Executives from AstraZeneca, Johnson & Johnson, Merck & Co., Moderna and Pfizer told the US Congress that the FDA has not eased its requirements for proving their coronavirus vaccines are safe and effective, reported CNBC.
"I think the guidelines the FDA have issued are absolutely to the normal standards and I think that if we are able to meet them, we will have a safe and efficacious vaccine," Mene Pangalos, AstraZeneca's head of BioPharmaceuticals R&D, said during a hearing with the US House Energy and Commerce Committee on efforts to create a vaccine.
"There's nothing that gives me pause that they’re lowering their standards in any way," he added.
Julie Gerberding, chief patient officer at Merck, emphasized that there are still some safety concerns that scientists have to watch out for, including "enhancement of the respiratory disease under this kind of immunologic pressure."
"I think while we are fully prepared to move as quickly as we can through the things we can do in parallel, and gearing up for manufacturing now at-risk, we do not expect to be able to accelerate the safety assessment," she said.
"In fact, we're quite relieved the FDA insisted upon applying the same high standards of safety and efficacy even under these emergency conditions and that they would apply to any of the vaccines that we've" produced in the past, Gerberding added.
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