Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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Desolate winter scene.

A Timeline of Biden’s Pandemic Response, Part 4: Winter of Death (December 2021 – Present)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first, second, and third parts here.

By Justin Feldman

On December 1, 2021, the CDC issued a press release announcing that it had identified a case of the Omicron variant in the U.S. for the first time.

White House insiders admit that they were unprepared for Omicron, just as they were unprepared for Delta. Vice President Harris recently told an interviewer that the administration was caught flatfooted because their scientific advisors never warned that such variants could crop up (at least two of these advisors, Rick Bright and Celine Gounder, begged to differ).

While vaccination still provides powerful protection against hospitalization and death due to infection from Omicron, protection against symptomatic illness is weaker than before, particularly among those who have not received boosters. And though evidence is mounting that the risk of hospitalization and death is lower for each person infected compared to Delta, Omicron’s extremely high transmissibility means that a large fraction of the population will become infected in a short time period, particularly in the absence of additional public health measures.

On December 21, as the highly contagious variant started to sweep the country, President Biden delivered remarks about the new threat. For the hundred million Americans who remain unvaccinated, the president’s speech warned of the imminent risk of hospitalization and death. For the vaccinated and boosted, Biden’s message was: Keep Calm and Carry On, all will likely be fine. And for Wall Street, the speech was meant to provide a crucial piece of reassurance: There would be no federal support for public health measures that restrict commerce.

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Empty toolbox.

A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first and second parts here.

By Justin Feldman

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures.

It was initially unclear whether the issue was Delta’s higher transmissibility or waning immunity from vaccines, as the first groups had been vaccinated nearly a year prior. There was noticeable concern from CDC, which acknowledged the “war has changed” in a set of leaked slides from July 29, 2021. Of particular concern were case reports from Massachusetts and internationally of high viral loads observed among those who were vaccinated and infected. In late July, CDC reversed course on its mask guidance and recommended indoor masking for all, including the fully vaccinated, in counties with high transmission. In late September 2021, CDC reversed course on its quarantine guidance, which had previously stated that fully vaccinated people should not quarantine after a known SARS-CoV-2 exposure.

These changing epidemiologic realities could have brought about a course correction and a push for other public health policies to complement vaccination. Instead, the administration mostly adapted by shifting its messaging.

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Vial and syringe.

A Timeline of Biden’s Pandemic Response, Part 2: A Pandemic of the Unvaccinated (May – Sept. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first part here.

By Justin Feldman

Framing vaccination as a way to opt out of the pandemic, and understanding the unvaccinated to be political enemies, has helped absolve the Biden administration of its responsibilities to protect the public’s health and facilitated the relentless push to restore “normalcy” (i.e., full economic activity).

The administration knows better: In September 2020, while the vaccines were still being tested, key figures in Biden’s orbit warned that it was unlikely vaccination alone could sufficiently control the pandemic.

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A half face dust mask and HEPA filter over white background.

Being an Adult in the Face of Omicron

By Jennifer S. Bard

To those who believe that the federal government is a benign force doing the best they can to fight the COVID-19 pandemic and keep us all safe, I have two words of advice: Grow up.

Neither the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), or Dr. Fauci should be anthropomorphized into a benevolent but perhaps out-of-touch parental figure. They are not.

As a matter of law, the government, in contrast to your parents, or school, or perhaps even your employer, does not have a fiduciary duty to protect your (or any individual’s) health and safety. As the Supreme Court said in Deshaney v. Winnebago Country Dept of Social Services, 489 U.S. 189 (1980) and again in Castlerock v. Gonzales, 545 U.S. 748 (2005), individuals do not have an enforceable right to government protection unless the state itself creates the danger. Their duty, if it exists, is to the public in general, which can encompass many factors beyond any one person’s health.

Just knowing that the government, duly elected or not, has no obligation to protect you or your family should be enough to look at its pandemic guidance as minimum, rather than maximum, standards. It should also encourage you to be proactive in taking precautions beyond those “recommended,” rather than seeing these minimal standards as unwarranted restrictions that can be negotiated down.

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Freeway on-ramp

The Government Needs to Construct On, Not Off, Ramps to Combat the Latest Wave of COVID

By Jennifer S. Bard

Over the past two weeks, the news coming in about the spread of COVID-19 has been eerily familiar. Cases are rising all over Europe, not just in under-vaccinated Eastern European countries, but in England, the Netherlands, and Germany — all of whom have much higher rates of vaccination than the U.S. At the same time, cases across the U.S., including in cities like LA, DC, and Chicago have stopped falling, and are rising rapidly in the Mountain West, including the Navajo Nation. Hospitals in Colorado have already reached crisis capacity.

Whether the increase is attributable to the emergence of yet another variant, or perhaps is a natural artifact of waning immunity, it is very real and demands a level of attention from our federal government that, once again, it is failing to provide.

Yet in the face of now too familiar signs of resurgence, already being called a “Fifth Wave,” not only are the usual minimizers advocating reducing existing measures to prevent spread, but cities and states are rolling back what few protections remain intact. It is in the face of this foolish movement to drop our guard that the federal government is, again, failing to use the powers it has beyond vaccine mandates to create much needed on-ramps for mitigation measures as the country heads into winter.

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NEW YORK, NEW YORK - APRIL 05: Emergency medical technician wearing protective gown and facial mask amid the coronavirus pandemic on April 5, 2020 in New York City.

Déjà Vu All Over Again

By Jennifer S. Bard

The COVID-19 pandemic has shown us time and time again that whatever progress we make in curbing transmission of the virus is tenuous, fragile, and easily reversed.

And yet, we continue on a hapless path of declaring premature victory and ending mitigation measures the moment cases begin to fall. We need only look back to recent history to see why relaxing at this present moment of decline is ill-advised.

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Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

By Govind PersadPatricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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Patient receives Covid-19 vaccine.

What’s the Law on Vaccine Exemptions? A Religious Liberty Expert Explains

This article is republished from The Conversation under a Creative Commons license. Read the original article.

By Douglas Laycock, University of Virginia

For Americans wary of COVID-19 vaccine mandates, like the sweeping requirements President Joe Biden announced Sept. 9, 2021, it seems there are plenty of leaders offering ways to get exemptions – especially religious ones.

No major organized religious group has officially discouraged the vaccine, and many, like the Catholic Church, have explicitly encouraged them. Yet pastors from New York to California have offered letters to help their parishioners – or sometimes anyone who asks – avoid the shots.

These developments point to deep confusion over how to win a religious exemption. So what are they, and is the government even required to offer the exemptions in the first place?

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