For Covid Vaccine Access, Developing Countries Have Capacity To Make Their Own

Despite self-serving claims to contrary by Moderna and Pfizer, as many as 10 companies on three continents - including Africa and South America - have the capability to make their own mRNA vaccines and are demanding the licenses to do so. JL 

Stephanie Nolen reports in the New York Times:

Experts in both the development and production of vaccines say the mRNA vaccines involve fewer steps, fewer ingredients and less physical capacity than traditional vaccines. Companies in Africa, South America and parts of Asia already have much of what they need to make them; the technology specific to the mRNA production process can be delivered as a ready-to-use modular kit. 10 candidates to produce mRNA Covid vaccines are in six countries on three continents. The key criteria include existing facilities, human capital, the regulatory system for medicines and the political and economic climate.

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 already 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.

Despite mounting pressure, the chief executives of Moderna and Pfizer have declined to license their mRNA technology in developing countries, arguing it makes no sense to do so. 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 because of the urgent need to maximize production at their own network of facilities.

“You cannot go hire people who know how to make mRNA: Those people don’t exist,” the chief executive of Moderna, Stéphane Bancel, told analysts.

But public health experts in both rich and poor countries 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 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 slow and limited. Wealthier countries have locked up the supply. Just 4 percent of people in low-income countries are fully vaccinated.

Experts in both the development and production of vaccines say the mRNA vaccines involve fewer steps, fewer ingredients and less physical capacity than traditional vaccines. Companies in Africa, South America and parts of Asia already 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. A few large pharmaceutical producers in developing countries have these funds at hand; others 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, as low-interest loans or a share of equity.

The New York Times interviewed dozens of executives and scientists at vaccine, drug and biotechnology companies across the developing world and from those conversations, found 10 strong candidates to produce mRNA Covid vaccines in six countries on three continents. The key criteria include existing facilities, human capital, the regulatory system for medicines and the political and economic climate.

Those companies include the Serum Institute of India, the world’s largest vaccine maker; Gennova Biopharmaceuticals in Pune, India; Biological E in Hyderabad, India; BioNet-Asia, a Thai drug maker; Aspen Pharmacare in Durban, South Africa; Biovac Institute of Cape Town; Bio-Manguinhos, the immunobiology arm of a venerated Brazilian public health research organization; Instituto Butantan, a renowned scientific research institute in São Paulo, Brazil; Singerium Biotech, based in Argentina; and BioFarma, a large state-owned company in Indonesia.