Person receiving vaccine.

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

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

By Lisa Larrimore OuelletteNicholson PriceRachel 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.

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Person smoking cigarette.

Should Smokers be Prioritized for COVID Vaccine?

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.” 

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COVID-19 fake news concept illustration.

COVID-19 Vaccine Misinformation and the Anti-Vaccine Movement

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.

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Vial and syringe.

What to Know About the COVID-19 Vaccine Dosing Debate

By Dorit Rubinstein Reiss

Faced with limited COVID-19 vaccine doses and the ever-mounting toll and strain of the pandemic, a new debate has emerged as to the best strategy for allocating the vaccines.

Both COVID-19 vaccines authorized for emergency use in the U.S., which are produced by Pfizer/BioNTech and Moderna, have been studied under two-dose clinical trials. The two-dose regime is thought to accord a more robust immune response against COVID-19.

In the U.K., however, due to concerns about the shortage of COVID-19 vaccines, the government has deviated from established protocols. First, it decided to delay (but not omit) the administration of the second dose of the available vaccines, in order to increase the number of people getting at least one dose; second, it decided to allow mixing and matching of doses across vaccine types.

The United States is considering following the U.K. and moving to give more first doses, at the cost of delaying completion of the series.

Experts are sharply divided on whether that is a good or bad idea.

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Vial and syringe.

Congress Should Enact No-Fault Compensation for COVID-19 Vaccine Injuries

By Dorit Rubinstein Reiss

If COVID-19 vaccines lead to any serious harms, society should compensate those victims generously and quickly.

Currently, under the Public Readiness and Emergency Preparedness (PREP) Act, COVID-19 vaccine manufacturers and providers are immune from liability.

Anyone seeking compensation for a severe side effect from a COVID-19 vaccine needs to go through a government program that is extremely narrow and hard to win; the Countermeasures Injury Compensation Program (CICP). The program requires “compelling, reliable, valid, medical and scientific evidence” to be compensated — a very high bar. It has compensated only a very small percentage of claims submitted over the years.

But we have an alternative. The Vaccine Injury Compensation Program (VICP) provides compensation under a much more generous standard. It has been used for years for childhood vaccines, and has served us well. While not perfect, it offers a decent path forward.

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Person receiving vaccine.

What You Should Know About the COVID-19 Vaccine

Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020. 

By Jeff Neal

The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.

On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.

To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.

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Spoonful of sugar.

From “A Spoonful of Sugar” to Operation Warp Speed: COVID-19 Vaccines and Their Metaphors

By Ross D. Silverman, Katharine J. Head, and Emily Beckman

As professors studying public health policy, narrative medicine, and how providers and the public communicate about vaccines, we recognize the power and peril of using the rhetorical tool of metaphors in vaccination and, more broadly, the COVID-19 response efforts.

Metaphors can be an effective shorthand to help people understand complex ideas, but we also must remain cognizant of the many ways metaphors may distort, divide, or misrepresent important details.

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Close up of a Doctor making a vaccination in the shoulder of patient.

Authorize Emergency Vaccines for COVID-19, but Do It Well

By Holly Fernandez Lynch, Alison Bateman-House, and Arthur Caplan

The U.S. Food and Drug Administration (FDA) is expected to grant emergency use authorization (EUA) for one or more COVID-19 vaccines before the end of the year — perhaps even before the end of the day, given today’s advisory committee meeting.

The agency’s decision on these EUAs will balance the need for additional data on safety and efficacy against the potential to protect at-risk groups as quickly as possible. EUAs tip the balance in favor of speed, which can be reasonable for these populations given the circumstances, especially in light of the strong trial data reported for three COVID-19 vaccines since mid-November. But the tradeoff is very real: vaccine EUAs will substantially lower the likelihood of ongoing trials completing and new trials successfully recruiting volunteers. There are a few ways to minimize these consequences.

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Syringe and money.

Why the Government Shouldn’t Pay People to Get Vaccinated Against COVID-19

By Ana Santos Rutschman

As several pharmaceutical companies approach the U.S. Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19.

This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is dubious public health policy likely to backfire in terms of (re)building public trust in vaccines.

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Restaurant closed sign - "we cannot wait to see you again. stay safe."

Under an EUA, Can Businesses Require Employees and Customers to Get Vaccinated?

By Dorit Rubinstein Reiss

As promising data emerges for COVID-19 vaccines in clinical trials, two manufacturers of these vaccines, Pfizer and Moderna, have submitted requests for Emergency Use Authorizations (EUA).

An EUA would allow vaccines to be used before full FDA approval, during the time that COVID-19 is an emergency.

The promise of a safe, effective vaccine offers a glimmer of hope not just for individuals around the world affected by the pandemic, but also for businesses large and small that have struggled with closures and public health-related changes to operations. A natural question that has emerged as private businesses contemplate a return to normalcy is whether they can mandate that employees and customers receive these vaccines authorized for emergency use.

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