Close up of a Doctor making a vaccination in the shoulder of patient.

The Legality and Feasibility of COVID-19 Vaccine Mandates for Children

By Dorit Rubinstein Reiss

On May 10, 2021 the U.S. Food and Drug Administration (FDA) expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include children aged 12-15.

The vaccine was previously authorized for use in those aged 16 and older. The company has announced it will seek emergency use authorization for younger children by September.

Now that children over the age of 12 can get vaccinated against COVID-19, will immunization against SARS-CoV-2 become a requirement for the return to public schools this fall?

My answer: In the near term, we probably will not see COVID-19 vaccine mandates for school children. And in the longer term, it depends.

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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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Patient receives Covid-19 vaccine.

10 Design Considerations for Vaccine Credentials

By Adrian Gropper

As COVID-19 vaccines become widely, if not fairly, available in different regions, both the public and private sector are working to develop vaccine credentials and associated surveillance systems.

Information technology applied to vaccination can be effective, but it can also be oppressive, discriminatory, and counter-productive.

But these systems can be tuned to reflect and address key concerns.

What follows is a list of ten separable concerns, and responsive design strategies. The concept of separation of concerns in technology design offers a path to better health policy. Because each concern hardly interacts with the others, any of them can be left out of the design in order to prioritize more important outcomes. Together, all of them can maximize scientific benefit while enhancing social trust.

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Syringe being filled from a vial. Vaccine concept illustration.

The COVID-19 Vaccine Patent Waiver: The Wrong Tool for the Right Goal

By Ana Santos Rutschman and Julia Barnes-Weise

As the toll of COVID-19 continues to increase in many countries in the Global South, there has been a renewed push to address the problem of vaccine scarcity through a waiver of patent rights. Calls for waivers have been recurring throughout the pandemic, from formal proposals introduced in 2020 by some of the larger developing economies (India and South Africa), to op-eds in mainstream media, and editorials in scientific publications, such as Nature. This push gained momentum in early May 2021, just before the meeting of the World Trade Organization’s General Council.

Waiver proposals have attracted the support of prominent names in public health. Dr. Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization, endorsed patent waivers as a tool to address the current vaccine scarcity problem in an article titled Waive Covid Vaccine Patents to Put World on “War Footing.” Others — including, most recently, Dr. Anthony Fauci — have been critical of waiver proposals.

In this piece, we explain the mechanics of patent waivers and argue that waivers alone are the wrong policy tool in the context of the COVID-19 pandemic. We agree with supporters of the waivers in their ultimate goal — that of scaling up the manufacturing of COVID-19 vaccines, and then distributing them according to more equitable models than the ones adopted thus far. However, we doubt that the particular types of goods at stake here can be easily replicated and produced in substantially larger quantities simply through a waiver of intellectual property rights.

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Fake Vaccine Cards and the Challenges of Decentralized Health Data

By Carmel Shachar and Chloe Reichel

Soon the U.S. will have vaccinated all adults who are not vaccine hesitant. Our next key challenges will be reopening workplaces, restaurants, schools, and other public areas, as well as encouraging vaccine uptake among those who are hesitant or resistant to the vaccine.

Vaccine passports or certifications could be a tool used to address both of those challenges.

But our approach to health care data management may undermine this next stage of the pandemic response.

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Empty classroom.

The National Anti-Vaccine Movement Heads to Hartford to Intimidate CT Legislators

By Arthur Caplan and Dorit Rubinstein Reiss

As Connecticut’s Senate prepares to vote tomorrow on whether to repeal Connecticut’s religious exemption from school immunization mandates, out-of-state anti-vaccine activists are mobilizing to threaten and intimidate legislators to vote against the bill.

The legislators should hold firm, and pass the bill the Governor says he will sign. They must not let aggressive attackers stop them from acting to make Connecticut’s children safer. Legislators should show the out-of-state anti-vaccine movement that intimidation doesn’t work here.

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EU flag and digital health pass.

Are COVID Certificates the Answer to Safe EU Travel During the Pandemic?

By Iris Goldner Lang

On March 17, the European Commission put forward its Proposal for a Regulation on Digital Green Certificates which would facilitate safe EU cross-border movement for purposes of work and tourism.

Considering the length of the EU decision-making process and the technical work that will need to be done, the digital green certificates will not be ready for use until late June or July this year.

The proposed certificates will include three categories of EU citizens and third-country nationals legally staying/residing in the EU: those who have been vaccinated against COVID-19, those who have recovered from COVID-19, and those who can produce a negative test result. A non-EU national travelling to the EU – such as a U.S. citizen – could request a digital green certificate from an EU Member State he/she is travelling to, by providing all the relevant information to the national authorities, which would then have to assess whether to issue the certificate.

The proposed EU certificates would also allow the Commission to issue a decision recognizing certificates issued by third countries to EU citizens and their family members, where such certificates meet quality standards and are interoperable with the EU system. Additionally, the Commission intends to make certificates compatible with systems in third countries, such as the U.S,, and is open to global initiatives.

EU Member States’ reactions to this initiative have been diverse. While some Member States – particularly those dependent on tourism – such as Cyprus, Greece, Italy, Portugal, Iceland, Denmark, and Spain – support the initiative, others – like Belgium, France, Germany and the Netherlands – express concerns. In the meantime, both Greece and Cyprus have reached agreements with Israel that should enable their citizens who have been vaccinated to travel between these two EU Member States and Israel without the need to quarantine.

This blog post examines what the European Commission sees as the three main advantages of its Proposal for digital green certificates – the first being that digital green certificates facilitate EU cross-border movement, the second that they preclude more restrictive national measures, and the third that they prevent discrimination.

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international connections concept art.

‘We Claimed Victory Before Time’: COVID-19 in Uruguay

By Chloe Reichel

Leer en español.

Uruguay, once hailed as a model for its pandemic response, recently has seen some of the world’s sharpest increases in COVID-19 cases. Earlier this month, the infection rate in the country surpassed 1,300 cases per 100,000 residents over a 14-day period.

What happened?

I asked Dr. Gonzalo Moratorio, virologist at the Institut Pasteur de Montevideo and professor on the Faculty of Science at the Universidad de la República, to explain the shift. Moratorio was instrumental to Uruguay’s early successes in the pandemic, developing and distributing test kits that allowed the country to efficiently identify and isolate cases.

In this Q&A, which has been edited and condensed, he offers a look at the past, present, and future of the COVID-19 pandemic in Uruguay.

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a pill in place of a model globe

Monthly Round-Up of What to Read on Pharma Law and Policy 

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on pharmaceutical policy.

Below are the citations for papers identified from the month of March. The selections feature topics ranging from a commentary on the evidence base for the Alzheimer’s drug aducanumab (which is currently under FDA review), to a comparative study of drug pricing in the U.S. and France, to a study of the demographic characteristics of participants in vaccine trials leading to FDA approval. A full posting of abstracts/summaries of these articles may be found on our website.

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globe.

‘I Think of It in Terms of Years’: The Future of the COVID-19 Pandemic in South Africa

By Chloe Reichel

“No One Is Safe Until Everyone Is Safe” goes the rallying cry for global vaccine equity.

We would think that the COVID-19 pandemic already has made this point clear enough.

And yet, pundits are heralding the “end” of the pandemic in the U.S., all while viral variants that may be capable of evading the protection of vaccines continue to crop up both domestically and internationally.

In this Q&A, South African journalist and human rights activist Mark Heywood offers a look at the national COVID-19 epidemic in South Africa. The sobering reality there, in terms of morbidity and mortality, and in terms of expectations for the future, underscores the urgency for globally coordinated leadership and action to address the pandemic.

Our conversation from late March 2021, which has been edited and condensed, follows.

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