Reports: China sets-out rules for vaccine approval

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.”

Information is not available in English from the NMPA at time of publishing. Find out more in the Fierce Pharma article, or in Chinese from the NMPA website.

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Published on 18. August 2020 in Interesting Reads, News