The difficulty of learning the technology behind mRNA vaccines poses a major obstacle to President Joe Biden’s proposal aiding poor countries by defying the pharmaceutical industry and waiving patent protections for COVID-19 vaccines.
The rationale for the patent waiver would be to allow developing countries to reproduce currently existing COVID-19 vaccines without having to worry about getting sued by the pharmaceutical companies that hold the patents.
But in the case of the mRNA vaccines produced by Pfizer/BioNTech and Moderna, doing so would be very difficult. As of March, mRNA vaccines accounted for 43% of the COVID-19 vaccines produced, according to British software company Airfinity.
There are relatively few people who are trained at manufacturing mRNA vaccines.
“The expertise for this is very limited,” Zoltan Kis, a chemical engineer at the Future Vaccine Manufacturing Hub at Imperial College London, told the Washington Examiner. “But personnel with similar expertise could be retrained.”
Retraining, of course, takes time. Additionally, sending trained personnel to instruct people at a site in the developing world could mean stretching resources thin.
“Sending an employee of this caliber out of the original manufacturing site to a partner site risks reducing the capacity of the first site,” wrote Ana Santos Rutschman, an assistant professor at Saint Louis University School of Law, and Julia Barnes-Weise, executive director of the Global Healthcare Innovation Alliance Accelerator.
The reason for the limited expertise is that an mRNA technology that actually works is still relatively new. There hasn’t been enough time to train multitudes of employees.
“mRNA as a vaccine technology has been worked on for some twenty to twenty-five years now, from what I can see, and … we’re very fortunate that it had worked out (and quite recently) several of its outstanding problems just before this pandemic hit,” wrote former pharmaceutical researcher Derek Lowe for his blog In the Pipeline at Science magazine. “Five years ago we simply could not have gone from sequence to vaccine inside of a year.”
Another hurdle is that manufacturing an mRNA is a complex process involving six steps that are completed at separate manufacturing sites. For example, step one involves producing DNA, which Pfizer does in St. Louis and Moderna outsources to a Swiss firm called Lonza. Steps five and six entail mixing together ingredients into vials and then packaging the vials so they can be shipped. Pfizer does these steps in Michigan and Belgium, while Moderna outsources it to firms known as Catalent, Rovi, and Recipharm.
The most complicated part is step four, which entails combining the mRNA with fatty cells known as lipids. Achieving that requires getting liquids to flow through very small channels so they can be mixed very precisely. Lowe wrote that it likely takes a specially built microfluidics device to do this and that Pfizer, BioNTech, and Moderna “have largely taken up the production capacity for” building more of those devices.
Replicating the manufacturing process for mRNA vaccines in the developing world would be no easy feat.
Lowe doubts that waiving patents would make much difference.
“The supply of vaccines has been increasing, and would continue to increase without the patent waiver idea,” he wrote. “The constraints are physical ones, supply chains and engineering ones, not legal.”