vaccines - Bill of Health

‘We Claimed Victory Before Time’: COVID-19 in Uruguay

April 23, 2021April 24, 2021 Chloe Reichel Leave a comment

By Chloe Reichel

Uruguay, once hailed as a model for its pandemic response, recently has seen some of the world’s sharpest increases in COVID-19 cases. Earlier this month, the infection rate in the country surpassed 1,300 cases per 100,000 residents over a 14-day period.

What happened?

I asked Dr. Gonzalo Moratorio, virologist at the Institut Pasteur de Montevideo and professor on the Faculty of Science at the Universidad de la República, to explain the shift. Moratorio was instrumental to Uruguay’s early successes in the pandemic, developing and distributing test kits that allowed the country to efficiently identify and isolate cases.

In this Q&A, which has been edited and condensed, he offers a look at the past, present, and future of the COVID-19 pandemic in Uruguay.

‘I Think of It in Terms of Years’: The Future of the COVID-19 Pandemic in South Africa

April 20, 2021April 19, 2021 Chloe Reichel Leave a comment

By Chloe Reichel

“No One Is Safe Until Everyone Is Safe” goes the rallying cry for global vaccine equity.

We would think that the COVID-19 pandemic already has made this point clear enough.

And yet, pundits are heralding the “end” of the pandemic in the U.S., all while viral variants that may be capable of evading the protection of vaccines continue to crop up both domestically and internationally.

In this Q&A, South African journalist and human rights activist Mark Heywood offers a look at the national COVID-19 epidemic in South Africa. The sobering reality there, in terms of morbidity and mortality, and in terms of expectations for the future, underscores the urgency for globally coordinated leadership and action to address the pandemic.

Our conversation from late March 2021, which has been edited and condensed, follows.

How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line

March 8, 2021March 5, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from COVID-19 and The Law, where it originally appeared on January 27, 2021.

By Kareem Carryl

Since the Food & Drug Administration granted emergency use authorization for the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna in December 2020, there have been many debates on vaccine allocation and prioritization.

As noted by Harvard Law School Professor Glenn Cohen in a recent interview with Annie Kapnick for the COVID-19 and The Law series, the issue of vaccine distribution is “complicated” because of competing factors decision-makers must consider. The relative weights placed on these factors has led to very different prioritization schemes. Initially, the Centers for Disease Control and Prevention (CDC) recommended a hybrid plan that appeared to prioritize individuals who were most likely to contract the virus (e.g., first responders, grocery store workers) over individuals most vulnerable to severe symptoms or death from the virus if contracted (e.g., individuals over the age of 65 not in long-term care facilities). In the United Kingdom, the prioritization groups were primarily based on vulnerability. Similarly, when looking more narrowly at the various plans being implemented at the state level in the United States, there are high degrees of variation.

This post does not seek to evaluate the merits of these or other specific vaccine allocation plans. Rather, it will address a risk that all plans likely face: the potential of individuals using their wealth and access to “cut the line” and be vaccinated ahead of schedule.
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Health care workers in personal protective equipment attend to a patient.

How Can Policymakers Overcome the Hurdles to Scaling up Antibody Manufacturing?

March 1, 2021March 1, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on February 18, 2021.

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

In our last post, we introduced some of the clinical evidence supporting the use of therapeutic antibodies against COVID-19—including Regeneron’s casirivimab and imdevimab and Eli Lilly’s bamlanivimab—and analyzed the existing problems in the distribution and administration of those therapies. Even in just the last few weeks, further clinical evidence has supported the use of these technologies, leading the FDA to issue an additional emergency use authorization for Lilly’s bamlanivimab and etesevimab cocktail. In the near future, though, problems in administering our existing supply of these new drugs may give way to problems producing enough of them—a challenge that is also affecting the vaccine rollout. In this post, we consider the difficult manufacturing issues involved in the therapeutic antibody context (a subject we’ve previously explored regarding vaccines), and what might be done to address them.

These patients’ samples were to be tested for SARS-CoV-2 antibodies, using the Centers for Disease Control and Prevention (CDC) serologic test.

Why Aren’t Therapeutic Antibodies Being Used More to Treat COVID-19?

February 22, 2021February 22, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on January 29, 2021.

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

When former President Donald Trump contracted COVID-19 in fall 2020, he was treated with monoclonal antibodies, touted as potentially miraculous treatments. Unlike other treatments so touted, there is some rigorous evidence to support these assertions: antibody drugs look like the best treatments currently available to prevent COVID cases from progressing to hospitalization. But months later, the drugs are in limited use and seem to be only a moderately important part of the COVID-19 response. Why aren’t antibodies making more of a difference for ordinary Americans?

What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout?

January 29, 2021January 29, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on January 12, 2021.

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

In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good news to the fight against the pandemic: the FDA’s emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines and the ensuing nationwide rollouts. The record-breaking vaccine development timeline and the videos of healthcare workers receiving early vaccines are worth celebrating.

But the subsequent distribution has been tragically slow—echoing distribution challenges for COVID-related goods ranging from PPE to diagnostics. On Dec. 29, Dr. Leana Wen noted that at the initial vaccination rate, it would take 10 years to vaccinate the roughly 80% of Americans needed to achieve herd immunity. According to Bloomberg’s vaccine tracker, as of today, fewer than 10 million vaccines have been administered in the United States. States are still sitting on nearly two-thirds of the doses they have received, and the federal government is holding half the U.S. supply in reserve. In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.

Syringe being filled from a vial. Vaccine concept illustration.

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

January 28, 2021May 6, 2021 The Petrie-Flom Center Staff Leave a comment

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

By Jonathan Iwry

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.

Is Israel Trading Medical Information for Vaccines? Ethical and Legal Considerations

January 25, 2021January 25, 2021 Shelly Simana Leave a comment

By Shelly Simana

On January 7, Israeli Prime Minister Benjamin Netanyahu announced that millions of vaccines are expected to arrive in Israel, and that by March, anyone who wishes to get vaccinated will be able to do so.

He concluded his speech with a controversial statement: “as part of the agreement [with Pfizer], we stipulated that Israel will serve as a global model state for a rapid vaccine rollout of an entire country… Israel will share with Pfizer, with all of humanity, the statistics that will help in developing strategies to defeat the coronavirus” (my translation, from Hebrew).

But which statistics, what kind of data, will be shared with Pfizer? This question remains a mystery.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

January 19, 2021January 15, 2021 The Petrie-Flom Center Staff Leave a comment

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

How Can Policymakers Encourage COVID-19 Vaccine Trials for Children?

January 11, 2021January 11, 2021 The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on December 18, 2020.

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

The past two weeks have been full of exciting COVID-19 vaccine news, including the FDA’s emergency use authorizations (EUAs) for the Pfizer–BioNTech and Moderna vaccines and the nationwide rollout of Pfizer’s vaccine. Choosing how to allocate access to vaccine doses has been left to individual states, leaving policymakers with difficult decisions about how to prioritize their populations, complicated in part by the federal government’s reduction in some vaccine shipments.

With a limited supply of doses, who should get the first shots? Some commentators have suggested prioritizing children early for a host of reasons, including hope about children returning to school. Last month a New York Times column asserted that “saving the most lives could mean prioritizing the vaccination of children and young adults.” But there is an important reason that kids can’t be part of the vaccine line yet: we don’t know whether these vaccines work for them. In this post, we explain why COVID-19 vaccines are only just starting to be tested in children and what policymakers can do to spur pediatric vaccine trials.

Tag: vaccines