The Path to Vaccine Equity
Across the developing world, hundreds of millions of people are unable to get a vaccine to protect themselves from the ravages of Covid-19, and millions of them have become infected and died.
Depending on wealthy nations to donate billions of doses is not working, public health experts say. The solution, many now believe, is for the countries to do something that the big American mRNA vaccine makers say is not feasible: Manufacture the gold-standard mRNA shots themselves.
The chief executives of Moderna and Pfizer have declined to license their mRNA technology in developing countries. They say that the process is too complex, that it would be too time- and labor-intensive to establish facilities that could do it, and that they cannot spare the staff.
“You cannot go hire people who know how to make mRNA: Those people don’t exist,” the chief executive of Moderna, Stéphane Bancel, has said.
But public health experts argue that expanding production to the regions most in need is not only possible, it is essential for safeguarding the world against dangerous variants of the virus and ending the pandemic.
Setting up mRNA manufacturing operations in other countries should start immediately, said Tom
Gennova in Pune, India, is one company in the developing world that would be capable of making Covid shots using mRNA technology.
Frieden, the former director of the Centers for Disease Control and Prevention in the United States, adding: “They are our insurance policy against variants and production failure” and “absolutely can be produced in a variety of settings.”
The vaccine needs of poorer countries were supposed to be met through Covax, a multinational body meant to facilitate global vaccine distribution — but donations have been limited. Wealthier countries have locked up supply. Just 4 percent of people in low-income countries are fully vaccinated.
Experts in the development and production of vaccines say the
mRNA vaccines involve fewer steps, fewer ingredients and less physical capacity than traditional vaccines. Firms in Africa, South America and Asia have much of what they would need to make them, they say; the technology specific to the mRNA production process can be delivered as a ready-to-use modular kit.
Most estimates put the cost of setting up production at $100 million to $200 million. Some large pharmaceutical producers in developing countries would need loans or investors. The U.S. International Development Finance Corporation and the International Finance Corporation both have billions of dollars in funding available for this kind of project.
The New York Times interviewed dozens of executives and scientists at vaccine, drug and biotechnology companies across the developing
world and found 10 candidates to produce mRNA Covid vaccines. The key criteria include existing facilities, human capital, the regulatory system for medicines and the political and economic climate.
The candidates include companies that are already making other Covid vaccines, such as the Serum Institute of India, the world’s largest vaccine maker; public institutions that are testing their own mRNA vaccines for the coronavirus; and firms tapped by the World Health Organization to be regional centers for mRNA development.
Two companies in Asia are making their own mRNA vaccines against Covid.
Gennova Biopharmaceuticals in Pune, India, has one in Phase 2 and 3 clinical trials.
The company is negotiating with contract manufacturers to make its vaccine while also working to expand its existing production capacity to one billion doses from 100 million a year, and it could be in production with its Covid shot within months, said Sanjay Singh, the head of Gennova.
BioNet-Asia, a Thai drug maker, is producing test batches of a Covid mRNA vaccine developed at Chula Vaccine Research Center in Bangkok that is in Phase 2 trials. If results continue to be positive, the vaccine could go to Thailand’s drug regulator by March, and BioNet would be ready for commercial production on approval, said Kiat Ruxrungtham, who heads the research team making the ChulaCov19 vaccine.
“Having this capability and capacity of this technology platform within the country — the goal is when you have a new variant spreading or you have the next pandemic, you can start things very quickly,” Dr. Ruxrungtham said.
Other drug companies would like to license one of the existing mRNA vaccines and start making it as quickly as possible. Stephen Saad, chief executive of Aspen Pharmacare in Durban, South Africa, said that with an investment he estimated at $100 million, his firm could be producing a billion doses of mRNA vaccine within a year — more than enough to supply all of Africa, across which Aspen already has a distribution network.
Bio-Manguinhos, the immunobiology arm of a venerated Brazilian public health research organization, will soon start clinical trials of an RNA-based Covid vaccine, said Sotiris Missailidis, deputy director of technology development for the center.
This year, Bio-Manguinhos nearly doubled its production capacity — to 215 million doses — of other vaccines.
The W.H.O. is backing an effort to reverse-engineer Moderna’s vaccine at a technology transfer hub in South Africa, said Martin Friede, who runs the Initiative for Vaccine Research at the W.H.O. The biotechnology company Afrigen Biologics will make the mRNA, and the Biovac Institute will manufacture the vaccines.
“Richer countries are going to have to put their hands in their pockets and contribute to the construction and maintenance of these facilities,” Dr. Friede said. “Because in a pandemic, you’re not safe until your neighbor is safe.”