A panel of independent experts to the U.S. health regulator will decide on the nature of clinical trials that coronavirus vaccines should go through after receiving U.S. emergency use authorization.
The panel will also deliberate whether during such trials, volunteers should continue to receive placebo – usually a mixture of salt and water – documents posted on the regulator’s website showed on Wednesday. (bit.ly/2Tbdyuy)
The U.S. Food and Drug Administration’s (FDA) experts will also discuss on Thursday the criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead.
“Emergency use authorization will be granted to a vaccine that shows a very good safety profile and efficacy at or around 60% better than placebo, but I don’t think the vaccine trials right now are being run very scientifically,” said Jared Holz, healthcare strategist for brokerage Jefferies.
“Tomorrow’s meeting will serve as a barometer of what the agency will be looking at once clinical trial data is available.”
The FDA has vowed to ensure the safety of COVID-19 vaccines before approving them.
The U.S. government’s efforts to speed development of a COVID-19 vaccine has led to concerns of political interference in the regulatory process at the expense of safety.
The recommendations of the committee will inform the FDA’s decision around approval of a vaccine, although the agency is not required to follow the panel’s advise.