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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pills

Cuts to 340B Drug Reimbursement May be Harmful During COVID-19

By Sravya Chary

On October 19, 2020, the U.S. Court of Appeals for the District of Columbia decided not to revisit two rulings that upheld Medicare reimbursement cuts for hospitals that participate in the 340B program.

The 340B program provides drugs at discounted prices to hospitals that primarily help under-served populations. Slashing Medicare reimbursement for safety-net hospitals that participate in the program may have devastating effects on the individuals who rely on these hospitals for discounted drugs and care, especially during the COVID-19 pandemic.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Experts Question FDA Approval of Remdesivir for COVID-19

By Sravya Chary

Experts are calling into question the recent decision of the U.S. Food and Drug Administration (FDA) to approve remdesivir (sold under the brand name Veklury) for the treatment of COVID-19 and casting scrutiny as to whether the decision is truly in the public’s interest.

Evaluating and approving an effective treatment for SARS-CoV-2 virus has been a top priority for regulatory authorities, especially in the absence of a viable vaccine. On October 22, 2020, the FDA approved Veklury for the treatment of COVID-19 in adult and pediatric patients requiring hospitalization.

The FDA cited three randomized, controlled clinical trials as the evidence supporting its decision to approve Veklury. The findings from the three studies were as follows: first, that the median time to recovery from COVID-19 was 5 days sooner in the Veklury group compared to the placebo group. Second, that the odds of a research subject’s COVID-19 symptoms improving were statistically significantly higher in the five-day treatment group than the standard of care group (the 10-day treatment group did not show a statistically significant difference from the standard of care group). Third, that there were no statistically significant differences in recovery or mortality rates between subjects in the five-day Veklury group versus the ten-day Veklury group.

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Cartoon of contact tracing for COVID-19.

To Combat the COVID-19 Pandemic, the US Should Crowdsource Contact Tracing

By James Toomey

As states across the U.S. contemplate another lockdown to curb rising COVID-19 infections, it’s clear that we need to do something differently this time to ensure that our sacrifices are not wasted when we emerge.

To that end, we should try a crowdsourced, privately-run, anonymous, voluntary, and collaborative approach to contact tracing.

We’ve heard it countless times and in countless ways: the United States has failed at contact tracing. The technique, which has been effective at limiting transmission in many other countries, has plainly failed to contain the spread of the virus here.

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Vaccine.

Past Anti-Vax Campaign Provides Insights for Current COVID-19 Debates

By Dorit Rubinstein Reiss

A new book on a prominent misinformation campaign targeting the measles, mumps, and rubella (MMR) vaccine has profound insights into current vaccine debates, such as those emerging around a potential COVID-19 immunization.

The Doctor Who Fooled the World: Science, Deception, and the War on Vaccines,” by Brian Deer, exposes the elaborate fraud perpetrated by Andrew Wakefield, the former British gastroenterologist who, in the late 1990s, created a scare about MMR vaccine by suggesting it caused autism.

Brian Deer is the journalist who, through several years of dogged investigation, exposed Wakefield’s hidden conflicts of interests and misrepresentations, showing that the small study used to create the scare was not just deeply flawed – as was apparent on its face – but an elaborate fraud.

Unfortunately, Wakefield and his misrepresentations are still with us, and are still putting children at risk all around the world. This makes Deer’s book – which teaches us how Wakefield tricked the world, and the lasting impact of his fraud – timely and important.

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Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts

By Barbara J. Evans and Ellen Wright Clayton

The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19.

As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to “invent their own differing systems” to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses.

Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada’s nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false.

On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials’ action was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests.

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Supreme Court of Mexico.

How Does the Mexican Constitution Regulate Crisis?

By David García Sarubbi

When the Mexican Constitution was issued in 1917, one of its main concerns was to regulate how democracy must deal with crisis, that is, with exceptional situations that demand the exercise of powers outside the Constitution’s regular limits to suppress potential dangers.

There is not an “off switch” available for political powers to put the Constitution to rest while solving urgent issues. Instead, there are complex rules to govern decisions in extraordinary circumstances.

The Constitution’s Article 29 has a Suspension Clause, which contains a detailed regulation for such cases. Moreover, in Article 73, Section XVI, there is another regulation relating to pandemics like the one we are experiencing currently.

Thus, from the founding era, the Mexican constitution has upheld the value of the rule of law, even in extraordinary circumstances.

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Pile of colorful pills in blister packs

Duplicate Discounts Threaten the 340B Program During COVID-19

By Sravya Chary

The 340B program, which provides discount drugs to safety-net hospitals, faces an uncertain future due to revenue leakage faced by pharmaceutical manufacturers and increased demand spurred by the COVID-19 pandemic.

Over the last few months, growing demand for 340B drugs and hard-to-monitor billing issues have placed an immense and unforeseen financial burden on pharmaceutical manufacturers. In response, some pharmaceutical manufacturers have threatened to withhold 340B drugs from contract pharmacies, thus limiting access to steeply discounted drugs for eligible patients.

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covid-19 virus.

Health Justice Strategies to Combat the Pandemic: Video Preview with Ruqaiijah Yearby

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Ruqaiijah Yearby, Seema Mohapatra, Lindsay Wiley, and Emily Benfer give a preview of their paper, “Health Justice Strategies to Combat the Pandemic: Eliminating Discrimination, Poverty, and Health Disparities During and After COVID-19,” which Yearby will present at the Health Law Policy workshop on October 13, 2020. Watch the full video below:

Social distancing concept image.

Democratizing the Law of Social Distancing: Video Preview with Lindsay F. Wiley

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Lindsay F. Wiley gives a preview of her paper “Democratizing the Law of Social Distancing,” which she presented at the Health Law Policy workshop on September 14, 2020. Watch the full video below: