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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Syringe being filled from a vial. Vaccine concept illustration.

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021. 

By

The ongoing fight against COVID-19 has thrown a spotlight on the Food and Drug Administration (FDA) and its power to grant emergency use authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety.

Under § 564 of the Food, Drug, and Cosmetic Act (FD&C Act), use of FDA’s EUA authority requires a determination that an emergency exists by secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services (HHS), as well as a declaration by the HHS Secretary that emergency circumstances exist warranting the issuance of EUAs. Each issuance of an EUA requires that FDA conclude that:

  • it is reasonable to believe that a given product “may be effective” as an emergency countermeasure,
  • the known and potential benefits of authorization outweigh the known and potential risks, and
  • no formally approved alternatives are available at the time.

Annie Kapnick’s post on COVID-19 and FDA’s EUA authority provides a helpful overview of FDA’s emergency powers and their use in response to the pandemic. A brief look at the history of FDA’s emergency powers, including key events leading up to their enactment — Thalidomide, swine flu, AIDS, and 9/11 — offers perspective on the situation facing FDA today and its implications for the future. The history of EUA illustrates how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.

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Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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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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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

COVID-19 and the FDA Emergency Use Authorization Power

Cross-posted from COVID-19 and The Law, where it originally appeared on November 10, 2020. 

By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs. In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

Click here to read the full post on COVID-19 and The Law.

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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Syringe being filled from a vial. Vaccine concept illustration.

What Does the Good News on the Vaccine Front Mean?

By Dorit Rubinstein Reiss

In the past weeks, three companies in advanced stages of COVID-19 vaccine trials reported good news. Moderna and Pfizer reported, respectively, 94.5% and 95% effectiveness of their mRNA vaccines in preventing symptomatic disease and similarly high effectiveness in preventing severe disease.

This was shortly followed by news that the AstraZeneca vaccine had over 70% effectiveness, and 90% with a different dosage regime.

The companies have also reported a favorable safety profile, with no serious harms attributed to the vaccine, though the vaccines do cause a high rate of temporary and unpleasant side effects, including local reactions and temporary flu-like symptoms.

Pfizer has already applied for an Emergency Use Authorization (EUA) from the FDA, and I would expect Moderna and AstraZeneca to follow suit.

What does this mean? First, a note of caution. These are reports from the companies; the FDA has not yet finished examining the data. Examination may raise questions. The data submitted has to pass dual review.

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