Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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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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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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Person receiving vaccine.

Complex Regulations Push Employers Toward Voluntary Vaccination Programs, Not Mandates

By Lauren Hammer Breslow, JD, MPH

As COVID-19 vaccines become increasingly available, employers have been thrust into the spotlight on the public health question of whether or not to mandate vaccination for employees.

Despite strong evidence that mandatory vaccines best serve public health, a rubric of laws making mandatory programs complicated to deploy is leading many employers to favor vaccine encouragement policies.

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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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