FDA to make emergency use authorization data public for COVID-19 vaccines
(Reuters) – 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.