claims of deaths from vaccines. We need to be aware of its efforts, and be prepared to respond.

It’s worth emphasizing that this blog post is focused on the anti-vaccine movement, not people with concerns about vaccines (the “vaccine hesitant”).

In relation to COVID-19, anti-vaccine activists have aggressively promoted misinformation from the start of the pandemic.

In March 2020, anti-vaccine activists incorrectly alleged – by misrepresenting a study – that flu vaccines increase COVID-19 risks. In June, anti-vaccine activist Del Bigtree described COVID-19 as a “cold,” blamed those who died for their own deaths, and called on his followers to “catch that cold.”

And from the beginning, anti-vaccine activists were committed to the ideas that COVID-19 vaccines would not work, would be dangerous, and would be promoted by a nefarious global conspiracy. They continue to spread these allegations, for example, using the fact that there are liability protections for COVID-19 vaccines to imply the vaccines are dangerous. Liability protections for COVID-19 vaccine manufacturers are real; but they are not evidence that the vaccines are unsafe.

This post will focus on one type of misinformation: alleged deaths from COVID-19 vaccines.

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Vial and syringe.

What to Know About the COVID-19 Vaccine Dosing Debate

By Dorit Rubinstein Reiss

Faced with limited COVID-19 vaccine doses and the ever-mounting toll and strain of the pandemic, a new debate has emerged as to the best strategy for allocating the vaccines.

Both COVID-19 vaccines authorized for emergency use in the U.S., which are produced by Pfizer/BioNTech and Moderna, have been studied under two-dose clinical trials. The two-dose regime is thought to accord a more robust immune response against COVID-19.

In the U.K., however, due to concerns about the shortage of COVID-19 vaccines, the government has deviated from established protocols. First, it decided to delay (but not omit) the administration of the second dose of the available vaccines, in order to increase the number of people getting at least one dose; second, it decided to allow mixing and matching of doses across vaccine types.

The United States is considering following the U.K. and moving to give more first doses, at the cost of delaying completion of the series.

Experts are sharply divided on whether that is a good or bad idea.

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Vial and syringe.

Congress Should Enact No-Fault Compensation for COVID-19 Vaccine Injuries

By Dorit Rubinstein Reiss

If COVID-19 vaccines lead to any serious harms, society should compensate those victims generously and quickly.

Currently, under the Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers and providers are immune from liability.

Anyone seeking compensation for a severe side effect from a COVID-19 vaccine needs to go through a government program that is extremely narrow and hard to win; the Countermeasures Injury Compensation Program (CICP). The program requires “compelling, reliable, valid, medical and scientific evidence” to be compensated — a very high bar. It has compensated only a very small percentage of claims submitted over the years.

But we have an alternative. The Vaccine Injury Compensation Program (VICP) provides compensation under a much more generous standard. It has been used for years for childhood vaccines, and has served us well. While not perfect, it offers a decent path forward.

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Close up of a Doctor making a vaccination in the shoulder of patient.

Authorize Emergency Vaccines for COVID-19, but Do It Well

By Holly Fernandez Lynch, Alison Bateman-House, and Arthur Caplan

The U.S. Food and Drug Administration (FDA) is expected to grant emergency use authorization (EUA) for one or more COVID-19 vaccines before the end of the year — perhaps even before the end of the day, given today’s advisory committee meeting.

The agency’s decision on these EUAs will balance the need for additional data on safety and efficacy against the potential to protect at-risk groups as quickly as possible. EUAs tip the balance in favor of speed, which can be reasonable for these populations given the circumstances, especially in light of the strong trial data reported for three COVID-19 vaccines since mid-November. But the tradeoff is very real: vaccine EUAs will substantially lower the likelihood of ongoing trials completing and new trials successfully recruiting volunteers. There are a few ways to minimize these consequences.

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Syringe and money.

Why the Government Shouldn’t Pay People to Get Vaccinated Against COVID-19

By Ana Santos Rutschman

As several pharmaceutical companies approach the U.S. Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19.

This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is dubious public health policy likely to backfire in terms of (re)building public trust in vaccines.

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Restaurant closed sign - "we cannot wait to see you again. stay safe."

Under an EUA, Can Businesses Require Employees and Customers to Get Vaccinated?

By Dorit Rubinstein Reiss

As promising data emerges for COVID-19 vaccines in clinical trials, two manufacturers of these vaccines, Pfizer and Moderna, have submitted requests for Emergency Use Authorizations (EUA).

An EUA would allow vaccines to be used before full FDA approval, during the time that COVID-19 is an emergency.

The promise of a safe, effective vaccine offers a glimmer of hope not just for individuals around the world affected by the pandemic, but also for businesses large and small that have struggled with closures and public health-related changes to operations. A natural question that has emerged as private businesses contemplate a return to normalcy is whether they can mandate that employees and customers receive these vaccines authorized for emergency use.

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