Top US drug authority floats skipping standard testing milestone for COVID vaccines

“It is up to the [vaccine developer] to apply for authorization or approval,’ said the head of the U.S. Food and Drug Administration, ‘and we make an adjudication of their application. If they do that before the end of Phase Three, we may find that appropriate.’
Mon Aug 31, 2020 – 11:43 am EST

WASHINGTON, D.C., August 31, 2020 (LifeSiteNews) — The head of the U.S. Food and Drug Administration (FDA) has indicated that his agency is willing to skip critical Phase III testing for potential COVID-19 vaccines, raising concerns about the safety of the final product.

In an interview with the Financial Times on Sunday, FDA commissioner Stephen Hahn said, “It is up to the sponsor [vaccine developer] to apply for authorisation or approval, and we make an adjudication of their application. If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

According to the Centers for Disease Control and Prevention (CDC), vaccine trials involve three phases, with a fourth sometimes added after the vaccine has already been approved.

“During Phase I, small groups of people receive the trial vaccine,” the government agency explains on its website. “In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.”

Phase IV would comprise ongoing studies.

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