US FDA to make emergency use authorization data public for COVID-19 vaccines

FILE PHOTO: Small bottles labelled with “Vaccine” stickers stand near a medical syringe in front of displayed “Coronavirus COVID-19” words in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration

The U.S. Food and Drug Administration said on Tuesday it would make public reviews of all data and information regarding the emergency use authorization (EUA) granted to COVID-19 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.

Hahn said all FDA drug and biological product centers intend, “to the extent appropriate and permitted by law”, to share information about scientific review documents supporting the issuance, revision or revocation of EUAs.

Countries around 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 recognizes 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 said.