China’s National Medical Products Administration (NMPA) has reportedly revealed its criteria for approving COVID-19 vaccines for use.
According to Fierce Pharma, NMPA has declared its approval threshold for efficacy “preferably” reach 70%, and be at least 50% more effective than placebo. This is higher than that asked for by the US Food and Drugs Administration (FDA), which has set 50% as its own threshold.
Further criteria include demonstrating immunity lasts at least six months, but ideally for a year.
Fierce Pharma said:
“China’s NMPA, in its version, also allows for conditional approval if an interim analysis finds ‘clear and acceptable’ efficacy from an experimental shot before final readouts.”