Syringe being filled from a vial. Vaccine concept illustration.

What Does the Good News on the Vaccine Front Mean?

By Dorit Rubinstein Reiss

In the past weeks, three companies in advanced stages of COVID-19 vaccine trials reported good news. Moderna and Pfizer reported, respectively, 94.5% and 95% effectiveness of their mRNA vaccines in preventing symptomatic disease and similarly high effectiveness in preventing severe disease.

This was shortly followed by news that the AstraZeneca vaccine had over 70% effectiveness, and 90% with a different dosage regime.

The companies have also reported a favorable safety profile, with no serious harms attributed to the vaccine, though the vaccines do cause a high rate of temporary and unpleasant side effects, including local reactions and temporary flu-like symptoms.

Pfizer has already applied for an Emergency Use Authorization (EUA) from the FDA, and I would expect Moderna and AstraZeneca to follow suit.

What does this mean? First, a note of caution. These are reports from the companies; the FDA has not yet finished examining the data. Examination may raise questions. The data submitted has to pass dual review.

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Vaccine.

How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process?

Cross-posted from Written Description, where it originally appeared on October 2, 2020. 

By Rachel SachsJacob S. SherkowLisa Larrimore Ouellette, and Nicholson Price

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

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Vaccine.

Past Anti-Vax Campaign Provides Insights for Current COVID-19 Debates

By Dorit Rubinstein Reiss

A new book on a prominent misinformation campaign targeting the measles, mumps, and rubella (MMR) vaccine has profound insights into current vaccine debates, such as those emerging around a potential COVID-19 immunization.

The Doctor Who Fooled the World: Science, Deception, and the War on Vaccines,” by Brian Deer, exposes the elaborate fraud perpetrated by Andrew Wakefield, the former British gastroenterologist who, in the late 1990s, created a scare about MMR vaccine by suggesting it caused autism.

Brian Deer is the journalist who, through several years of dogged investigation, exposed Wakefield’s hidden conflicts of interests and misrepresentations, showing that the small study used to create the scare was not just deeply flawed – as was apparent on its face – but an elaborate fraud.

Unfortunately, Wakefield and his misrepresentations are still with us, and are still putting children at risk all around the world. This makes Deer’s book – which teaches us how Wakefield tricked the world, and the lasting impact of his fraud – timely and important.

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Vaccine.

Compulsory Licensing for Pharmaceuticals in the EU: A Reality Check

By Caranina (Nina) Colpaert

As pharma races to develop a COVID-19 vaccine, researchers and governments are working in parallel to pinpoint strategies to secure its widespread access.

To that end, many countries plan to seek refuge in a long-existing strategy: compulsory licensing.

In the European Union (EU), however, compulsory licensing is not as self-evident as it might seem. This blog post focuses on four specific challenges that come with compulsory licensing in the EU and potential alternative solutions.

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Researcher works at a lab bench

Deconstructing Moderna’s COVID-19 Patent Pledge

By Jorge L. Contreras, JD

On October 8, Cambridge-based biotech company Moderna, Inc., a leading contender in the race to develop a COVID-19 vaccine, publicly pledged not to enforce its COVID-19 related patents against “those making vaccines intended to combat the pandemic.”

It also expressed willingness to license its intellectual property for COVID-19 vaccines to others after the pandemic. In making this pledge, Moderna refers to its “special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible.”

Moderna holds seven issued U.S. patents covering aspects of an mRNA-based candidate vaccine directed to COVID-19 which entered Phase III clinical trials in July. The potential market for a COVID-19 vaccine is potentially enormous. As of this writing, the U.S. government has committed approximately $1.5 billion to acquire 100 million doses of Moderna’s vaccine if it proves to be safe and effective (with an option for 100 million more), and the Canadian government has agreed to purchase 20 million doses for an undisclosed amount.

In the high-stakes market for COVID-19 vaccines, it is worth considering the full range of factors that might motivate a private firm to relinquish valuable intellectual property rights for the public good. A better understanding of these factors could help policymakers to secure additional pledges from firms that have not yet volunteered their intellectual property in the fight against the pandemic.

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Vaccine.

The Ethics of COVID-19 Vaccine Trials in Developing Countries

By Sunnie Ning

As more COVID-19 vaccine candidates enter clinical trials, many developing countries are being tapped to participate.

But the history of clinical trials in developing countries is fraught with ethics violations and discrimination. In June, several protests broke out in South Africa over the University of Oxford’s COVID-19 vaccine trial. Demonstrators held signs that said: “We are not guinea pigs.”

In this post, I explore some of the ethics issues of clinical trials conducted by groups in developed countries but carried out in developing countries.

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Syringe and vials of vaccine.

Why a COVID-19 Vaccine Shouldn’t be Mandatory

By Dorit Rubinstein Reiss and Y. Tony Yang

A future COVID-19 vaccine will not work without sufficient uptake, and some are considering mandates to get that uptake. Some scholars have gone so far as to call for compulsory vaccination for all U.S. residents in a recent USA Today column.

We believe premature mandates won’t work. In fact, they could backfire spectacularly.

There are several reasons for this. First, once we have an approved vaccine, we will not have enough doses to go around for those who want them. Forget mandates: even if all goes remarkably well, we will begin by producing and distributing tens of millions of doses—not the hundreds of millions needed to cover the entire United States.

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Syringe and vials of vaccine.

How Does Moderna’s COVID-19 Vaccine Work, and Who Is Funding Its Development?

Cross-posted from Written Description, where it originally appeared on August 19, 2020. 

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

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a pile of vaccine vials and a needle

COVID-19 Vaccine Advance Purchases Explained

Cross-posted from Written Description, where it originally appeared on August 5, 2020. 

By Nicholson PriceRachel SachsJacob S. Sherkow, and Lisa Larrimore Ouellette

No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play.
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Vials of medications with syringe and needle.

Is “Implied Consent” Ethically Permissible in WHO’s Malaria Vaccine Pilot Introduction?

By Beatrice Brown

A recent BMJ article has exposed ethical concerns with the informed consent process in the World Health Organization’s (WHO) large, randomized cluster trial of the world’s first licensed malaria vaccine, RTS,S, known as Mosquirix. The study is being conducted in Malawi, Ghana, and Kenya, and 720,000 children will receive the vaccine. The vaccine is currently limited to pilot implementation because of residual safety concerns from previous clinical trials, including: a tenfold rate of meningitis in those who received the vaccine versus those who did not, “increased cerebral malaria cases, and a doubling in the risk of death in girls.” Rather than engaging in the traditional informed consent process, the WHO is utilizing an implied consent process, leading several bioethicists, including Charles Weijer, Christine Stabell Benn, and Jonathan Kimmelman, to voice concern.

The WHO has defended their use of implied consent to BMJ on the grounds that “the study is a ‘pilot introduction’ and not a ‘research activity.'” A WHO spokesperson explained that in an implied consent process, “parents are informed of imminent vaccination through social mobilisation and communication, sometimes including letters directly addressed to parents. Subsequently, the physical presence of the child or adolescent, with or without an accompanying parent at the vaccination session, is considered to imply consent.” However, as Weijer rightly points out, this is not truly consent, as “We have no assurance that parents, in fact, received information about the study let alone that they understood it.” After the publication of the original article criticizing the WHO for going against international ethical standards for research involving human participants, the WHO released a response in BMJ and on their own website, contending that this implied consent process is “used for all vaccines provided through the Expanded Programme on Immunization” and that the study is in accordance with international ethical standards. Here, I further explore whether this implied consent process is ethically permissible in this specific trial by exploring the guidelines set out by two organizations.

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