Tag: covid vaccine

Baby held in someone's arms.

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

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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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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

Jorge Contreras 7 Comments

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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Vaccines.

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

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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.

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Vial and syringe.

Causes of COVID Vaccine Hesitancy

The Petrie-Flom Center Staff 1 Comment

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:

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Vial and syringe.

The OSHA Vaccine Mandate: A Roundup of State Responses

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By Kaitlynn Milvert

When the federal Occupational Health and Safety Administration (OSHA) published its “vaccine-or-test” requirements for large employers on November 5, 2021, it immediately faced backlash from many states.

In the weeks that have followed, states not only have filed numerous lawsuits challenging the OSHA requirements, but also have actively pushed through legislation that seeks to limit the scope or use of vaccine requirements in the workplace.

This new wave of state legislation contributes to a landscape of uncertainty surrounding the legal status of workplace vaccine requirements and available exemptions.

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Decolonizing the Pandemic Treaty Through Vaccine Equity

The Petrie-Flom Center Staff Leave a comment

By Tlaleng Mofokeng, Daniel Wainstock, and Renzo Guinto

In recent years, there have been growing calls to “decolonize” the field of global health. Global health traces its roots back to colonial medicine when old empires sought to address tropical diseases which, if not controlled, could be brought by colonizers back home.

Today, many countries in the Global South may have already been liberated from their colonizers, but the colonial behavior of global health continues to manifest in policies, funding, research, and operations.

Unlike the tropical diseases of the past, SARS-CoV-2 has affected rich and poor countries alike, but the tools for putting this pandemic under control — most notably vaccines — remain unevenly distributed across the world. As of October 27, 2021, 63.5% of individuals in high-income countries have been vaccinated with at least one shot of the COVID-19 vaccine. Meanwhile, in low-income countries, only 4.8% of the population has been vaccinated with at least one dose.

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Vial and syringe.

The Pandemic Treaty and Intellectual Property Sharing: Making Vaccine Knowledge a Public Good 

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By Ellen ‘t Hoen

The COVID-19 pandemic has laid bare the lack of regulation for the sharing of intellectual property (IP) and technology needed for an effective and equitable response to the crisis.

The Pandemic Treaty (or other legal instrument) scheduled for discussion at the World Health Assembly in the fall of 2021 should focus on establishing the norm that the IP and knowledge needed to develop and produce essential pandemic health technologies become global public goods. It should also ensure predictable and sufficient financing for the development of such public goods.

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Bill of Health - Globe and vaccine, covid vaccine

Promoting Vaccine Equity

The Petrie-Flom Center Staff Leave a comment

By Ana Santos Rutschman

The COVID-19 pandemic has brought into sharp relief longstanding equity problems surrounding the allocation of newly developed vaccines against emerging pathogens.

In my upcoming book, Vaccines as Technology: Innovation, Barriers, and the Public Health, I examine these problems and look into possible solutions to incrementally build more equitable frameworks of access to vaccines targeting emerging pathogens. These solutions focus on ensuring that vaccines are made available affordably to the populations that need them the most according to public health parameters.

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Person receiving vaccine.

Should the Seasonal Flu Vaccine Be Integrated into COVID-19 Vaccine Mandates?

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By Matt Bauer

As mandates for COVID-19 vaccinations expand, should we consider including the seasonal flu vaccine along with it?

Vaccine mandates

The Biden administrations recently announced its plans to require all employers with 100 or more employees to arrange for their workers to be vaccinated or test regularly. The mandate will likely impact over 80 million workers in the private sector. Health care and federal workers are also subject to new vaccination mandates.

Many universities, colleges, and secondary schools also have vaccination requirements, specifically for enrollment. And these requirements shift in light of changing circumstances:  A 2017 mumps outbreak across the broader Harvard and MIT communities prompted universities to revisit vaccine statuses for mumps (typically included in the MMR vaccine). More recently, many institutions of higher education have implemented COVID-19 vaccination requirements, which have subsequently met legal challenges.

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Child with bandaid on arm.

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

The Petrie-Flom Center Staff Leave a comment

By Govind Persad, Patricia 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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