Vial and syringe.

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

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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Globe and vaccine.

Promoting Vaccine Equity

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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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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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.

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Globe and vaccine.

Access-to-Medicines Activists Demand Health Justice During COVID-19 Pandemic

By Brook K. Baker 

It was apparent from the outset of the COVID-19 pandemic that a business-as-usual approach — perpetuating the biopharmaceutical industry’s intellectual property-based monopolies and allowing artificial supply scarcity and nationalistic hoarding by rich countries — would result in systemic failure and gross inequity.

The world had seen it all before, from the Big Pharma blockade of affordable antiretrovirals to treat HIV/AIDS, to the hoarding of vaccines by the global north during the H1N1 bird flu outbreak in 2009 and its stockpiling of Tamiflu.

Activists in the access-to-medicines movement quickly mobilized to combat the threat of vaccine/therapeutic apartheid.

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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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international connections concept art.

The Prospects for an IP Waiver Under the TRIPS Agreement

By Duncan Matthews and Timo Minssen

The informal meeting of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Council today, July 6, 2021, focuses international attention once more on prospects for a waiver of the TRIPS Agreement in response to the COVID-19 pandemic.

Regardless of whether an actual TRIPS waiver ultimately comes to pass, the real significance of these efforts lies in the increased focus they have placed on the role of IP and trade secrets in improving access and affordability, and scaling-up of manufacturing and supply of vaccines and other health-related technologies. These conversations have introduced the possibility of a rethinking of the relationship between IP, innovation, conservation, and access.

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Photo of person with gloved hand holding flask at lab bench.

US Support for a WTO Waiver of COVID-19 Intellectual Property – What Does it Mean?

By Jorge L. Contreras

On May 5, 2021, U.S. Trade Representative Katherine Tai announced that the U.S. would support a “waiver of IP protections on COVID-19 vaccines to help end the pandemic” currently being discussed at the World Trade Organization (WTO). This announcement, representing a reversal of longstanding U.S. policy toward intellectual property, came as a welcome surprise to much of the world, but elicited strong negative responses from the pharmaceutical industry as stock prices of leading vaccine producers sank.

In the short time since the announcement was made, there has been a fair amount of speculation, hyperbole, and misinformation on the topic. In this post, I offer an explanation of what just happened, and my guess as to what its likely effects will be, bearing in mind that the situation is fast-moving and somewhat unpredictable.

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