Person filling syringe from vial.

Religious Exemptions to Vaccines and the Anti-Vax Movement

By Dorit Rubinstein Reiss

Two major problems with granting religious exemptions to vaccine mandates are that they are very hard to police, and that they are routinely gamed.

Religious freedom is a core value in the United States. This makes policing religious exemptions to vaccination hard – and rightly so. The government policing people’s religion raises a number of thorny issues.

The problem is that the same people who eagerly promote anti-vaccine misinformation are just as eager to misuse religion to avoid vaccinating, and have no hesitation or compunction about coaching others to do the same. And without policing, it is easy for those misled by anti-vaccine misinformation to use the religious exemption.

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

The Legality and Feasibility of COVID-19 Vaccine Mandates for Children

By Dorit Rubinstein Reiss

On May 10, 2021 the U.S. Food and Drug Administration (FDA) expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include children aged 12-15.

The vaccine was previously authorized for use in those aged 16 and older. The company has announced it will seek emergency use authorization for younger children by September.

Now that children over the age of 12 can get vaccinated against COVID-19, will immunization against SARS-CoV-2 become a requirement for the return to public schools this fall?

My answer: In the near term, we probably will not see COVID-19 vaccine mandates for school children. And in the longer term, it depends.

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Empty classroom.

The National Anti-Vaccine Movement Heads to Hartford to Intimidate CT Legislators

By Arthur Caplan and Dorit Rubinstein Reiss

As Connecticut’s Senate prepares to vote tomorrow on whether to repeal Connecticut’s religious exemption from school immunization mandates, out-of-state anti-vaccine activists are mobilizing to threaten and intimidate legislators to vote against the bill.

The legislators should hold firm, and pass the bill the Governor says he will sign. They must not let aggressive attackers stop them from acting to make Connecticut’s children safer. Legislators should show the out-of-state anti-vaccine movement that intimidation doesn’t work here.

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Patient receives Covid-19 vaccine.

Can Employers Mandate a Vaccine Under Emergency Use Authorization?

By Dorit Rubinstein Reiss

Several months ago, I wrote a post asking whether employers can mandate the uptake of a vaccine under an Emergency Use Authorization (EUA). My view then was that there was substantial legal uncertainty, but that the balance indicated that at the least, they may be possible, at the discretion of the Secretary of the Department of Health and Human Services (HHS).

Much of that discussion is still relevant, but developments and new points brought to my attention since have changed my view.

At this point, while there is still legal uncertainty, my view is that the balance of factors supports the ability of employers (or states) to require EUA vaccines. Courts vary, but my current assessment is that most courts would be inclined to uphold an employer mandate for an EUA COVID-19 vaccine.

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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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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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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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