US forges partnership with South Africa's mRNA tech transfer hub

On Friday, the company hosting the World Health Organization’s technology transfer hub in South Africa announced a partnership with the U.S. government for the development of messenger RNA vaccines against diseases like COVID-19, tuberculosis, malaria, and Ebola.

The hub, established last year, aims to expand know-how around the production of mRNA vaccines in low- and middle-income countries. It’s the first of its kind globally.

Afrigen Biologics Ltd. formed the new partnership with the U.S. National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Moderna’s mRNA vaccine for COVID-19 was developed in collaboration with NIH, although the agency was not included as a patent holder.

The coronavirus pandemic marked the first time this technology was approved for use in vaccines, although researchers at NIH had been developing it for decades. The South African hub aims to create a platform for mRNA vaccine production for a variety of diseases beyond just COVID-19.

The partnership will include the sharing of technical skills and materials to hasten vaccine production and help the hub produce “large amounts of DNA, in the mRNA in vitro transcription process, lipid nanoparticle formulation, and upon mutual agreement, research” for new vaccines, according to a press release.

NIAID’s Vaccine Research Center will provide the starting material — the plasmid DNA for mRNA drug substance manufacturing, which will help with clinical trials — as well as technology transfer and training so the hub can establish the process in-house, said Caryn Fenner, the executive director at the mRNA hub, during a webinar Friday.

The hub has sought a commercial manufacturer, such as Moderna, to hasten the development process by sharing technology but has not yet found one. In its absence, the hub crafted its own vaccine, using the mRNA sequence from Moderna’s COVID-19 vaccine.

Ultimately, the hub aims to create its own intellectual property, Fenner said. In June, Afrigen announced a partnership with the Belgium-based Univercells Group, with support from mRNA specialist eTheRNA, to develop a new mRNA vaccine using IP from the companies. The partnership also aims to help the hub develop its own IP.

Preliminary research has shown that the hub’s prototype is performing well. A study in mice that was launched six weeks ago found a “very good immune response” to the COVID-19 virus, said Patrick Arbuthnot, research lab head at the University of the Witwatersrand, Johannesburg. And on Thursday, the results of a neutralization assay, which indicates whether antibodies are capable of stopping a virus from infecting a cell, found that antibodies produced in the mice were “extremely effective.”

But the hub’s vaccine still needs to go through clinical trials in humans — a step that could have been avoided if technology had been shared from a company that had already gone through the approval process. Clinical trials are expected to start early next year, said Glenda Gray, the head of the South African Medical Research Council, during the webinar. Trials will also examine the effectiveness of the vaccine for people living with HIV, she said.

The new partnership is expected to help the hub quickly ready materials for the trials, according to Afrigen Managing Director Petro Terblanche, saying that the project’s timeline can be shortened by about three months — a significant reduction for a fresh effort like this.

Even though the partnership was just announced, collaboration with NIH has been ongoing and has “significantly fast-tracked our vaccine development program,” Fenner said. Currently, 15 “spokes” — companies from LMICs — are in the hub’s network that will be trained in mRNA vaccine development. Five have already started training, and another four will begin by the end of the year, Fenner said.

Against this backdrop of progress, the hub’s leadership has expressed concern that Moderna’s patents in South Africa, which lay claim to the production of all mRNA vaccines in the country, could serve as a roadblock when it finishes clinical trials and prepares for commercialization.

In addition to Afrigen, WHO, and the South African Medical Research Council, the hub’s partners include the Medicines Patent Pool, the Access to COVID-19 Tools Accelerator, the COVAX initiative, the African Union, the Africa Centres for Disease Control and Prevention, South Africa’s Department of Science and Innovation, and the Biovac Institute.