FDA May Authorize Vaccine Before Trials Finish

FDA Commissioner Stephen Hahn stated that the agency might fast track a COVID-19 vaccine if deemed appropriate, granting emergency authorization before phase three trials conclude. He emphasized that this decision would be based on science, not politics, and clarified that emergency authorization differs from full approval, requiring that benefits outweigh risks in a public health emergency. The authorization could be used to vaccinate high-risk groups before trials are complete. Hahn has faced political pressure from President Trump, who accused the FDA of slowing vaccine development to affect his reelection chances.

What is the primary basis for the FDA's decision to fast-track a COVID-19 vaccine?

• Public opinion

• Political influence

• Economic factors

• Scientific and medical data

How does emergency authorization differ from full approval according to Dr. Hahn?

• It requires more clinical trials

• It is based on political decisions

• It is a permanent approval

• It is granted when benefits outweigh risks in emergencies

Why might emergency authorization be granted before clinical trials are complete?

• To meet political deadlines

• To save costs on trials

• To avoid further testing

• To vaccinate high-risk groups sooner

What pressure is Dr. Hahn facing regarding the vaccine approval process?

• Pressure from international organizations

• Pressure from the media

• Pressure from President Trump

• Pressure from the scientific community

What has President Trump claimed about the FDA's vaccine development process?

• It is the fastest in history

• It is fully transparent

• It is being deliberately slowed to affect his reelection

• It is ahead of schedule