This week, the U.S. Department of Health and Human Services agreed to Emergent BioSolution’s request to end our 9-year pandemic manufacturing partnership that began after the 2009 H1N1 “swine flu” pandemic. We did not come to this decision easily.
Emergent was founded to help respond to and prepare for public health threats. And even though we’re ending this manufacturing partnership with the government, our Bayview facility will continue producing COVID-19 vaccines and treatments for our private sector partners, and we will continue to supply the U.S. government with other needed medical countermeasures. We’re proud of what our hundreds of employees have been able to accomplish right here in Baltimore. As the country looks ahead to preparing for the next pandemic, I want to share with you our experience and what we learned, so the country is better prepared for the future.
The original intent of this partnership was to create a facility that could produce 50 million dose-equivalents of influenza vaccine drug substance in four months in the event of a pandemic. Facility expansion was only a first step. To build and maintain a state of readiness, continued investment is a necessity. The government maintained that they would provide us with the necessary drug development work to build and maintain those capabilities. That didn’t happen.
Fast forward to the emergence of COVID-19. The federal government sought domestic manufacturing capacity as pharmaceutical companies began trials on dozens of vaccine candidates. Despite the eight years and over $200 million of additional Emergent investment, our Bayview facility was still developing clinical-stage drug substance material, with fewer than 100 employees, and had never been tested by the government for influenza, much less a new virus. Ultimately, Emergent would hire and train more than 300 new employees and deploy never-before-tested processes and technologies to manufacture not one, but two, novel coronavirus vaccine candidates.
We had already committed to Johnson & Johnson to manufacture their vaccine candidate when the U.S. government, through the Center for Innovation in Advanced Development and Manufacturing (CIADM) program, reserved the remaining capacity at Bayview to be used at their discretion. They directed us to work with AstraZeneca. No one at the time knew which vaccine candidates would succeed. So, even though the U.S. government, we and our partners understood the risks of producing two viral-vector vaccines in the same facility, we took on the challenge.
Then, in March of this year, a single batch of the J&J vaccine was cross contaminated with the AstraZeneca vaccine. Emergent has taken full responsibility for this incident and addressed the conditions that caused it. And, thanks to the dedicated work of our employees alongside J&J, manufacturing of the vaccine resumed in late July. Despite the setback, there are approximately 100 million people in the world who are safer because of vaccine made at Bayview, with more batches still under review. We are proud of this accomplishment. As of today, except for Emergent, none of the companies selected by the Biomedical Advanced Research and Development Authority to create CIADMs have yet produced usable vaccine.
As we prepare for future pandemics, there are a few key lessons we need to take from this experience. First, we shouldn’t assume the next pandemic will be just like this one. The investment in our Bayview facility was born out of a review of the 2009 influenza pandemic. We need to take an expansive view of potential public health threats and create the capabilities to respond.
Second, we need to approach manufacturing with a military readiness mentality. Proactively producing a variety of drug substances will allow us to develop the technologies, processes, and worker expertise to manufacture whatever is needed to defeat the next pandemic.
Third, we need to invest in the jobs and training to prepare for the next pandemic. That means investing now in the people and training to manufacture the next therapeutic or vaccine that will lead us out of a future pandemic.
Many companies stepped up to help fight this pandemic, often attempting to do things that had never been done before. Not everything went perfectly. We know that firsthand at Emergent. But if you want companies to engage, you need to be willing to stand by them through both challenge and achievement. As difficult as that is, it’s essential to America’s success in combating the public health threats of the future.
Robert Kramer (firstname.lastname@example.org) is president and chief executive officer of Emergent BioSolutions, in Gaithersburg, Md.