Pfizer’s successful partnership with BioNTech was backed by years of ground-breaking scientific research and development but it still had to defy approval conventions to win public trust.
Marc Kaptein, Medical Director at Pfizer, revealed how the company had to take calculated risks to manufacture the vaccine, which was first delivered to a patient in December 2020 as part of the biggest global vaccination programme in history that has now passed 13 billion doses.
His reflections shed light on Pfizer’s twin challenge of getting the science right and then being able to flex rules and regulations to win clinical approvals and public trust.
“We had been collaborating with BioNTech but the new CEO of Pfizer, Albert Bourla, who was appointed in 2019, still had to make the biggest gamble of his and the company’s life within a year of taking over,” he said at the CMS Global Life Sciences & Healthcare Forum 2023 Blurring Boundaries – Exploring the convergence of life sciences and law.
The company decided against pursuing established vaccine platforms and, instead, authorised the investment of $2 billion into mRNA research that was already advanced in a flu vaccine but completely untested in public.
“He (Bourla) said: ‘Listen, if we aren’t going to do it, who is?’ We just did it. This is like the moon shot, it is something we believe in and we think we can make a difference,” said Kaptein.
Pfizer and BioNTech accelerated the vaccine’s development on a handshake so that contract negotiations could take place alongside the R&D to avoid any delays to the process.
Kaptein recalled that the vaccine’s first clinical trial of 44,000 patients hit an effectiveness level of 90% but the Pfizer team then faced a challenge of public perception as the vaccine and mRNA was novel.
“We observed a lack of trust in the Netherlands,” added Kaptein. “They needed to see a face from the company, someone they could connect with who could explain how the vaccine was manufactured, where it came from and how it worked.”
Kaptein was thrust into the spotlight with the task of reassuring the public but treading a tightrope of not breaching promotional regulations that were fixed in place but were not devised for a pandemic.
“It was a super intense period for me and the company but it is something we can look back on and say we made a difference,” he added.
Nick Beckett, Global Co-Head of CMS Life Sciences & Healthcare Sector Group, said: “It was a compelling narrative on the importance of bold decision making and how rules and regulations can be tested, and how collaboration across all sectors can smooth the way in even the most challenging circumstances.”
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