Strolling through immaculate premises, the Director General of the World Health Organization makes his way through television cameras and scientific equipment. It’s February 11 and Tedros Adhanom Ghebreyesus visits the South African laboratory Afrigen, accompanied by Caryn Fenner, the company’s chief technology officer. The event is celebrated: the African biotech is the first on the continent to have manufactured a messenger RNA vaccine against Covid-19, based on the Moderna vaccine model.
“At laboratory scale, we have a vaccine that we now need to test,” said Afrigen CEO Petro Terblanche. There is still a long way to go before this vaccine can be marketed and find its first patients. Animal testing will begin next month, and human studies won’t begin until around November 2022. “We have completed the process from concept to final formula. It’s a small step but it’s a good start, it’s a fabulous start”, rejoiced the director of the laboratory.
Currently, the two behemoths Moderna and Pfizer/BioNTech dominate a market protected by a series of patents which cover both the technologies and the production processes specific to messenger RNA. This pilot project, supported by the WHO and the Covax initiative, should ultimately make it possible to set up a transfer of technological skills to install messenger RNA vaccine production capacities in several African countries. The list, unveiled on February 18, includes, in addition to South Africa, Egypt, Kenya, Nigeria, Senegal and Tunisia.
A game-changing investment
Whereas the debate on intellectual property and the lifting of patents vaccines is raging at the World Trade Organization, South African scientists and industrialists have embarked on a race for autonomy. In the absence of patent licenses, they relied on public data. The researchers exploited the sequence developed by Stanford University and used by Moderna for its vaccine, then made the DNA, RNA and finally their own product. For this, biotech was not alone, it was able to count on the support of international and local scientists. “A lot of information is in the public domain, including the RNA sequence contained in the vaccine, but we are also in contact with vaccine specialists around the world who have confirmed the data available in the literature. therefore simple to adapt them for our vaccine model”, explains Patrick Arbuthnot, the director of gene therapy research at the University of the Witwatersrand, who worked with his team to produce this material for the Afrigen vaccine.
Their success could be an important first step in a continent where just over 11% of the population is fully immunized. For more than a year, a group of states led by South Africa has been calling for a suspension of patents for vaccines against Covid-19 in order to be able to produce them on their soil, and strengthen their autonomy in health products. “It’s an investment that could possibly be a game-changer in the fight against major diseases,” said Tedros Adhanom Ghebreyesus.
Developing alternative versions of the vaccine
This step also allows South Africa to show that the development of vaccines, even based on messenger RNA, is possible outside the major producing countries. “We see that the melody that the industrialists sing, saying that the production of RNA vaccines is technically too complicated, is not based on anything”, comments Marie-Paule Kieny, virologist and president of the Medicine Patent Pool (MPP). This public health organization dedicated to drug patents and supported by the United Nations, granted a grant of 39 million euros to the project. An envelope that will cover the work of the technology transfer center until 2026.
Despite a successful first step, the sensitive issue of intellectual property should soon arise for the designers of this vaccine. In a text published at the end of 2020, Moderna said it will not enforce its Covid-19-related patents against those who make vaccines intended to fight the pandemic as long as it continues. A promise whose duration also depends on how the end of the pandemic is qualified or not: according to the director of the WHO, the “acute phase” of the epidemic could end when “70% of the population will be vaccinated” .
“We certainly do not want to try to market this vaccine, it must be used as a reference base to develop a more efficient vaccine”, defends Patrick Arbuthnot, who considers the idea of seizing Moderna’s patents “stupid”. to market this product. Achieving a more stabilized RNA, allowing better preservation at lower temperatures, is in particular one of the avenues for improving these injections intended above all for populations in Africa and poor countries. “The objective of this project is to replicate Moderna’s vaccine to demonstrate that we are able to do it and then develop alternative versions, this ‘hub’ does not intend to hack Moderna’s intellectual property “, abounds Marie-Paule Kieny.
Two ways
However, the transition from the laboratory to the production of the first units remains the main challenge. “It’s not easy and we don’t pretend to have finished”, underlines the director of the MPP. This change of scale will require more collaboration. The South African pharmaceutical company Biovac has already been chosen for the production of a first batch of vaccines, and other manufacturing units are expected to open in South America. But some are already pointing to the need for a rapprochement with Moderna, particularly with a view to producing these new doses on a large scale. “It is clear that we will have to reach a negotiation with Moderna to obtain a license for certain patents filed in South Africa”, comments Marie-Paule Kieny. If the American biotech has refrained from commenting on the Afrigen initiative so far, the main players recognize the role it can play in increasing the production capacity of the vaccine.
“There are two ways”, explains Patrick Tippoo, scientific and innovation director of Biovac, “cooperation with Moderna, and the possibility of having licenses on certain patents, or the development of new technologies which would not infringe not intellectual property”. According to the MPP, discussions will continue with the new giant of the anti-Covid vaccine. But as recognized by a diplomatic source familiar with the matter, “it is true that laboratories should accept more skills transfers in Africa”. A crucial objective for this project and for the continent of 1.3 billion inhabitants, on which only 1% of the vaccines used locally are produced.