Hundreds of millions of people across the developing world cannot receive the vaccination to protect themselves from the risks related to COVID-19, and millions of them have already contracted the virus and many more have died. Public health experts say that relying on rich countries to donate billions of doses does not work. In contrast, many now believe that the solution is to manufacture these vaccines themselves, something that the American mRNA vaccine makers say is not possible, but health experts say the opposite.
In her report published by the American newspaper “The New York Times”, writer Stephanie Nolen said that despite the mounting pressure, the CEOs of “Moderna” and “Pfizer” companies refused to grant a license to manufacture the vaccine. with their mRNA technology in developing countries, arguing that it does not make sense to do so. They say the process is too complex, that setting up facilities that can do this require too much time and labour, and that they cannot provide staff because of the urgent need to ramp up production in their facilities network.
But public health experts in both rich and poor countries argue that expanding production in areas of greatest need is not only possible, but necessary to protect the world from dangerous variants of the virus and end the pandemic.
The vaccine needs of poor countries were supposed to be met by Covax, a multinational body aimed at facilitating global vaccine distribution, but donations have been slow and limited and only 4% of the population in low-income countries has been fully vaccinated. .
By most estimates, the cost of setting up the production is from one hundred to two hundred million dollars. A few large pharmaceutical producers in developing countries will have this money, while others will need loans or investors. Both the US International Development Finance Corporation and the International Finance Corporation have billions of dollars in financing available for this type of project, in the form of low-interest loans or equity.
The New York Times interviewed dozens of CEOs and scientists at vaccine, drug, and biotechnology companies across the developing world, and among those conversations, it found 10 strong candidates to produce mRNA vaccines against COVID-19 in 6 countries on 3 continents. Key criteria include: existing facilities, human capital, the pharmaceutical regulatory system and the political and economic climate.
Among the candidates are companies already making other vaccines against Covid, such as India’s Serum Institute of India, the world’s largest vaccine maker, public institutions that are already testing their mRNA vaccines against the Corona virus, and companies selected by the World Health Organization as centers Regional for mRNA development.
Two companies in Asia are already making their own mRNA vaccines against the COVID-19 virus. One is Gennova, a biopharmaceutical company in Pune, India, which has a trial in Phase II and III clinical trials. The company says that unlike the mRNA vaccines currently in use, its vaccine can be stored at the temperature of a standard medical refrigerator.
The other company is BioNet-Asia, a Thai pharmaceutical manufacturer, which produces test kits of the mRNA vaccine against COVID-19 developed at the Chola University Vaccine Research Center in Bangkok which is in phase two trials. If results remain positive, the vaccine may go to the Drug Regulatory Authority in Thailand by next March, and Punt-Asia will be ready for commercial production after that, said Kate Ruksrongham, head of the research team that makes the ChulaCov19 vaccine. approval.
The author indicated that other pharmaceutical companies would like to license one of the existing messenger RNA vaccines, and start making it as soon as possible. With an investment of about $100 million, his company could produce one billion doses of the messenger RNA vaccine within a year, which is more than enough to supply a single dose of mRNA, said Stephen Saad, CEO of Aspen Pharmacare in Durban, South Africa. the whole of Africa.
Bio-Manguinhos, the immunobiology arm of the Brazilian Public Health Research Organization, will soon begin clinical trials of an RNA-based Covid vaccine, according to Sotiris Mesalidis, deputy director of technology development for the research center. This year, BioManginhos has nearly doubled its production capacity of other vaccines, including its contract vaccine, AstraZeneca. Brazil has a medical regulatory body that maintains the same standards as the US Food and Drug Administration and the European Medicines Agency.
The author pointed out that a combination of factors led to the restriction of access to vaccines in developing countries, including the supply chain, shipping bottlenecks and politics. The Serum Institute was supposed to supply the Kovacs system with vaccines, but the government of India banned exports at the height of the second wave of the virus in the country. Aspen in South Africa won a contract to package the Johnson & Johnson vaccine, but had to export many doses to Europe and Canada, sparking public anger from activists.
The COVID mRNA vaccines have made more profit in one year than any previous product in pharmaceutical history, and are on track to generate more than $53 billion in revenue this year alone.
The writer explained that the controversy over the manufacture of messenger RNA vaccines against the Covid virus is similar to an event two decades ago about HIV treatments. Hundreds of thousands of people died of AIDS in Africa long after antiretroviral drugs were widely available in rich countries, because patented medicines were being sold at too high a price for governments in the worst-affected countries to buy them.
Access advocates have organized a global campaign calling on drugmakers to license low-cost producers, or give up their intellectual property rights to allow someone else to fill the gap.
Although major Western drug companies insist there is no way to make drugs cheaper, Indian, Brazilian, Thai and South African drugmakers have said they can do so. Many formulas have been reverse-engineered by Indian companies, and today the bulk of the world’s AIDS drugs are manufactured in these countries.
Now, the World Health Organization faces a similar challenge. Because efforts to win licensing deals or other collaborations from Pfizer and Moderna continue to fail, the organization is supporting an effort to reverse engineer Moderna’s vaccine at the Technology Transfer Center in South Africa, said Martin Freed, who directs the WHO’s Vaccine Research Initiative. The mRNA will be manufactured by the biotech company, African Biologics, and the vaccines will be manufactured by The Biovac Institute.
Instead of being granted a license to manufacture, Moderna announced earlier this month that it would spend as much as $500m to build its own vaccine plant in Africa. BioNTech, the inventor of Pfizer’s mRNA technology, has announced plans to build factories in Africa in the next four years. In contrast, the Western pharmaceutical industry, and some supply chain and health experts, say the fastest way to close the Covid vaccine gap is to focus on a more equitable distribution of vaccines made by incumbent companies.
To spread production capacity throughout the developing world, WHO is also working on a second track that seeks partnerships with institutions such as the Dr. Roxerungham Research Center in Bangkok. These vaccines may be cheaper to produce, and most importantly, they do not require very cold storage, and thus are more suitable for use in low-resource settings, said Dr. Freed.
Some companies and research centers are producing innovations that can benefit their regions beyond the current pandemic. Genova in India has worked with a Seattle startup called HDT Bio to develop a new method for delivering messenger RNA to lipid nanoparticles, one that does not require extreme cold storage.
Genova CEO Dr. Singh said the company has received seed funding from the Government of India and plans to use internal resources and the potential partnership it is negotiating with a large multilateral agency to move forward with its vaccine.
While Genova has the technology, other producers such as Brazilian and Argentine vaccine makers will need infrastructure. As for producers not yet working on mRNA technology, the fastest way to start making Covid vaccines would be a partnership with Pfizer or Moderna, but the technology transfer would involve hundreds of steps, says Prashant Yadav, a supply chain expert at the Center for Global Development.
Yadav estimated that it would take up to 18 months for a ready-to-use mRNA vaccine from a producer in South Africa or Brazil. There must also be a parallel process of strengthening the capacity of national regulatory agencies, which will be critical to maintaining the quality of vaccines.