When it comes to the development and distribution of a COVID-19 vaccine, the health care industry has a lot of work to do in gaining the public’s trust. According to a recent survey from Pew Research Center, only half of Americans say they would take a vaccine if one were available—down from 72 percent of those surveyed in May 2020.
This is where health care CEOs can play a role.
“My plea is that CEOs are trust amplifiers for us. FDA is maintaining objectivity. It’s a science-based organization that has put out clear criteria of their expectations in the context of a global public health crisis. The companies that are pursuing a solution have issued a pledge to follow the science, follow the FDA’s guidance and are doing the best we can to make sure this is an objective, science-driven assessment,” said Peter Honig, MD, SVP & Head of Global Regulatory Affairs and Group Head of Development China and Development Japan, Pfizer.
“Everyone’s reputation is a stake. Pfizer’s reputation and FDA’s as well. It’s going to be a pyrrhic victory to have a safe and effective vaccine if we don’t have trust of the public. We need to rely on health care leaders to be trust amplifiers,” he added. His comments come as two major vaccine trials—from Johnson & Johnson and Eli Lilly—were paused due to safety concerns.
Honig was joined by 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.
The four experts discussed how regulatory and manufacturer protocols are balancing the speed of development with importance of maintaining safety precautions, what CEOs can do to help regain public trust in vaccines and more.
Speed AND safety
FDA’s Marks began the discussion with clarification on emergency use authorization (EUA) and whether or not that pathway could be used for making a vaccine availalble. He said that while an EUA has been used for therapeutics, an EUA would not likely be applied in the same way for a vaccine that will be used as a prophylactic for millions of healthy people.
“We’ll want to see data like something that we might use for a Biologics License Application. This is data from a well-designed, phase three clinical trial that shows clear and compelling efficacy of the vaccine,” said Marks. If an EUA is used, he said, an advisory committee meeting will review the case and broadcast it to the public.
Marks said that the floor for FDA is at least 50 percent efficacy above a placebo of a vaccine in a trial, but obviously they are shooting for higher levels than that. Mayo Clinic’s Poland sees efficacy levels as a sliding scale. A 50 percent effective vaccine taken by 100 percent of the population goes a long way toward achieving herd immunity, compared to a 90 percent effective vaccine taken by only 10 percent of the population. The challenge will be to get vaccines as efficacious as possible, while being acceptable to the largest number of people in a timely manner that does not neglect safety protocols.
“I published an article called Tortoises, hares, and vaccines: A cautionary note. The idea being fables are fables because they encapsulate a truth. And the truth here is that the race is not always to the swiftest. In the short to midterm, there is an irresolvable tension between speed and safety. You’re trying to balance the cost and consequences of a pandemic against the early release of a vaccine,” said Poland. He warned that a misstep in vaccine development will cause a setback in vaccine confidence for a long time.
