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FDA Commissioner Stephen Hahn. (REUTERS)
FDA Commissioner Stephen Hahn. (REUTERS)

US to make emergency use authorisation data public for coronavirus vaccines

  • 'Today's transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential Covid vaccines,' FDA Commissioner Stephen Hahn said

Emergency use authorisations, or EUAs, are an important tool in fight against the novel coronavirus pandemic and other public health emergencies.

The US Food and Drug Administration (FDA) on Tuesday said that it would make public reviews of all data and information regarding the EUA granted to coronavirus drugs and vaccines.

"Today's transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential COVID-19 vaccines," FDA Commissioner Stephen Hahn said in a statement.

The FDA Commissioner said that all FDA drug and biological product centres intend, "to the extent appropriate and permitted by law", to share information about scientific review documents supporting the issuance, revision or revocation of EUAs, reports Reuters.

Meanwhile, nations across the world are racing to develop Covid-19 vaccines and treatments, and the rapid pace of development has had doctors and experts concerned about transparency and regulatory reviews.

The FDA said it recognises disclosing such information would also contribute to the public's confidence in the agency's rigorous review of scientific data.

"We will also continue to follow the science and ensure that science remains the driver of the agency's regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health," Hahn added.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

With agency inputs

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