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.

Read More

Vaccines.

Promote Trust, Avoid Fraud: Lessons in Public Health Messaging from the Booster Roll Out

By Carmel Shachar

Even in September 2021, it was fairly clear that boosters for all adults, regardless of risk factors or which vaccines they initially received, would be coming soon.

Indeed, within two months, the U.S. Centers for Disease Control and Prevention (CDC) revised its recommendations to say that all vaccinated adults should receive a COVID-19 booster.

Unfortunately, the discrepancy between past messaging, which restricted access to boosters to select groups, and the current, broad recommendation has spawned two, related public health communications problems.

Read More

Vial and syringe.

Causes of COVID Vaccine Hesitancy

By Jasper L. Tran

Vaccinated individuals — like Tolstoy’s happy families — are all alike; each unvaccinated individual is hesitant for her own reason.

Prior research conducted in developed countries reveals five main individual-level determinants of pre-COVID vaccine hesitancy (commonly referred to as the 5 C model drivers of vaccine hesitancy): (1) Confidence (trust in vaccine’s effectiveness and safety, vaccine administrators and their motives); (2) Complacency (perceiving infection risks as low and vaccination as unnecessary); (3) Convenience / Constraints (structural or psychological barriers to converting vaccination intentions into vaccine uptake); (4) Risk Calculation (perceiving higher risks related to vaccination than the infection itself); and (5) Collective Responsibility (willingness to vaccinate to protect others through herd immunity).

COVID-19 vaccines see these five hesitancy determinants again, only further exacerbated by waves of misinformation promulgated on social media, including through “bot” accounts, that prey on the concerns and insecurities of an already vulnerable public.

On the one hand, irrational and unreasonable conspiracy theories about COVID-19 and its vaccine abound among the anti-vaxxers — a subgroup of science deniers. These conspiracy theories include:

Read More

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).

Read More

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?

Read More

doctor holding clipboard.

Preventing Misuse of COVID-19 Vaccine Medical Exemptions

By Ross D. Silverman and Gabriel T. Bosslet

As COVID-19 vaccination mandates become increasingly common, we can expect exemption requests (and misuse) to become increasingly widespread, too.

Most entities requiring vaccination mandates or proof of vaccination upon entry may offer limited grounds upon which an individual may request an exemption, usually based upon religious beliefs or medical reasons. Recent history with childhood immunization programs shows less rigorously-structured and -enforced vaccination exemption policies are vulnerable to increased usage, relative to narrower or more stringently-monitored programs. That history also shows there is a possibility some health care licensees may be willing to support individuals seeking to circumvent COVID-19-related requirements through offering questionable medical exemptions.

Entities imposing COVID-19 vaccination mandates, and state health care licensure boards, can take several simple but significant steps to counter misuse of medical exemptions and better protect communities from COVID-19. These safeguards also can decrease the temptation for licensed health professionals to recklessly undermine critical, lawful, evidence-driven public health efforts.

Read More

Person receiving vaccine.

Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines?

Cross-posted from Written Description, where it originally appeared on June 30, 2021. 

By Lisa Larrimore OuelletteNicholson PriceRachel Sachs, and Jacob S. Sherkow

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult — even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

Read More

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.

Read More

Emergency department entrance.

“Stick to the Science”? FDA, Ethics, and Pandemics

Cross-posted from COVID-19 and The Law, where it originally appeared on February 8, 2021. 

By

Throughout the current pandemic, Dr. Anthony Fauci and other public health experts have called on the government to “stick to the science.” This was at the same time that former President Donald Trump repeatedly undermined scientific expertise and prioritized political interests over responsible public health practices. Yet the particular ways in which the Trump administration mishandled the pandemic can divert attention from more fundamental challenges confronting government actors in any emergency — challenges that respect for science alone is insufficient to address. These challenges concern the norms guiding regulators’ exercise of their power under the law, as well as the proper role of values in public health and public policy more broadly.

FDA has struggled throughout COVID-19 to maintain high standards of integrity, including independence from undue political influence. We see this most clearly in the decisions FDA has faced in applying its power to issue emergency use authorizations (EUAs) for medical countermeasures against COVID-19. FDA’s experience using its emergency powers during COVID-19 speaks to the complex relationship between science and ethics in health policy — between empirical fact finding and normative questions involving ethics and public values.

This post reflects on the ethical implications of FDA’s use of its emergency powers, and suggests opportunities for greater accountability and more systematic decision-making by health regulators moving forward.

Read More