Pfizer leadership shares vaccine development and lessons they will carry forward
Pfizer, who forged a partnership with BioNTech two years prior, was well positioned to be the hero of 2020. BioNTech pioneered the mRNA platform as a technology for vaccines, and Pfizer had the capabilities to move the vaccine through research, clinical trials, regulatory approval, and manufacturing and distribution in record time.
They discovered more than a life-saving vaccine; they discovered new ways of managing research, trials, and data that can be applied in the future.
Pfizer’s story was recounted at a virtual Chamber Business Breakfast on May 19 by John Burkhardt, Senior Vice President, Head of Global Drug Safety Research and Development (DSRD), Head of Comparative Medicine and Groton Site Head for Pfizer Laboratories, and Jean Lee, Vice President and Head of Portfolio and Project Management.
Urgency drove the singular focus that reduced the traditional seven-year timeline for a new vaccine to seven months from first dosing to Emergency Use Authorization by the FDA.
Burkhardt broke down the science and described the in-house, end-to-end capabilities and expertise Pfizer has in place that enabled this innovative vaccine to be tested, manufactured, and distributed quickly.
Lee cited collaboration, solid science, expert teams and 24/7 commitment as essential to executing at that speed: “Meetings that we normally wait months for… we got in hours. We had conversations with the health authorities daily.”
Constantly optimizing for time and for everyone in the system, every process was examined. “If there was something that got in the way of progressing to the next step, they put together their great brains and we found a way to move on, find a solution, and innovate around those problems,” said Lee.
Lessons learned that are repeatable, scalable, and sustainable over time are processes that will be adapted and adopted for future programs.
Pfizer’s ability to mobilize from research to manufacture is now projected to result in 2.5 billion doses worldwide by the end of 2021, a significant increase from the 1.3 billion doses initially projected. Pfizer is on track to deliver 300 million doses to the U.S. government by the middle of July, ahead of schedule. Increased production of the Pfizer BioNTech is important as it is currently the only vaccine approved for children 12 and over, with trials already underway for those younger.
“It’s the mindset we’ve gotten into that it’s not good enough. Continuous improvement on every step of every process along the entire supply chain,” said Lee.
Connecticut’s Pfizer team contributed throughout the vaccine development process and led or supported: safety, design, formulation, supply and procurement, clinical trial operations, and lipid manufacturing.
“People just really stepped up. They knew they had the chance to be the hero and they did it,” said Burkhardt.
Preparations to keep the Groton site safe and functioning included enhanced tech and data transfer, limited chances for contamination, expanded dining services, and even anticipated onsite accommodation, if that became necessary. Adaptations and ways of working permeated the whole process locally and globally.
“People had the confidence, and our leaders at the organization supported it as well, to take the risk because there was no alternative,” said Lee, as clinical trials needed to adapt to remote work. “We’ve come out of it stronger and more confident in changing some of those ways of working.”
Pfizer continues its research to combat COVID-19 with a treatment option for those who contract the virus. An orally-administered COVID-19 protease inhibitor is in clinical trials in New Haven. The medication works by blocking an enzyme the virus depends upon to replicate and proliferate. Protease inhibitors have been effective in treated other viral pathogens such as HIV and hepatitis C virus. This solution can benefit those unable to receive the vaccine.
Pfizer continues to study the vaccine in regard to its cold storage requirements, collecting temperature data on every shipment using GPS trackers. This new data will help Pfizer refine the process and determine if it can be stored at higher temperatures.
Studies in the original clinical trial continue and will determine if booster shots may be needed for those vaccinated.
Chamber President and CEO Tony Sheridan opened the program by expressing the appreciation our region and global community feel for Pfizer’s work, “I speak for all of us when I express our sincerest gratitude to you and the entire Pfizer team for your tireless efforts throughout the pandemic and your success with the vaccine.”
His sentiments were mirrored as the presentation wrapped up in the pride Burkhardt expressed regarding the work of the Pfizer team. “I tell people at work you’ll be telling your grandchildren about these times and about what you did to help bring those tragedies to an end,” said Burkhardt. “It’s been very humbling for us to be involved.”