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04 May 2017

Advancing Disruptive mRNA Vaccines: Opportunity and Obligation

Michael Watson
MB ChB, MRCP, AFPM, President, Infectious Diseases, Moderna
Evan Rachlin
MD, Senior Director of Strategic Planning, Moderna

As physicians by training, we’re often asked by friends and family why we made the decision to jump from clinical care to the biopharmaceutical space. The potential to bring new medicines to patients – medicines that can impact and improve many, many lives – is tantalizing.

What attracted both of us to Moderna specifically was its potential to bring not just one or two new medicines to market – but to possibly launch an entire new class of medicines that could help people impacted by many types of diseases. Go big or go home.

The underlying premise across our organization, our development pipeline, and our research programs at Moderna is universal: use mRNA as instructions to direct the body’s cells to make proteins to fight or prevent disease. Think: “biologic software code.”

The exciting thing about our approach is that, if we can successfully make mRNA work for one application, we should be able to make it work over and over for other ‘like’ applications. We just tweak the software code to program cells to make different medicines.

A perfect example of this is our vaccines.

Vaccines arguably are the greatest medical innovation of all time. They‘ve prevented countless infections, reduced hospitalizations, and saved untold millions. If you look back even just 50 years ago in the U.S., half a million people were hospitalized for measles every year. Now that number is down to only 60. The reason? Vaccines. 

But, despite these successes, traditional vaccines could be better.   

For one, there are a number of pathogens from which we cannot yet protect people. There are hundreds of thousands, even millions, of children and adults who suffer infections and death each year around the world because we don’t yet have prophylactic vaccines to address certain viral and bacterial pathogens and other parasites.

Second, by virtue of population growth, and increased travel, and greater mixing of social behaviors, we are seeing more epidemics and pandemics. Bird flu, Ebola, and (most recently) Zika, to name a few.  Traditional vaccine approaches do not lend themselves to rapid response in the face of these regional and global surges in disease. With the traditional vaccine model, by the time we can get organized and develop a vaccine five, sometimes even ten, years later, it’s often too late. At a minimum, we’ve missed the opportunity to help many people who’ve already fallen ill.

It’s for these reasons that we and many other companies, governments and organizations in the U.S. and globally are so dedicated and focused intensely on a disruptive model for vaccine development.

At Moderna, we have the potential to be that new model. 

And not just for one infectious disease, but for many infectious diseases.

Our mRNA approach and the infrastructure we are building to research, develop and manufacture vaccines position us to potentially help address persistent, serious unmet needs and to respond rapidly to emerging pandemics and epidemics. Plus, we can improve upon existing vaccines.

Among its many potential advantages, mRNA vaccine technology offers precision and speed; flexibility and adaptability; the ability to scale rapidly and to manufacture multiple vaccines at a single facility; and the opportunity to develop both complex and combination vaccines that simply are not possible using traditional approaches. There’s still much work to do, and science’s candid objectivity could still have surprises in store. But that’s the whole idea; we wouldn’t be drawn to the challenge if it were easy.

Perhaps the most exciting thing about this vaccine technology: it’s not some futuristic, theoretical concept. We’re making great progress to advance mRNA vaccines.

We already have four ongoing clinical programs for influenza, mosquito-borne and respiratory pathogens, including one program with our partner Merck.  This includes our Zika mRNA vaccine (mRNA-1325), which is currently in Phase 1/2 study in the U.S., and which we were able to advance from idea to clinical study in just 12 months. That is not typical drug development.

We also have four additional mRNA prophylactic vaccine development programs advancing toward the clinic, and multiple research-stage programs that include monovalent, multivalent and multi-pathogen vaccines. Last week, we published our first human data from an ongoing Phase 1 study of our first mRNA prophylactic vaccine program, mRNA-1440 (influenza H10 vaccine) demonstrating promising efficacy and safety results. 

To be sure, we are early on in the development process and still have a lot of work before one of our vaccines could make it to market. But based on the progress we’ve made to date and what we’re learning about this technology on a daily basis, the sense of excitement across our organization is palpable. Potential for breakthrough science? Check. Potential to impact millions? Check. Potential to disrupt the industry? Check.

As physicians, we feel a deep, insatiable obligation to personally deliver on our oath. While our colleagues directly save patients every day (thank you), we hope that they could one day use our mRNA vaccines as well.

We invite you to read more about the disruptive promise of mRNA vaccines and how they differ from traditional vaccine approaches and DNA vaccines in a white paper we issued today on this topic:  “mRNA Vaccines: Disruptive Innovation in Vaccination.”