Tag: COVID19

Grocery store.

COVID-19 Highlights the Vital Connection Between Food and Health

The Petrie-Flom Center Staff Leave a comment

By Browne C. Lewis

Together, food insecurity and COVID-19 have proven to be a deadly combination for Black and Brown people.

Data published by the Centers for Disease Control and Prevention indicates that COVID-19 hospitalization rates among Black and Latino populations have been approximately 4.7 times the rate of their white peers. The CDC suggests that a key driver of these disparities are inequities in the social determinants of health.

Healthy People 2020 defines social determinants of health as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” The lack of access to good quality food is one of the main social determinants of health. People who eat unhealthy food are more likely to have diet-related medical conditions, like hypertension and diabetes, that make them more susceptible to developing severe or fatal COVID-19.

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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

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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.[1] 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.[2] 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.”[3] 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.

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Janitor mopping floor in hallway office building or walkway after school and classroom silhouette work job with sun light background.

Overworked, Overlooked, and Unprotected: Domestic Workers and COVID-19

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By Mariah A. Lindsay*

The COVID-19 pandemic has disproportionately affected communities already facing multiple oppressions, including women, people of color, people living with low incomes, and immigrants.

This post focuses on the impacts of the pandemic on a group that encompasses many of these identities: domestic workers, such as home health care workers, house cleaners, and child care workers.

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a crowd of people shuffling through a sidewalk

COVID-19 Immunity as Passport to Work Will Increase Economic Inequality

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By Ifeoma Ajunwa

As scientists develop increasingly accurate tests for COVID-19 immunity, we must be on guard as to potential inequities arising from their use, particularly with respect to their potential application as a prerequisite for returning to the workplace.

A focus on immunity as a yardstick for return to work will only serve to widen the gulf of economic inequality, especially in countries like the U.S., which has severe racial health care disparities and uneven access to effective healthcare. This focus could also serve to diminish societal support for further understanding and curtailing the disease.

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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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Society or population, social diversity. Flat cartoon vector illustration.

Unequal Representation: Race, Sex, and Trust in Medicine — COVID-19 and Beyond

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By Allison M. Whelan*

The COVID-19 pandemic has given renewed importance and urgency to the need for racial and gender diversity in clinical trials.

The underrepresentation of women in clinical research throughout history is a well-recognized problem, particularly for pregnant women. This stems, in part, from paternalism, a lack of respect for women’s autonomy, and concerns about women’s “vulnerability.” It harms women’s health as well as their dignity.

Over the years, FDA rules and guidance have helped narrow these gaps, and recent data suggest that women’s enrollment in clinical trials that were used to support new drug approvals was equal to or greater than men’s enrollment. Nevertheless, there is still progress to be made, especially for pregnant women. In the context of COVID-19 research, one review of 371 interventional trials found that 75.8% of drug trials declared pregnancy as an exclusion criteria, a concerning statistic given that recent data suggest that contracting COVID-19 during pregnancy may increase the risk of preterm birth.

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Syringe being filled from a vial. Vaccine concept illustration.

What Does the Good News on the Vaccine Front Mean?

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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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pills

Cuts to 340B Drug Reimbursement May be Harmful During COVID-19

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By Sravya Chary

On October 19, 2020, the U.S. Court of Appeals for the District of Columbia decided not to revisit two rulings that upheld Medicare reimbursement cuts for hospitals that participate in the 340B program.

The 340B program provides drugs at discounted prices to hospitals that primarily help under-served populations. Slashing Medicare reimbursement for safety-net hospitals that participate in the program may have devastating effects on the individuals who rely on these hospitals for discounted drugs and care, especially during the COVID-19 pandemic.

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Vaccine.

How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process?

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Cross-posted from Written Description, where it originally appeared on October 2, 2020. 

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

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