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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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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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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Syringe being filled from a vial. Vaccine concept illustration.

What Does the Good News on the Vaccine Front Mean?

By Dorit Rubinstein Reiss

In the past weeks, three companies in advanced stages of COVID-19 vaccine trials reported good news. Moderna and Pfizer reported, respectively, 94.5% and 95% effectiveness of their mRNA vaccines in preventing symptomatic disease and similarly high effectiveness in preventing severe disease.

This was shortly followed by news that the AstraZeneca vaccine had over 70% effectiveness, and 90% with a different dosage regime.

The companies have also reported a favorable safety profile, with no serious harms attributed to the vaccine, though the vaccines do cause a high rate of temporary and unpleasant side effects, including local reactions and temporary flu-like symptoms.

Pfizer has already applied for an Emergency Use Authorization (EUA) from the FDA, and I would expect Moderna and AstraZeneca to follow suit.

What does this mean? First, a note of caution. These are reports from the companies; the FDA has not yet finished examining the data. Examination may raise questions. The data submitted has to pass dual review.

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Roche and City of Hope Claim Pfizer Biosimilar Version of Trastuzumab Will Infringe “At Least” 40 Patents

By James Love

On November 17, 2017, Genentech, a subsidiary of the giant Swiss drug company Roche, together with City of Hope, a charity, filed a complaint in a U.S. District Court, seeking an injunction to block introduction of a Pfizer biosimilar version of Herceptin (INN: trastuzumab), as well as other remedies to infringement, including compensation for Roche’s lost profits if competition occurs. The complaint (Genentech vPfizer, 17-cv-1672, U.S. District Court, District of of Delaware (Wilmington), filed November 17, 2017) illustrates the complexity of the patent landscape on a drug placed on the market more than 19 years ago and the need for compulsory licensing of patents.

Trastuzumab is a very important drug for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+). My wife was treated with trastuzumab for several years, and is currently on a follow-on Roche treatment named Kadcyla, which is a combination of trastuzumab and the small molecule DM1. (DM1 is an NIH funded drug now off patent).

The early development of trastuzumab was dramatic, and documented in such accounts as Robert Bazell’s very readable book, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, published in 1998, and the 2008 movie Living Proof, starting Harry Connick, Jr..  Bazell’s book was referred in the New York Times and the New England Journal of Medicine. The Bazell book and the Living Proof movie provide a dramatic account of the unwillingness of Genentech to invest in the research that led to the approval of trastuzmab, and the role of the Revlon Foundation to support Dr. Dennis Slamon’s critical work at UCLA.

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Kaiser v. Pfizer and the Question of Who Pays When Fraudulent Pharmaceutical Promotion Has Its Intended Effect

By Kate Greenwood

Cross-Posted at Health Reform Watch

On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion.  The decisions were noteworthy because in them the First Circuit lent its imprimatur to a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid.  In the lead case, brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, the  appellate court upheld a jury verdict that, after trebling, came to $142 million.

Not surprisingly, Pfizer has petitioned for certiorari, arguing that the First Circuit’s decisions “warrant review because they…raise important and recurring questions concerning the proper test for proximate cause under RICO and the permissibility of aggregate statistical proof in collective fraud cases.”  Amici briefs filed by BIO, PhRMA, and the Washington Legal Foundation echo these arguments, leaning heavily on the spectre of a “staggering” increase in suits founded on “pharmaceutical companies’ alleged off-label promotion.”  In addition to the financial burden posed by the “likely surge”, amici argue that it would chill their “truthful and constitutionally protected speech concerning beneficial off-label uses of FDA-approved drugs.”

Civil RICO claims cannot be predicated on “off-label promotion”, however.  To state a claim, a plaintiff has to allege that the defendant pharmaceutical company engaged in one of the predicate acts enumerated in the RICO statute, typically mail or wire fraud.  In this case, the jury found that Pfizer promoted the anti-seizure drug Neurontin as a safe and effective treatment for indications for which Pfizer knew it was no more effective than a placebo.  On appeal, Pfizer did not contest the jury’s finding that it committed fraud.  This distinguishes this case from those decided by other circuits and suggests that the First Circuit’s decisions may not open the floodgates quite as wide as Pfizer and its amici claim.

There is also reason to question the claim that the First Circuit adopted a new, more “relaxed” standard of causation in the case. Read More