As Great Britain becomes the first country to begin vaccinations against COVID-19 using Pfizer/BioNTech’s BNT162b2 vaccine, and as the FDA is widely expected to grant the vaccine authorization this week, The National Herald reached out to Pfizer CEO Albert Bourla with questions on the vaccine’s efficacy, the clinical trials process, and the next steps in the global immunization effort.

The National Herald: BNT162b2 requires two shots, 21 days apart. What is the corresponding jump in antibodies, and can a degree of protection be expected after the initial dose?

Albert Bourla: Right now we have studied the candidate in a two-dose regimen and we saw initial efficacy after the first dose compared the placebo; however, the level of protection we understand is based on two doses. We will be sharing the full data set, including neutralizing antibody levels, in an upcoming peer-reviewed journal publication.

TNH: What protection does BNT162b2 offer against more severe disease from SARS-CoV-2, and against reinfection of those vaccinated following an earlier infection, assuming the need for the latter to be vaccinated? Also, is there evidence that vaccination impedes transmission directly? How long do you expect each of these effects to last?

AB: Analysis of data from our phase 3 trial showed our vaccine to be 95% effective in helping to prevent  COVID-19 at least 28 days after the second dose. During our trial, we observed 170 cases of COVID-19 in those without previous infection. Out of these 170 cases, 162 received placebo and 8 were on the vaccine arm of the trial. There were 10 severe cases of COVID-19 observed in the trial, nine of the cases occurred in the placebo group and one in the BNT162b2 vaccinated group. Immunity after vaccination is a question we continue to explore in our research. The duration of immunity after COVID-19 requires observing a large number of people who have had the disease once until some get it a second time. Because the first known cases of COVID-19 only occurred in December 2019, there hasn’t been enough time to observe a significant number of second illnesses to know the duration of natural protection. Similarly, determining the duration of immunity after immunization will require observing a large number of people who have been immunized with an effective vaccine to see if or when their rates of COVID-19 will start to increase relative to the time of immunization. We will better understand transmission, asymptomatic disease, and the severity of the disease when we have data on protection for those who were previously exposed to SARS-CoV-2 or infected with COVID-19. Our trial will continue to examine those areas to determine the full protection and potential of the vaccine.

TNH: More than 40% of your participants are 56-85 years of age. What about younger ages? Where that is allowed, you are now enrolling participants as young as 12 years old? What was your original sample size for those ages, and what kind of solicited adverse events were observed?

AB: We agree that it is important to study the effect of the vaccine in younger adolescents and children as a broad use of a potential SARS-CoV-2 vaccine is critically important to combat the pandemic in a meaningful way. For some background, in September, we expanded our initial, planned enrollment in the study from 30,000 people to approximately 44,000 people. This allowed us to include additional populations, including people as young as 16 years and people with chronic, stable HIV (human immunodeficiency virus), HCV (Hepatitis C virus), or HBV (Hepatitis B virus). The additional amendment in October enabled us to study adolescents as young as 12. There is growing evidence that younger adolescents can transmit the disease to others. According to a report from the CDC, since March, 277,285 COVID-19 cases in children have been reported. COVID-19 incidence among adolescents aged 12–17 years was approximately twice that in children aged 5–11 years. Underlying conditions were more common among school-aged children with severe outcomes related to COVID-19. Weekly incidence, SARS-CoV-2 test volume, and percentage of tests positive among school-aged children varied over time and by region of the United States. Severe disease caused by SARS-CoV-2 may occur at any age, and early studies show us there is a need for an adolescent and pediatric immunization strategy to better understand severity or burden of the disease. On Friday, November 20 we submitted an emergency use authorization application to the FDA. This application included solicited safety data on approximately 100 children 12-15 years of age.

TNH: How inclusive was your sample of participants in the so-called high-risk groups for severe COVID-19, like those with preexisting diseases such as hypertension, diabetes, pulmonary disease, people receiving immunosuppressive therapy, or HIV-positive individuals?

AB: It was important to us to evaluate the vaccine in as many people with different health conditions as possible. I believe we did this well. Over 50% of enrolled subjects had at least one comorbidity, including people with chronic, stable HIV, Hepatitis C, and Hepatitis B infection. By doing so, we are able to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds which is very important when we are battling a global pandemic.

TNH: Much has been said about the supply chain management (SCM) challenges Pfizer’s vaccine poses, and you have developed many ways to address them. These challenges remain a key part of the balance between the alternative vaccines expected to receive authorization – for example, from Moderna and AstraZeneca. However, these alternatives are unlikely to reach the general population as options, with governments stressing that people will not be able to choose which vaccine they will receive. Given the already established levels of general vaccine hesitation, how, if at all, do you expect people’s lack of a vaccine choice to affect building herd immunity, especially against the absence of a universal vaccination mandate?

AB: It is understandable that some people may have concerns around the COVID vaccines, so we have a responsibility to work alongside governments to address questions and misperceptions from the public and build vaccine confidence. Not only do we need the public to understand the importance of getting vaccinated, but we also want people to understand the rigorous safety standards we have gone through in developing our vaccines.

TNH: Is Pfizer working to develop alternative forms of its vaccine to address the refrigeration requirements, the Cold Chain?

AB: We are always innovating at Pfizer. A decision to start development activities on a next-generation vaccine candidate will depend on many factors, including the performance of the current candidate, the evolution of the virus, the remaining unmet medical need, and the advancements that may be made in research, among others. We’re also considering multiple areas of continued innovation including formulation improvements potentially through lyophilization. This could negate the very low storage temperatures seen today and improve the supply chain. By doing so it could further expand potential points of vaccination and could also benefit last mile transport and storage in emerging markets that don’t always have the cold storage supply chain available.

TNH: Does Pfizer have plans currently to share data from its clinical trials for peer review?

AB: Along with our partner BioNtech, we plan to submit the full safety and efficacy data from our phase 3 trial for peer-review in a scientific journal once the data is analyzed over the next weeks.

TNH: Reports indicate that, initially, about 40 million doses will be available by the end of 2020. How will those be distributed among different countries, and what is your delivery plan for the following months?

AB: We will continue to work tirelessly to ensure our vaccine can be rapidly scaled, deployed, and distributed around the world to put an end to this pandemic. Based on current projections, we expect to produce up to 50 million doses by end of 2020 and 1.3 billion doses in 2021.

TNH: In mid-March, early in Pfizer’s vaccine development process, you presented a five-point plan, where you mentioned “offering [your] manufacturing capabilities” as one of those points. You wrote about “potentially shifting production to support others in rapidly getting … life-saving breakthroughs into the hands of patients as quickly as possible.” Pfizer is now not only one of the largest vaccine manufacturers, but also the company whose vaccine shows the greatest efficacy. With your earlier proposition reversed, and the motivating need still applying, will you be, or have you been, reaching out to others to support your production so that your vaccine reaches more patients “as quickly as possible,” since Pfizer/BioNTech’s capacities alone indicate a timeline stretching into the last quarter of 2021?

AB: It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission date. We have operated at extraordinary speed in our clinical development program from concept to regulatory filing, while always maintaining our focus on safety. We are so proud of our achievements. Our focus now is expanding our manufacturing capacity to ensure as many people as possible across the world receive our vaccine.

TNH: Initially focused on flu vaccines, the Pfizer/BioNTech collaboration started out just two years ago. Now it is proving monumental by any measure. Do you see greater potential for the mRNA drug class, and what diseases might it target primarily?

AB: Our partnership with BioNtech is leveraging decades of scientific expertise in pioneering vaccine discovery and development to respond to global a health crisis. We see great potential with the mRNA technology as mRNA is a pathway for choice for vaccine development given its fast manufacturability, cost-effectiveness, safety profile and flexibility.

TNH: Generally commenting on pricing, you have mentioned it needs to be based on the value of what a Pfizer product brings to society. As the manufacturing cost of a drug can be appraised more objectively than is the value of a human life and its betterment, might the case be more that drug pricing needs to be based on that cost?

AB: This is not business as usual. During the pandemic, instead of using a traditional cost-effectiveness approach, we will price the vaccine in a way that can help governments to ensure that there is little to no out-of-pocket costs for their populations. Broad access to our vaccine is important – speed, safety, and availability are driving us.

TNH: Does Pfizer have plans to participate in the development of the COVAX * facility, and how closely are you working with CEPI?

AB: I am proud to lead a global company that prioritizes patients all over the world. We are in active conversations with GAVI now about potential supply to the COVAX facility and both parties are eager to get a contract in place.

TNH: Pfizer has been planning a research hub in Thessaloniki. You have met with various authority figures, including the Greek PM, members of his cabinet, EU Commission Vice-President Schinas, and U.S. Ambassador Pyatt – the last two of them in Thessaloniki. How is that project moving along? How have you seen Pfizer change Thessaloniki so far, and vice versa?

AB: At Pfizer, we’ve made it a priority to meet the evolving needs of the healthcare industry by increasing our investments in technology, data and digital capabilities and as a result we are expanding our worldwide network of Digital & Technology Hubs. This includes our facility in Thessaloniki. Our Thessaloniki hub will be home to highly technical and specialized digital capabilities, including AI, Advanced Analytics, and Agile Software Development – all of which, ultimately, have the potential to accelerate our scientific discovery and bring breakthroughs to patients more quickly. Our decision to establish a Digital and Innovation Hub in Thessaloniki reflects our belief that both the country and the city meet these requirements. Thessaloniki won the investment for the centre … but it was no surprise to me. I knew that this hub would be extremely successful – I know the quality of the scientists that the Greek universities produce and the warmth with which Greeks, and especially young people, work and want to learn. So, it was no surprise at all that they won.

TNH: How Greek do you still feel after leaving your home country many years ago? What are the persistent features of your heritage in your life? Which have been the most helpful, and which were the ones you did away most easily?

AB: My career at Pfizer has given me the opportunity to see the world. On my journey I have lived in eight different cities in five different countries before my family settled in New York but no matter how many times I move around or where I live, Greece will always be my home. Let's not forget that I lived in Greece into my thirties, so I had a whole life in Greece. I still have all my Greek friends and every summer I return and enjoy meeting up with everyone. I am honored to be Greek and it’s very much a part of who I am. It is a privilege to lead Pfizer at such a pivotal time in our company’s history – and the history of global health in general. I hope, in some small way, it may inspire others to know that they can move around and lead others and still be who they are.

TNH: Do you think Greece is doing well in handling the current wave of the pandemic?

AB: The way Greece has dealt with the pandemic and the fact that it actually stands out as one of the most successful countries in dealing with it, is something that makes me extremely proud. This effort has been discussed a lot internationally – during this dark time, it brings me great joy to read in the press about how well my nation has fared. The thing that has impressed me most is how the people, Government, healthcare professionals have all come together for the greater good. The measures were implemented in a timely manner following the recommendation of the expert scientists’ committee. The Healthcare professionals in the hospitals fought on the forefront of the ‘battle’ against COVID-19, saving the lives of many people. Also, the majority of the citizens showed a responsible social attitude and complied with the measures from day one.

TNH: Marshall Goldsmith is an executive leadership coach and author who has worked with top CEOs across many industries. Among many other things, Goldsmith suggests people keep a list of questions they ask themselves to evaluate how they did in each day. He also says that finding success and making something of it requires different skill sets. How is the pandemic helping you evolve your leadership style, and what initiatives that had not occurred to you before will you be implementing in its wake?

AB: Leading the efforts to develop this vaccine has taught me many important things that I will carry with me on my journey. It has taught me that it is possible to change what is impossible and possible. We started with a brave, moon shot-like goal –to have millions of doses of vaccine in the hands of vulnerable populations before the end of the year. This was unprecedented and we were not sure it was even possible but here we are, only 10 months later where we have just received our first approval by the UK regulators and patients are due to be dosed in the coming days.

Marshall Goldsmith also said “giving yourself a purpose adds clarity to all actions and decisions that follow.”  At Pfizer our purpose is clear – we are here to deliver breakthrough medicines that change patient’s lives. This purpose has been pivotal to our success.

TNH: What are the top three questions you ask yourself at the end of each day about how you did in it? Have they changed much during the past few months?

AB: The key question always on my mind is “what have we done today for patients?” Now more than ever, people are relying on us to deliver these medical breakthroughs. This question was an important driver for me during the pandemic. The world needed solutions and I thought … if not us, then who?

TNH: Your prominence in the business and scientific worlds aside, development of this vaccine makes you a more broadly historical figure. How does it feel to enter the history books like this?

AB: I am humbled by what we have achieved over these last few months. Let me be clear this is a collaborative effort made possible by both Pfizer and BioNtech as well as the many scientists and healthcare professionals around the world who worked with us. Importantly, we must also thank the trial participants who made this all possible. I will always remember the moment when we got our first reading of the efficacy results – it was the most incredible day and is surely a historic day for science.

* COVAX was launched in April 2020 by the World Health Organization, and it works with governments, global health organizations, manufacturers, scientists, the private sector, civil society, and philanthropic institutions to provide global distribution of vaccines. It supports the research, development and manufacturing of a wide range of COVID-19 vaccine candidates, and negotiates their pricing. The COVAX Facility, is a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), and WHO. Gavi-Global Vaccine Alliance is a global partnership of public and private entities, working to increase access to vaccines and immunization in poor countries. CEPI was launched in Davos in 2017 as a global partnership between public, private, philanthropic, and civil society organizations, with the aim of accelerating the development of vaccines against emerging infectious diseases and enable equitable access to these vaccines for people during outbreaks.