Moderna and Pfizer’s ethical duties go beyond just creating vaccines

Both Pfizer and Moderna have done amazing work in bringing remarkably effective vaccines using new mRNA technology to market and scaling up production, saving millions of lives. But, unless these companies either scale up production capacity far beyond what they have already done or transfer technology to other producers, millions may die because the world won’t be able to vaccinate against a nightmare variant in the six-month time frame needed.  

In the case of Pfizer, it took a significant risk, as it did not accept development funds from Operation Warp Speed (although it did receive some funding from the German government through its partner BioNTech). If its vaccine had turned out not to work well, as was the case with the vaccine created by CureVac, it would have lost most of its investment. And, particularly in the case of Pfizer, it has done remarkably well scaling up production entirely within its company. The fact that one company can make billions of doses is a remarkable tribute to its ingenuity and hard work.  

Moderna is less laudable. Moderna’s technology was created and developed by the National Institutes of Health using U.S. taxpayer dollars. Because it is a small company, it has not been able to scale production nearly as much or as quickly. Nevertheless, it has a remarkably effective vaccine, is making hundreds of millions of doses, and, like Pfizer, has conducted meticulous clinical trials resulting in full FDA approval and licensure.  

Both companies are remarkable success stories where new technology leads to a life-saving product that will allow us to move forward despite the presence of deadly variants of the SARS-CoV-2 virus.  

Why, then, do I say that these companies (and their CEOs) potentially could bear ethical responsibility for hundreds of thousands of deaths?  

No one knows what will happen next with COVID. It’s possible that omicron will have been the pandemic’s last gasp and we won’t experience another major wave. It’s possible that there will be scattered outbreaks that show up as clusters and small waves. But it’s also possible that a nightmare variant will emerge that’s as transmissible as omicron, deadlier than delta, and able to evade the immunity conferred by our current vaccines or prior infection with other variants. 

Furthermore, if such a nightmare variant does arise, it’s possible that only mRNA vaccine technology would be able to be tweaked fast enough to be rapidly rolled out in the quantities needed.  

Such a variant could kill at least 10 million people around the world in one year. What’s the likelihood that such a variant emerges? No one knows. For calculation’s sake let’s say that it is at least 10 percent.  

Ten percent of 10 million is 1 million deaths.  

Between them, Pfizer and Moderna currently have the capacity to produce about 5 or 6 billion doses in a year.  

If the nightmare variant requires a two-dose series, which is likely, then at least 10 billion doses will be needed in the six months after it emerges. In other words, the production capacity of these two companies is only about a quarter (or half, in the event that a single dose works) of what the world would need.  

This scenario would leave half to three-fourths of the world — undoubtedly those living in poorer countries unable to pay top dollar — to face the nightmare variant without the benefit of a vaccine that was produced by taxpayer-funded research over the past two decades.  

World Trade Organization agreements and discussions of intellectual property can’t solve this problem. The only way to scale up production capacity to the much higher level needed is for these two companies to transfer their technologies to regional vaccine production hubs, similar to the one already set up in South Africa that could be quickly established in South Korea, Brazil, India, and elsewhere. Transferring their technology is essential because even if another company replicates the technology, it would need to take the new vaccine through clinical trials before getting licensure.  

The U.S. government shares the blame. They likely could have done much more to force Moderna to share technology, whether through the Defense Production Act, the Bayh-Dole Act, or by enforcing patent protections of the NIH-developed vaccine technology used by Moderna without a license.  

Pfizer and Moderna have valid concerns about protecting their intellectual property and about protection from lawsuits if another manufacturer makes an error producing their vaccines and people are left unprotected or harmed as a result. These are important considerations but can be managed. The companies can be indemnified, their intellectual property protected, and they can be compensated for the production of vaccines that use their technology. What cannot be restored are millions of people’s lives if production capacity is not further increased.  

Life-saving COVID vaccines are a global public good; the interests of society, in this limited case, far outweigh the self-interest of two companies.  

Maybe we’ll get lucky and no nightmare variant will emerge. And maybe, even if it does emerge, we’ll get lucky and multiple vaccines will work well against it. But gambling with millions of lives is reckless and unnecessary.  

Pfizer and Moderna must transfer technology so that sufficient quantities of tweaked vaccines can be made to immunize the world in six months. They — and the governments that do not impel them to do this — do not just bear moral responsibility if a variant that requires their technology emerges, but bear the moral responsibility today for failure to take actions that could prevent deaths tomorrow. 

Dr. Tom Frieden is president and CEO of Resolve to Save Lives, an initiative of Vital Strategies and senior fellow for Global Health at the Council on Foreign Relations. Frieden was director of the Centers for Disease Control and Prevention from 2009-2017 and oversaw responses to the H1N1 influenza, Ebola and Zika epidemics.