USA against vaccination licenses: Why the patent dispute is so bitter

USA against vaccination licenses: Why the patent dispute is so bitter

The USA as Robin Hood in the global vaccination campaign? Why so many countries and NGOs want to suspend vaccine patents – and what speaks against it.

The aid organization Doctors Without Borders calls the announcement by the USA a “milestone”: Joe Biden’s government supports the temporary suspension of patents for the corona vaccines. The force with which this news from yesterday evening caused movement became clear the morning after: EU Commission President Ursula von der Leyen promptly announced that the European Union was “ready to discuss any proposal that addresses this crisis effectively and pragmatically”.

Willingness to discuss should be a milestone? In fact, a defensive wall is falling here that has been blocking a heated debate in the World Trade Organization (WTO) in Geneva since October 2020. Heated because science agrees on the following: Extensive immunization of the world population is the only sustainable way out of the corona pandemic – for everyone.

What is the problem?
There is nowhere near enough vaccine available for the nearly eight billion people. And that – as it stands now – will not change anytime soon. At the same time, the world is under massive time pressure. It is currently India and Brazil in particular, whose health systems are collapsing and reporting staggering numbers of deaths. But all over the world it is evident that the availability of the few vaccines that have already been approved is a matter of life and death.

While in some places people suffocate in hospital parking lots, states like the USA, Israel and some European countries see the situation easing as the vaccination campaign continues. Against this background, the member states of the WTO are arguing about suspending the patents on corona vaccines, their components and medical devices. To use more capacity. But what is the current capacity?

What will manufacturers achieve in 2021?
By taking over a former Novartis plant in Marburg, Biontech and Pfizer are able to significantly increase their production for Europe. At the beginning of the year, they corrected their planned global delivery volume for 2021 significantly upwards: from 1.3 to initially 2 and then a maximum of 2.5 billion cans. Since complete protection can only be achieved with two vaccinations, Biontech can help 1.25 billion people to become immunized this year.

The US company Moderna has its vaccine produced outside the US by the Swiss pharmaceutical company Lonza. The manufacturer announced last week that it would build three additional production lines. The delivery quantity is to be increased from 700 to now 800 to a maximum of 1000 million cans in 2021. If two doses are required per immunization, Moderna could provide full vaccination protection for a maximum of 500 million people in the current year.

The Chinese company Sinovac announced a few weeks ago that its active ingredient CoronaVac would be on the market with up to two billion doses in 2021. However, the vaccine recently disappointed in efficacy studies. With 50.7 percent effectiveness, it was only slightly above the mark prescribed by the World Health Organization (WHO) for vaccines. That’s 50 percent. Preparations such as the Biontech vaccine and that from Moderna are more than 90 percent effective.

Astrazeneca has had supply problems since India imposed an export ban on the quantities produced there in order to inoculate them against its own suffering population. With Johnson & Johnson, which only needs to be vaccinated once, and the Russian active ingredient Sputnik V, other vaccines are available, but it is already clear: The approximately 2 x 8 = 16 billion vaccine doses that would be needed to protect every citizen of the world from Covid- 19, the big players will not even be able to produce. And Pfizer boss Albert Bourla is currently assuming that a third Biontech vaccination will be necessary as a booster, as well as annual injections afterwards.

What will producers earn in 2021?
The sales of the major developers and manufacturers will be in the double-digit billion range in 2021. On Tuesday, Pfizer announced that in the first three months of the year alone, the company made $ 3.5 billion from its vaccine, which it developed with Biontech. The company had previously predicted $ 26 billion in annual sales for the vaccine.

Moderna announced in February that the existing sales contracts for the vaccine would generate sales of $ 19.2 billion in 2021. In contrast, the pharmaceutical company’s investment costs for its vaccine are zero. Because the public funding covered 100 percent of the costs for research, as the BBC shows in an overview.

The Mainz researchers from Biontech were given less lavish consideration: around one sixth of the development costs could be financed through funding. But when it comes to partner Pfizer’s sales forecasts, it becomes clear that research on the truly groundbreaking mRNA vaccine has already more than paid off financially.

What are the arguments for or against the patents?
Pharmaceutical associations oppose the option of temporarily suspending the patents on the corona active ingredients, arguing that they are investing millions in research at their own risk. Most of the projects, however, according to statements from the associations. But once a successful remedy emerges, the company must also be able to generate returns in order to recoup the investments and to reward shareholders.

With zero investment costs and 19.2 billion in sales in the case of Moderna, the concerns of the pharmaceutical industry are apparently no longer shared by the US government. After all, the companies will have the revenue from the existing contracts, regardless of the question of whether others will be able to produce their vaccine in the future.

And there is another important fact that the pharmaceutical representatives mostly ignore: their companies are only at the end of a long chain of development steps leading to a drug or a vaccine. The basic research that ultimately makes the product possible is publicly funded at universities.

In the case of the mRNA vaccines, it was French researchers, among others, who succeeded in injecting the mRNA into experimental mice as a messenger of genetic information and using it to reproduce virus proteins in their bodies. The mice’s immune systems developed antibodies. But in those years it was not yet possible to convert this knowledge into a vaccine product.

This decisive step did not take place until 25 years later, but again based on many interim results from other researchers over the past two decades. Companies like Biontech, Moderna and Curevac, all three of which only started in the 2000s, were able to build their research on broad foundations for which they pay little or no license fee.

The US developer Moderna worked closely with the US health institute NIH for its active ingredient and declared as early as 2020 that it did not want to assert its claim to license fees. The fact that Moderna vaccine is not being produced on a global scale is due to the fact that producers need far more than the legal possibility of producing a vaccine. First and foremost: tech transfer.

Why are not only patents important?
The Biontech vaccine has 280 components from 86 suppliers in 19 countries, said a Pfizer spokeswoman in the “New York Times”. In order to process it, complex special systems and trained personnel are necessary. However, Lonza, Moderna’s Swiss partner, took over the demanding production without having previously manufactured vaccines. Switching the production to the mRNA vaccine was then possible in a relatively short time. Now, however, according to MSF, Lonza does not pass on its knowledge to third parties.

The renovation of the Biontech plant in Marburg also took place in record time – production could begin there after less than five months. “In Africa, a study has located seven companies whose equipment would make it possible to set up production lines for the manufacture of the corona vaccine,” says Lara Dovifat, patent expert from Doctors Without Borders. And the World Health Organization sees resources and know-how all over the world to put vaccine production on a broader footing. For the necessary technology transfer, she has set up a platform that is supposed to bring companies together.

Unlike in the case of Moderna, Pfizer is relying on its patent protection and so far the WTO regulations have proven the pharmaceutical giant right. If a state were to grant a compulsory license on its own, it would have to be prepared to be sued by the company concerned on the basis of the WTO guidelines.

In order to override these international copyright regulations for the vaccines, it would need the approval of more than 160 countries. However, the US has a powerful voice in this. Apparently, they have decided to use these now for the benefit of the countries that face the virus with almost no resistance. According to the WHO, 700 million doses of vaccines against corona had been delivered worldwide by mid-April. The share that poor countries received: 0.2 percent.

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Author: Killian Jones
Graduated From Princeton University.He has been at the USTV since 2017.
Function: Chief-Editor

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