US FDA panel to discuss COVID-19 vaccine trials after emergency authorisation
The panel will deliberate whether during trials, volunteers should continue to receive placebo – usually a mixture of salt and water
A panel of independent experts to the US health regulator will decide on the nature of clinical trials that coronavirus vaccines should go through after receiving US emergency use authorisation.
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. The US Food and Drug Administration’s (FDA) experts will also discuss on the criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead.
“Emergency use authorisation will be granted to a vaccine that shows a very good safety profile and efficacy at or around 60 per cent 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.
The FDA has vowed to ensure the safety of COVID-19 vaccines before approving them.
The US 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 advice.
