A South African biotech company has recreated small quantities of Moderna’s Covid-19 vaccine. Its achievement, done in partnership with the World Health Organization, is part of a broader plan to help low- and middle-income countries become less reliant on US and European drug makers, which have been slow to send their vaccines.
The WHO is investing $100 million over five years to develop an mRNA hub in South Africa, with expertise centered at Afrigen Biologics and Vaccines. Afrigen is expected to share the know-how it develops with other countries eager to establish their own vaccine infrastructure. Brazil and Argentina are next in line.
This ambitious plan could set up countries to better respond to future pandemics — as well as ongoing scourges such as malaria and tuberculosis. It’s also exactly the kind of program that might lose steam once the Covid threat becomes less acute and global attention shifts elsewhere.
To make sure this momentum doesn’t fizzle, companies like Moderna, Pfizer and BioNTech should pitch in now by sharing their vaccine-making expertise.
Afrigen’s goal is to design and, with the Biovac Institute (another partner in the WHO’s network), manufacture a new vaccine. Much has been made about the Moderna copy, but the South African scientists ultimately want to create their own intellectual property.
Their original intent had been to license IP from Moderna or Pfizer/BioNTech. In October, when WHO said it had hired Afrigen to cook up the Moderna vaccine recipe, the global health agency sounded confident that the companies would grant access to their technologies. Only after attempts to engage them went nowhere did the group change their strategy to developing a separate vaccine.
Ideally the shot that Afrigen ultimately creates will be an mRNA vaccine that is relatively easy and cheap to produce, and is stable at room — or at least fridge — temperature so that it’s practical in places with patchy cold-chain distribution.
Afrigen was able to make Moderna’s vaccine in microliter quantities by poring through publicly available documents that detail its various components. An impressive feat, but “microliters is the operative word,” said Patrick Arbuthnot, a gene therapy expert at the University of Witwatersrand who is helping with the project. That’s about enough to vaccinate a mouse. Making enough for an entire country or continent is a different proposition.
Securing all the components to make a vaccine will not be easy. One particular need is for large quantities of modified bases — building blocks of mRNA that have been adapted to survive the inhospitable environment of living cells — and the enzymes used to link them up. Another is for the lipids that form a protective bubble around mRNA as it travels to cells. Those lipid nanoparticle components have been in short supply throughout the pandemic. Contract manufacturing firms have ramped up capacity over the past year, but the customer queue is very long.
Petro Terblanche, Afrigen’s chief executive officer, told me her company’s vaccine milestone would have been achieved three months ago were it not for the long wait for these key raw materials — and that was just to make a mouse-sized dose of the vaccine.
Technical hurdles stand in the path of moving from mouse to millions of humans. Vaccine companies must document for regulatory authorities each step of their manufacturing process, and Terblanche says that Moderna’s vaccine has 900 steps.
So many things need to go right for this effort to succeed.
Help from Moderna and Pfizer/BioNTech could significantly improve its chances. Afrigen and WHO would also be happy to see any of the other firms that have mRNA-based Covid vaccines still in development lend a hand.
So far, companies have only weighed in on the topic of patents. Moderna has said that it won’t enforce its vaccine patents while the pandemic is underway. Pfizer has been more reluctant. Last spring, when President Joe Biden endorsed waiving patent rights on Covid vaccines, Pfizer’s CEO Albert Bourla argued it would harm the company’s ability to access raw materials and would disincentivize companies from making risky investments in future pandemics. BioNTech, meanwhile, has been actively working to undermine Afrigen’s efforts, according to a recent report from the BMJ, by claiming it was based on patent infringement.
Yet the patents, while helpful, are not the main issue. Afrigen can create its own vaccine. But that may go nowhere for years unless the big vaccine makers share their know-how for producing shots at scale.
In resisting the WHO’s calls for help, the companies imply that the vaccine business is too complicated for any country without a thriving biopharmaceutical ecosystem — so just let the American and European firms handle it. Both Moderna and BioNTech are building facilities in Africa to supply the continent with their own Covid shots. And Pfizer has partnered with Biovac to put its vaccine into vials and distribute it.
All such efforts to distribute Covid shots worldwide are needed and welcome.
But it’s also essential that low- and middle-income countries can develop the capability to create vaccines of their own. It is in the interest of US and European governments to invest in making sure that momentum for Afrigen’s effort continues as the omicron surge of Covid-19 subsides — so that all countries can better face the next Covid surge and the next pandemic. Moderna and Pfizer/BioNTech only need to lend their expertise.
Bloomberg
