Marks dishes on COVID-19 vaccine development at BIO

Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) told a panel at BIO Digital he thinks global regulators will be aligned on the clinical endpoints and design features of Phase 2 and 3 clinical trials for vaccines to prevent coronavirus disease (COVID-19).
Marks also emphasized that FDA is working closely with its colleagues around the world to expedite the development and availability of safe and effective vaccines to address the pandemic.
“We’re very committed to working with our European colleagues and other global regulators to help make sure that as we see developments in the United States that they are able to benefit from the knowledge that we gain,” Marks said, adding that, “This is really a global issue … and until this particular virus is wiped out across the globe, we’re all going to have issues with it.”
Marks’ statements followed a pre-recorded interview with Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, who called the virus his “worst nightmare” due to its rapid transmission and lethality.
“Global regulators will need to collaborate,” Marks said, noting that dozens of regulators and health authorities from around the world have met under the auspices of the International Coalition of Medicines Regulatory Authorities (ICMRA).
“There are a lot of discussions about what success will look like, what will be necessary here, and discussions of issues ranging from what will we need for demonstration of safety and efficacy, what will need to be done to make sustainability of manufacture of these vaccines and how we’ll deal with special populations,” Marks added.
Marks expressed optimism that developers could find success with multiple vaccines. “I truly believe there’s probably room for multiple vaccines here, and if we do things right, we’ll actually figure out that there may be populations that benefit from one vaccine more than another,” he said.
When asked if he thinks there will be any challenges to reaching alignment with other regulators on the endpoints and clinical design features for Phase 2 and 3 trials for vaccines, Marks said, “I actually don’t, in part because it’s such a bad pandemic.”
“For the first vaccines that come down the line, we’re going to be looking at clinical endpoints and I don’t think we’re going to be arguing with the [European Medicines Agency] over [which assay to look at].”
Marks said he doesn’t think regulators will argue over the size of the studies needed, “Because I think we all kind of understand that if you’re going to be thinking about treating hundreds of millions of people with a vaccine, you’re going to want to have safety datasets to start that are reasonably sized, that you’re following people closely, because you may not get another chance – even with real world evidence – to follow people quite that closely.”
“That being said, we are thinking about how we’ll use real world evidence to gather information on people over the longer term as they have these vaccines,” he added.
Marks also stressed that standards should not be dropped, despite the urgent need for a vaccine, so that people will be confident in an eventual vaccine’s safety and efficacy.
“If 30% or 40% of the population will not take this vaccine, even if the vaccine effectiveness is 70% or 80%, we will not be in a position to have herd immunity,” he said.
Marks also acknowledged the possibility of some countries engaging in so-called “vaccine nationalism,” but downplayed the risks.
“Every country – though we say we’re working together – there’s always a little bit behind that we’re going to make sure that our own are taken care of first,” Marks said before adding he thinks it’s “not actually all that big a problem because ultimately … this is a global problem that we all have to address.”

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