How can a government stop shortages

US government wants to relax patents : What good is Biden's plan for the release of the vaccine licenses?

The surprise of US President Joe Biden is great - and so is the joy, at least for the World Health Organization (WHO). WHO chief Tedros Ghebreyesus praised the fact that Biden wants to temporarily suspend the license rights for corona vaccines.

Biden announced on Wednesday through his trade representative Katherine Tai that his country supports the initiative of more than 100 developing and emerging countries after a patent suspension. With this change of course, the aim is to bring "as many safe and effective vaccinations as possible to as many people as possible as quickly as possible," said Tai.

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Without the hurdle of patents, poorer countries could also start production - and thus end the global shortage of vaccines. But there are doubts as to whether the plan will work.

For the pharmaceutical companies Biontech, Curevac and Moderna, the Americans' change in course is not good news. Shortly after the U.S. government announced, its stock prices plummeted. Biontech founder Ugur Sahin had already spoken out against releasing the licenses last week. "That's not a solution," he said.

Pharmaceutical companies worry about their sales

Biontech promises to increase its production to three billion cans by 2022. "We are determined to deliver our vaccine to people around the world in all countries and across all income groups," the company said on request. "Patents are not the limiting factor in the production or supply of our vaccine, however. They would not increase the global production and supply of vaccine doses in the short or medium term. "

The pharmaceutical companies are not only concerned about their own sales. Pharmaceutical associations also warn of negative consequences for the quality of vaccines and supply chains. Gabriel Felbermayr, President of the Kiel Institute for the World Economy, fears that future investments will not be made: "Now there is a risk that industry will cut its research spending."

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The reactions in Berlin and Brussels are mixed. The federal government refuses to suspend the licenses. "The protection of intellectual property is a source of innovation and must remain so in the future," says a government spokeswoman. Health Minister Jens Spahn (CDU) appealed to the USA to reconsider its export ban on vaccines. EU Commission chief Ursula von der Leyen (CDU) was ready to discuss Biden's proposal.

USA put Europe under pressure

The US President's move is putting the EU under pressure to move forward with the release of vaccination licenses. "After the signal from the USA, Ursula von der Leyen cannot afford to continue blocking," says the SPD MEP Udo Bullmann. But implementing the license release is difficult. This would require a unanimous vote from the so-called TRIPS Committee, which is responsible for the protection of intellectual property in the World Trade Organization.

Alternatively, a two-thirds majority in general advice from the WTO would suffice. He could decide that the patents of the companies are not legally protected for 20 years as before.

That is exactly what development organizations want. Karoline Lerche, interim director of One Deutschland, also said: "That alone will not solve the problem with capacities in the short term." And even if Biden's idea were to find a majority in the WTO, the pharmaceutical companies can hardly be forced to reveal their special know-how about vaccines.

Why is it so important to vaccinate everyone?

Around 600 million people have so far been vaccinated against Covid-19 at least once. That sounds like a lot, but given the earth's seven billion inhabitants, there are still enough opportunities for the coronavirus to spread. So far it has remained with appeals to distribute the vaccines more fairly.

While the proportion of the vaccinated population is rising steadily in the rich industrialized countries, poorer countries have not even started their vaccination campaigns because of a lack of vaccination doses. While almost every fourth person in Germany is now vaccinated at least once, in Uganda, for example, only one in 3000 people is protected from Covid-19.

"Countries that are now vaccinating younger, healthy people whose risk of disease is low are doing so at the cost of the lives of doctors, the elderly and risk groups in other countries," said WHO chief Tedros recently.

The consequences are already evident: Covid-19 outbreaks around the world are spiraling out of control, says Charlie Weller, head of vaccine initiatives at the Wellcome Trust. The corona crisis is not only escalating in India, but also in parts of South Asia, Central and South America and the Middle East. "If we let this continue, the virus will have more opportunities to multiply and mutate," warns Weller.

These mutations will lead to new virus mutants, some of which could be those that limit the effectiveness of existing vaccines. That puts the progress of the past 15 months at risk. “We absolutely have to prevent this development,” says Weller. Now is the time for rich countries to show leadership and provide adequate vaccine to poorer countries.

There is still no virus variant against which the previous Covid-19 vaccines would no longer offer protection. But if more people are vaccinated now, the selection pressure on the virus increases. The more opportunities the virus has to multiply and thus also to mutate, the higher the probability that among the millions and millions of mutants there is one against which the vaccines no longer protect - and which then also endangers the vaccinated in Germany.

This is why it is so important to vaccinate as many people as possible in the shortest possible time and thus deprive the virus of the opportunity to multiply, mutate and undermine vaccine protection. Because once there is a vaccine-resistant variant, it will not stop at national borders.

It's not the licenses that are the problem

It is not the patents that are the cause of the unequal distribution of vaccines in the world, but rather political decisions to first and foremost provide the industrialized countries with the vaccines currently available. Even for these countries, for which patents are not a hurdle, there was and still is not enough vaccine available.

In addition, the companies have made it clear for months that they do not want to enforce the patents. Moderna officially announced this in October 2020. This also applies to the Tübingen biotech company Curevac, for whose vaccine candidate efficacy data are expected in May. "We don't see patents as the bottleneck to higher vaccine production," says Sarah Fakih, Curevac spokeswoman.

As with Biontech and Moderna, whose vaccines, along with AstraZenecas and Johnson + Johnsons, have proven to be particularly rapidly scalable, it is an mRNA-based vaccine, a vaccine technology that was in development before 2020 but had never been approved . "It's more the pressure on the supply chain and the complexity of producing the mRNA vaccines," says Fakih.

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There are only a few suppliers worldwide for the special raw materials, manufacturing chemicals and packaging materials that are now being requested in huge quantities by Biontech, Moderna, Curevac and others - manufacturers, some of whom were not even prepared because they were only in have produced comparatively small quantities.

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Just one example: The mRNA, the actual active ingredient in the Covid-19 vaccine from BioNTech, Moderna and CureVac, is packaged in fat droplets that are millionths of a millimeter in size and manufactured by a single company in Canada, Acuitas. Before the pandemic in the milligram range, lipids are now needed by the kilogram. The export restrictions that the USA, for example, have issued for vaccine-relevant chemicals, for example, are at least not helpful in this regard.

The other component is that pharmaceutical companies in India and Brazil have little or no experience with the production of mRNA vaccines, but also with the so-called vector vaccines from AstraZeneca and Johnson & Johnson. An “intensive technology transfer” is therefore necessary in order to create more production capacities, says Fakih.

Above all, there is a lack of money

So that the poor countries do not fall further behind in the fight against the pandemic, they need more vaccine above all. That would require more money and fewer export restrictions. “So that 30 percent of the population in the poorest countries can be vaccinated by the beginning of 2022, almost 20 billion dollars are still missing for vaccines, diagnostics and therapeutics,” says Development Minister Gerd Müller (CSU).

The EU has pledged 2.5 billion euros to the Covax initiative under the umbrella of the WHO to support the 92 poorest countries, while the USA intends to contribute four billion euros. According to the Federal Development Ministry (BMZ), 53 million doses have been administered via Covax so far.

So far, the donations of vaccine doses have not been able to change the shortage. "When it comes to donations, we are only now slowly getting into the area of ​​relevant figures," says MEP Bullmann. The largest donors are China, India and Russia. The People's Republic has so far donated almost 20,000 single doses, India around half. Since the coronavirus has been rampant there and infected more than 21 million people, the country needs its own vaccine itself.

Many African countries had relied on India as a supplier of a cheap vaccine. The West must step in all the more, demands One director Lercher. In Germany, the supply of vaccines is expected to exceed demand at the end of June. “But waiting that long would be fatal,” she says. "We should start now to gradually pass on vaccines to Covax."

In addition, she would like the pharmaceutical companies to sign “license agreements” with companies in poorer countries on their own initiative. Müller also wants to expand global production through such partnerships. "It's possible, but it requires an investment program of at least $ 10 billion," he says. His ministry is holding talks with South Africa, Ghana and Senegal.

The distribution of vaccination doses is also a problem in the global south. There is often a lack of logistical infrastructure in order to maintain the necessary cold chains for the vaccine. Michael Knipper, an expert on global health at the University of Giessen, on the other hand, gives hope.

In the past, there have also been successful vaccination campaigns in poor countries, for example against polio. “You should rely on this experience and let the WHO do its job,” he says. This has also shown the experience with other epidemics: "They can be brought under control if local authorities, WHO and international partners pull together."

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