Tag: vaccines

Multiethnic women in colorful casual clothes discussing in the group meeting.

Rebuilding Trust in Public Health and Public Health Law

The Petrie-Flom Center Staff Leave a comment

By Leslie E. Wolf

With our recent (and continuing) experience of the devastating COVID-19 global pandemic, one might think that our collective appreciation for public health efforts and the people advancing those efforts would be high. Instead, public health officials have been vilified and attacked, and public health laws have been weakened, leaving us vulnerable to the next public health emergency.

So, how do we move forward? An essential first step is to refocus on the “public” in public health. Public health efforts and public health law depend on community support.

Read More

simple black childish hand drawing lines lightbulbs on yellow background.

Failures of Imagination in Public Health Policy

The Petrie-Flom Center Staff Leave a comment

By Daniel Swartzman

If public health is to prosper, we will need to overcome the after-effects of several failures of imagination.

  • Failing to recognize the threat to liberal democracy from the last 50 years of coordinated conservative political and policy actions.
  • Failing to use litigation against inadequate public health actions, as did the early civil rights and environmental movements.
  • Failing to anticipate litigation that challenges our efforts, such as with the ACA or the upcoming attempt to “codify Roe v. Wade.”
  • Failing to demand moral leadership of governmental actors.
  • Failing to make political action and advocacy an integral part of professional education in public health.

Read More

Hospital beds in a room filled with smoke.

The End of Public Health? An Introduction to the Symposium

Jennifer S. Bard Leave a comment

By Jennifer S. Bard

Teaching public health law over these past three years has meant contending with a series of federal and state court rulings that in different ways have called into question many of what seemed to be the most established principles of public health law. The double whammy of the pandemic and a new, and very different Supreme Court have already resulted in more dramatic changes to public health law in the past few years than in the preceding one hundred plus years.

Read More

Single strand ribonucleic acid.

The Secret World of mRNA: HDT Bio Corp v. Emcure and Access to Next-Gen mRNA

Aparajita Lath Leave a comment

By Aparajita Lath

The future of public health in an “RNA world” is on trial in a trade secrecy dispute worth $950 million currently being fought before the District Court of the Western District of Washington, Seattle between HDT Bio Corp. and Emcure Pharmaceuticals.

The trade secrets at issue concern an improvement over existing mRNA technology called “self-amplifying RNA” or “saRNA.” saRNA are effective at much smaller doses and lower costs. The saRNA technology is being used to develop vaccines for COVID, Zoster, Zika and Rabies.

Read More

FRAND Terms for Pandemic-essential Intellectual Property Rights

The Petrie-Flom Center Staff Leave a comment

This post was originally published on the Verfassungsblog as part of our joint symposium on international pandemic lawmaking.

By Kaat Van Delm

Our international norms are arguably ill adapted to emergencies such as pandemics. In this contribution I discuss a potential remedy for one related challenge, namely, cooperation amongst competitors for the accelerated development of vaccines. A way to foster cooperation could be the use of fair, reasonable and non-discriminatory (“FRAND”) terms to the licensing of pandemic-essential intellectual property rights (IPR). Specifically, states could make participation in public procurement for vaccines by pharmaceutical companies conditional upon accepting FRAND terms for their IPR relevant for vaccine development. I do not suggest changes to the existing rules for allocation of IPR. Rather, I attempt to explore an acceptable limitation of such rights in case of a pandemic. 

Transposing the concept of FRAND terms from standardization to the licensing of pandemic-essential IPR has potential because of the concept’s flexibility. FRAND terms do not require commitment to specific royalties in advance, therefore leaving room for considering new information such as the monetary value of the IPR concerned or the severity of the health crisis.

Read More

Person receiving vaccine.

Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?

The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on June 30, 2021. 

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

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult — even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

Read More

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.

Read More

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?

Read More

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.

Read More