The CEO of Pfizer on Developing a Vaccine in Record Time

On March 19, 2020, as Covid-19 swept across the world, I challenged everyone at Pfizer to “make the impossible possible”: to develop a vaccine more quickly than anyone ever had before, ideally within six months and certainly before the end of the year. Uğur Şahin, the CEO of our partner BioNTech—a German company focused on cancer immunotherapies—did the same with his team. Less than eight months later, on Sunday, November 8, a few senior executives and I gathered to hear whether our researchers, scientists, clinical trial organizers, manufacturers, and logistics experts had collectively accomplished that goal. Four independent data monitors were meeting remotely to review the preliminary results of the vaccine candidate trial our two companies were running. This was a double-blind study—none of the scientists, the clinical trial investigators, or the patients knew who was getting the real thing versus a placebo—so we were braced for three possible outcomes: The data monitors might tell us to stop the trial because it was a failure, to continue because the results were inconclusive, or to continue and immediately apply for emergency-use authorization because the vaccine worked and was safe. Knowing that the monitors would meet at 11 AM, a group of us congregated then as well: Mikael Dolsten, the chief scientific officer; Rod MacKenzie, the chief development officer; Sally Susman, the chief corporate affairs officer; Yolanda Lyle, my chief of staff; our general counsel, Doug Lankler; and I. Our lead Covid-19 scientists, who had been working around the clock at our Pearl River, New York, facility, would get the news first and pass it on to us. We tried to distract ourselves by discussing other matters, but anxiety was high. Finally, at close to 2 PM, Yolanda got a text message: The results were in, and the Pearl River researchers wanted to videoconference with us via Webex. During the agonizing minutes it took them to connect, I joked that this was payback for all the pressure I’d put on them over the past few months. But when their faces appeared on-screen, their smiles told us that the news was good. The independent committee had “highly” recommended that we seek approval for use. Ten minutes later we were confidentially informed of the exact efficacy rate: a stunning 95.6%. By December, 74 million doses of our vaccine had been manufactured, and 46 million had been released. By the time this article is published, thanks to our work and that of the other companies whose vaccines have also been authorized, we hope that 300 million doses will be available around the world. That’s our short story. But we believe the longer one is worth telling because of what we learned along the way. It took a moon-shot challenge, out-of-the-box thinking, intercompany cooperation, liberation from bureaucracy, and, most of all, hard work from everyone at Pfizer and BioNTech to accomplish what we did in 2020. Organizations of any size or in any industry can use these strategies both to solve their own problems and to produce important work that benefits society. A Patient-First Mentality A veterinarian with a PhD in the biotechnology of reproduction, I joined Pfizer in 1993 as a technical director in its animal health division in my native Greece. I worked my way up through various positions across Europe to group president overseeing the unit’s global operations from our U.S. headquarters. In 2014 I became group president of our global vaccines, oncology, and consumer health care businesses, and two years later I took on the leadership of Pfizer Innovative Health, overseeing R&D in our consumer health care, vaccines, oncology, inflammation and immunology, internal medicine, and rare disease business groups. In that role I tried to operate like a venture capitalist or a private equity fund manager: The best ideas got the biggest investments. In January 2018 I was promoted to COO, and a year later I succeeded Ian Read as CEO. During my 27 years with Pfizer, my family and I have lived in eight cities and five countries. My exposure to so many cultures, my background as a scientist, and the diversity of roles I had taken on across Pfizer helped prepare me for my new responsibilities, as did my Jewish upbringing in Greece. Coming from a country that’s a small player on the world stage and being a religious minority taught me to fight for what I believe is right and to never give up. Throughout my career my focus has always been on the end users of our products, whether they are animals and their caregivers or general consumers, and I have encouraged the entire organization to adopt the same patient-first mentality, measuring outcomes by people (or animals) served rather than drugs sold. That included spearheading the creation of a Patient and Health Impact Group, which is dedicated to increasing innovation and access. When I assumed the top job at Pfizer, the company was in a good position. Ian, my predecessor, had successfully navigated a large wave of revenue loss as products came off patents. Perhaps more important, he had transformed our R&D function from mediocre to one of the best in the industry. During his tenure we won approval of the first CDK inhibitor for breast cancer and the first JAK inhibitor for various autoimmune diseases, and Pfizer expanded from having a single vaccine to having multiple marketed ones and a robust vaccine pipeline. I wanted to build on that success by focusing on science and patients. To get to the next level, we would need to find better homes for our consumer health business and Upjohn and acquire cutting-edge innovation to supplement our areas of expertise, such as targeted cancer and gene therapies. We would need to focus on all stakeholders, not just shareholders, to create long-term value. We hung pictures of patients on the walls of our buildings around the world to drive that point home for our executives and employees. Finally, we had to become a more modern company, digitizing data through every link in our value chain. To that end, we strengthened the leadership team. We brought on Lidia Fonseca as chief digital and technology officer, to expand and improve our digital capabilities; Angela Hwang as group president of our biopharmaceuticals unit, to reimagine our go-to-market model; Payal Sahni as chief human resources officer, to drive a culture of courage, excellence, equity, and joy; and Bill Carapezzi as an executive vice president, to transform our business services. From June 2019 through April 2020 we also added four board members with either significant scientific backgrounds or global business expertise: Sue Desmond-Hellmann, previously the CEO of the Bill & Melinda Gates Foundation and a former Genentech executive; Susan Hockfield, a neuroscientist and the president emerita of MIT; Scott Gottlieb, a physician and a former FDA commissioner; and James Quincey, the chairman and CEO of Coca-Cola. The Pandemic Strikes Covid-19 first came onto our radar screen in January 2020, when we began hearing reports of severe respiratory illness and deaths in Wuhan, China. As a company deeply invested in infectious disease and vaccine research, we paid close attention. By February it was clear that this virus would spread to many parts of the world, and we knew Pfizer would have to play a pivotal role in stopping it. We had already been working with BioNTech to apply its primary technology, messenger RNA (mRNA), to flu vaccines. Traditionally, making a vaccine starts with growing weakened forms of the virus, which can take months. That’s why it took four years for the mumps vaccine, heralded as one of the fastest ever previously developed, to move from the lab to distribution in the 1960s. But mRNA vaccines are created synthetically, using just the pathogen’s genetic code, which can be done much more quickly. Uğur Şahin and Özlem Türeci, the Turkish husband-and-wife team behind BioNTech, immediately saw how mRNA could be applied to a Covid-19 vaccine and put their team on the case. On March1 they called Kathrin Jansen, our head of vaccine R&D, to ask if we were interested in partnering with them to test the candidates they had already developed, which numbered about 20. Of course we were interested! The only downside was that no mRNA vaccines had ever been approved for clinical use. As we initiated this collaboration, the outbreak spread. On March 11 the World Health Organization declared a pandemic. On March 13, even as we were virtualizing our operations to account for new social-distancing protocols around the world, we released a five-point plan to guide our company and its big-pharma peers in a cooperative effort to defeat the coronavirus. We suggested that we share insights and tools, such as viral screening and other models, along with associated data and analysis; marshal our people, including virologists, biologists, chemists, clinicians, epidemiologists, and other experts; share drug development expertise with smaller biotechs, as we were doing with BioNTech, to help them navigate complex clinical and regulatory processes; offer manufacturing capabilities to any approved therapy or vaccine; and reach out to federal agencies to build a rapid-response team of scientists for future epidemics. Left: Hospital nurses in Italy receive the Pfizer-BioNTech vaccine on December 27, 2020. Right: Vaccine doses are prepared for shipping at a Pfizer manufacturing plant in Portage, Michigan, on December 13, 2020. Left: Piero Cruciatti/AFP via Getty Images; right: Morry Gash/Getty Images On March 16 our top executives met and agreed that it was time to go all in on developing this vaccine with BioNTech—along with treatments for Covid-19—even if that meant spending as much as $3 billion. For context, the typical vaccine development program can take up to 10 years and cost anywhere from $1 billion to more than $2 billion. We did not want our decision to be driven by the need for financial returns alone. Saving lives—as many and as soon as possible—would be our top priority. I pushed to have a vaccine ready by the fall, when cases were expected to spike again. Everyone knew it would be an enormous, perhaps unattainable, task, but we all knew it was one we were obligated to take on. The Work Begins Pfizer signed a letter of intent with BioNTech the next day—a commitment to pair its innovative mRNA technology with our research, regulatory, manufacturing, and distribution capabilities. The financial details would be hashed out later. Time was of the essence. We decided to work on several vaccine candidates in parallel instead of testing the most promising ones in sequence, as was usual. This was financially risky but, again, would generate results more quickly. We also declined government funding, to liberate our scientists from bureaucracy and protect them from unnecessary slowdowns. Our Covid-19 vaccine project group began meeting via Webex on Mondays and Thursdays, but ad hoc meetings were held regularly too. By April 12 we had narrowed the candidates from 20 to four on the basis of molecular signs of efficacy seen in lab cultures and in mice. Normally we would have run tests on larger animals before starting phase one human trials, which involve 20 to 100 participants and typically last several months, but given the urgency, we asked for and received approval from the U.S. Food and Drug Administration and the German regulatory authority, the Paul Ehrlich Institute, to do them simultaneously. The same was granted for our unprecedented request to combine phase two trials (which cover hundreds of subjects and typically last one to three years) and phase three trials (hundreds to thousands over one to four years). On April 23 we began phase one trials. A small number of volunteers in Germany got the first injections, and we began to collect data on the efficacy of each of our four candidates: Did it demonstrate an immune response? Cause any serious side effects? By May we had narrowed our choices to two and begun testing in the United States at varying doses. Early results were promising, and we saw that each candidate would require two injections, three weeks apart, but we couldn’t tell immediately which was the best bet. Finally, on July 23, the day before we’d told the FDA we would decide which vaccine would move to the combined phase two and three trials, we learned that although both seemed to generate a strong immune response, one produced considerably fewer side effects, such as fever and chills. Meanwhile, our manufacturing team, led by Mike McDermott, the president of global supply, was gearing up to deliver tens of thousands of trial doses and hundreds of millions of final doses around the world as soon as the vaccine was ready. Pfizer had never produced an mRNA vaccine before, and it would require new equipment and processes. We purchased new mRNA formulation machines, installed them in plants from Michigan and Massachusetts to Belgium, and came up with novel approaches to accelerate our eventual output—from storage in disposable bags instead of steel tanks to cold transportation and storage solutions. One big wrinkle was the fact that any of the vaccine candidates would have to be stored at subzero temperatures to stay stable and potent. Our engineers started working on a thermal shipping and storage box that could hold thousands of doses for hospitals and health centers and had it ready, complete with a remotely monitored temperature gauge and a GPS tracker, by July. Once we’d settled on our final vaccine candidate, we preemptively began production. We were banking on a successful trial and had 1.5 million doses made, frozen, and ready to ship as early as September. Obviously, if it had failed, we’d have had to throw them all out. Though our scientists and manufacturing teams were working harder than ever to meet the accelerated timetable, and we all faced immense political and personal pressure, we remained clear about one thing: We would move only as fast as the science allowed. During one of my calls with Alex Gorsky, the chairman and CEO of Johnson & Johnson, we agreed to initiate the signing of an industrywide pledge to adhere to rigorous scientific processes and safety standards in our collective search for a Covid-19 vaccine. We decided to engage all the companies that were developing one. I called half of them and Alex called the other half; within 48 hours seven other biopharma companies had signed on. Speed was critical—but not at the expense of scientific rigor. Of course, Pfizer is a massive company, with close to 79,000 employees, a presence in more than 125 countries, and many other concerns besides the Covid-19 vaccine. Some of our other research groups were hard at work on treatments that would ameliorate the effects of the coronavirus. Those initiatives included the development of antiviral compounds and studies on Covid-19’s interaction with pneumonia and the use of azithromycin. While our vaccine group was preoccupied with Covid-19, it continued to work on other debilitating ailments, such as respiratory syncytial virus and meningitis. And although I was devoting about 70% of my time to the pandemic response, we empowered our other five units to keep at their important efforts—and they delivered. For example, our biopharma business increased revenues 7% on an operational basis during the first nine months of the year. Throughout the early fall, data slowly filtered in. We needed to recruit more trial volunteers and go to places where the coronavirus was picking up steam. By November only 94 of the 43,538 people to whom we had administered the vaccine candidate or a placebo had become sick, which triggered the independent review that brought us such good news on November 8. Nearly every person who had come down with Covid was in the placebo group. Those in the vaccine group had been almost completely protected, despite the likelihood that they had also been exposed. Once the data had been presented to regulatory agencies and the vaccine was authorized, the rollout could finally begin. The UK was the first country to authorize the use of our vaccine, and Margaret Keenan got the first dose, on December 8, 2020. The United States followed suit, and Sandra Lindsay was the first American to get the injection, on December 14. There have been hiccups—including challenges in securing raw materials—but we produced 74 million doses and released more than 45 million by the end of 2020, and we are on track to produce more than 2 billion in 2021. Lessons Learned In the insane year that was 2020, what did we learn at Pfizer? First and most important, success is a team effort. Every single person in our company and at BioNTech—from senior executives to manufacturing and transportation staffers—was instrumental in the development of our vaccine. Without the tremendous sacrifices of team members who gave up their weekends and holidays, went months on end without seeing their families, and worked harder and more hours than they ever had before, we never would have succeeded. I am awed by, and immensely grateful for, what all these people have accomplished. Second, it can pay to put purpose first. The positive financial impact for Pfizer of the Covid-19 vaccine became possible only because return on investment was never a consideration. We drove ahead with mission in mind. Still, even if we hadn’t developed an impressively effective vaccine, distributed it as quickly as we did, and earned back our outlay, our decision to do the right thing would have been worth it for me, our employees, and our industry. The private sector has a responsibility to help solve society’s biggest problems. If it doesn’t, none of us have a future. Third, moon-shot challenges that align with the right purpose are galvanizing. When I first suggested a six-month vaccine development timeline, our scientists were incredulous. But they got to work with the BioNTech team and nearly hit that mark. The same was true for our supply group when we tasked its members with finding a way to produce and transport at arctic temperatures millions of doses of a vaccine that had yet to be finalized. They didn’t think they could, but they ultimately found a way to make the impossible possible. Fourth, when you set a huge goal, you must encourage the out-of-the-box thinking required to achieve it. What worked in the past won’t build you a new reality. In the spring of 2020 various teams presented senior leaders and me with multiple ideas for solving particular problems: “One, two, three. This is what has been done before.” We kept asking them for a fourth, fifth, and sixth choice, and creatively, they complied. After a few months it became a habit. People brainstormed new options on their own. I think a fifth key to our success was that we isolated our scientists from financial concerns and freed them from excessive bureaucracy. Our board accepted that this was a high-risk endeavor but understood the significance of success and gave us the leeway to spend as needed. Our people didn’t need to worry about the budget targets we’d set in 2019 or hitting our annual earnings per share expectations. And because we took no money from the U.S. or the German government, we didn’t have to report or explain our decisions, and we were subject to oversight only from the appropriate regulatory authorities. A final lesson is the need to embrace cooperation—especially in a crisis. As I said, our work on Covid-19 with BioNTech began without a final contract. In fact, the terms of that partnership weren’t hammered out until after the year’s end. But investments were made and confidential information shared in March because we already had experience working together, had the same high ethical standards, and were aligned on wanting to move quickly to make a difference. Similarly, I’ve been heartened by the growing information- and expertise-sharing we’ve seen across companies and countries as this pandemic has progressed. If today’s science were simpler, we could all operate independently and make our own bets. But to beat back scourges like Covid-19 and cancer, we need to regard ourselves as contributors to a broad scientific ecosystem and innovation network. The business world can step up and insist on it. Sometimes personal outreach is critical in this regard. In February, when Gilead Sciences was showing some early success with remdesivir treatments in China, I phoned its leader and said that if the company needed access to our large manufacturing capacity in that country, we were ready to help—which we eventually did in the United States. When we and BioNTech needed to persuade a relatively small supplier in Austria to drop everything to make a certain compound critical to our vaccine, Uğur and I flew to talk to the supplier’s CEO face-to-face. We told him this was his chance to help save the world, and he agreed. A Bright Future The pandemic was the ultimate test of the pharmaceutical industry’s credibility and relevance, and in my view, the industry passed with flying colors. Although the public has vilified it in recent years, accusing it of focusing on the wrong products, excessively marketing unnecessary drugs, price gouging, and caring more about sales than about patient support, we have proved that we’re a group of vibrant companies willing and able to mobilize our exceptionally talented workforces and marshal all other resources to solve a life-or-death problem. Dozens of companies have developed effective treatments and vaccines, and more are on the way. We’re now working together to prepare for the next virus or disease. I also see a bright future for Pfizer. Messenger RNA technology is poised to revolutionize vaccines, and we and BioNTech have a competitive edge. Our other business units also continue to thrive. For instance, our inflammation and immunology business has one of the most robust pipelines of targeted JAK inhibitors in the industry; our rare-disease business is pioneering gene therapy with three late-stage programs; and our oncology business has a number of flagship therapies for melanoma and breast and prostate cancer and is working to bring forward the next generation of targeted cancer agents and immunotherapies. The can-do, mission-driven culture at Pfizer will take innovation to new and higher planes. Throughout my career at Pfizer, I’ve seen our people do extraordinary things when motivated. None of us know what we’re capable of until confronted with the most challenging tasks. Our work in 2020 was just the latest and greatest example. So the next time a colleague says that something is impossible, I expect his or her peers to say, “Look at what the Covid-19 vaccine group accomplished. If they could do that, we can do this.”

The CEO of Pfizer on Developing a Vaccine in Record Time

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