On Monday morning, Pfizer announced that its COVID-19 vaccine trial in collaboration with German company BioNTech was 90 percent effective against COVID-19 in participants without prior evidence of SARS-CoV-2 infection in a Phase 3 study. The development was very welcome in the race to a vaccine.
Health Evolution interviewed Peter Honig, MD, SVP & Head of Global Regulatory Affairs and Group Head of Development China and Development Japan at Pfizer about the recent developments, next steps in the vaccine process, when we might see widespread distribution of this vaccine, and more.
Health Evolution: What is the next step in the process for this potential vaccine?
Honig: Pfizer is preparing to submit an EUA [emergency use authorization] application which will go in soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. Subsequently, FDA will convene a Vaccine and Related Products Advisory Committee meeting to discuss the safety and efficacy of the vaccine and likely populations to be indicated under an Emergency Use Authorization. FDA Emergency Use Authorization is anticipated in December.
Health Evolution: If everything goes right, how long will it take for widespread distribution of this vaccine?
Honig: Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Health Evolution: How do you envision vaccines being distributed? Who will get it first? How many will be ready for the first round of distribution? The second? Third? Subsequent rounds?
Honig: If our vaccine candidate is successful, we would allocate the available 2020 doses proportionally across the countries where we have fully executed supply agreements that include delivery of a portion of doses in 2020. The allocation of doses to the appropriate populations within a country is a decision for local governments based on relevant health authority guidance. We are committed to working collaboratively with governments to support the public health need, but believe that front line health care workers, essential workers, immunocompromised individuals, nursing homes, and public safety officials should be prioritized consistent with global public health guidelines.
Health Evolution: We hear a lot about herd immunity. What is the timing for when we might achieve that given the vaccine?
Honig: It is premature to answer that question without knowing additional important information that will be forthcoming such as efficacy in all population cohorts, duration of protection, and other important considerations.
Health Evolution: What does this mean for other, non-Pfizer vaccines? Do you collaborate on your findings?
Pfizer has publicly stated that it would be advantageous to have multiple safe and effective vaccines.
Health Evolution: This is clearly a milestone of sorts, but we are not across the finish line yet. What concerns you the most about work that remains?
Honig: There is much work left to do. We stand by our pledge that we will only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities, such as the FDA. Currently, Pfizer is fully focused on compiling the EUA package to FDA as soon as possible and producing as much vaccine for distribution as possible.
Health Evolution: How should health care CEOs – particularly those outside of life sciences in the payer and provider world – digest this development?
Honig: CEOs and everyone should view this as a triumph of science. This vaccine has the potential to contribute to the end of the pandemic and a reopening of our economies and a return to a normal life. Business leaders should also carefully consider the learnings from COVID-19 that they may want to consider as a durable new normal of running their business including virtual workplaces, telecommuting, digital business practices and others.
Editor’s note: Honig recently joined Wayne Koff, President & CEO, Human Vaccines Project, Peter Marks, MD, Director, Center for Biologics Evaluation and Research, FDA and Greg Poland, MD, Director, Mayo Clinic’s Vaccine Research Group in the Health Evolution Executive Briefing webcast, The Race for a Vaccine: Regulatory Policymaking and Expedited Clinical Trial Innovation. Read more or watch the webcast: With public trust in COVID vaccines fading, CEOs must be trust amplifiers
