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Op-Ed | February 9, 2022

Making the Next Coronavirus Vaccine Truly Public

CoronavirusIntellectual PropertyPharma
Making the Next Coronavirus Vaccine Truly Public

The vaccine developed at the Walter Reed Army Institute should not be privatized for maximum profit.

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It has been over two full years since the start of the COVID-19 pandemic and there currently seems to be no end in sight.

Numerous pharmaceutical treatments have been developed to prevent the virus or limit its damage, including vaccines, monoclonal antibodies, and pills. But almost all of these treatments have been patented, copyrighted, and further restricted from mass production via intellectual-property tools. The consequence of this is a world where only 53 percent of people have been vaccinated, and only 12 percent have received a booster dose.

As the world has learned the hard way, scarcity of COVID-19 treatments only leads to more variants and more death. So long as anyone on Earth is unprotected against the virus, it can mutate in ways that potentially evade existing protections, and trigger potentially more widespread mortality. With the development of a fully public vaccine on the way, the mistaken path of empowering a private partner with patent protection must not be taken.

Countries and activists have pushed for waivers on intellectual-property protections, but these pleas have so far fallen on deaf ears, with richer countries such as Germany and the United Kingdom blocking decisive action at the World Trade Organization.

Rich countries have been obstructing in concert with pharmaceutical companies. Manufacturers Pfizer and Moderna continue to refuse to share the complete recipes for their highly effective mRNA vaccines. This decision is ridiculous for a couple of reasons. First, it prioritizes current and future profits over public health. Refusal to share guarantees these firms full access to a large and likely growing global market, especially as new variants necessitate the administration of booster shots. The mRNA technology also holds promise beyond the current crisis, with potential to treat cancers and other infectious diseases.

Second, Big Pharma resistance ignores the role public money played in fostering the development of these vaccines through direct and indirect research funding, and advance purchase commitments. In Moderna’s case, the U.S. government’s $1 billion contribution covered 100 percent of the company’s vaccine research costs. Similarly, Pfizer received a $455 million grant from the German government for vaccine development, as well as $6 billion in purchase commitments from the United States and the European Union.

Moderna’s disdain for the public goes beyond its refusal to share its vaccine recipe. Despite the fact that its vaccine technology was developed in conjunction with three scientists from the National Institutes of Health, the company attempted to file for a patent that failed to recognize their contributions. It eventually paused that confrontation as press attention narrowed in.

Now, the Walter Reed Army Institute of Research has developed its own vaccine, the spike ferritin nanoparticle COVID-19 vaccine (SpFN), which uses harmless portions of the virus to stimulate the body’s protection. Moderna’s behavior must represent a clear lesson as the Army looks for industry partners to trial its pan-coronavirus vaccine, which it hopes will be effective against COVID-19 and its variants, as well as previous SARS viruses.

Distinct from current vaccines in circulation, the SpFN vaccine uses a soccer ball–shaped protein with 24 faces onto which scientists can attach the spikes of multiple coronavirus strains. It also comes with less restrictive storage and handling requirements than the mRNA vaccines. The SpFN vaccine can be kept in a refrigerator for up to six months, and at room temperature for up to one month.

The Army’s Phase 1 human trials wrapped up in December 2021 and yielded positive results. Those results are now undergoing final review as the Army seeks an industry partner for Phase 2 and 3 trials. These would test how the SpFN vaccine interacts with people who were previously vaccinated or sick, among other things.

So far, development of the SpFN vaccine has been a public triumph. But this next phase is where the pharmaceutical industry can get in on a vaccine developed by and for the public. The U.S. Army Medical Research and Development Command’s Office of Research and Technology Applications (ORTA) will oversee the process of seeking industry partners. Also known as the Technology Transfer Office, ORTA coordinates intellectual-property licensing on behalf of the U.S. Army Medical Research and Development Command (USAMRDC). In this capacity, the office manages nondisclosure agreements, cooperative research and development agreements, license agreements, contracts, and grants with outside parties.

There are a few options available to the USAMRDC’s Technology Transfer Office to ensure a successful vaccine is not restricted by IP protections to become another corporate plaything. If the office chooses to employ license agreements when seeking commercial partners, it must first assess companies’ commitment to freely sharing the vaccine technology. This assessment must be backed up by contractual agreements with the interested partners.

Moreover, the concept of sharing should not be limited to patents, but would need to include industrial production secrets as well. Different types of IP restrictions are typically applied to different aspects of medical product production. So while most of the public supports waiving vaccine “patents,” a bad industry partner could turn around and simply open the patents while maintaining copyrights, trade secrets, and more. The end result would be the same: No one but the company would be able to produce the vaccine, for entirely arbitrary reasons.

With a contractual assurance that every aspect of vaccine production would be open-source, the Technology Transfer Office could then sign nonexclusive license agreements that would grant licensees the right to use the intellectual property, while retaining the government’s ability to license the IP to other institutions.

Another option would be to work with the Department of Health and Human Services and the White House’s coronavirus response coordinator to identify suitable partners to scale up production. In this scenario, the Technology Transfer Office would assess laboratories and companies’ capacity to deliver a vaccine and then provide the requisite funding for the process. This is not dissimilar to the strategy utilized to support Moderna’s vaccine development. However, this time around, government lawyers must ensure that advance funding and purchase commitments are tied to a contractual obligation to share the details of the production process. The office can even create a site to document the process allowing all potential producers to access knowledge that will facilitate increased global production.

As economist Dean Baker has repeatedly argued, an open-source system would not only ensure greater supply, but also lower prices. Freely available technology would allow laboratories across the globe to attempt their hand at the vaccine production process, likely improving their overall technical capacity. Moreover, cheaper prices would allow poorer countries to purchase more significant quantities of vaccines, eliminating the current unreliable system of dependence.

To manage this pandemic and any future ones, we need to choose international collaboration over corporate interests. It’s evident that companies are likely to prioritize their profits in their decision-making. Indeed, under the dominant “shareholder maximization” doctrine governing modern corporations, it is dangerous for the public to remain wholly at the mercy of corporations. To protect the broader public, governments must adopt an open system that will support smooth transfer of vital technologies globally. This would mean choosing public funding, open-source research, and transparent nonexclusive licensing contracts over restrictive government-granted monopolies.

Image: “Vaccine production” by Sanofi Pasteur is licensed under CC BY-NC-ND 2.0

CoronavirusIntellectual PropertyPharma

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