Desolate winter scene.

A Timeline of Biden’s Pandemic Response, Part 4: Winter of Death (December 2021 – Present)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first, second, and third parts here.

By Justin Feldman

On December 1, 2021, the CDC issued a press release announcing that it had identified a case of the Omicron variant in the U.S. for the first time.

White House insiders admit that they were unprepared for Omicron, just as they were unprepared for Delta. Vice President Harris recently told an interviewer that the administration was caught flatfooted because their scientific advisors never warned that such variants could crop up (at least two of these advisors, Rick Bright and Celine Gounder, begged to differ).

While vaccination still provides powerful protection against hospitalization and death due to infection from Omicron, protection against symptomatic illness is weaker than before, particularly among those who have not received boosters. And though evidence is mounting that the risk of hospitalization and death is lower for each person infected compared to Delta, Omicron’s extremely high transmissibility means that a large fraction of the population will become infected in a short time period, particularly in the absence of additional public health measures.

On December 21, as the highly contagious variant started to sweep the country, President Biden delivered remarks about the new threat. For the hundred million Americans who remain unvaccinated, the president’s speech warned of the imminent risk of hospitalization and death. For the vaccinated and boosted, Biden’s message was: Keep Calm and Carry On, all will likely be fine. And for Wall Street, the speech was meant to provide a crucial piece of reassurance: There would be no federal support for public health measures that restrict commerce.

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Empty toolbox.

A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first and second parts here.

By Justin Feldman

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures.

It was initially unclear whether the issue was Delta’s higher transmissibility or waning immunity from vaccines, as the first groups had been vaccinated nearly a year prior. There was noticeable concern from CDC, which acknowledged the “war has changed” in a set of leaked slides from July 29, 2021. Of particular concern were case reports from Massachusetts and internationally of high viral loads observed among those who were vaccinated and infected. In late July, CDC reversed course on its mask guidance and recommended indoor masking for all, including the fully vaccinated, in counties with high transmission. In late September 2021, CDC reversed course on its quarantine guidance, which had previously stated that fully vaccinated people should not quarantine after a known SARS-CoV-2 exposure.

These changing epidemiologic realities could have brought about a course correction and a push for other public health policies to complement vaccination. Instead, the administration mostly adapted by shifting its messaging.

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Vial and syringe.

A Timeline of Biden’s Pandemic Response, Part 2: A Pandemic of the Unvaccinated (May – Sept. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first part here.

By Justin Feldman

Framing vaccination as a way to opt out of the pandemic, and understanding the unvaccinated to be political enemies, has helped absolve the Biden administration of its responsibilities to protect the public’s health and facilitated the relentless push to restore “normalcy” (i.e., full economic activity).

The administration knows better: In September 2020, while the vaccines were still being tested, key figures in Biden’s orbit warned that it was unlikely vaccination alone could sufficiently control the pandemic.

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President Joe Biden and Vice President Kamala Harris.

From Shutting Down the Virus to Letting it Rip: A Timeline of Biden’s Pandemic Response

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. 

By Justin Feldman

Welcome to our “winter of severe illness and death.”

Hospitals are becoming overwhelmed in various parts of the U.S., and one model predicts more than 120,000 COVID deaths will occur in the first two months of 2022.

How did we get here? How is our Democratic president — who ran, in part, against Trump’s horrid pandemic response — letting the virus rip? How did we get to a point where a key organizer of the Great Barrington Declaration, a right-wing libertarian campaign opposed to public health measures, has stated that Republican and Democratic states alike have adopted policies in line with their philosophy? As hospitals fill up around the country, why are political leaders doing nothing to at least try to “flatten the curve”?

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Chicago, IL, USA - October 18 2021: BinaxNOW Covid-19 Antigen Self Test. Results in 15 minutes at home.

The Devil is in the Details with Biden’s Free COVID Testing Plan

By David A. Simon

Yesterday, President Biden announced a new requirement that private insurers must reimburse purchases of at-home COVID-19 tests.

This represents a significant departure from current policy, which only requires insurance companies to pay for testing at the direction of a healthcare provider. The new policy has yet to take effect — the Department of Health and Human Services (HHS) will release formal guidance for private insurers by January 15th.

Removing the need for clinician approval to access free COVID-19 testing is a noteworthy step; however, the new policy raises a host of questions that remain to be addressed, which are discussed briefly below.

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mask

COVID-19 is Still a Crisis for All

By Chloe Reichel

Recently, a narrative that COVID-19 is now a “pandemic of the unvaccinated” has emerged.

Setting aside the callousness of the claim, the biggest problem with this narrative is that it’s wrong. COVID-19 continues to threaten the health and well-being of all, regardless of vaccination status.

As we now know, vaccinated individuals can be infected with and transmit the delta variant. “Breakthrough” infections are not rare — countries with better data collection efforts than the U.S., including Israel and the United Kingdom, estimate vaccine efficacy against infection by the delta variant at around 40-50%.

This isn’t to say that the vaccines are worthless. We should continue to work to promote vaccine uptake, as the vaccines do provide a level of protection against the most severe outcomes.

But we need to understand: We can’t end this pandemic with vaccines alone.

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Burgess Hill, West Sussex – 12 January, 2021 Covid-19 home PCR self-test kit.

Pandemic Diagnostics: Present and Future Implications of Self-Testing Reimbursement

By David A. Simon

The process of diagnosing a disease or condition, including detection of SARS-CoV-2 infection, is changing.

Consumers now can not only collect their specimen from their living room couch, but they can test it while watching Netflix. Sampling, testing, and obtaining results all can be done in a patient’s home.

For communicable diseases like COVID-19, the disease caused by SARS-CoV-2 infection, at-home testing has considerable public health benefits. In addition to being more convenient than traditional diagnostics, self-testing can substantially reduce or eliminate the risk that infected individuals will spread the virus en route to a testing site.

This innovation has been spurred, in part, by a powerful incentive: the federal government has all-but guaranteed reimbursement for these tests.

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Emergency department entrance.

“Stick to the Science”? FDA, Ethics, and Pandemics

Cross-posted from COVID-19 and The Law, where it originally appeared on February 8, 2021. 

By

Throughout the current pandemic, Dr. Anthony Fauci and other public health experts have called on the government to “stick to the science.” This was at the same time that former President Donald Trump repeatedly undermined scientific expertise and prioritized political interests over responsible public health practices. Yet the particular ways in which the Trump administration mishandled the pandemic can divert attention from more fundamental challenges confronting government actors in any emergency — challenges that respect for science alone is insufficient to address. These challenges concern the norms guiding regulators’ exercise of their power under the law, as well as the proper role of values in public health and public policy more broadly.

FDA has struggled throughout COVID-19 to maintain high standards of integrity, including independence from undue political influence. We see this most clearly in the decisions FDA has faced in applying its power to issue emergency use authorizations (EUAs) for medical countermeasures against COVID-19. FDA’s experience using its emergency powers during COVID-19 speaks to the complex relationship between science and ethics in health policy — between empirical fact finding and normative questions involving ethics and public values.

This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability and more systematic decision-making by health regulators moving forward.

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people waiting in a line.

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

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

By

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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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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