Patient receives Covid-19 vaccine.

What’s the Difference Between Vaccine Approval (BLA) and Authorization (EUA)?

Cross-posted from Written Description, where it originally appeared on June 3, 2021. 

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

Recently, Pfizer and BioNTech and Moderna announced that they are seeking full FDA approval for their mRNA COVID-19 vaccines — filing, in FDA parlance, a Biologics License Application (BLA). Johnson & Johnson plans to file its own BLA later this year. But currently, all three vaccines are being distributed under a different FDA mechanism, the Emergency Use Authorization (EUA). What’s the difference, under the hood, between these two mechanisms? Why would these companies want to go through the BLA process? And what tools can policymakers use to make the EUA to BLA shift better?

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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?

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

By Rachel SachsJacob S. SherkowLisa 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.

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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?

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

By Nicholson PriceRachel SachsJacob 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?

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Vial and syringe.

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

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

By Lisa Larrimore OuelletteNicholson PriceRachel 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.

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Empty classroom.

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

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.

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child getting vaccinated

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

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.

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Vaccine.

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

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

By Rachel SachsJacob S. SherkowLisa 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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Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

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

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

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