Category: Vaccines

Emergency department entrance.

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

The Petrie-Flom Center Staff Leave a comment

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

By Jonathan Iwry

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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Patient receives Covid-19 vaccine.

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

The Petrie-Flom Center Staff Leave a comment

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

By Jacob S. Sherkow, Lisa 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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a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Washington, DC, USA - Closeup view of December, 23, 2020: COVID-19 Vaccination Record Card by CDC on blurred documents background.

Key Considerations for the Ethical Design of COVID-19 Vaccine Passports

Chloe Reichel Leave a comment

By Chloe Reichel

States, employers, retailers, and other industries are now grappling with how to update mask policies in light of recent CDC guidance, which suggests vaccinated individuals may remove their face coverings indoors. 

But without a system in place to discern who has been vaccinated, the guidance poses a major risk: unvaccinated individuals, who can still contract and spread the virus, may also opt to go maskless. 

COVID-19 digital health passes, often called vaccine passports, may prove useful as a tool to relax mask policies. Vaccine passports can help to verify whether individuals may safely enter a space without a face covering.

Their ethical implementation, however, is contingent upon a number of factors: first and foremost, equitable access to vaccines. Other considerations include minimizing distrust, accessibility, risks of discrimination, and privacy protections.

For policy makers considering the implementation of COVID-19 vaccine credentialing programs, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Edmond J. Safra Center for Ethics at Harvard University have developed a road map highlighting key considerations for their ethical design.

This post provides a summary of key considerations and responsive policy recommendations presented in the paper to guide more equitable implementation of vaccine passports and to minimize distrust.

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Reston, USA - April 9, 2020: Social distancing sign at cashier check-out aisle inside Trader Joe's grocery shop store during coronavirus with woman employee in mask.

Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health

Carmel Shachar Leave a comment

By Carmel Shachar

As Americans shed their masks in response to recent U.S. Centers for Disease Control and Prevention (CDC) guidance, the most vulnerable among us face an unfair choice: either to enforce public health hygiene or forgo being in public spaces entirely.

The new guidance, which states that fully vaccinated people can resume activities without wearing masks or socially distancing, is too nuanced for a country in which a significant percentage of adults continue to refuse vaccination and there are no mechanisms to enforce masking or social distancing for the unvaccinated.

Ultimately, this shift in policy unfairly burdens small businesses and individuals to be the guardians of public health, when it should be our community leaders responsible for enforcing public health norms.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

Are Employers That Ditch Mask Mandates Liable for COVID-19 Infections at Work?

Chloe Reichel Leave a comment

By Chloe Reichel

Last week, in response to U.S. Centers for Disease Control and Prevention (CDC) guidance indicating that vaccinated individuals need not wear face coverings indoors, a number of states and businesses swiftly did away with indoor mask mandates.

Widespread criticism followed, focusing on the dangerous policy vacuum that now exists. The CDC has suggested unvaccinated individuals follow an honor system and continue masking — but such an honor system is difficult, if not impossible, to enforce.

In the absence of indoor mask policies, individuals face increased risk of exposure to the virus. And some groups are particularly at risk of contracting the virus now, including immunocompromised individuals, for whom vaccines may not confer protection, and children under the age of 12, for whom a vaccine has not yet been authorized.

To better understand the new guidance and its implications for workers who are no longer protected by mask mandates, I spoke with Sharona Hoffman, an expert in health and employment law. Hoffman is the Edgar A. Hahn Professor of Law, a professor of bioethics, and Co-Director of Law-Medicine Center at Case Western Reserve University School of Law. In our interview, Hoffman explained whether an employer may be held liable if an employee contracts COVID-19 after an occupational exposure, and highlighted other key issues to anticipate regarding COVID-19 and the workplace.

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a crowd of people shuffling through a sidewalk

What Makes a Bad Public Health Decision? And How Can We Make Good Ones?

Jennifer S. Bard Leave a comment

By Jennifer S. Bard

What makes a bad public health decision?

What we’ve seen across both the Trump and Biden administrations is that relying on the CDC’s medical model of decision-making isn’t working. No matter how sound the underlying science or medicine, public health guidance cannot be effective if its target audiences don’t understand it and it’s impossible to deploy.

The recent U.S. Centers for Disease Control and Prevention (CDC) guidance suggesting that people who are vaccinated do not have to wear masks is an instructive example.

Reporters over the past few days have confirmed that this decision was made inside the CDC, by its director, without any notice to, let alone consultation of, the state and local health authorities, retailers, and schools that would have to implement it.

But the job of public health demands an approach that encompasses such groups. Unlike medical doctors (and practicing attorneys) who bear fiduciary duties to individual patients, public health professionals’ obligations are not to individuals, but to populations. And fulfilling these obligations is very hard. It’s one thing to tailor an intervention or craft an explanation for the person in front of you, and quite another to do the same for a community.

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Key Takeaways from Petrie-Flom Center Discussion on Vaccine Passports

The Petrie-Flom Center Staff Leave a comment

As mask mandates fall to the wayside, COVID-19 digital health passes, often called vaccine passports, hold promise as a tool to verify whether individuals may enter a space without a face covering.

Vaccine passports, however, also pose a number of ethical and legal challenges. Panelists discussed these concerns during an April 28 webinar hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics titled, “Vaccine Passports: A Path to the New Normal?”

This article highlights key points made during the conversation.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of April. The selections feature topics ranging from the pre-market development times for innovative vaccines, to an assessment of FDA postmarketing requirements and commitments from 2009 to 2018, to an analysis of implementation challenges and potential effects of U.S. adoption of international reference pricing for prescription drugs. A full posting of abstracts/summaries of these articles may be found on our website.

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A pile of three surgical masks.

Public Health Law vs. Individual Advice: Why Discarding Indoor Mask Mandates Is a Mistake

Jennifer S. Bard Leave a comment

By Jennifer S. Bard

The U.S. Centers for Disease Control and Prevention (CDC) announced today that fully vaccinated individuals no longer need to wear masks indoors or outdoors in most cases.

The agency has emphasized that this is merely guidance, and is not intended to affect public policy or to change practices of private companies. But it is naïve to imagine that health departments and private organizations will not make changes in response to the announcement.

There is a growing public wish to put COVID-19 behind us by eliminating visible signs that it still exists (e.g., mask wearing). But guidance driven by this magical thinking will cause unnecessary harm. Public health measures should protect the larger population, including those who cannot be or have not yet been vaccinated. This CDC guidance proffers individual advice at the expense of the goals of public health.

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