By Lauren Hammer Breslow, JD, MPH
As COVID-19 vaccines become increasingly available, employers have been thrust into the spotlight on the public health question of whether or not to mandate vaccination for employees.
Despite strong evidence that mandatory vaccines best serve public health, a rubric of laws making mandatory programs complicated to deploy is leading many employers to favor vaccine encouragement policies.
Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021.
By Jeff Neal
Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes.
CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.
Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.”
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.
Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021.
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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:
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.
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 December. The selections feature topics ranging from an analysis of potential approaches for evaluating novel SARS-CoV-2 vaccine candidates after other vaccines have already been authorized; to an examination of social, cultural, and economic aspects of microbial resistance; to a study on clinical evidence supporting FDA clearance of novel therapeutics devices via the de novo pathway. A full posting of abstracts/summaries of these articles may be found on our website.
By Carmel Shachar
Looking back at the first month of COVID-19 vaccine administration, it is clear that something was lost in the translation of vaccine allocation plans into reality.
What went wrong?
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.
By Dorit Rubinstein Reiss
The anti-vaccine movement is aggressively working to promote misinformation about COVID-19 vaccines, up to and including promoting fake claims of deaths from vaccines. We need to be aware of its efforts, and be prepared to respond.
It’s worth emphasizing that this blog post is focused on the anti-vaccine movement, not people with concerns about vaccines (the “vaccine hesitant”).
In relation to COVID-19, anti-vaccine activists have aggressively promoted misinformation from the start of the pandemic.
In March 2020, anti-vaccine activists incorrectly alleged – by misrepresenting a study – that flu vaccines increase COVID-19 risks. In June, anti-vaccine activist Del Bigtree described COVID-19 as a “cold,” blamed those who died for their own deaths, and called on his followers to “catch that cold.”
And from the beginning, anti-vaccine activists were committed to the ideas that COVID-19 vaccines would not work, would be dangerous, and would be promoted by a nefarious global conspiracy. They continue to spread these allegations, for example, using the fact that there are liability protections for COVID-19 vaccines to imply the vaccines are dangerous. Liability protections for COVID-19 vaccine manufacturers are real; but they are not evidence that the vaccines are unsafe.
This post will focus on one type of misinformation: alleged deaths from COVID-19 vaccines.
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.
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.