In two years, Moderna has evolved from a small biotech in Cambridge, Massachusetts to a company widely recognized on the world stage for developing and manufacturing a highly effective COVID-19 vaccine. On the one year anniversary of the FDA’s authorization of the Moderna COVID-19 vaccine, we spoke with president Stephen Hoge about the company’s journey to scale up and manufacture millions of doses, the next phase of the battle against COVID-19, and the future of mRNA technology.
It’s been a year since the FDA granted emergency approval of the Moderna vaccine. What was that moment like for you?
In an instant, there was this sense of elation and relief: that we had not wasted 10 years of our lives, and certainly the last year in trying to advance this vaccine. Then there was this rapid transition to a sense of anxiety about what lay ahead. There was a sense of obligation to try and deliver on the promise that had just been provided by the clinical trial result. We were going to have to go through this massive scale-up in manufacturing as well.
How did Moderna anticipate and prepare to make the rapid transition from an R&D operation to a large-scale manufacturer?
We're still fighting through it. Our manufacturing colleagues, led by our CTO, Juan Andres, have carried us forward. Weekends, nights, and holidays were canceled. We had to go from never having made more than a hundred thousand doses to manufacturing 20 million in 2020, to 100 million in the first quarter of 2021, to 800 million by the end of this year.
Every step, it felt like, "Okay. Great. Congratulations. You scaled tenfold. Now you have a month to do it again.” You bring a bunch of incredibly talented people in, and you basically just say, "We have to work this problem until it's not a problem anymore. We have to keep going until the pandemic's done, and not just done in the United States, but everywhere.”
Now that suddenly you are one of the few organizations producing a relatively scarce but deeply important product, what do you see as Moderna’s responsibility in terms of global supply equity?
Our responsibility is to make sure there's as much of our vaccine as we can make. Full stop. The only way out of this problem is everybody who needs a vaccine getting one, and that means we have to do our part. A large majority of our doses going forward will be going to countries that couldn’t purchase in the first wave.
We don’t have infrastructure to distribute vaccines in most of these countries, but we have partnered with the African Union, Unicef, and COVAX which distributes vaccines to low and middle income countries. Our responsibility is to make as much as we can and get it into the hands of those institutions.
It doesn’t seem like Covid is going away anytime soon. What do you foresee the pandemic looking like long term? Is there an actual “end” in sight?
We're going to go through another cycle of seasonal bumps. Hopefully nothing on the scale of Delta, but there will be echo waves of Delta. Our expectation is that we'll then transition to what we would call an endemic phase by sometime next year, at which point this will become like the flu, which we just accept as a background infection in our society. We think, as a practical matter, that will go on forever. So where do we transition our focus? It will be much more about the question of how do we protect the high risk population.
What is the data saying about boosters?
The data looks really strong. Our vaccine was holding up really well prior to the booster. But if you look at the benefit of boosting, you get to levels of protection that are above the levels you saw after just the primary series. So we're very confident about boosters providing that value for everybody who gets them.
Our booster dose is also half the mass of the full dose, which means we can make twice as many doses in the same amount of time. We think that’s ultimately going to help accelerate the end of the pandemic next year, because those boosters will be rapidly available globally.
Has the widespread recognition of mRNA technology’s effectiveness accelerated the timeline for other Moderna therapeutics beyond Covid?
Yes and no. The experience we’ve gained with manufacturing, safety, and clinical trials has allowed us to accelerate programs dealing with respiratory viruses. We have a flu program, and a respiratory syncytial virus (RSV) program that have moved into pivotal studies because patients and institutions are now very comfortable with technology that two years ago they had never heard of.
But there are definitely places, for instance, in our cancer programs, where we face the same challenges as everybody else in the industry. We have been impacted by disruptions in the supply chain, and also by the challenge of getting people in for clinical trials. But we hope to get those programs restarted soon.