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# International Regulators Working on Covid Vaccine: Marks
- URL: https://www.fdaweb.com/international-regulators-working-on-covid-vaccine-marks/
- Published: 2020-06-10T12:00:00.000Z
- Updated: 2026-09-14T16:17:42.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146976

CBER director **Peter Marks** told a Biotechnology Innovation Organization virtual meeting that regulators such as FDA, the European Medicines Agency (EMA), and Health Canada are working together to reach an agreement on how clinical trials should be designed and conducted for coronavirus vaccines. “Because it’s such a bad pandemic, for the 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 EMA over whether it is this assay or that immunoassay,” Marks said, according to a *BioPharmaDive* [report](https://www.biopharmadive.com/news/coronavirus-vaccine-regulators-agreement-bio-marks/579512/?ref=fdaweb.com).

The online newsletter points out that typically vaccines take many years to win approval based on their ability to prevent infections or disease. However, governments are aiming to speed development to limit illness and death from Covid-19 and the economic disruption caused by public health measures intended to curb infections.

Despite the urgency, Marks said FDA and its international counterparts will still want large clinical trials. “I don’t think there’s going to be a lot of arguing about the size of the trials, because I think we all 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,” Marks said. He said that in such trials manufacturers will have to follow people closely because they might not get another chance to evaluate a product’s safety as effectively.

To achieve herd immunity, Marks told the conference, vaccines will need to be highly potent and public health authorities will need to persuade people skeptical of vaccines to receive an injection.

“If 30% or 40% of the population will not take this vaccine, even if the vaccine effectiveness is 70% to 80%, we will not be in a position to have herd immunity,” he said.