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Over the last seven months, our industry has been working around the clock to combat the COVID-19 virus, including developing potential therapeutics to treat COVID-19 and vaccines to prevent future infections.
Last week, I had the opportunity to connect with Albert Bourla, Chairman & CEO of Pfizer Inc., about the fight against COVID-19.
Stephen Ubl (SU): Pfizer is using a completely different approach to bringing about a potential vaccine, mRNA. Can you talk about what this is and why you feel optimistic the platform will be successful?
Albert Bourla (AB): Let me start by saying that my optimism is fueled by my firm belief that science will win. I believe it will win this battle against COVID-19 much like it is increasingly winning battles against some of the world’s most devastating diseases.
We believe Messenger RNA, or mRNA, vaccines are promising because of their potential for high potency, safe administration, and capacity for rapid development and manufacturing. Unlike conventional vaccines, which can take months to produce by growing weakened forms of the virus, RNA vaccines can be constructed quickly using only the pathogen’s genetic code.
mRNA vaccine candidates carry instructions to the body’s cells to make certain proteins. They work by introducing into the body’s cells the messenger RNA sequence, which codes for, and tells the cell to build, a disease-specific protein of the virus using the cell’s natural processes. Once produced within the cell, the protein is displayed on the outside of the cell and the immune system can then recognize the protein - or antigen - and can build up immunity against it.
With our German partner, BioNTech, we selected a lead mRNA vaccine candidate - BNT162b2 - out of four potential candidates we studied in our Phase 1/2 studies, to advance to late-stage trial. BNT162b2, which has received the FDA’s Fast Track designation, encodes an optimized SARS-Cov-2 full-length spike glycoprotein. It is a nucleoside-modified messenger RNA (modRNA) administered at a 30µg dose level in a 2-dose regimen, three weeks apart. The Phase 2/3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review.
We have reason to feel cautiously optimistic about our vaccine candidate. Preliminary data from our Phase 1/2 studies showed that the vaccine elicited virus-neutralizing antibodies and virus-specific T cells. We have to wait for the results of the Phase 2/3 trial and FDA’s evaluation but, based on the data we have now, we saw that in older adults (65-85 years of age), two 30µg doses of BNT162b2, spaced three weeks apart, elicited an average titer of neutralizing antibodies that was higher than the average in a panel of 38 sera from subjects who had contracted SARS-CoV-2.
SU: Once a vaccine is approved, what is the plan to ramp up production and distribution to quickly get the products to patients?
AB: All of us at Pfizer recognize we have a great opportunity and responsibility to serve patients at this moment in time. I am happy to say that Pfizer already has activated its extensive manufacturing network, including thousands of highly skilled U.S. workers in multiple states and localities, to prepare to produce the COVID-19 vaccine. We are investing at risk to do what it takes to bring as many doses of a vaccine forward as quickly as possible, subject to clinical success and regulatory approval.
We have already taken a number of steps to accelerate the scale-up of manufacturing. We have agreements with key suppliers in place for raw materials and have already placed orders worth hundreds of millions of dollars. We have put two parallel supply chains in place - one in the U.S. and one in Europe - to create a robust supply chain and have the appropriate redundancies. We are modifying facilities and putting plans in place to accelerate the manufacturing of other medicines and vaccines to allow us to divert capacity from other products without impacting their supply. Lastly, we are hiring and training staff in select sites to give our operations the support and flexibility they need.
Pfizer is a proven and reliable multi-national vaccine producer, supplying vaccines to more than 165 countries. Today, Pfizer manufactures more than 200 million vaccine doses yearly, and is one of the largest sterile injectables suppliers in the world, producing more than one billion sterile units per year. Our track record gives us confidence in our ability to quickly scale, manufacture, and distribute large quantities of a potential COVID-19 vaccine, using multiple sites in the U.S. and Europe, subject to the success of our clinical program and regulatory approval or authorization. Pfizer and BioNTech’s combined manufacturing facilities network has the capacity to produce up to 100 million doses globally by end of 2020 and approximately 1.3 billion doses by end of 2021.
To date, Pfizer has entered into agreements with several governments regarding our potential COVID-19 vaccine. We will work with those governments to support distribution to their defined priority groups based on health authority guidelines. We anticipate that points of vaccination will vary but may include hospitals, outpatient clinics, mass community vaccination locations and potentially, large pharmacies.
SU: Can you touch a bit on the collaboration going on between companies to find effective treatments and vaccines for COVID-19?
AB: I am very proud of the unprecedented level of cooperation among industry stakeholders in the fight against COVID-19. We have truly come together as one force to fight one common enemy - the virus. We recognize that no single company will have all the answers, and that we are in a race, not against each other, but against time.
No one vaccine, test, or medicine is likely to be an effective solution to overcoming the tremendous task at hand. The pursuit of promising therapies and vaccines requires a multi-pronged approach with unprecedented collaboration across the health innovation ecosystem - from the academic community, industry partners, policymakers, and regulatory bodies.
At Pfizer, we are proud of the work we are doing with our German partner, BioNTech, on our vaccine development program. We are also proud to manufacture and supply Gilead’s investigational antiviral remdesivir, as one of various manufacturing organizations supporting their efforts to scale up supply of the medicine. Pfizer’s partnership with Gilead is an excellent example of industry members working together to deliver medical solutions. Together, we are more powerful than alone.
SU: We have seen reports that COVID-19 is disproportionately impacting communities of color. Can you describe how you are engaging diverse communities in the vaccine development process?
AB: At Pfizer, we believe that every person deserves to be seen, heard and cared for. It’s why we have identified equity as one of our four core values. As such, we recognize that the global COVID-19 pandemic is an urgent health crisis that disproportionately impacts diverse communities with resultant higher rates of infection, more severe illnesses, hospitalizations, and increased mortality. Together with our partner, BioNTech, we are committed to decreasing health disparities in underrepresented populations through the clinical trial process.
To that end, we have selected many investigator sites in the diverse communities that have been disproportionately affected by COVID-19 so that communities that have been most impacted have the opportunity to participate. We are doing everything we can to ensure that the demographics of our trial population reflect the demographics of the states and communities that have been most impacted by COVID-19.
We are working together with investigator sites, advocacy partners, and the media to raise awareness about the importance of clinical trials. We are providing tools and information to Principal Investigators and clinical trial study sites to help them enhance their recruitment efforts and develop impactful strategies to address local needs.
Lastly, we are working to mitigate barriers unique to the underrepresentation of minority communities. For example, we have developed patient-focused materials in various languages for prospective clinical trial participants explaining what they can expect when participating in the clinical trial. To improve access, we are working with sites that have established community networks and engagement strategies for diverse populations. Additionally, we are partnering with grassroots organizations which are trusted voices to those affected communities and that share Pfizer’s commitment to equity in clinical trial recruitment.
As always, you can stay up-to-date with the work the biopharmaceutical industry is doing to combat COVID-19 here.
Stephen J. Ubl
Stephen J. Ubl is president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents America’s leading biopharmaceutical research companies. The U.S. biopharmaceutical sector directly employs more than 800,000 Americans and invests more than $100 billion in research and development annually – more than any other industry in America.
Ubl leads PhRMA’s work preserving and strengthening a health care and economic environment that encourages medical innovation, new drug discovery and access to life-saving medicines. Ubl is recognized around the world as a leading health care advocate and policy expert who collaborates successfully with diverse stakeholder groups – including patient and physician groups, regulators, public and private payers, and global trade organizations – to help ensure timely patient access to innovative treatments and cures. The New York Times writes, “If anyone can find areas of agreement with the critics, or at least work productively with them, it may be Mr. Ubl. He is more conversant with the intricacies of health policy, and more adept at the politics."
Previously, Ubl served as president and CEO of medical technology association AdvaMed, where he helped facilitate landmark reforms related to the U.S. Food and Drug Administration product review process and Medicare’s coverage and reimbursement of medical technologies. He led the industry’s defense of breakthrough R&D, successfully delaying an innovation-stifling device tax, and, in 2013, was recognized by a leading industry publication as one of 10 people to have a lasting impact on the medical technology industry.
Ubl has worked extensively with patient advocacy organizations in health policy, including longstanding service on the board of the National Health Council, a leading umbrella organization for voluntary health care organizations and has been personally involved with JDRF (formerly known as the Juvenile Diabetes Research Foundation).
He is routinely recognized as one of Washington’s most effective advocates. Ubl has been recognized on Business Insider’s “DC Healthcare Power Players” and Modern Healthcare’s “100 Most Influential People in Healthcare.” He is identified as a top health influencer by Medical Marketing & Media and PR Week magazines.
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