When the pandemic began, the challenge for Pfizer and our partner BioNTech wasn’t just developing a vaccine—we also had to make it, and by the billions. This was no small feat—especially when you consider that the companies were looking to do what would normally take five years in less than one. Until the very end of 2020, no mRNA vaccine had ever been authorized and thus, one had never been manufactured at scale by any company. Pfizer invested more than $2 billion at risk on our Covid-19 vaccine development program—with $500 million of that spent on scaling up our manufacturing capabilities, before we knew the results of our clinical trials. There were no guarantees. But, with 172 years of experience on our side, we’ve arguably developed the most efficient vaccine manufacturing machine that the pharmaceutical industry has seen.
In addition to the technical aspects of making a complex mRNA vaccine while moving at the speed of science, we focused on always prioritizing quality, safety, and compliance; keeping colleagues in our research and manufacturing plants safe; and continuing to protect the environment. That message has been consistently reinforced by our CEO and leaders and includes amplified messaging about our Open Door policy, office of the Ombuds, and anonymous Compliance Hotline, to encourage our colleagues to speak up. And when issues or concerns are raised, we listen and respond.
Our speed was driven by working on activities in parallel, being flexible, and adding extra resources and innovative thinking. For example, in 2020 our manufacturing facility in Kalamazoo, Michigan, designed two separate vaccine manufacturing lines, one in an existing production area while the second was being designed as a prefabricated modular system constructed at an off-site facility and transported and placed in existing space at the Pfizer site. That meant two separate environmental permitting scenarios, two separate safety profiles, and the need to have both designs completed and constructed more quickly than we ever had before—because that is what patients around the world needed. This generated financial risk for the company, and our teams worked incredibly hard, but it enabled Pfizer to be ready with manufacturing capability if, and immediately when, we received emergency use authorization from the FDA.
We eliminated hierarchy in internal reporting and made meetings more efficient. The right subject matter experts and decisionmakers were in daily core meetings, irrespective of titles or reporting lines, to assure that all colleagues involved in the process design, construction, and startup stayed connected. We redesigned our processes to enhance efficiencies and drive effectiveness. That does not mean we eliminated critical decisionmaking processes; in fact, it was streamlined processes that enabled us to move fast with confidence, ensuring we maintained our high standards for quality, safety, and integrity.
We established a risk management framework specific to the vaccine project to ensure that we were developing mitigation strategies for existing and emerging risks. Elevated risks were escalated to leadership to enable the rapid deployment of resources and support so identified risks could be proactively mitigated and not become roadblocks. For example, relative to process safety and environmental risks, we implemented an OSHA Process Hazard Assessment approach for all steps in the production process regardless of whether the step used flammable or hazardous materials. And we repeated the PHA at key phases of design, construction, and startup.
We established open, transparent, and cooperative lines of communication with the government, including environmental agencies. We needed new authorizations for air emissions from state agencies and for wastewater discharges from local publicly owned treatment works. Having authorizations timely issued and compliance at all stages was of paramount importance, so we developed detailed environmental data in advance to cover multiple potential operating scenarios. Our facilities established early lines of communication with their regulators, who recognized the urgency of our mission and our commitment to environmental compliance. They were flexible when we presented multiple scenarios for operation while we awaited the decision on final design. With this common purpose, the agencies were able to prioritize and expedite our applications while maintaining their rigorous and robust review processes.
These were important aspects of our ability to deliver the vaccine in unprecedented time. However, the most important factor was ultimately our colleagues and the individuals employed by our partners and government who, working collectively with shared purpose, delivered breakthroughs and innovation in record time—proving that when humanity works toward common goals with urgency and focus, we can address the world’s greatest challenges.
Performing at the Speed of Science Yields Complex Covid-19 Vaccine