Is Patent Suspension the Solution to the Vaccine Shortage?

In the midst of the second wave of COVID-19 hitting the world and so countries find it difficult to get vaccinated to vaccinate their populationsEarlier this month, the Joe Biden administration announced its support for lifting patent protection for vaccines, a move to increase supplies so people around the world can receive vaccines.

Every second, a person receives the coronavirus vaccine in rich countries. Meanwhile, most poor countries have not applied a single dose, according to the United Nations.

The World Health Organization (WHO) is one of the biggest supporters of the temporary suspension of vaccine patents produced by Pfizer, Moderna, Johnson & Johnson and AstraZeneca. The initial proposal comes from two emerging powers with thriving pharmaceutical industries: India and South Africa, which in October requested the suspension of patents on medical equipment, treatments and vaccines in order to eliminate the obstacles to production in the poorest regions of the planet.

In this context, most countries where vaccine research and development has taken place are opposed, including the European Union (EU). Instead, the bloc proposed that drug companies sell their developments at cost, along with other measures to make it easier to export doses.

On the same side, manufacturing companies and pharmaceutical companies also reject the granting of patents.

The final decision has not yet been scheduled. Yes proponents of the proposal and its detractors recognize that this measure will not result in additional vaccines anytime soon, and it probably won’t help end the pandemic any faster than if countries bought the injections from producing companies.

In addition, many believe the situation could get worse.

“Removing the patent barrier is only the first step”. Rachel Cohen is the North American director of DNDi, an organization co-founded by WHO, Doctors Without Borders and several research institutes to bring drugs for neglected diseases to developing countries and said that “the next step is to get the companies to give up their knowledge and trade secrets to produce the vaccines; and finally obtain funding to establish factories where they can be produced without patents. It will all take months, but it can be done. It is a political decision ”.

Of all vaccines already applied, only 0.2% reached poor countries, the WHO reported in April. This is largely due to the fact that messenger RNA vaccines are formulations which, due to their storage (they require refrigeration at temperatures of 70 degrees below zero), make their distribution in many rural areas impossible. Africa, Asia and America.

As the president of the company Pfizer, Albert Bourla, explains in an open letter in which he expressed his refusal to lift the patents, “the problem is not the lack of infrastructure, but of raw materials: there is no there are no vials, sterile bags, reagents or enzymes necessary for the preparation of the vaccine ”.

Pfizer’s product requires 280 ingredients and materials from 19 different countries. And according to him, “if developing countries start producing their own injections, they will enter the market and buy these raw materials.” “Entities with little or no vaccine manufacturing experience will demand these raw materials that we need, thus endangering the safety and health of all,” Bourla explained in his letter.

Zoltán Kis is a bio-engineer at the Future Vaccine Production Center at Imperial College London, a project to develop a point of manufacture for vaccines against new emerging viruses. Specifically, Kis studied the technology needed to produce RNA vaccines. “The facilities and processes required are not much more complex than other vaccines produced in cell culture,” he said. The real limits are the lack of experts, raw materials and single-use equipment“.

The expert gave a skeptical opinion on the possibility of suspending patents. “If the cost of vaccines were $ 10, for example, vaccinating the entire population of the planet would cost around 0.07% of the world’s gross domestic product. Remember that Most countries have lost 10% of their GDP due to the pandemic, so the price of vaccination is minimal in comparison – he said -. Developing vaccines from issued patents would cost more or less the same, the most plausible solution is therefore to negotiate with the patent holders so that they manufacture more and sell at a fair price ”.

Alain Alsalhani, pharmacist at Médecins sans frontières, analyzed: “There is a general assumption that the production of these vaccines is too complex, but in fact some of the companies that manufacture them have already transferred technology in specific cases. .

The vast majority of the knowledge underlying COVID-19 vaccines has been undertaken in public research centers and has been publicly funded. The formula for creating stable messenger RNA molecules was developed by Katalin Karikó and Drew Weissman of the University of Pennsylvania. Meanwhile, the coronavirus protein that most vaccines are based on was developed in a public lab at the National Institutes of Health in the United States.

The nanoparticles used by Pfizer and Moderna, for example, also come from publicly funded laboratories, including that of Norbert Pardi of the University of Pennsylvania. Pharmaceutical companies have perfected the production technique and put their infrastructure, essential to manufacture billions of doses. Most importantly, experts say, a patent suspension can affect not only COVID vaccines, but many other treatments: from cancer vaccines to immunizations against 30 other diseases.

“There is a lot of discussion, but we have very little information,” said Benjamín Martínez, biotechnology patent expert and professor of economics at the Autonomous University of Madrid. “The original petition from India and South Africa is five lines, two paragraphs long. It is not known which countries the suspension would affect, for how long, which patents it would include he evaluated. From a theoretical point of view, this may not be possible because there is no abuse of monopoly and in some cases it is sold almost at cost ”.

Mario Gaviria is a chemist at the University of Michigan and has just published a first study that attempts to clarify the number of patents behind RNA vaccines and who their owners are. His team has detected at least 89 of them, although there are likely many more. His work shows a graphic with a tangle of patents shared between big companies such as BioNtech, Moderna, Acuitas – which produces the fat nanoparticles – even Tesla, Elon Musk’s company, which shares one with Curevac to create factories. RNA mobiles. The main players in this network are companies from developed countries. In some cases they share patents out of court and in others they are mired in litigation to prevent their use.

At this point, one of the arguments of the pharmaceutical industry is that suspending patents would harm innovation. “Much of the technology for COVID vaccines has been developed by small biotech companies. Without patent protection, they probably would not have succeeded, ”said David Curiel, a researcher at the Washington University School of Medicine, who is working on a vaccine similar to AstraZeneca’s but which would not require testing. refrigeration, which is ideal for developing countries.

As this complex debate settles, WHO has decided to pursue an alternative path for developing countries to manufacture their own RNA vaccines without relying on Big Pharma’s patents or knowledge. They are based on the cooperation of scientists from public and private institutions who know how these products are made. The idea is to create knowledge exchange and training centers in the less favored countries, ideally those which already have a drug production infrastructure.

“We have already been contacted by ten research groups and experts from small biotech companies in the United States, Europe and Canada eager to advise and lead the project,” said Martin Friede, head of research on vaccines at WHO. At the same time, India – where a company has already developed a messenger RNA vaccine and is about to start clinical trials – South Africa and Senegal have also expressed interest in hosting future factories.

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