Tag: coronavirus

This 2006 image depicted a nurse, who was administering an intramuscular vaccination into a middle-aged man’s left shoulder muscle. The nurse was using her left hand to stabilize the injection site.

An Equity-Based Strategy for COVID-19 Vaccine Distribution

Megan Shen Leave a comment

By Megan J. Shen

How COVID-19 vaccines roll out in the U.S. will highlight the nation’s priorities, and potentially also its persistent disparities.

Top of the list to receive the vaccine are frontline healthcare workers, who were the first to receive Pfizer’s new vaccine this week.

Next will come long-term care facility residents and workers. This is critical, as long-term care residents have suffered perhaps the most devastating death toll, killing over 100,000 residents.

But there is still a long winter ahead where many will not yet have access to the vaccine. And it remains unclear how the next round of vaccine recipients will be allocated to serve the most vulnerable populations.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

Sravya Chary Leave a comment

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Spoonful of sugar.

From “A Spoonful of Sugar” to Operation Warp Speed: COVID-19 Vaccines and Their Metaphors

The Petrie-Flom Center Staff Leave a comment

By Ross D. Silverman, Katharine J. Head, and Emily Beckman

As professors studying public health policy, narrative medicine, and how providers and the public communicate about vaccines, we recognize the power and peril of using the rhetorical tool of metaphors in vaccination and, more broadly, the COVID-19 response efforts.

Metaphors can be an effective shorthand to help people understand complex ideas, but we also must remain cognizant of the many ways metaphors may distort, divide, or misrepresent important details.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

Sravya Chary Leave a comment

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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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

Holly Fernandez Lynch Leave a comment

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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Waitress wears face mask and face shield, cleans table with alcohol and wet wipe at restaurant.

The Problem with Individual-Level Interventions to Curb the COVID-19 Pandemic

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By Daniel Goldberg

The failure to control the COVID-19 pandemic in the United States rests, in part, on the individualist nature of our public health responses.

Public health simply does not work well when we base our interventions on the individual level. This is known as “methodological individualism,” and the evidence suggests it is both ineffective and can expand existing health inequalities. It is problematic in any public health context, but especially in pandemic response and control.

Take, for example, the ongoing debate over mask mandates. Multiple governors have refused to issue mask mandates, instead simply requesting that people don masks. The objection, interestingly, is not to the idea of masking as a public health intervention, but to the existence of a mandate itself.

Yet a model of public health which consists of nothing more than pleading with individuals to avoid behaving in ways injurious to public health would be an abject failure. Imagine if, instead of imposing minimum requirements for clean water, we simply asked regulated industries to avoid polluting watersheds. Or perhaps instead of passing laws discouraging or even criminalizing obviously harmful behavior, we simply asked people to avoid driving drunk.

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people waiting in a line.

Advance Health Equity by Getting Vaccine Distribution Right

Nicolas P. Terry Leave a comment

By Sarah de Guia and Nicolas Terry

The U.S. Food and Drug Administration (FDA) is poised to decide soon whether to authorize the emergency use of COVID-19 vaccines. While this is positive news, critical decisions remain about the equitable allocation of the vaccine.

On December 10, 2020, the FDA will hold a meeting of its vaccine advisory committee to consider an emergency use authorization (EUA) sought by Pfizer/BioNTech for its COVID-19 vaccine candidate. A week later, the committee likely will consider a similar request from Moderna for its candidate. The UK is moving on an even more aggressive timeline and has already approved the Pfizer/BioNTech candidate.

In 2020, it is expected that doses will be ready for only 20 million Americans; there will not be general availability until the second quarter of 2021.

So, who will get the vaccine soonest, and will those decisions be based on equitable criteria?

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Highway alert: Covid-19 checkpoint ahead, overhead sign in Florida on state border.

Amending the Public Health Service Act to Encourage CDC Action to Stop COVID-19

Jennifer S. Bard Leave a comment

By Jennifer S. Bard

The U.S. Centers for Disease Control and Prevention (CDC) already has all the power it needs to limit the movement of people in order to slow the spread of COVID-19.

Yet, throughout this pandemic, they have taken no steps beyond issuing stark warnings, which have been only marginally effective. For example, this Thanksgiving, estimates indicate that almost 5 million flew and up to 50 million drove to join others. Dr. Deborah Birx is warning that everyone who did so should consider themselves infected.

The CDC’s historic reluctance to institute the politically unpopular measure of restricting travel could be countered by adding a self-executing amendment to 42 U.S. Code 264 requiring that the option be assessed at the beginning of an outbreak and periodically reviewed. More specifically, this amendment should create a review committee and set metrics for travel restrictions.

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Syringe and money.

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

The Petrie-Flom Center Staff 3 Comments

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?

Dorit Reiss 18 Comments

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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