Radha Rangarajan, CSO of a medical devices company, and healthcare journalist Sujata Srinivasan, interviewed Advait Badkar, a Senior Director in Pfizer’s Drug Product Design and Development organization. Badkar is leading the efforts on the Pfizer-BioNTech COVID-19 vaccine program with respect to the formulation and process development, scale-up, technology transfer, and registration across global markets. The team Badkar heads specializes in novel delivery technologies with emphasis and expertise in nanoparticle-based modalities.
IC: Are there any differences in immunogenicity in subpopulations?
Pfizer and BioNTech’s Phase 3 clinical trial data demonstrated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Efficacy was consistent across age, gender, race, and ethnicity demographics.
IC: Participants enrolled in Pfizer’s clinical trials were known not to have been infected previously with COVID-19, for obvious reasons. But now that the vaccine is publicly available, it is not possible to test every person before vaccinating. In India, 70%-80% of people have the asymptomatic disease and are unaware of their COVID-19 status. Are any studies planned to assess the safety and efficacy of the vaccine in previously exposed populations?
Yes. 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.
We will better understand transmission when we have data on protection for those who were previously exposed to SARS-CoV-2 or infected with COVID-19, asymptomatic disease and severity of the disease. Our trial will continue to study those areas to determine the full protection and potential of the vaccine.
IC: Even though the science behind mRNA vaccine is not new, some fear that it might alter the genetic makeup, or cause other irreversible side effects. How is Pfizer’s outreach arm dispelling these myths?
There is no evidence to support that notion. To the contrary, the mRNA platform is well suited for a pandemic response on many levels.
First, one aspect of safety – unlike some conventional vaccines, mRNA vaccines are non-infectious, and there is no need for a viral vector to deliver the mRNA vaccine. Second, because no viral vector is used, mRNA vaccines pose no risk of an anti-vector neutralizing antibody response, thereby permitting repeated boosting, which may be important if additional vaccinations are recommended in the future. Third, speed, mRNA technology enables rapid development if the vaccine needs to quickly adapt to potential mutations. mRNA vaccines have an efficient, fast production process, without the need for complex mammalian cell systems.
IC: Is there any plan to simplify the vaccination protocol to one dose?
No. Pfizer and BioNTech’s Phase 3 study for the COVID-19 vaccine was designed to evaluate the vaccine’s safety and efficacy following a 2-dose schedule, separated by 21 days. The study concluded that the two doses are required to provide the maximum protection against the disease, a vaccine efficacy of 95 percent.
IC: What are your thoughts on how to choose between the different vaccines?
At Pfizer, we understand that mitigating this global pandemic will require more than one vaccine and more than one company’s efforts. In March of 2020, Pfizer announced a 5-point plan calling on the biopharmaceutical industry to join the company in committing to an unprecedented level of collaboration to combat COVID-19. The industry responded. We are rooting for each other’s success and are confident that science will win.
IC: What is the plan for a global supply? How will these be administered?
Pfizer and BioNTech are firmly committed to equitable and affordable access for its COVID-19 vaccine for people around the world. That commitment includes the allocation of doses for supply to low-income countries at a not-for-profit price. We are actively working with governments all around the world, as well as with global health partners to work towards fair and equitable access to our vaccine. We are also partnering with global health stakeholders to provide expertise and resources that can strengthen healthcare systems where greater support may be needed to deploy COVID-19 vaccines.
Radha Rangarajan, Ph.D., is Chief Scientific Officer at HealthCubed Inc., a medical devices company. Prior to this, she was the founder and CEO of Vitas Pharma, a drug discovery and development company focused on novel drugs to treat multidrug-resistant infections. Radha has also worked in the Drug Discovery division of Dr. Reddy’s Laboratories. She received her bachelor’s degree from Stanford University, her Ph.D. from Rockefeller University, and was a postdoctoral fellow at the Harvard School of Public Health before moving back to India in 2003.
Sujata Srinivasan is an award-winning, independent business and healthcare journalist with the nonprofit Connecticut Health Investigative Team, whose grant-funded, data-driven reporting is carried by media outlets statewide. Previously, she was the Connecticut correspondent for Crain’s Business, business reporter at NPR’s regional station WNPR, U.S. correspondent for the Indian edition of Forbes, editor of Connecticut Business Magazine, and Interim Chief of Bureau at CNBC-TV 18, Chennai, India. You can follow her on Twitter @SujataSrini