Gabriel Perna | October 14, 2020
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.
Peter Marks, MD, Director, Center for Biologics Evaluation and Research, FDA
No corners being cut
At the FDA, Marks is well aware of the public’s already waning trust in vaccines and said the situation is not ideal. Without referring to specific manufacturer trials, he said that when vaccine trials are put on pause, the FDA is going to have to be even more vigilant in the investigational phase on potential issues.
Marks noted that this is something manufacturers are already collecting, knowing FDA’s requirements. Honig concurred and said the idea of speed equates to cutting corners is misinformed rhetoric.
“We’re expanding enormous amounts of manpower and resources to ensuring we deliver an outcome that FDA and the public can rely on. Some aspects of that include real-time data review and cleanup, daily operational reviews, pharmacovigilance assessments on a daily basis and process auditing in real time,” Honig said.
What’s helped development, he said, was the fact the spiked protein of the coronavirus was cloned in record time, allowing manufacturers to develop RNA sequences for their vaccines. Furthermore, he noted there was significant pre-investment into manufacturing and development resources plus engagement from regulatory authorities both in the U.S. and abroad. All of these factors have accelerated the process.
One thing that complicates the regulatory process is the potential harmonization between the various manufacturers and regulatory authorities across the globe. “We have a number of vaccine candidates in the race, if you will, but a number of us believe it’s not really a race. We need a large number of vaccines to be able to deploy this across the millions, if not billions, of people that will need them,” says Koff.
Honig, who published a paper on the COVID-19 vaccine development process, added that a “winner takes all” scenario for vaccines is unlikely. In other words, the first producer of a vaccine might not be the best and that most public health authorities agree that there will need to be several vaccines to meet the needs of the public.
Marks said that the FDA has worked with regulators in Europe, Japan, Canada, Australia and elsewhere to share information about safety and what efficacy looks like. However, the idea of different regulatory agencies harmonizing EUAs is unlikely, he said, adding that Russia and China have already authorized emergency use of vaccines faster than other countries. “Harmonization comes in the flavor of information exchange so different regulatory authorities are able to make these decisions eyes wide open,” Marks said.
How to improve public confidence
Knowing the persuasive challenges awaiting them when a COVID vaccine is approved, panelists called on health care CEOs and leaders to help spread the message of vaccine safety to the general public.
Honig said CEOs should know that when it comes to vaccine development, speed does not equate to haste and the company is putting a lot of resources into ensuring safety and quality. “These trials will be scrutinized like no other trial in history, not only by FDA but by third parties as well. They’re going to make sure all the I’s are dotted, the T’s are crossed, and that there’s complete data ascertainment and quality,” said Honig.
Poland said he liked the idea of CEOs being trust conveyors. “I construe your job as you don’t want to be behind the science, you don’t want to be in front of the science—you want to understand the science and its limits, and construct policy and comments around that. Think through how to put together an immunization program for the area you lead that is a focal part of your time in that position.”
He also urged CEOs to leave personal feelings aside. “You need to resist the temptation to conflate science with your particular religious or political viewpoints,” Poland said. “Science needs to take the lead here, not politics, economics or religion.”
Marks called on CEOs to use their bully pulpits to help the public regain confidence in vaccines. He said that two separate forces have made people lose faith in them over time. People don’t see how vaccines have eliminated other infectious diseases like smallpox and polio. “These bad things aren’t there because vaccines are so successful,” he said. Also, he said social media is the perfect arena for conspiracy theories that undermine public trust in vaccines.
“We can use everyone’s help regaining people’s confidence in the process. I think the manufacturers have done a great job with their pledges on this. From the FDA’s perspective, we are career scientists who are absolutely devoted to ensuring safety. We just need to all come together because that’s how we’re going to get out of this mess. Yes, therapeutics are great, but nothing will help us climb out of this like a vaccine,” Marks said.