This interview is part of COVID-19 vaccines: The road to recovery and beyond, a series that includes a broad array of voices leading the historic global effort to develop, distribute, and provide equitable access to COVID-19 vaccines, including the Africa CDC; CEPI; Gavi, the Vaccine Alliance; Moderna; and Pfizer.
The COVID-19 pandemic continues to leave a devastating impact around the world. And Pfizer, a global pharmaceutical brand, is turning out to be one of its formidable foes. The 172-year-old drugmaker is leveraging its full capabilities and resources to reduce the risks of COVID-19, putting it at the forefront of vaccine creation. It teamed up with BioNTech, a biotech company based in Germany, to bring the first-of-its-kind vaccine based on messenger RNA (mRNA) to billions of people around the world. The companies have increased their drug-manufacturing forecast, aiming to produce three billion COVID-19-vaccine doses in 2021 and four billion in 2022.
With roughly 80,000 employees and a strong, binding culture, Pfizer is also adding a human edge to tackling one of the most complex health crises the world has ever faced.
Angela Hwang, group president of Pfizer Biopharmaceuticals, feels that Pfizer’s history has helped it push the front lines of COVID-19-related scientific breakthroughs. But it’s not just about the science: she explains how Pfizer’s deep roots and belief in itself have enabled it to become a major force in helping ease global vaccine-supply constraints.
In December 2020, a Pfizer and BioNTech partnership (Pfizer–BioNTech) produced one of the first COVID-19 vaccines to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for those aged 16 and over. It was later expanded to include adolescents aged 12 to 15 years. In August 2021, the Pfizer–BioNTech COVID-19 vaccine was granted full FDA approval for use among the 16 and older age group.
Efforts for vaccine R&D now focus on critical recovery issues, such as variant strains, as well as the potential future need for and accessibility of boosters. “This vaccine program has taught us a lot about where time is spent and where time can be shortened. I definitely think we will all move forward from a development perspective and have an even clearer sense as to where the points of acceleration might be,” says Hwang.
The Pfizer executive spoke with McKinsey senior partner David Quigley about how the company has been able to scale up quickly in the fight against COVID-19, the role that booster shots might play in global recovery, and why Pfizer believes that tapping the human spirit is a necessary ingredient for success. What follows is an edited excerpt of their conversation.
McKinsey: Pfizer is one of the world’s oldest and largest pharmaceutical companies. What elements of Pfizer’s culture and organization enabled it to respond quickly to the COVID-19 crisis?
Pfizer: Leading through extraordinary challenges
Angela Hwang: The first thing we had to recognize is that we were in a pandemic and that time was not on our side. When the infection rates began to rise, we knew that if we were going to have any impact at all, we would need to create a vaccine in record time. This context supercharged our mindset, our energy levels, and our resilience and determination in addressing the problem. When you know there’s no time, that definitely elevates your level of creativity, speed, and decision making.
It was an extraordinary journey, driven by the goal we all had, which was that the world, including ourselves and our families, needed a vaccine. When you’re being confronted with something like this, all of a sudden, you surprise yourself with what you can do.
But we also did have our moments, with questions like, “Can we really do this? Can we pull this off?” We focused on getting the whole company to believe in itself: that developing this vaccine, at this pace, at the required volume—and doing all of this according to Pfizer’s high standards for quality and safety—was actually possible. So we worked on getting our employees—and ourselves—to believe.
Then the teamwork follows: having a common goal, sharing information, being on the same page,
and taking that next step together. If you want to do something this massive, you can’t be divided. There’s only one goal and one way that we can march toward it. Teamwork and trust were a vital part of being able to move at the pace required. It’s always been part of our culture that with high levels of
trust, you feel more comfortable challenging the thinking of others, which pushes us all to pursue excellence and never settle for “good enough.”
What gave us additional know-how were the partnerships we established early on. Despite our vaccine track record, we had never clinically developed or commercialized an mRNA vaccine
before. We had been working with mRNA pioneer BioNTech, a leading biotech company in Germany, since 2018. Our first collaboration was focused on developing an mRNA-based flu vaccine. This foundation enabled us and BioNTech to start working together early to develop a vaccine for COVID-19, and the basis of trust and established processes helped us shave off every minute we could find.
It was Pfizer’s confidence, culture, and expertise coupled with BioNTech’s technology and innovation that enabled us to bring this vaccine to market under what may have previously seemed like impossible time frames. All in all, we developed and began distribution of a COVID-19 vaccine in about eight months.
McKinsey: How were existing leadership practices at Pfizer challenged by the pressure to deliver a vaccine at record speed?
Angela Hwang: One of the most important leadership changes that happened was in the area of decision making. Typically, in any development program, there are processes and milestones we have to pass. There’s very strict governance for how we move from one stage of clinical development to the next. Knowing that we didn’t have much time, we had to obliterate all the regular governance structures and just focus on, “What do we need to do to solve the problem?” and mobilize everybody to do it. Whether it’s been done before or not, we had to disband all the previous notions we used to have.
We sat together practically every day—the CEO, the executive-leadership team, and subject-matter experts on a variety of topics—with the sole purpose of sharing information, getting on the same page, and only leaving the room when decisions were made so that we could take the next action. Every day presents you with new issues that you didn’t have the day before due to how the world is constantly changing. You can’t move the goalpost, so this flow of information is very important when you are trying to move at incredible speeds.
This rapid decision making tested our risk priorities in terms of capital investment and capital allocation. We had no time to worry about cost. We just needed to purchase all of the raw materials required. We knew that we had to manufacture at scale because we would not have the time to do the typical step-ups of a traditional vaccine-development program. There were risks involved in our decision to purchase raw materials and in the design and engineering of our manufacturing units to make the vaccine. We began discussing possible contracts with countries during the development process before we even had data on the vaccine. Everything needed to be done well ahead of time, which meant everything was at risk.
But when the goal is so clear, what happens next is incredible problem solving that allows you to find
the “white spaces” and identify what you can remove to anticipate potential barriers. Knowing that step two is coming, how do you prepare for it while you’re doing step one so that steps one and two are happening almost simultaneously?
Changing our goal setting and problem solving to match the issue at hand were probably the two greatest adaptions in leadership practices on this entire journey.
Changing our goal setting and problem solving to match the issue at hand were probably the two greatest adaptions in leadership practices on this entire journey. Because when you make these two things work together, you will amaze yourself and your teams in what you can come up with, even in the darkest of times.
McKinsey: The Pfizer–BioNTech vaccine is the first to receive US EUA for adolescents aged 12 to 15 years. What comes next in addressing the ongoing threat of COVID-19?
Angela Hwang: Our COVID-19-vaccine program aims to be comprehensive and robust. Just to use the example of the 12-to-15-year-olds: that age group is critical as we look into expanding our vaccinations to younger and younger people. In March 2021, we started to study the vaccine in children aged six months to 11 years.
There is also a tremendous amount of work going on regarding the formulation of the actual vaccine. The frozen-liquid form was what we needed to use to come out of the gate fast. But to reach as many people as possible, we need to continue to find ways to make the vaccine and its storage conditions simpler. Other questions we need to answer include those on the durability of the vaccine.
Then there’s our work on the variants. There are two paths to consider. The first is to understand whether the current vaccine will be sufficient to protect against COVID-19 caused by the variants that are emerging. So that’s one train of thought. At the same time, we’re also evaluating the potential need for a new or updated vaccine having a different mRNA to match, for example, the spike protein of a variant that has escaped protection from the current vaccine. What would that look like?
The good news is, we’re thinking about all these questions, and trials are going on now. When I talk about this, I often get asked, “Well, if you do have to make a new or updated vaccine, how long will it take? Will it take us a whole year again?” We don’t believe so. That’s the beauty of mRNA technology. Our estimation—depending on regulatory process—is that we’d be able to develop a new or updated vaccine in about 100 days. It gives us peace of mind, believing we likely have the tools we need to address the virus from a vaccine-development perspective as it continues to change and move around the world.
McKinsey: What do you think the current pace of innovation means for vaccine development beyond those for COVID-19? How could drug development in general be affected?
Angela Hwang: Our new world is not the world that we lived in—not even a year ago. The COVID-19 pandemic has changed us so profoundly in so many ways, whether it’s at work or at home. Many of the lessons we learned for drug development throughout this journey are replicable. For example, when you’re typically recruiting for your clinical trials, there are standard processes and activities to follow. During the pandemic, we learned how to use electronic patient diaries so that the patient data could be collected instantaneously, which helped drive efficiencies in our clinical studies and interactions with regulatory authorities. I think efficient and tech-enabled processes like these will stay in place.
Pfizer: A bold and quick response to COVID-19
In another proactive step, we had all of our clinical-trial sites engaged while the protocols were being reviewed by the FDA. I remember the afternoon when the FDA approved our Phase III protocol: within two hours, we were able to vaccinate our first person in our Phase III trial.
Moving to more quickly initiating clinical trials and receiving data could be a game changer for emergency and nonemergency drug approvals going forward, even beyond vaccines. Many of our medications and therapeutics are vital, and those treatments are also needed as fast as possible.
As a team, we’re now conditioned to be resilient to the need to problem solve, the need to bring people together, and the need to be decisive. All of these tools are replicable and help us move along much faster than we ever did before in all our programs and phases of development.
McKinsey: As vaccination efforts extend across the world, what can be done to raise further awareness of vaccines and reduce vaccine hesitancy?
Angela Hwang: There is a lot more that we have to do to help the world and the public understand the risk–benefit trade-offs of what happens when you don’t get vaccinated. This is on the shoulders of all vaccine manufacturers, as well as governments.
We’re in a good moment in time to really amp up the education efforts and help people understand why vaccinations are important and what it really means for them—not just as individuals but as a public-health good. When you vaccinate, it’s not just about preventing you from having the disease. It’s equally about you helping slow the transmission of the virus so that the continued transmission and outbreaks in your community can diminish over time.
Real-world data is a testament to this. When we did the clinical trial of our COVID-19 vaccine, more than 44,000 people were enrolled in our study, with half getting the vaccine. Now nearly a quarter of the world’s population has been fully vaccinated.
The retrospective analysis we are collecting in certain countries is also telling. Israel has published its data. The United Kingdom has published its data. The US Centers for Disease Control and Prevention has published its data. This information will be vital in helping drive vaccine confidence. A sample of that size is incredibly powerful when you can use it to describe what people’s experiences were like and help those who may be on the fence. The real-world experience cannot be underestimated and will help educate people so they can make informed decisions about getting vaccinated.
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COMIRNATY® (COVID-19 vaccine, mRNA)* is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It is approved as a two-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under EUA to be administered for emergency use to prevent COVID-19 in individuals 12 through 15 years of age and to be provided as a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to prevent COVID-19 in individuals 12 years of age and older, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The emergency use of the product has not been approved or licensed by FDA but has been authorized by FDA under an EUA to prevent COVID-19 for use in individuals 12 years of age and older, and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see the full prescribing information (16 years of age and older) and older recipient and caregiver fact sheet (12 years of age and older) on labeling.pfizer.com.
*The licensed COMIRNATY® vaccine has the same formulation as the authorized vaccine Pfizer–BioNTech COVID-19 vaccine, and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct, with certain differences that do not affect safety or effectiveness.