Doug Lankler, Pfizer EVP and general counsel, spoke this month at the University of Richmond’s Robins Executive Speaker Series.
The moderator asked him to share a month-by-month account of what unfolded from the moment they knew that COVID needed a vaccine. Lankler spoke about the actions, decisions, potential for failure, and moments of triumph during the development of the Pfizer-BioNTech COVID Vaccine.
As I listened to this fascinating history, it became clear – there were specific factors in play that are a must for any high-stakes project to succeed.
Tone at the Top
Lankler described outstanding leadership who delivered both inspiration and resources focused on a sudden higher purpose.
In 2019, Pfizer came under the leadership of a new CEO, Albert Bourla. Lankler relayed that mammoth Pfizer typically works methodically… and slowly. He labels Bourla’s leadership as very different from prior CEOs, describing him as “societal-based” and “patient-focused.” Lankler believes the vaccine would not have come to fruition at Pfizer under the past CEO and noted that Bourla was constantly battling the conservative approach of a big company.
Bourla committed to not taking development money from government, so they would not get hung up anywhere in the process. He said, “tell me what you need,” equipment, support navigating FDA, whatever it takes. Daily, Bourla was helping teams remove common barriers.
Collaboration and Teamwork
With so much at stake, there was no room for egos, silos, or a lack of accountability.
On March 16, 2020, Bourla declared Pfizer was not going to stand by, and initiated conversations with partner companies such as BioNTech, who was already working with messenger RNA (mRNA) to create a new drug class, potentially for vaccines. When Bourla heard this new technology might work on a COVID-type virus, he said “go.”
Pfizer also created parallel paths rather than working sequentially. They knew the vaccine would need very cold storage and the manufacturing and distribution teams worked simultaneously to solve this problem right alongside vaccine development. When Pfizer hit problems finding a lipids partner, they didn’t waste time with those who couldn’t or wouldn’t deliver – and then they found the perfect partner. Lawyers were moving multiple possibilities through the regulatory process so they would not be delayed when the final science was ready. They were already training administrators on how to deliver the vaccine and had DHL and UPS preparing to safely transport as well.
Notably, Lankler said that people, organizations, and governments around the world were offering anything to help, which is unusual. And their families and neighbors were rooting them on.
Staying True to Core Competencies
Pfizer stuck closely to the scientific method. Clinical trials were held in the Fall of 2020, keeping true to blind research methods: 50 thousand people joined the trials around the world; great diversity with many people of color and Asian descent; only two employees in the company knew who had what formula and who had placebos. (Previously mRNA had only been studied in animals, so this was the first science with mRNA and humans, but they had no trouble getting people to participate. So many people wanted to be part of the solution.)
Being Agile with Pace and Processes
There’s a saying about moving at the “speed of science,” but Pfizer made that measure different in this case, becoming more efficient than ever. Because of the parallel pursuits and the FDA moving more quickly than typical, they shaved time off their review without taking shortcuts in the science steps.
Bourla now calls this new way of operating their “high-speed methodology”. Further, he says it’s ok if it costs money and they fail. He has declared Pfizer is not going to spend money on being a “me too” for additional therapies or drugs; rather, they are going to be the company that creates “breakthroughs that change people’s lives”. Lankler says now the obvious question is: “Is oncology less important?”
Frequent and Open-Door Communication
Bourla put a small, top-notch team together and they reported to him daily. This caused and carried momentum. If a scientist got a call from a university with a good idea, it was immediately shared; if someone was stuck, they were able to quickly find another source for what was needed.
Ultimately, Lankler says they “got lucky a million times”. Maybe. Or maybe, this was the result of decades of preparatory research, the relentless pursuit of science, and outstanding leadership.
While mRNA science has been studied for more than a decade, the process of getting emergency authorization happened in a matter of months.
March 16, 2020: Pfizer CEO Bourla says “go.”
Mid-April 2020: Pfizer scientists report they have four possibilities, which is very unusual as they typically have no more than one when they start this type of development.
July 19, 2020: Amid promising research, Bourla delivers a “JFK-type Man-on-the-Moon” speech, declaring he wanted people working vigorously on a vaccine and a second group working on therapies.
Fall 2020: Moderna was also putting their efforts into mRNA, so there were concerns that if mRNA didn’t work, the world would be back to the drawing board.
November 2020: Success! The great reveal… the chief scientist declared it successful, and Pfizer filed for emergency authorization. They’d previously determined success would be a threshold of 50% efficacy – and were stunned that it was 94% effective. Shortly thereafter, Moderna and Johnson & Johnson data showed similar thresholds of efficacy.
Today: Data collection continues, to watch for longer-term potential side effects, additional potential boosters, and protection against new variants.