US FDA to Release Emergency Use Authorization Data for COVID-19 Vaccines



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FILE PHOTO: Small vials labeled with “Vaccine” stickers are placed near a medical syringe in front of the words “Coronavirus COVID-19” shown in this illustration taken on April 10, 2020. REUTERS / Dado Ruvic / Illustration

The US Food and Drug Administration said Tuesday it would make public reviews of all data and information regarding the Emergency Use Authorization (US) granted for COVID-19 drugs and vaccines.

“Today’s transparency action is just one of the steps we are taking to ensure public confidence in our US review process for drugs and biologics, especially any potential COVID-19 vaccines,” said the FDA commissioner, Stephen Hahn, in a statement.

Hahn said that all FDA drug and biologics centers intend, “to the extent appropriate and permitted by law,” to share information on scientific review documents that support US issuance, revision or revocation.

Countries around the world are racing to develop COVID-19 vaccines and treatments, and the rapid pace of development has made doctors and experts worry about transparency and regulatory reviews.

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

“We will also continue to follow science and ensure that science remains the engine of the agency’s regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health,” Hahn said.

For more news on the new coronavirus, click here.

What you need to know about the coronavirus.

For more information on COVID-19, call the DOH hotline: (02) 86517800 local 1149/1150.

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